Aripiprazole Zentiva
1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 5 mg tablets 
Aripiprazole Zentiva 10 mg tablets 
Aripiprazole Zentiva 15 mg tablets 
Aripiprazole Zentiva 30 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Aripiprazole Zentiva 5 mg tablets 
 
Each tablet contains 5 mg of aripiprazole. 
 
Excipient with known effect 
 
Each tablet contains 33 mg of lactose (as monohydrate). 
 
Aripiprazole Zentiva 10 mg tablets 
 
Each tablet contains 10 mg of aripiprazole. 
 
Excipient with known effect 
 
Each tablet contains 66 mg of lactose (as monohydrate). 
 
Aripiprazole Zentiva 15 mg tablets 
 
Each tablet contains 15 mg of aripiprazole. 
 
Excipient with known effect 
 
Each tablet contains 99 mg of lactose (as monohydrate). 
 
Aripiprazole Zentiva 30 mg tablets 
 
Each tablet contains 30 mg of aripiprazole. 
 
Excipient with known effect 
 
Each tablet contains 198 mg of lactose (as monohydrate). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet 
 
Aripiprazole Zentiva 5 mg tablets 
 
White to off-white round flat bevel edged uncoated tablets with ‘5’ debossed on one side and plain 
on the other side with diameter approx. 6 mm. 



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Aripiprazole Zentiva 10 mg tablets 
 
White to off-white round uncoated tablets with ‘10’ debossed on one side and snap tab breakline 
on the other side with diameter approx. 8 mm. 
The score line is not intended for breaking the tablet. 
 
Aripiprazole Zentiva 15 mg tablets 
 
White to off-white round flat bevel edged uncoated tablets with ‘15’ debossed on one side and plain 
on the other side with diameter approx. 8.8 mm. 
 
Aripiprazole Zentiva 30 mg tablets 
 
White to off-white capsule shaped uncoated tablets with ‘30’ debossed on one side and snap tab 
breakline on the other side with dimensions approx. 15.5 x 8 mm. 
The score line is not intended for breaking the tablet. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 
15 years and older. 
 
Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I 
Disorder and for the prevention of a new manic episode in adults who experienced predominantly 
manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1). 
 
Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic 
episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1). 
 
4.2 Posology and method of administration 
 
Posology 
 
Adults 
 
Schizophrenia 
The recommended starting dose for Aripiprazole Zentiva is 10 or 15 mg/day with a maintenance dose 
of 15 mg/day administered on a once-a-day schedule without regard to meals. 
 
Aripiprazole Zentiva is effective in a dose range of 10 to 30 mg/day. Enhanced efficacy at doses 
higher than a daily dose of 15 mg has not been demonstrated although individual patients may benefit 
from a higher dose. The maximum daily dose should not exceed 30 mg. 
 
Manic episodes in Bipolar I Disorder 
The recommended starting dose for Aripiprazole Zentiva is 15 mg administered on a once-a-day 
schedule without regard to meals as monotherapy or combination therapy (see section 5.1). Some 
patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg. 
 



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Recurrence prevention of manic episodes in Bipolar I Disorder 
For preventing recurrence of manic episodes in patients, who have been receiving aripiprazole 
as monotherapy or combination therapy, continue therapy at the same dose. Adjustments of daily 
dosage, including dose reduction should be considered on the basis of clinical status. 
 
Paediatric population 
 
Schizophrenia in adolescents aged 15 years and older 
The recommended dose for Aripiprazole Zentiva is 10 mg/day administered on a once-a-day schedule 
without regard to meals. Treatment should be initiated at 2 mg (using an appropriate aripiprazole 
containing medicinal product) for 2 days, titrated to 5 mg for 2 additional days to reach 
the recommended daily dose of 10 mg. When appropriate, subsequent dose increases should 
be administered in 5 mg increments without exceeding the maximum daily dose of 30 mg (see section 
5.1). 
 
Aripiprazole Zentiva is effective in a dose range of 10 to 30 mg/day. Enhanced efficacy at doses 
higher than a daily dose of 10 mg has not been demonstrated although individual patients may benefit 
from a higher dose. 
 
Aripiprazole Zentiva is not recommended for use in patients with schizophrenia below 15 years of age 
due to insufficient data on safety and efficacy (see sections 4.8 and 5.1). 
 
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older 
The recommended dose for Aripiprazole Zentiva is 10 mg/day administered on a once-a-day schedule 
without regard to meals. Treatment should be initiated at 2 mg (using an appropriate aripiprazole 
containing medicinal product) for 2 days, titrated to 5 mg for 2 additional days to reach 
the recommended daily dose of 10 mg. 
 
The treatment duration should be the minimum necessary for symptom control and must not exceed 12 
weeks. Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated, and a 
daily dose of 30 mg is associated with a substantially higher incidence of significant adverse reactions 
including EPS related events, somnolence, fatigue and weight gain (see section 4.8). Doses higher than 
10 mg/day should therefore only be used in exceptional cases and with close clinical monitoring (see 
sections 4.4, 4.8 and 5.1). 
 
Younger patients are at increased risk of experiencing adverse events associated with aripiprazole. 
Therefore, Aripiprazole Zentiva is not recommended for use in patients below 13 years of age 
(see sections 4.8 and 5.1). 
 
Irritability associated with autistic disorder 
The safety and efficacy of aripiprazole in children and adolescents aged below 18 years have not yet 
been established. Currently available data are described in section 5.1 but no recommendation 
on a posology can be made. 
 
Tics associated with Tourette’s disorder 
The safety and efficacy of aripiprazole in children and adolescents 6 to 18 years of age have not yet 
been established. Currently available data are described in section 5.1 but no recommendation 
on a posology can be made. 
 



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Special populations 
 
Hepatic impairment 
No dosage adjustment is required for patients with mild to moderate hepatic impairment. In patients 
with severe hepatic impairment, the data available are insufficient to establish recommendations. 
In these patients dosing should be managed cautiously. However, the maximum daily dose of 30 mg 
should be used with caution in patients with severe hepatic impairment (see section 5.2). 
 
Renal impairment 
No dosage adjustment is required in patients with renal impairment. 
 
Elderly 
The safety and efficacy of aripiprazole in the treatment of schizophrenia or manic episodes in Bipolar I 
Disorder in patients aged 65 years and older has not been established. Owing to the greater sensitivity 
of this population, a lower starting dose should be considered when clinical factors warrant (see 
section 4.4). 
 
Gender 
No dosage adjustment is required for female patients as compared to male patients (see section 5.2). 
 
Smoking status 
According to the metabolic pathway of aripiprazole no dosage adjustment is required for smokers 
(see section 4.5). 
 
Dose adjustments due to interactions 
When concomitant administration of strong CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, 
the aripiprazole dose should be reduced. When the CYP3A4 or CYP2D6 inhibitor is withdrawn from 
the combination therapy, aripiprazole dose should then be increased (see section 4.5). 
When concomitant administration of strong CYP3A4 inducers with aripiprazole occurs, 
the aripiprazole dose should be increased. When the CYP3A4 inducer is withdrawn from 
the combination therapy, the aripiprazole dose should then be reduced to the recommended dose 
(see section 4.5). 
 
Method of administration 
 
Aripiprazole Zentiva is for oral use. 
 
Orodispersible tablets may be used as an alternative to Aripiprazole Zentiva tablets for patients who 
have difficulty swallowing Aripiprazole Zentiva tablets (see section 5.2). 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
During antipsychotic treatment, improvement in the patient’s clinical condition may take several days 
to some weeks. Patients should be closely monitored throughout this period. 
 



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Suicidality 
 
The occurrence of suicidal behaviour is inherent in psychotic illnesses and mood disorders and 
in some cases has been reported early after initiation or switch of antipsychotic treatment, including 
treatment with aripiprazole (see section 4.8). Close supervision of high-risk patients should 
accompany antipsychotic treatment. 
 
Cardiovascular disorders 
 
Aripiprazole should be used with caution in patients with known cardiovascular disease (history 
of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), 
cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, 
hypovolemia, and treatment with antihypertensive medicinal products) or hypertension, including 
accelerated or malignant. 
 
Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products. 
Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible 
risk factors for VTE should be identified before and during treatment with aripiprazole and preventive 
measures undertaken. 
 
QT prolongation 
 
In clinical trials of aripiprazole, the incidence of QT prolongation was comparable to placebo. 
Aripiprazole should be used with caution in patients with a family history of QT prolongation 
(see section 4.8). 
 
Tardive dyskinesia 
 
In clinical trials of one year or less duration, there were uncommon reports of treatment emergent 
dyskinesia during treatment with aripiprazole. If signs and symptoms of tardive dyskinesia appear 
in a patient on aripiprazole, dose reduction or discontinuation should be considered (see section 4.8). 
These symptoms can temporally deteriorate or can even arise after discontinuation of treatment. 
 
Other extrapyramidal symptoms 
 
In paediatric clinical trials of aripiprazole akathisia and Parkinsonism were observed. If signs and 
symptoms of other EPS appear in a patient taking aripiprazole, dose reduction and close clinical 
monitoring should be considered. 
 
Neuroleptic Malignant Syndrome (NMS) 
 
NMS is a potentially fatal symptom complex associated with antipsychotics. In clinical trials, rare 
cases of NMS were reported during treatment with aripiprazole. Clinical manifestations of NMS are 
hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular 
pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may 
include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. 
However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with 
NMS, have also been reported. If a patient develops signs and symptoms indicative of NMS, 
or presents with unexplained high fever without additional clinical manifestations of NMS, 
all antipsychotics, including aripiprazole, must be discontinued. 
 



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Seizure 
 
In clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole. 
Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder 
or have conditions associated with seizures (see section 4.8). 
 
Elderly patients with dementia-related psychosis 
 
Increased mortality 
In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 56 – 99 years) of aripiprazole 
in elderly patients with psychosis associated with Alzheimerʼs disease, patients treated with 
aripiprazole were at increased risk of death compared to placebo. The rate of death in aripiprazole-
treated patients was 3.5% compared to 1.7% in the placebo group. Although the causes of deaths were 
varied, most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) 
or infectious (e.g. pneumonia) in nature (see section 4.8). 
 
Cerebrovascular adverse reactions 
In the same trials, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including 
fatalities, were reported in patients (mean age: 84 years; range: 78 – 88 years). Overall, 1.3% 
of aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6% 
of placebo-treated patients in these trials. This difference was not statistically significant. However, 
in one of these trials, a fixed-dose trial, there was a significant dose response relationship 
for cerebrovascular adverse reactions in patients treated with aripiprazole (see section 4.8). 
Aripiprazole is not indicated for the treatment of patients with dementia-related psychosis. 
 
Hyperglycaemia and diabetes mellitus 
 
Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma 
or death, has been reported in patients treated with atypical antipsychotics, including aripiprazole. Risk 
factors that may predispose patients to severe complications include obesity and family history of 
diabetes. In clinical trials with aripiprazole, there were no significant differences in the incidence rates 
of hyperglycaemia-related adverse reactions (including diabetes) or in abnormal glycaemia laboratory 
values compared to placebo. Precise risk estimates for hyperglycaemia-related adverse reactions in 
patients treated with aripiprazole and with other atypical antipsychotics are not available to allow 
direct comparisons. Patients treated with any antipsychotic, including aripiprazole, should be observed 
for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) 
and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored 
regularly for worsening of glucose control (see section 4.8). 
 
Hypersensitivity 
 
Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole 
(see section 4.8). 
 
Weight gain 
 
Weight gain is commonly seen in schizophrenic and bipolar mania patients due to co-morbidities, 
use of antipsychotics known to cause weight gain, poorly managed life-style, and might lead to severe 
complications. Weight gain has been reported post-marketing among patients prescribed aripiprazole. 
When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid 
disorder or pituitary adenoma. In clinical trials aripiprazole has not been shown to induce clinically 



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relevant weight gain in adults (see section 5.1). In clinical trials of adolescent patients with bipolar 
mania, aripiprazole has been shown to be associated with weight gain after 4 weeks of treatment. 
Weight gain should be monitored in adolescent patients with bipolar mania. If weight gain is clinically 
significant, dose reduction should be considered (see section 4.8). 
 
Dysphagia 
 
Oesophageal dysmotility and aspiration have been associated with the use of antipsychotics, including 
aripiprazole. Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia. 
 
Pathological gambling and other impulse control disorders 
 
Patients can experience increased urges, particularly for gambling, and the inability to control these 
urges while taking aripiprazole. Other urges, reported, include: increased sexual urges, compulsive 
shopping, binge or compulsive eating, and other impulsive and compulsive behaviours. It is important 
for prescribers to ask patients or their caregivers specifically about the development of new 
or increased gambling urges, sexual urges, compulsive shopping, binge or compulsive eating, or other 
urges while being treated with aripiprazole. It should be noted that impulse-control symptoms can 
be associated with the underlying disorder; however, in some cases, urges were reported to have 
stopped when the dose was reduced or the medication was discontinued. Impulse control disorders 
may result in harm to the patient and others if not recognised. Consider dose reduction or stopping 
the medication if a patient develops such urges while taking aripiprazole (see section 4.8). 
 
Patients with attention deficit hyperactivity disorder (ADHD) comorbidity 
 
Despite the high comorbidity frequency of Bipolar I Disorder and ADHD, very limited safety data are 
available on concomitant use of aripiprazole and stimulants; therefore, extreme caution should 
be taken when these medicinal products are co-administered. 
 
Falls 
 
Aripiprazole may cause somnolence, postural hypotension, motor and sensory instability, which may 
lead to falls. Caution should be taken when treating patients at higher risk, and a lower starting dose 
should be considered (e.g., elderly or debilitated patients; see section 4.2). 
 
Lactose 
 
Aripiprazole Zentiva tablets contain lactose. Patients with rare hereditary problems of galactose 
intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
 
Sodium 
 
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect 
of certain antihypertensive medicinal products. 
 



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Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole 
is administered in combination with alcohol or other CNS medicinal products with overlapping 
adverse reactions such as sedation (see section 4.8). 
 
If aripiprazole is administered concomitantly with medicinal products known to cause QT 
prolongation or electrolyte imbalance, caution should be used. 
 
Potential for other medicinal products to affect aripiprazole 
 
A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this 
effect is deemed not clinically relevant. 
 
Aripiprazole is metabolised by multiple pathways involving the CYP2D6 and CYP3A4 enzymes but 
not CYP1A enzymes. Thus, no dosage adjustment is required for smokers. 
 
Quinidine and other CYP2D6 inhibitors 
In a clinical trial in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole 
AUC by 107%, while Cmax was unchanged. The AUC and Cmax of dehydro-aripiprazole, the active 
metabolite, decreased by 32% and 47%, respectively. Aripiprazole dose should be reduced 
to approximately one-half of its prescribed dose when concomitant administration of aripiprazole with 
quinidine occurs. Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may 
be expected to have similar effects and similar dose reductions should therefore be applied. 
 
Ketoconazole and other CYP3A4 inhibitors 
In a clinical trial in healthy subjects, a strong inhibitor of CYP3A4 (ketoconazole) increased 
aripiprazole AUC and Cmax by 63% and 37%, respectively. The AUC and Cmax of dehydro-aripiprazole 
increased by 77% and 43%, respectively. In CYP2D6 poor metabolisers, concomitant use of strong 
inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that 
in CYP2D6 extensive metabolizers. When considering concomitant administration of ketoconazole 
or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential 
risks to the patient. When concomitant administration of ketoconazole with aripiprazole occurs, 
aripiprazole dose should be reduced to approximately one-half of its prescribed dose. Other strong 
inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors, may be expected to have 
similar effects and similar dose reductions should therefore be applied (see section 4.2). 
 
Upon discontinuation of the CYP2D6 or CYP3A4 inhibitor, the dosage of aripiprazole should 
be increased to the level prior to the initiation of the concomitant therapy. 
 
When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. escitalopram) are used 
concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may 
be expected. 
 
Carbamazepine and other CYP3A4 inducers 
Following concomitant administration of carbamazepine, a strong inducer of CYP3A4, and oral 
aripiprazole to patients with schizophrenia or schizoaffective disorder, the geometric means of Cmax 
and AUC for aripiprazole were 68% and 73% lower, respectively, compared to when aripiprazole 
(30 mg) was administered alone. Similarly, for dehydro-aripiprazole the geometric means of Cmax and 
AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those 
following treatment with aripiprazole alone. 
 
Aripiprazole dose should be doubled when concomitant administration of aripiprazole occurs with 
carbamazepine. Concomitant administration of aripiprazole and other inducers of CYP3A4 (such 
as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John’s 



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Wort) may be expected to have similar effects and similar dose increases should therefore be applied. 
Upon discontinuation of strong CYP3A4 inducers, the dosage of aripiprazole should be reduced 
to the recommended dose. 
 
Valproate and lithium 
When either valproate or lithium was administered concomitantly with aripiprazole, there was 
no clinically significant change in aripiprazole concentrations and therefore no dose adjustment 
is necessary when either valproate or lithium is administered with aripiprazole. 
 
Potential for aripiprazole to affect other medicinal products 
 
In clinical studies, 10 – 30 mg/day doses of aripiprazole had no significant effect on the metabolism 
of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), 
CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan). Additionally, aripiprazole and dehydro-
aripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro. Thus, 
aripiprazole is unlikely to cause clinically important medicinal product interactions mediated by these 
enzymes. 
 
When aripiprazole was administered concomitantly with either valproate, lithium or lamotrigine, there 
was no clinically important change in valproate, lithium or lamotrigine concentrations. 
 
Serotonin syndrome 
Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and 
symptoms for this condition can occur especially in cases of concomitant use with other serotonergic 
medicinal products, such as selective serotonin reuptake inhibitor/selective serotonin noradrenalin 
reuptake inhibitor (SSRI/SNRI), or with medicinal products that are known to increase aripiprazole 
concentrations (see section 4.8). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no adequate and well-controlled trials of aripiprazole in pregnant women. Congenital 
anomalies have been reported; however, causal relationship with aripiprazole could not be established. 
Animal studies could not exclude potential developmental toxicity (see section 5.3). Patients must be 
advised to notify their physician if they become pregnant or intend to become pregnant during 
treatment with aripiprazole. Due to insufficient safety information in humans and concerns raised by 
animal reproductive studies, this medicinal product should not be used in pregnancy unless the 
expected benefit clearly justifies the potential risk to the foetus. 
 
Newborn infants exposed to antipsychotics (including aripiprazole) during the third trimester 
of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms 
that may vary in severity and duration following delivery. There have been reports of agitation, 
hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, 
newborn infants should be monitored carefully (see section 4.8). 
 
Breast-feeding 
 
Aripiprazole/metabolites are excreted in human milk.A decision must be made whether to discontinue 
breast-feeding or to discontinue/abstain from aripiprazole therapy taking into account the benefit 
of breast-feeding for the child and the benefit of therapy for the woman. 
 



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Fertility 
 
Aripiprazole did not impair fertility based on data from reproductive toxicity studies. 
 
4.7 Effects on ability to drive and use machines 
 
Aripiprazole has minor to moderate influence on the ability to drive and use machines due to potential 
nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred, diplopia (see 
section 4.8). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most commonly reported adverse reactions in placebo-controlled trials were akathisia and nausea 
each occurring in more than 3% of patients treated with oral aripiprazole. 
 
Tabulated list of adverse reactions 
 
The incidences of the Adverse Drug Reactions (ADRs) associated with aripiprazole therapy are 
tabulated below. The table is based on adverse events reported during clinical trials and/or post-
marketing use. 
 
All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 
to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) 
and not known (cannot be estimated from the available data). Within each frequency grouping, 
adverse reactions are presented in order of decreasing seriousness. 
 
The frequency of adverse reactions reported during post-marketing use cannot be determined as they 
are derived from spontaneous reports. Consequently, the frequency of these adverse events is qualified 
as “not known”. 
 

 Common Uncommon Not known 
Blood and lymphatic 
system disorders 

  Leukopenia 
Neutropenia 
Thrombocytopenia 

Immune system 
disorders 

  Allergic reaction 
(e.g. anaphylactic reaction, 
angioedema including 
swollen tongue, tongue 
oedema, face oedema, 
pruritus allergic, or urticaria) 

Endocrine disorders  Hyperprolactinaemia Diabetic hyperosmolar coma 
Diabetic ketoacidosis 

Metabolism and 
nutrition disorders 

Diabetes mellitus Hyperglycaemia Hyponatremia 
Anorexia 

Psychiatric disorders Insomnia 
Anxiety 
Restlessness 

Depression 
Hypersexuality 

Suicide attempt, suicidal 
ideation and completed 
suicide (see section 4.4) 
Pathological gambling 
Impulse-control disorders 
Binge eating 



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 Common Uncommon Not known 
Compulsive shopping 
Poriomania 
Aggression 
Agitation 
Nervousness 

Nervous system 
disorders 

Akathisia 
Extrapyramidal 
disorder 
Tremor 
Headache 
Sedation 
Somnolence 
Dizziness 

Tardive dyskinesia 
Dystonia 

Neuroleptic Malignant 
Syndrome 
Grand mal convulsion 
Serotonin syndrome 
Speech disorder 

Eye disorders Vision blurred Diplopia  
Photophobia 

Oculogyric crisis 

Cardiac disorders  Tachycardia Sudden unexplained death 
Torsades de pointes 
Ventricular arrhythmias 
Cardiac arrest 
Bradycardia 

Vascular disorders  Orthostatic 
hypotension 

Venous thromboembolism 
(including pulmonary 
embolism and deep vein 
thrombosis) 
Hypertension 
Syncope 

Respiratory, thoracic 
and mediastinal 
disorders 

 Hiccups Aspiration pneumonia 
Laryngospasm 
Oropharyngeal spasm 

Gastrointestinal 
disorders 

Constipation 
Dyspepsia 
Nausea 
Salivary 
hypersecretion 
Vomiting 

 Pancreatitis 
Dysphagia 
Diarrhoea 
Abdominal discomfort 
Stomach discomfort 

Hepatobiliary 
disorders 

  Hepatic failure 
Hepatitis 
Jaundice 

Skin and 
subcutaneous tissue 
disorders 

  Rash 
Photosensitivity reaction 
Alopecia 
Hyperhidrosis 

Musculoskeletal and 
connective tissue 
disorders 

  Rhabdomyolysis 
Myalgia 
Stiffness 

Renal and urinary 
disorders 

  Urinary incontinence 
Urinary retention 

Pregnancy, 
puerperium and 
perinatal conditions 

  Drug withdrawal syndrome 
neonatal (see section 4.6) 



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 Common Uncommon Not known 
Reproductive system 
and breast disorders 

  Priapism 

General disorders 
and administration 
site conditions 

Fatigue  Temperature regulation 
disorder (e.g. hypothermia, 
pyrexia) 
Chest pain 
Peripheral oedema 

Investigations   Weight decreased  
Weight gain  
Alanine Aminotransferase 
increased 
Aspartate Aminotransferase 
increased 
Gamma-glutamyltransferase 
increased 
Alkaline phosphatase 
increased 
QT prolonged 
Blood glucose increased 
Glycosylated haemoglobin 
increased 
Blood glucose fluctuation 
Creatine phosphokinase 
increased 

 
Description of selected adverse reactions 
 
Adults 
 
Extrapyramidal symptoms (EPS) 
Schizophrenia – in a long term 52-week controlled trial, aripiprazole-treated patients had an overall-
lower incidence (25.8%) of EPS including Parkinsonism, akathisia, dystonia and dyskinesia compared 
with those treated with haloperidol (57.3%). In a long term 26-week placebo-controlled trial, 
the incidence of EPS was 19% for aripiprazole-treated patients and 13.1% for placebo-treated patients. 
In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated 
patients and 15.1% for olanzapine-treated patients. 
 
Manic episodes in Bipolar I Disorder – in a 12-week controlled trial, the incidence of EPS was 23.5% 
for aripiprazole-treated patients and 53.3% for haloperidol-treated patients. In another 12-week trial, 
the incidence of EPS was 26.6% for patients treated with aripiprazole and 17.6% for those treated with 
lithium. In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of 
EPS was 18.2% for aripiprazole-treated patients and 15.7% for placebo-treated patients. 
 
Akathisia 
In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole 
and 3.2% with placebo. In schizophrenia patients the incidence of akathisia was 6.2% with 
aripiprazole and 3.0% with placebo. 
 
Dystonia 
Class effect – Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in 
susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of 



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the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty 
breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur 
more frequently and with greater severity with high potency and at higher doses of first generation 
antipsychotic medicinal products. An elevated risk of acute dystonia is observed in males and younger 
age groups. 
 
Prolactin 
In clinical trials for the approved indications and post-marketing, both increase and decrease in serum 
prolactin as compared to baseline was observed with aripiprazole (see section 5.1). 
 
Laboratory parameters 
Comparisons between aripiprazole and placebo in the proportions of patients experiencing potentially 
clinically significant changes in routine laboratory and lipid parameters (see section 5.1) revealed 
no medically important differences. Elevations of CPK (Creatine Phosphokinase), generally transient 
and asymptomatic, were observed in 3.5% of aripiprazole treated patients as compared to 2.0% 
of patients who received placebo. 
 
Paediatric population 
 
Schizophrenia in adolescents aged 15 years and older 
In a short-term placebo-controlled clinical trial involving 302 adolescents (13 – 17 years) with 
schizophrenia, the frequency and type of adverse reactions were similar to those in adults except 
for the following reactions that were reported more frequently in adolescents receiving aripiprazole 
than in adults receiving aripiprazole (and more frequently than placebo): Somnolence/sedation and 
extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, 
and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10). 
The safety profile in a 26-week open-label extension trial was similar to that observed in the short-
term, placebo-controlled trial. 
The safety profile of a long-term, double-blind placebo controlled trial was also similar except 
for the following reactions that were reported more frequently than paediatric patients taking placebo: 
weight decreased, blood insulin increased, arrhythmia, and leukopenia were reported commonly 
(≥ 1/100, < 1/10). 
 
In the pooled adolescent schizophrenia population (13 – 17 years) with exposure up to 2 years, 
incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 29.5% and 
48.3%, respectively. In the adolescent (13 – 17 years) schizophrenia population with aripiprazole 
exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females 
(< 3 ng/ml) and males (< 2 ng/ml) was 25.6% and 45.0%, respectively. 
In two long term trials with adolescent (13 – 17 years) schizophrenia and bipolar patients treated with 
aripiprazole, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 
37.0% and 59.4%, respectively. 
 
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older 
The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar 
to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0%), 
extrapyramidal disorder (18.4%), akathisia (16.0%), and fatigue (11.8%); and commonly (≥ 1/100, 
< 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle 
twitching, and dyskinesia. 
 
The following adverse reactions had a possible dose response relationship; extrapyramidal disorder 
(incidences were 10 mg, 9.1%, 30 mg, 28.8%, placebo, 1.7%,); and akathisia (incidences were 10 mg, 
12.1%, 30 mg, 20.3%, placebo, 1.7%). 
 



15 

Mean changes in body weight in adolescents with Bipolar I Disorder at 12 and 30 weeks 
for aripiprazole were 2.4 kg and 5.8 kg, and for placebo 0.2 kg and 2.3 kg, respectively. 
 
In the paediatric population somnolence and fatigue were observed more frequently in patients with 
bipolar disorder compared to patients with schizophrenia. 
 
In the paediatric bipolar population (10 – 17 years) with exposure up to 30 weeks, incidence of low 
serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0% and 53.3%, 
respectively. 
 
Pathological gambling and other impulse control disorders 
Pathological gambling, hypersexuality, compulsive shopping and binge or compulsive eating can 
occur in patients treated with aripiprazole (see section 4.4). 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. 
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Signs and symptoms 
 
In clinical trials and post-marketing experience, accidental or intentional acute overdose 
of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg 
with no fatalities. The potentially medically important signs and symptoms observed included 
lethargy, increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea. 
In addition, reports of accidental overdose with aripiprazole alone (up to 195 mg) in children have 
been received with no fatalities. The potentially medically serious signs and symptoms reported 
included somnolence, transient loss of consciousness and extrapyramidal symptoms. 
 
Management of overdose 
 
Management of overdose should concentrate on supportive therapy, maintaining an adequate airway, 
oxygenation and ventilation, and management of symptoms. The possibility of multiple medicinal 
product involvement should be considered. Therefore cardiovascular monitoring should be started 
immediately and should include continuous electrocardiographic monitoring to detect possible 
arrhythmias. Following any confirmed or suspected overdose with aripiprazole, close medical 
supervision and monitoring should continue until the patient recovers. 
 
Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax 
by about 41% and AUC by about 51%, suggesting that charcoal may be effective in the treatment 
of overdose. 
 
Haemodialysis 
 
Although there is no information on the effect of haemodialysis in treating an overdose with 
aripiprazole, haemodialysis is unlikely to be useful in overdose management since aripiprazole 
is highly bound to plasma proteins. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


16 

 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12 
 
Mechanism of action 
 
It has been proposed that aripiprazole’s efficacy in schizophrenia and Bipolar I Disorder is mediated 
through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and 
antagonism of serotonin 5-HT2A receptors. Aripiprazole exhibited antagonist properties in animal 
models of dopaminergic hyperactivity and agonist properties in animal models of dopaminergic 
hypoactivity. Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 
5-HT1A and 5-HT2A receptors and moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, 
alpha-1 adrenergic and histamine H1 receptors. Aripiprazole also exhibited moderate binding affinity 
for the serotonin reuptake site and no appreciable affinity for muscarinic receptors. Interaction with 
receptors other than dopamine and serotonin subtypes may explain some of the other clinical effects of 
aripiprazole. 
Aripiprazole doses ranging from 0.5 to 30 mg administered once a day to healthy subjects for 2 weeks 
produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor ligand, 
to the caudate and putamen detected by positron emission tomography. 
 
Clinical efficacy and safety 
 
Adults 
 
Schizophrenia 
In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult 
patients, presenting with positive or negative symptoms, aripiprazole was associated with statistically 
significantly greater improvements in psychotic symptoms compared to placebo. 
 
Aripiprazole is effective in maintaining the clinical improvement during continuation therapy in adult 
patients who have shown an initial treatment response. In a haloperidol-controlled trial, the proportion 
of responder patients maintaining response to medicinal product at 52-weeks was similar in both 
groups (aripiprazole 77% and haloperidol 73%). The overall completion rate was significantly higher 
for patients on aripiprazole (43%) than for haloperidol (30%). Actual scores in rating scales used 
as secondary endpoints, including PANSS and the Montgomery-Asberg Depression Rating Scale 
(MADRS) showed a significant improvement over haloperidol. 
In a 26-week, placebo-controlled trial in adult stabilised patients with chronic schizophrenia, 
aripiprazole had significantly greater reduction in relapse rate, 34% in aripiprazole group and 57% 
in placebo. 
 
Weight gain 
In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain. In a 26-
week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 
adult patients and where the primary end-point was weight gain, significantly less patients had at least 
7% weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg) 
on aripiprazole (n = 18, or 13% of evaluable patients), compared to olanzapine (n = 45, or 33% 
of evaluable patients). 
 



17 

Lipid parameters 
In a pooled analysis on lipid parameters from placebo controlled clinical trials in adults, aripiprazole 
has not been shown to induce clinically relevant alterations in levels of total cholesterol, triglycerides, 
High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL). 
 
Prolactin 
Prolactin levels were evaluated in all trials of all doses of aripiprazole (n = 28,242). The incidence 
of hyperprolactinaemia or increased serum prolactin in patients treated with aripiprazole (0.3%) was 
similar to that of placebo (0.2%). For patients receiving aripiprazole, the median time to onset was 42 
days and median duration was 34 days. 
 
The incidence of hypoprolactinaemia or decreased serum prolactin in patients treated with aripiprazole 
was 0.4%, compared with 0.02% for patients treated with placebo. For patients receiving aripiprazole, 
the median time to onset was 30 days and median duration was 194 days. 
 
Manic episodes in Bipolar I Disorder 
In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or 
mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo 
in reduction of manic symptoms over 3 weeks. These trials included patients with or without psychotic 
features and with or without a rapid-cycling course. 
In one 3-week, fixed-dose, placebo-controlled monotherapy trial involving patients with a manic 
or mixed episode of Bipolar I Disorder, aripiprazole failed to demonstrate superior efficacy to placebo. 
 
In two 12-week, placebo- and active-controlled monotherapy trials in patients with a manic or mixed 
episode of Bipolar I Disorder, with or without psychotic features, aripiprazole demonstrated superior 
efficacy to placebo at week 3 and a maintenance of effect comparable to lithium or haloperidol 
at week 12. Aripiprazole also demonstrated a comparable proportion of patients in symptomatic 
remission from mania as lithium or haloperidol at week 12. 
 
In a 6-week, placebo-controlled trial involving patients with a manic or mixed episode of Bipolar I 
Disorder, with or without psychotic features, who were partially non-responsive to lithium 
or valproate monotherapy for 2 weeks at therapeutic serum levels, the addition of aripiprazole 
as adjunctive therapy resulted in superior efficacy in reduction of manic symptoms than lithium 
or valproate monotherapy. 
 
In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who 
achieved remission on aripiprazole during a stabilization phase prior to randomisation, aripiprazole 
demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing 
recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into 
depression. 
 
In a 52-week, placebo-controlled trial, in patients with a current manic or mixed episode of Bipolar I 
Disorder who achieved sustained remission (Young Mania Rating Scale [YMRS] and MADRS with 
total scores ≤ 12) on aripiprazole (10 mg/day to 30 mg/day) adjunctive to lithium or valproate for 12 
consecutive weeks, adjunctive aripiprazole demonstrated superiority over placebo with a 46% 
decreased risk (hazard ratio of 0.54) in preventing bipolar recurrence and a 65% decreased risk (hazard 
ratio of 0.35) in preventing recurrence into mania over adjunctive placebo but failed to demonstrate 
superiority over placebo in preventing recurrence into depression. Adjunctive aripiprazole 
demonstrated superiority over placebo on the secondary outcome measure in Clinical Global 
Impression - Bipolar version (CGI-BP) Severity of Illness (SOI; mania) scores. 



18 

In this trial, patients were assigned by investigators with either open-label lithium or valproate 
monotherapy to determine partial non-response. Patients were stabilised for at least 12 consecutive 
weeks with the combination of aripiprazole and the same mood stabilizer. 
Stabilized patients were then randomised to continue the same mood stabilizer with double-blind 
aripiprazole or placebo. Four mood stabilizer subgroups were assessed in the randomised phase: 
aripiprazole + lithium; aripiprazole + valproate; placebo + lithium; placebo + valproate. 
The Kaplan-Meier rates for recurrence to any mood episode for the adjunctive treatment arm were 
16% in aripiprazole + lithium and 18% in aripiprazole + valproate compared to 45% in placebo + 
lithium and 19% in placebo + valproate. 
 
Paediatric population 
 
Schizophrenia in adolescents 
In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13 – 17 years), 
presenting with positive or negative symptoms, aripiprazole was associated with statistically 
significantly greater improvements in psychotic symptoms compared to placebo. In a sub-analysis 
of the adolescent patients between the ages of 15 to 17 years, representing 74% of the total enrolled 
population, maintenance of effect was observed over the 26-week open-label extension trial. 
 
In a 60- to 89-week, randomised, double-blind, placebo-controlled trial in adolescent subjects 
(n = 146; ages 13 – 17 years) with schizophrenia, there was a statistically significant difference 
in the rate of relapse of psychotic symptoms between the aripiprazole (19.39%) and placebo (37.50%) 
groups. The point estimate of the hazard ratio (HR) was 0.461 (95% confidence interval, 
0.242 – 0.879) in the full population. In subgroup analyses the point estimate of the HR was 0.495 
for subjects 13 to 14 years of age compared to 0.454 for subjects 15 to 17 years of age. However, 
the estimation of the HR for the younger (13 – 14 years) group was not precise, reflecting the smaller 
number of subjects in that group (aripiprazole, n = 29; placebo, n = 12), and the confidence interval for 
this estimation (ranging from 0.151 to 1.628) did not allow conclusions to be drawn on the presence of 
a treatment effect. In contrast the 95% confidence interval for the HR in the older subgroup 
(aripiprazole, n = 69; placebo, n = 36) was 0.242 to 0.879 and hence a treatment effect could be 
concluded in the older patients. 
 
Manic episodes in Bipolar I Disorder in children and adolescents 
Aripiprazole was studied in a 30-week placebo-controlled trial involving 296 children and adolescents 
(10 – 17 years), who met DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders) for 
Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a YMRS 
score ≥ 20 at baseline. Among the patients included in the primary efficacy analysis, 139 patients had 
a current comorbid diagnosis of ADHD. 
 
Aripiprazole was superior to placebo in change from baseline at week 4 and at week 12 on the Y-MRS 
total score. In a post-hoc analysis, the improvement over placebo was more pronounced in the patients 
with associated comorbidity of ADHD compared to the group without ADHD, where there was no 
difference from placebo. Recurrence prevention was not established. 
 
The most common treatment-emergent adverse events among patients receiving 30 mg were 
extrapyramidal disorder (28.3%), somnolence (27.3%), headache (23.2%), and nausea (14.1%). Mean 
weight gain in the 30 weeks treatment-interval was 2.9 kg as compared to 0.98 kg in patients treated 
with placebo. 
 



19 

Irritability associated with autistic disorder in paediatric patients (see section 4.2) 
Aripiprazole was studied in patients aged 6 to 17 years in two 8-week, placebo-controlled trials [one 
flexible-dose (2 – 15 mg/day) and one fixed-dose (5, 10, or 15 mg/day)] and in one 52-week open-
label trial. Dosing in these trials was initiated at 2 mg/day, increased to 5 mg/day after one week, and 
increased by 5 mg/day in weekly increments to the target dose. Over 75% of patients were less than 13 
years of age. Aripiprazole demonstrated statistically superior efficacy compared to placebo 
on the Aberrant Behaviour Checklist Irritability subscale. However, the clinical relevance of this 
finding has not been established. The safety profile included weight gain and changes in prolactin 
levels. The duration of the long-term safety study was limited to 52 weeks. In the pooled trials, 
the incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) in 
aripiprazole-treated patients was 27/46 (58.7%) and 258/298 (86.6%), respectively. In the placebo-
controlled trials, the mean weight gain was 0.4 kg for placebo and 1.6 kg for aripiprazole. 
 
Aripiprazole was also studied in a placebo-controlled, long-term maintenance trial. After a 13 - 26 
week stabilisation on aripiprazole (2 – 15 mg/day) patients with a stable response were either 
maintained on aripiprazole or substituted to placebo for further 16 weeks. Kaplan-Meier relapse rates 
at week 16 were 35% for aripiprazole and 52% for placebo; the hazard ratio for relapse within 16 
weeks (aripiprazole/placebo) was 0.57 (non-statistically significant difference). The mean weight gain 
over the stabilisation phase (up to 26 weeks) on aripiprazole was 3.2 kg, and a further mean increase 
of 2.2 kg for aripiprazole as compared to 0.6 kg for placebo was observed in the second phase (16 
weeks) of the trial. Extrapyramidal symptoms were mainly reported during the stabilisation phase 
in 17% of patients, with tremor accounting for 6.5%. 
 
Tics associated with Tourette’s disorder in paediatric patients (see section 4.2) 
The efficacy of aripiprazole was studied in paediatric subjects with Tourette’s disorder (aripiprazole: n 
= 99, placebo: n = 44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed 
dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting 
dose of 2 mg. Patients were 7 – 17 years of age and presented an average score of 30 on Total Tic 
Score on the Yale Global Tic Severity Scale (TTS-YGTSS) at baseline. Aripiprazole showed an 
improvement on TTS-YGTSS change from baseline to week 8 of 13.35 for the low dose group (5 mg 
or 10 mg) and 16.94 for the high dose group (10 mg or 20 mg) as compared with an improvement of 
7.09 in the placebo group. 
 
The efficacy of aripiprazole in paediatric subjects with Tourette’s syndrome (aripiprazole: n = 32, 
placebo: n = 29) was also evaluated over a flexible dose range of 2 mg/day to 20 mg/day and a starting 
dose of 2 mg, in a 10 week, randomised, double blind, placebo-controlled study conducted in South-
Korea. Patients were 6 – 18 years and presented an average score of 29 on TTS-YGTSS at baseline. 
Aripiprazole group showed an improvement of 14.97 on TTS-YGTSS change from baseline to week 
10 as compared with an improvement of 9.62 in the placebo group. 
 
In both of these short term trials, the clinical relevance of the efficacy findings has not been 
established, considering the magnitude of treatment effect compared to the large placebo effect and the 
unclear effects regarding psycho-social functioning. No long term data are available with regard to the 
efficacy and the safety of aripiprazole in this fluctuating disorder. 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
the reference medicinal product containing aripiprazole in one or more subsets of the paediatric 
population in the treatment of schizophrenia and in the treatment of bipolar affective disorder 
(see section 4.2 for information on paediatric use). 
 



20 

5.2 Pharmacokinetic properties 
 
Absorption 
 
Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3 – 5 hours after 
dosing. Aripiprazole undergoes minimal pre-systemic metabolism. The absolute oral bioavailability 
of the tablet formulation is 87%. There is no effect of a high fat meal on the pharmacokinetics 
of aripiprazole. 
 
Distribution 
 
Aripiprazole is widely distributed throughout the body with an apparent volume of distribution 
of 4.9 l/kg, indicating extensive extravascular distribution. At therapeutic concentrations, aripiprazole 
and dehydro-aripiprazole are greater than 99% bound to serum proteins, binding primarily to albumin. 
 
Biotransformation 
 
Aripiprazole is extensively metabolised by the liver primarily by three biotransformation pathways: 
dehydrogenation, hydroxylation, and N-dealkylation. Based on in vitro studies, CYP3A4 and CYP2D6 
enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is 
catalysed by CYP3A4. Aripiprazole is the predominant medicinal product moiety in systemic 
circulation. At steady state, dehydro-aripiprazole, the active metabolite, represents about 40% of 
aripiprazole AUC in plasma. 
 
Elimination 
 
The mean elimination half-lives for aripiprazole are approximately 75 hours in extensive metabolisers 
of CYP2D6 and approximately 146 hours in poor metabolisers of CYP2D6. 
 
The total body clearance of aripiprazole is 0.7 ml/min/kg, which is primarily hepatic. 
 
Following a single oral dose of [14C]-labelled aripiprazole, approximately 27% of the administered 
radioactivity was recovered in the urine and approximately 60% in the faeces. Less than 1% 
of unchanged aripiprazole was excreted in the urine and approximately 18% was recovered unchanged 
in the faeces. 
 
Paediatric population 
The pharmacokinetics of aripiprazole and dehydro-aripiprazole in paediatric patients 10 to 17 years 
of age were similar to those in adults after correcting for the differences in body weights. 
 
Pharmacokinetics in special patient groups 
 
Elderly 
There are no differences in the pharmacokinetics of aripiprazole between healthy elderly and younger 
adult subjects, nor is there any detectable effect of age in a population pharmacokinetic analysis 
in schizophrenic patients. 
 
Gender 
There are no differences in the pharmacokinetics of aripiprazole between healthy male and female 
subjects nor is there any detectable effect of gender in a population pharmacokinetic analysis 
in schizophrenic patients. 
 



21 

Smoking 
Population pharmacokinetic evaluation has revealed no evidence of clinically significant effects from 
smoking on the pharmacokinetics of aripiprazole. 
 
Race 
Population pharmacokinetic evaluation showed no evidence of race-related differences 
on the pharmacokinetics of aripiprazole. 
 
Renal impairment 
The pharmacokinetic characteristics of aripiprazole and dehydro-aripiprazole were found to be similar 
in patients with severe renal disease compared to young healthy subjects. 
 
Hepatic impairment 
A single-dose study in subjects with varying degrees of liver cirrhosis (Child-Pugh Classes A, B, and 
C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of aripiprazole 
and dehydro-aripiprazole, but the study included only 3 patients with Class C liver cirrhosis, which 
is insufficient to draw conclusions on their metabolic capacity. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction 
and development. 
 
Toxicologically significant effects were observed only at doses or exposures that were sufficiently 
in excess of the maximum human dose or exposure, indicating that these effects were limited 
or of no relevance to clinical use. These included: dose-dependent adrenocortical toxicity (lipofuscin 
pigment accumulation and/or parenchymal cell loss) in rats after 104 weeks at 20 to 60 mg/kg/day 
(3 to 10 times the mean steady-state AUC at the maximum recommended human dose) and increased 
adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas in female rats 
at 60 mg/kg/day (10 times the mean steady-state AUC at the maximum recommended human dose). 
The highest nontumorigenic exposure in female rats was 7 times the human exposure at the 
recommended dose. 
 
An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates 
of hydroxy metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 
to 125 mg/kg/day (1 to 3 times the mean steady-state AUC at the maximum recommended clinical 
dose or 16 to 81 times the maximum recommended human dose based on mg/m2). However, 
the concentrations of the sulphate conjugates of hydroxy aripiprazole in human bile at the highest dose 
proposed, 30 mg per day, were no more than 6% of the bile concentrations found in the monkeys in 
the 39-week study and are well below (6%) their limits of in vitro solubility. 
 
In repeat-dose studies in juvenile rats and dogs, the toxicity profile of aripiprazole was comparable 
to that observed in adult animals, and there was no evidence of neurotoxicity or adverse reactions 
on development. 
 
Based on results of a full range of standard genotoxicity tests, aripiprazole was considered non-
genotoxic. Aripiprazole did not impair fertility in reproductive toxicity studies. Developmental 
toxicity, including dose-dependent delayed foetal ossification and possible teratogenic effects, were 
observed in rats at doses resulting in subtherapeutic exposures (based on AUC) and in rabbits at doses 
resulting in exposures 3 and 11 times the mean steady-state AUC at the maximum recommended 
clinical dose. Maternal toxicity occurred at doses similar to those eliciting developmental toxicity. 
 



22 

 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Lactose monohydrate 
Microcrystalline cellulose 
Crospovidone 
Hydroxypropyl cellulose 
Silica colloidal anhydrous 
Croscarmellose sodium 
Magnesium stearate 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
OPA/Alu/PVC/Alu foil blisters (Alu-Alu blister), carton box. 
Pack size: 14, 28, 49, 56, or 98 tablets 
 
Not all pack sizes may be marketed. 
 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 



23 

8. MARKETING AUTHORISATION NUMBER(S) 
 
Aripiprazole Zentiva 5 mg tablets 
 
EU/1/15/1009/001 
EU/1/15/1009/002 
EU/1/15/1009/003 
EU/1/15/1009/004 
EU/1/15/1009/005 
 
Aripiprazole Zentiva 10 mg tablets 
 
EU/1/15/1009/006 
EU/1/15/1009/007 
EU/1/15/1009/008 
EU/1/15/1009/009 
EU/1/15/1009/010 
 
Aripiprazole Zentiva 15 mg tablets 
 
EU/1/15/1009/011 
EU/1/15/1009/012 
EU/1/15/1009/013 
EU/1/15/1009/014 
EU/1/15/1009/015 
 
Aripiprazole Zentiva 30 mg tablets 
 
EU/1/15/1009/016 
EU/1/15/1009/017 
EU/1/15/1009/018 
EU/1/15/1009/019 
EU/1/15/1009/020 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 25 June 2015 
Date of latest renewal: 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


24 

1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 10 mg orodispersible tablets 
Aripiprazole Zentiva 15 mg orodispersible tablets 
Aripiprazole Zentiva 30 mg orodispersible tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Aripiprazole Zentiva 10 mg orodispersible tablets 
 
Each orodispersible tablet contains 10 mg of aripiprazole. 
 
Excipient with known effect 
 
Each orodispersible tablet contains 37 mg of lactose (as monohydrate). 
 
Aripiprazole Zentiva 15 mg orodispersible tablets 
 
Each orodispersible tablet contains 15 mg of aripiprazole. 
 
Excipient with known effect 
 
Each orodispersible tablet contains 55.5 mg of lactose (as monohydrate). 
 
Aripiprazole Zentiva 30 mg orodispersible tablets 
 
Each orodispersible tablet contains 30 mg of aripiprazole. 
 
Excipient with known effect 
 
Each orodispersible tablet contains 111 mg of lactose (as monohydrate). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Orodispersible tablet 
 
Aripiprazole Zentiva 10 mg orodispersible tablets 
 
White to off-white round tablets debossed ‘10’ on one side and snap break line on other side with 
diameter approx. 7 mm. 
The score line is not intended for breaking the tablet. 
 
Aripiprazole Zentiva 15 mg orodispersible tablets 
 
White to off-white round flat bevel edged tablets debossed ‘15’ on one side and plain on the other side 
with diameter approx. 8 mm. 
 
Aripiprazole Zentiva 30 mg orodispersible tablets 
 



25 

White to off-white round tablets debossed ‘30’ on one side and snap break line on the other side with 
diameter approx. 10.2 mm. 
The score line is not intended for breaking the tablet. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 
15 years and older. 
 
Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I 
Disorder and for the prevention of a new manic episode in adults who experienced predominantly 
manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1). 
 
Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic 
episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1). 
 
4.2 Posology and method of administration 
 
Posology 
 
Adults 
 
Schizophrenia 
The recommended starting dose for Aripiprazole Zentiva is 10 or 15 mg/day with a maintenance dose 
of 15 mg/day administered on a once-a-day schedule without regard to meals. 
 
Aripiprazole Zentiva is effective in a dose range of 10 to 30 mg/day. Enhanced efficacy at doses 
higher than a daily dose of 15 mg has not been demonstrated although individual patients may benefit 
from a higher dose. The maximum daily dose should not exceed 30 mg. 
 
Manic episodes in Bipolar I Disorder 
The recommended starting dose for Aripiprazole Zentiva is 15 mg administered on a once-a-day 
schedule without regard to meals as monotherapy or combination therapy (see section 5.1). Some 
patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg. 
 
Recurrence prevention of manic episodes in Bipolar I Disorder 
For preventing recurrence of manic episodes in patients who have been receiving aripiprazole 
as monotherapy or combination therapy, continue therapy at the same dose. Adjustments of daily 
dosage, including dose reduction should be considered on the basis of clinical status. 
 
Paediatric population 
 
Schizophrenia in adolescents aged 15 years and older 
The recommended dose for Aripiprazole Zentiva is 10 mg/day administered on a once-a-day schedule 
without regard to meals. Treatment should be initiated at 2 mg (using an appropriate aripiprazole 
containing medicinal product) for 2 days, titrated to 5 mg for 2 additional days to reach 
the recommended daily dose of 10 mg. When appropriate, subsequent dose increases should 
be administered in 5 mg increments without exceeding the maximum daily dose of 30 mg (see section 
5.1). 



26 

 
Aripiprazole Zentiva is effective in a dose range of 10 to 30 mg/day. Enhanced efficacy at doses 
higher than a daily dose of 10 mg has not been demonstrated although individual patients may benefit 
from a higher dose. 
 
Aripiprazole Zentiva is not recommended for use in patients with schizophrenia below 15 years of age 
due to insufficient data on safety and efficacy (see sections 4.8 and 5.1). 
 
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older 
The recommended dose for Aripiprazole Zentiva is 10 mg/day administered on a once-a-day schedule 
without regard to meals. Treatment should be initiated at 2 mg (using an appropriate aripiprazole 
containing medicinal product) for 2 days, titrated to 5 mg for 2 additional days to reach 
the recommended daily dose of 10 mg. 
 
The treatment duration should be the minimum necessary for symptom control and must not exceed 12 
weeks. Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated, and a 
daily dose of 30 mg is associated with a substantially higher incidence of significant adverse reactions 
including EPS related events, somnolence, fatigue and weight gain (see section 4.8). Doses higher than 
10 mg/day should therefore only be used in exceptional cases and with close clinical monitoring (see 
sections 4.4, 4.8 and 5.1). 
 
Younger patients are at increased risk of experiencing adverse events associated with aripiprazole. 
Therefore, Aripiprazole Zentiva is not recommended for use in patients below 13 years of age 
(see sections 4.8 and 5.1). 
 
Irritability associated with autistic disorder 
The safety and efficacy of aripiprazole in children and adolescents aged below 18 years have not yet 
been established. Currently available data are described in section 5.1 but no recommendation 
on a posology can be made. 
 
Tics associated with Tourette’s disorder 
The safety and efficacy of aripiprazole in children and adolescents 6 to 18 years of age have not yet 
been established. Currently available data are described in section 5.1 but no recommendation 
on a posology can be made. 
 
Special populations 
 
Hepatic impairment 
No dosage adjustment is required for patients with mild to moderate hepatic impairment. In patients 
with severe hepatic impairment, the data available are insufficient to establish recommendations. 
In these patients dosing should be managed cautiously. However, the maximum daily dose of 30 mg 
should be used with caution in patients with severe hepatic impairment (see section 5.2). 
 
Renal impairment 
No dosage adjustment is required in patients with renal impairment. 
 
Elderly 
The safety and efficacy of aripiprazole in the treatment of schizophrenia or manic episodes in Bipolar I 
Disorder in patients aged 65 years and older has not been established. Owing to the greater sensitivity 
of this population, a lower starting dose should be considered when clinical factors warrant (see 
section 4.4). 
 



27 

Gender 
No dosage adjustment is required for female patients as compared to male patients (see section 5.2). 
 
Smoking status 
According to the metabolic pathway of aripiprazole no dosage adjustment is required for smokers 
(see section 4.5). 
 
Dose adjustments due to interactions 
When concomitant administration of strong CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, 
the aripiprazole dose should be reduced. When the CYP3A4 or CYP2D6 inhibitor is withdrawn from 
the combination therapy, aripiprazole dose should then be increased (see section 4.5). 
When concomitant administration of strong CYP3A4 inducers with aripiprazole occurs, 
the aripiprazole dose should be increased. When the CYP3A4 inducer is withdrawn from 
the combination therapy, the aripiprazole dose should then be reduced to the recommended dose 
(see section 4.5). 
 
Method of administration 
 
Aripiprazole Zentiva is for oral use. 
 
The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disperse in 
saliva. It can be taken with or without liquid. Removal of the intact orodispersible tablet from 
the mouth is difficult. Since the orodispersible tablet is fragile, it should be taken immediately 
on opening the blister. Alternatively, disperse the tablet in water and drink the resulting suspension. 
 
The orodispersible tablets may be used as an alternative to Aripiprazole Zentiva tablets for patients 
who have difficulty swallowing Aripiprazole Zentiva tablets (see section 5.2). 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
During antipsychotic treatment, improvement in the patient’s clinical condition may take several days 
to some weeks. Patients should be closely monitored throughout this period. 
 
Suicidality 
 
The occurrence of suicidal behaviour is inherent in psychotic illnesses and mood disorders and 
in some cases has been reported early after initiation or switch of antipsychotic treatment, including 
treatment with aripiprazole (see section 4.8). Close supervision of high-risk patients should 
accompany antipsychotic therapy. 
 
Cardiovascular disorders 
 
Aripiprazole should be used with caution in patients with known cardiovascular disease (history 
of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), 
cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, 
hypovolemia, and treatment with antihypertensive medicinal products) or hypertension, including 
accelerated or malignant. 



28 

 
Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products. 
Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible 
risk factors for VTE should be identified before and during treatment with aripiprazole and preventive 
measures undertaken. 
 
QT prolongation 
 
In clinical trials of aripiprazole, the incidence of QT prolongation was comparable to placebo. 
Aripiprazole should be used with caution in patients with a family history of QT prolongation 
(see section 4.8). 
 
Tardive dyskinesia 
 
In clinical trials of one year or less duration, there were uncommon reports of treatment emergent 
dyskinesia during treatment with aripiprazole. If signs and symptoms of tardive dyskinesia appear 
in a patient on aripiprazole, dose reduction or discontinuation should be considered (see section 4.8). 
These symptoms can temporally deteriorate or can even arise after discontinuation of treatment. 
 
Other extrapyramidal symptoms 
 
In paediatric clinical trials of aripiprazole akathisia and Parkinsonism were observed. If signs and 
symptoms of other EPS appear in a patient taking aripiprazole, dose reduction and close clinical 
monitoring should be considered. 
 
Neuroleptic Malignant Syndrome (NMS) 
 
NMS is a potentially fatal symptom complex associated with antipsychotics. In clinical trials, rare 
cases of NMS were reported during treatment with aripiprazole. Clinical manifestations of NMS are 
hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular 
pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may 
include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. 
However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with 
NMS, have also been reported. If a patient develops signs and symptoms indicative of NMS, 
or presents with unexplained high fever without additional clinical manifestations of NMS, 
all antipsychotics, including aripiprazole, must be discontinued. 
 
Seizure 
 
In clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole. 
Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder 
or have conditions associated with seizures (see section 4.8). 
 
Elderly patients with dementia-related psychosis 
 
Increased mortality 
In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 56 – 99 years) of aripiprazole 
in elderly patients with psychosis associated with Alzheimer’s disease, patients treated with 
aripiprazole were at increased risk of death compared to placebo. The rate of death in aripiprazole-
treated patients was 3.5% compared to 1.7% in the placebo group. Although the causes of deaths were 



29 

varied, most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) 
or infectious (e.g. pneumonia) in nature (see section 4.8). 
 
Cerebrovascular adverse reactions 
In the same trials, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including 
fatalities, were reported in patients (mean age: 84 years; range: 78 – 88 years). Overall, 1.3% 
of aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6% 
of placebo-treated patients in these trials. This difference was not statistically significant. However, 
in one of these trials, a fixed-dose trial, there was a significant dose response relationship 
for cerebrovascular adverse reactions in patients treated with aripiprazole (see section 4.8). 
 
Aripiprazole is not indicated for the treatment of patients with dementia-related psychosis. 
 
Hyperglycaemia and diabetes mellitus 
 
Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma 
or death, has been reported in patients treated with atypical antipsychotics, including aripiprazole. Risk 
factors that may predispose patients to severe complications include obesity and family history of 
diabetes. In clinical trials with aripiprazole, there were no significant differences in the incidence rates 
of hyperglycaemia-related adverse reactions (including diabetes) or in abnormal glycaemia laboratory 
values compared to placebo. Precise risk estimates for hyperglycaemia-related adverse reactions in 
patients treated with aripiprazole and with other atypical antipsychotics are not available to allow 
direct comparisons. Patients treated with any antipsychotics, including aripiprazole, should be 
observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and 
weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should 
be monitored regularly for worsening of glucose control (see section 4.8). 
 
Hypersensitivity 
 
Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole 
(see section 4.8). 
 
Weight gain 
 
Weight gain is commonly seen in schizophrenic and bipolar mania patients due to co-morbidities, 
use of antipsychotics known to cause weight gain, poorly managed life-style, and might lead to severe 
complications. Weight gain has been reported post-marketing among patients prescribed aripiprazole. 
When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid 
disorder or pituitary adenoma. In clinical trials aripiprazole has not been shown to induce clinically 
relevant weight gain in adults (see section 5.1). In clinical trials of adolescent patients with bipolar 
mania, aripiprazole has been shown to be associated with weight gain after 4 weeks of treatment. 
Weight gain should be monitored in adolescent patients with bipolar mania. If weight gain is clinically 
significant, dose reduction should be considered (see section 4.8). 
 
Dysphagia 
 
Oesophageal dysmotility and aspiration have been associated with the use of antipsychotics, including 
aripiprazole. Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia. 
 



30 

Pathological gambling and other impulse control disorders 
 
Patients can experience increased urges, particularly for gambling, and the inability to control these 
urges while taking aripiprazole. Other urges, reported, include: increased sexual urges, compulsive 
shopping, binge or compulsive eating, and other impulsive and compulsive behaviours. It is important 
for prescribers to ask patients or their caregivers specifically about the development of new 
or increased gambling urges, sexual urges, compulsive shopping, binge or compulsive eating, or other 
urges while being treated with aripiprazole. It should be noted that impulse-control symptoms can 
be associated with the underlying disorder; however, in some cases, urges were reported to have 
stopped when the dose was reduced or the medication was discontinued. Impulse control disorders 
may result in harm to the patient and others if not recognised. Consider dose reduction or stopping 
the medication if a patient develops such urges while taking aripiprazole (see section 4.8). 
 
Patients with attention deficit hyperactivity disorder (ADHD) comorbidity 
 
Despite the high comorbidity frequency of Bipolar I Disorder and ADHD, very limited safety data are 
available on concomitant use of aripiprazole and stimulants; therefore, extreme caution should 
be taken when these medicinal products are co-administered. 
 
Falls 
 
Aripiprazole may cause somnolence, postural hypotension, motor and sensory instability, which may 
lead to falls. Caution should be taken when treating patients at higher risk, and a lower starting dose 
should be considered (e.g., elderly or debilitated patients; see section 4.2). 
 
Lactose 
 
Aripiprazole Zentiva orodispersible tablets contain lactose. Patients with rare hereditary problems 
of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take 
this medicine. 
 
Sodium 
 
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect 
of certain antihypertensive medicinal products. 
 
Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole 
is administered in combination with alcohol or other CNS medicinal products with overlapping 
adverse reactions such as sedation (see section 4.8). 
 
If aripiprazole is administered concomitantly with medicinal products known to cause QT 
prolongation or electrolyte imbalance, caution should be used. 
 
Potential for other medicinal products to affect aripiprazole 
 
A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this 
effect is deemed not clinically relevant. 
 



31 

Aripiprazole is metabolised by multiple pathways involving the CYP2D6 and CYP3A4 enzymes but 
not CYP1A enzymes. Thus, no dosage adjustment is required for smokers. 
 
Quinidine and other CYP2D6 inhibitors 
In a clinical trial in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole 
AUC by 107%, while Cmax was unchanged. The AUC and Cmax of dehydro-aripiprazole, the active 
metabolite, decreased by 32% and 47%, respectively. Aripiprazole dose should be reduced 
to approximately one-half of its prescribed dose when concomitant administration of aripiprazole with 
quinidine occurs. Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may 
be expected to have similar effects and similar dose reductions should therefore be applied. 
 
Ketoconazole and other CYP3A4 inhibitors 
In a clinical trial in healthy subjects, a strong inhibitor of CYP3A4 (ketoconazole) increased 
aripiprazole AUC and Cmax by 63% and 37%, respectively. The AUC and Cmax of dehydro-aripiprazole 
increased by 77% and 43%, respectively. In CYP2D6 poor metabolisers, concomitant use of strong 
inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that 
in CYP2D6 extensive metabolizers. When considering concomitant administration of ketoconazole 
or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential 
risks to the patient. When concomitant administration of ketoconazole with aripiprazole occurs, 
aripiprazole dose should be reduced to approximately one-half of its prescribed dose. Other strong 
inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors may be expected to have 
similar effects and similar dose reductions should therefore be applied (see section 4.2). 
 
Upon discontinuation of the CYP2D6 or CYP3A4 inhibitor, the dosage of aripiprazole should 
be increased to the level prior to the initiation of the concomitant therapy. 
 
When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. escitalopram) are used 
concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may 
be expected. 
 
Carbamazepine and other CYP3A4 inducers 
Following concomitant administration of carbamazepine, a strong inducer of CYP3A4, and oral 
aripiprazole to patients with schizophrenia or schizoaffective disorder, the geometric means of Cmax 
and AUC for aripiprazole were 68% and 73% lower, respectively, compared to when aripiprazole 
(30 mg) was administered alone. Similarly, for dehydro-aripiprazole the geometric means of Cmax and 
AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those 
following treatment with aripiprazole alone. 
 
Aripiprazole dose should be doubled when concomitant administration of aripiprazole occurs with 
carbamazepine. Concomitant administration of aripiprazole and other inducers of CYP3A4 (such 
as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John’s 
Wort) may be expected to have similar effects and similar dose increases should therefore be applied. 
Upon discontinuation of strong CYP3A4 inducers, the dosage of aripiprazole should be reduced 
to the recommended dose. 
 
Valproate and lithium 
When either valproate or lithium was administered concomitantly with aripiprazole, there was 
no clinically significant change in aripiprazole concentrations and therefore no dose adjustment 
is necessary when either valproate or lithium is administered with aripiprazole. 
 



32 

Potential for aripiprazole to affect other medicinal products 
 
In clinical studies, 10 – 30 mg/day doses of aripiprazole had no significant effect on the metabolism 
of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), 
CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan). Additionally, aripiprazole and dehydro-
aripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro. Thus, 
aripiprazole is unlikely to cause clinically important medicinal product interactions mediated by these 
enzymes. 
 
When aripiprazole was administered concomitantly with either valproate, lithium or lamotrigine, there 
was no clinically important change in valproate, lithium or lamotrigine concentrations. 
 
Serotonin syndrome 
Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and 
symptoms for this condition can occur especially in cases of concomitant use with other serotonergic 
medicinal products, such as selective serotonin reuptake inhibitor/selective serotonin noradrenalin 
reuptake inhibitor (SSRI/SNRI), or with medicinal products that are known to increase aripiprazole 
concentrations (see section 4.8). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no adequate and well-controlled trials of aripiprazole in pregnant women. Congenital 
anomalies have been reported; however, causal relationship with aripiprazole could not be established. 
Animal studies could not exclude potential developmental toxicity (see section 5.3). Patients must be 
advised to notify their physician if they become pregnant or intend to become pregnant during 
treatment with aripiprazole. Due to insufficient safety information in humans and concerns raised by 
animal reproductive studies, this medicinal product should not be used in pregnancy unless the 
expected benefit clearly justifies the potential risk to the foetus. 
 
Newborn infants exposed to antipsychotics (including aripiprazole) during the third trimester 
of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms 
that may vary in severity and duration following delivery. There have been reports of agitation, 
hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, 
newborn infants should be monitored carefully (see section 4.8). 
 
Breast-feeding 
 
Aripiprazole/metabolites are excreted in human milk. A decision must be made whether to discontinue 
breast-feeding or to discontinue/abstain from aripiprazole therapy taking into account the benefit 
of breast-feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
 
Aripiprazole did not impair fertility based on data from reproductive toxicity studies. 
 
4.7 Effects on ability to drive and use machines 
 
Aripiprazole has minor to moderate influence on the ability to drive and use machines due to potential 
nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred, diplopia (see 
section 4.8). 



33 

 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most commonly reported adverse reactions in placebo-controlled trials were akathisia and nausea 
each occurring in more than 3% of patients treated with oral aripiprazole. 
 
Tabulated list of adverse reactions 
 
The incidences of the Adverse Drug Reactions (ADRs) associated with aripiprazole therapy are 
tabulated below. The table is based on adverse events reported during clinical trials and/or post-
marketing use. 
 
All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 
to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) 
and not known (cannot be estimated from the available data). Within each frequency grouping, 
adverse reactions are presented in order of decreasing seriousness. 
 
The frequency of adverse reactions reported during post-marketing use cannot be determined as they 
are derived from spontaneous reports. Consequently, the frequency of these adverse events is qualified 
as “not known”. 
 

 Common Uncommon Not known 
Blood and lymphatic 
system disorders 

  Leukopenia 
Neutropenia 
Thrombocytopenia 

Immune system 
disorders 

  Allergic reaction 
(e.g. anaphylactic reaction, 
angioedema including 
swollen tongue, tongue 
oedema, face oedema, 
pruritus allergic, or urticaria) 

Endocrine disorders  Hyperprolactinaemia Diabetic hyperosmolar coma 
Diabetic ketoacidosis 

Metabolism and 
nutrition disorders 

Diabetes mellitus Hyperglycaemia Hyponatremia 
Anorexia 

Psychiatric disorders Insomnia 
Anxiety 
Restlessness 

Depression 
Hypersexuality 

Suicide attempt, suicidal 
ideation and completed 
suicide (see section 4.4) 
Pathological gambling 
Impulse-control disorders 
Binge eating 
Compulsive shopping 
Poriomania 
Aggression 
Agitation 
Nervousness 

Nervous system 
disorders 

Akathisia 
Extrapyramidal 
disorder 
Tremor 

Tardive dyskinesia 
Dystonia 

Neuroleptic Malignant 
Syndrome 
Grand mal convulsion 
Serotonin syndrome 



34 

 Common Uncommon Not known 
Headache 
Sedation 
Somnolence 
Dizziness 

Speech disorder 

Eye disorders Vision blurred Diplopia 
Photophobia 

Oculogyric crisis 

Cardiac disorders  Tachycardia Sudden death unexplained 
Torsades de pointes 
Ventricular arrhythmias 
Cardiac arrest 
Bradycardia 

Vascular disorders  Orthostatic 
hypotension 

Venous thromboembolism 
(including pulmonary 
embolism and deep vein 
thrombosis) 
Hypertension 
Syncope 

Respiratory, thoracic 
and mediastinal 
disorders 

 Hiccups Aspiration pneumonia 
Laryngospasm 
Oropharyngeal spasm 

Gastrointestinal 
disorders 

Constipation 
Dyspepsia 
Nausea 
Salivary 
hypersecretion 
Vomiting 

 Pancreatitis 
Dysphagia 
Diarrhoea 
Abdominal discomfort 
Stomach discomfort 

Hepatobiliary 
disorders 

  Hepatic failure 
Hepatitis 
Jaundice 

Skin and 
subcutaneous tissue 
disorders 

  Rash 
Photosensitivity reaction 
Alopecia 
Hyperhidrosis 

Musculoskeletal and 
connective tissue 
disorders 

  Rhabdomyolysis 
Myalgia 
Stiffness 

Renal and urinary 
disorders 

  Urinary incontinence 
Urinary retention 

Pregnancy, 
puerperium and 
perinatal conditions 

  Drug withdrawal syndrome 
neonatal (see section 4.6) 

Reproductive system 
and breast disorders 

  Priapism 

General disorders 
and administration 
site conditions 

Fatigue  Temperature regulation 
disorder (e.g. hypothermia, 
pyrexia) 
Chest pain 
Peripheral oedema 

Investigations   Weight decreased  
Weight gain  



35 

 Common Uncommon Not known 
Alanine Aminotransferase 
increased 
Aspartate Aminotransferase 
increased 
Gamma-glutamyltransferase 
increased 
Alkaline phosphatase 
increased 
QT prolonged 
Blood glucose increased 
Glycosylated haemoglobin 
increased 
Blood glucose fluctuation 
Creatine phosphokinase 
increased 

 
Description of selected adverse reactions 
 
Adults 
 
Extrapyramidal symptoms (EPS) 
Schizophrenia – in a long term 52-week controlled trial, aripiprazole-treated patients had an overall-
lower incidence (25.8%) of EPS including Parkinsonism, akathisia, dystonia and dyskinesia compared 
with those treated with haloperidol (57.3%). In a long term 26-week placebo-controlled trial, 
the incidence of EPS was 19% for aripiprazole-treated patients and 13.1% for placebo-treated patients. 
In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated 
patients and 15.1% for olanzapine-treated patients. 
 
Manic episodes in Bipolar I Disorder – in a 12-week controlled trial, the incidence of EPS was 23.5% 
for aripiprazole-treated patients and 53.3% for haloperidol-treated patients. In another 12-week trial, 
the incidence of EPS was 26.6% for patients treated with aripiprazole and 17.6% for those treated with 
lithium. In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of 
EPS was 18.2% for aripiprazole-treated patients and 15.7% for placebo-treated patients. 
 
Akathisia 
In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole 
and 3.2% with placebo. In schizophrenia patients the incidence of akathisia was 6.2% with 
aripiprazole and 3.0% with placebo. 
 
Dystonia 
Class effect – Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in 
susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of 
the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty 
breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur 
more frequently and with greater severity with high potency and at higher doses of first generation 
antipsychotic medicinal products. An elevated risk of acute dystonia is observed in males and younger 
age groups. 
 
Prolactin 
In clinical trials for the approved indications and post-marketing, both increase and decrease in serum 
prolactin as compared to baseline was observed with aripiprazole (see section 5.1). 



36 

 
Laboratory parameters 
Comparisons between aripiprazole and placebo in the proportions of patients experiencing potentially 
clinically significant changes in routine laboratory and lipid parameters (see section 5.1) revealed 
no medically important differences. Elevations of CPK (Creatine Phosphokinase), generally transient 
and asymptomatic, were observed in 3.5% of aripiprazole treated patients as compared to 2.0% 
of patients who received placebo. 
 
Paediatric population 
 
Schizophrenia in adolescents aged 15 years and older 
In a short-term placebo-controlled clinical trial involving 302 adolescents (13 – 17 years) with 
schizophrenia, the frequency and type of adverse reactions were similar to those in adults except 
for the following reactions that were reported more frequently in adolescents receiving aripiprazole 
than in adults receiving aripiprazole (and more frequently than placebo): Somnolence/sedation and 
extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, 
and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10). 
The safety profile in a 26-week open-label extension trial was similar to that observed in the short-
term, placebo-controlled trial. 
The safety profile of a long-term, double-blind placebo controlled trial was also similar except 
for the following reactions that were reported more frequently than paediatric patients taking placebo: 
weight decreased, blood insulin increased, arrhythmia, and leukopenia were reported commonly 
(≥ 1/100, < 1/10). 
 
In the pooled adolescent schizophrenia population (13 – 17 years) with exposure up to 2 years, 
incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 29.5% and 
48.3%, respectively. In the adolescent (13 – 17 years) schizophrenia population with aripiprazole 
exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females 
(< 3 ng/ml) and males (< 2 ng/ml) was 25.6% and 45.0%, respectively. 
In two long term trials with adolescent (13 – 17 years) schizophrenia and bipolar patients treated with 
aripiprazole, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 
37.0 % and 59.4 %, respectively. 
 
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older 
The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar 
to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0%), 
extrapyramidal disorder (18.4%), akathisia (16.0%), and fatigue (11.8%); and commonly (≥ 1/100, 
< 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle 
twitching, and dyskinesia. 
 
The following adverse reactions had a possible dose response relationship; extrapyramidal disorder 
(incidences were 10 mg, 9.1%, 30 mg, 28.8%, placebo, 1.7%,); and akathisia (incidences were 10 mg, 
12.1%, 30 mg, 20.3%, placebo, 1.7%). 
 
Mean changes in body weight in adolescents with Bipolar I Disorder at 12 and 30 weeks 
for aripiprazole were 2.4 kg and 5.8 kg, and for placebo 0.2 kg and 2.3 kg, respectively. 
 
In the paediatric population somnolence and fatigue were observed more frequently in patients with 
bipolar disorder compared to patients with schizophrenia. 
 
In the paediatric bipolar population (10 – 17 years) with exposure up to 30 weeks, incidence of low 
serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0% and 53.3%, 
respectively. 



37 

 
Pathological gambling and other impulse control disorders 
Pathological gambling, hypersexuality, compulsive shopping and binge or compulsive eating can 
occur in patients treated with aripiprazole (see section 4.4). 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. 
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Signs and symptoms 
 
In clinical trials and post-marketing experience, accidental or intentional acute overdose 
of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg 
with no fatalities. The potentially medically important signs and symptoms observed included 
lethargy, increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea. 
In addition, reports of accidental overdose with aripiprazole alone (up to 195 mg) in children have 
been received with no fatalities. The potentially medically serious signs and symptoms reported 
included somnolence, transient loss of consciousness and extrapyramidal symptoms. 
 
Management of overdose 
 
Management of overdose should concentrate on supportive therapy, maintaining an adequate airway, 
oxygenation and ventilation, and management of symptoms. The possibility of multiple medicinal 
product involvement should be considered. Therefore cardiovascular monitoring should be started 
immediately and should include continuous electrocardiographic monitoring to detect possible 
arrhythmias. Following any confirmed or suspected overdose with aripiprazole, close medical 
supervision and monitoring should continue until the patient recovers. 
 
Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax 
by about 41% and AUC by about 51%, suggesting that charcoal may be effective in the treatment 
of overdose. 
 
Haemodialysis 
 
Although there is no information on the effect of haemodialysis in treating an overdose with 
aripiprazole, haemodialysis is unlikely to be useful in overdose management since aripiprazole 
is highly bound to plasma proteins. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


38 

Mechanism of action 
 
It has been proposed that aripiprazole’s efficacy in schizophrenia and Bipolar I Disorder is mediated 
through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and 
antagonism of serotonin 5-HT2A receptors. Aripiprazole exhibited antagonist properties in animal 
models of dopaminergic hyperactivity and agonist properties in animal models of dopaminergic 
hypoactivity. Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 
5-HT1A and 5-HT2A receptors and moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, 
alpha-1 adrenergic and histamine H1 receptors. Aripiprazole also exhibited moderate binding affinity 
for the serotonin reuptake site and no appreciable affinity for muscarinic receptors. Interaction with 
receptors other than dopamine and serotonin subtypes may explain some of the other clinical effects of 
aripiprazole. 
Aripiprazole doses ranging from 0.5 to 30 mg administered once a day to healthy subjects for 2 weeks 
produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor ligand, 
to the caudate and putamen detected by positron emission tomography. 
 
Clinical efficacy and safety 
 
Adults 
 
Schizophrenia 
In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult 
patients, presenting with positive or negative symptoms, aripiprazole was associated with statistically 
significantly greater improvements in psychotic symptoms compared to placebo. 
 
Aripiprazole is effective in maintaining the clinical improvement during continuation therapy in adult 
patients who have shown an initial treatment response. In a haloperidol-controlled trial, the proportion 
of responder patients maintaining response to medicinal product at 52-weeks was similar in both 
groups (aripiprazole 77% and haloperidol 73%). The overall completion rate was significantly higher 
for patients on aripiprazole (43%) than for haloperidol (30%). Actual scores in rating scales used 
as secondary endpoints, including PANSS and the Montgomery-Asberg Depression Rating Scale 
(MADRS) showed a significant improvement over haloperidol. 
In a 26-week, placebo-controlled trial in adult stabilised patients with chronic schizophrenia, 
aripiprazole had significantly greater reduction in relapse rate, 34% in aripiprazole group and 57% 
in placebo. 
 
Weight gain 
In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain. In a 26-
week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 
adult patients and where the primary end-point was weight gain, significantly less patients had at least 
7% weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg) 
on aripiprazole (N = 18, or 13% of evaluable patients), compared to olanzapine (N = 45, or 33% 
of evaluable patients). 
 
Lipid parameters 
In a pooled analysis on lipid parameters from placebo controlled clinical trials in adults, aripiprazole 
has not been shown to induce clinically relevant alterations in levels of total cholesterol, triglycerides, 
High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL). 
 



39 

Prolactin 
Prolactin levels were evaluated in all trials of all doses of aripiprazole (n = 28,242). The incidence 
of hyperprolactinaemia or increased serum prolactin in patients treated with aripiprazole (0.3%) was 
similar to that of placebo (0.2%). For patients receiving aripiprazole, the median time to onset was 42 
days and median duration was 34 days. 
 
The incidence of hypoprolactinaemia or decreased serum prolactin in patients treated with aripiprazole 
was 0.4%, compared with 0.02% for patients treated with placebo. For patients receiving aripiprazole, 
the median time to onset was 30 days and median duration was 194 days. 
 
Manic episodes in Bipolar I Disorder 
In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or 
mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo 
in reduction of manic symptoms over 3 weeks. These trials included patients with or without psychotic 
features and with or without a rapid-cycling course. 
In one 3-week, fixed-dose, placebo-controlled monotherapy trial involving patients with a manic 
or mixed episode of Bipolar I Disorder, aripiprazole failed to demonstrate superior efficacy to placebo. 
 
In two 12-week, placebo- and active-controlled monotherapy trials in patients with a manic or mixed 
episode of Bipolar I Disorder, with or without psychotic features, aripiprazole demonstrated superior 
efficacy to placebo at week 3 and a maintenance of effect comparable to lithium or haloperidol 
at week 12. Aripiprazole also demonstrated a comparable proportion of patients in symptomatic 
remission from mania as lithium or haloperidol at week 12. 
 
In a 6-week, placebo-controlled trial involving patients with a manic or mixed episode of Bipolar I 
Disorder, with or without psychotic features, who were partially non-responsive to lithium 
or valproate monotherapy for 2 weeks at therapeutic serum levels, the addition of aripiprazole 
as adjunctive therapy resulted in superior efficacy in reduction of manic symptoms than lithium 
or valproate monotherapy. 
 
In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who 
achieved remission on aripiprazole during a stabilization phase prior to randomisation, aripiprazole 
demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing 
recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into 
depression. 
 
In a 52-week, placebo-controlled trial, in patients with a current manic or mixed episode of Bipolar I 
Disorder who achieved sustained remission (Young Mania Rating Scale [YMRS]  and MADRS with 
total scores ≤ 12) on aripiprazole (10 mg/day to 30 mg/day) adjunctive to lithium or valproate for 12 
consecutive weeks, adjunctive aripiprazole demonstrated superiority over placebo with a 46% 
decreased risk (hazard ratio of 0.54) in preventing bipolar recurrence and a 65% decreased risk (hazard 
ratio of 0.35) in preventing recurrence into mania over adjunctive placebo but failed to demonstrate 
superiority over placebo in preventing recurrence into depression. Adjunctive aripiprazole 
demonstrated superiority over placebo on the secondary outcome measure in Clinical Global 
Impression - Bipolar version (CGI-BP) Severity of Illness (SOI; mania) score . 
In this trial, patients were assigned by investigators with either open-label lithium or valproate 
monotherapy to determine partial non-response. Patients were stabilised for at least 12 consecutive 
weeks with the combination of aripiprazole and the same mood stabilizer. 
Stabilized patients were then randomised to continue the same mood stabilizer with double-blind 
aripiprazole or placebo. Four mood stabilizer subgroups were assessed in the randomised phase: 
aripiprazole + lithium; aripiprazole + valproate; placebo + lithium; placebo + valproate. 



40 

The Kaplan-Meier rates for recurrence to any mood episode for the adjunctive treatment arm were 
16% in aripiprazole + lithium and 18% in aripiprazole + valproate compared to 45% in placebo + 
lithium and 19% in placebo + valproate. 
 
Paediatric population 
 
Schizophrenia in adolescents 
In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13 – 17 years), 
presenting with positive or negative symptoms, aripiprazole was associated with statistically 
significantly greater improvements in psychotic symptoms compared to placebo. In a sub-analysis 
of the adolescent patients between the ages of 15 to 17 years, representing 74% of the total enrolled 
population, maintenance of effect was observed over the 26-week open-label extension trial. 
 
In a 60- to 89-week, randomised, double-blind, placebo-controlled trial in adolescent subjects 
(n = 146; ages 13 – 17 years) with schizophrenia, there was a statistically significant difference 
in the rate of relapse of psychotic symptoms between the aripiprazole (19.39%) and placebo (37.50%) 
groups. The point estimate of the hazard ratio (HR) was 0.461 (95% confidence interval, 
0.242 – 0.879) in the full population. In subgroup analyses the point estimate of the HR was 0.495 
for subjects 13 to 14 years of age compared to 0.454 for subjects 15 to 17 years of age. However, 
the estimation of the HR for the younger (13 – 14 years) group was not precise, reflecting the smaller 
number of subjects in that group (aripiprazole, n = 29; placebo, n = 12), and the confidence interval for 
this estimation (ranging from 0.151 to 1.628) did not allow conclusions to be drawn on the presence of 
a treatment effect. In contrast the 95% confidence interval for the HR in the older subgroup 
(aripiprazole, n = 69; placebo, n = 36) was 0.242 to 0.879 and hence a treatment effect could be 
concluded in the older patients. 
 
Manic episodes in Bipolar I Disorder in children and adolescents 
Aripiprazole was studied in a 30-week placebo-controlled trial involving 296 children and adolescents 
(10 – 17 years), who met DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders) for 
Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a Y-MRS 
score ≥ 20 at baseline. Among the patients included in the primary efficacy analysis, 139 patients had 
a current co-morbid diagnosis of ADHD. 
 
Aripiprazole was superior to placebo in change from baseline at week 4 and at week 12 on the Y-MRS 
total score. In a post-hoc analysis, the improvement over placebo was more pronounced in the patients 
with associated co-morbidity of ADHD compared to the group without ADHD, where there was no 
difference from placebo. Recurrence prevention was not established. 
 
The most common treatment-emergent adverse events among patients receiving 30 mg were 
extrapyramidal disorder (28.3%), somnolence (27.3%), headache (23.2%), and nausea (14.1%). Mean 
weight gain in the 30 weeks treatment-interval was 2.9 kg as compared to 0.98 kg in patients treated 
with placebo. 
 
Irritability associated with autistic disorder in paediatric patients (see section 4.2) 
Aripiprazole was studied in patients aged 6 to 17 years in two 8-week, placebo-controlled trials [one 
flexible-dose (2 – 15 mg/day) and one fixed-dose (5, 10, or 15 mg/day)] and in one 52-week open-
label trial. Dosing in these trials was initiated at 2 mg/day, increased to 5 mg/day after one week, and 
increased by 5 mg/day in weekly increments to the target dose. Over 75% of patients were less than 13 
years of age. Aripiprazole demonstrated statistically superior efficacy compared to placebo 
on the Aberrant Behaviour Checklist Irritability subscale. However, the clinical relevance of this 
finding has not been established. The safety profile included weight gain and changes in prolactin 
levels. The duration of the long-term safety study was limited to 52 weeks. In the pooled trials, 



41 

the incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) 
in aripiprazole-treated patients was 27/46 (58.7%) and 258/298 (86.6%), respectively. In the placebo-
controlled trials, the mean weight gain was 0.4 kg for placebo and 1.6 kg for aripiprazole. 
 
Aripiprazole was also studied in a placebo-controlled, long-term maintenance trial. After a 13 - 26 
week stabilisation on aripiprazole (2 – 15 mg/day) patients with a stable response were either 
maintained on aripiprazole or substituted to placebo for further 16 weeks. Kaplan-Meier relapse rates 
at week 16 were 35% for aripiprazole and 52% for placebo; the hazard ratio for relapse within 
16 weeks (aripiprazole/placebo) was 0.57 (non-statistically significant difference). The mean weight 
gain over the stabilisation phase (up to 26 weeks) on aripiprazole was 3.2 kg, and a further mean 
increase of 2.2 kg for aripiprazole as compared to 0.6 kg for placebo was observed in the second phase 
(16 weeks) of the trial. Extrapyramidal symptoms were mainly reported during the stabilisation phase 
in 17% of patients, with tremor accounting for 6.5%. 
 
Tics associated with Tourette’s disorder in paediatric patients (see section 4.2) 
The efficacy of aripiprazole was studied in paediatric subjects with Tourette’s disorder (aripiprazole: n 
= 99, placebo: n = 44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed 
dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting 
dose of 2 mg. Patients were 7 – 17 years of age and presented an average score of 30 on Total Tic 
Score on the Yale Global Tic Severity Scale (TTS-YGTSS) at baseline. Aripiprazole showed an 
improvement on TTS-YGTSS change from baseline to week 8 of 13.35 for the low dose group (5 mg 
or 10 mg) and 16.94 for the high dose group (10 mg or 20 mg) as compared with an improvement of 
7.09 in the placebo group. 
 
The efficacy of aripiprazole in paediatric subjects with Tourette’s syndrome (aripiprazole: n = 32, 
placebo: n = 29) was also evaluated over a flexible dose range of 2 mg/day to 20 mg/day and a starting 
dose of 2 mg, in a 10 week, randomised, double blind, placebo-controlled study conducted in South-
Korea. Patients were 6 - 18 years and presented an average score of 29 on TTS-YGTSS at baseline. 
Aripiprazole group showed an improvement of 14.97 on TTS-YGTSS change from baseline to week 
10 as compared with an improvement of 9.62 in the placebo group. 
 
In both of these short term trials, the clinical relevance of the efficacy findings has not been 
established, considering the magnitude of treatment effect compared to the large placebo effect and the 
unclear effects regarding psycho-social functioning. No long term data are available with regard to the 
efficacy and the safety of aripiprazole in this fluctuating disorder. 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
the reference medicinal product containing aripiprazole in one or more subsets of the paediatric 
population in the treatment of schizophrenia and in the treatment of bipolar affective disorder 
(see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3 – 5 hours after 
dosing. Aripiprazole undergoes minimal pre-systemic metabolism. The absolute oral bioavailability 
of the tablet formulation is 87%. There is no effect of a high fat meal on the pharmacokinetics 
of aripiprazole. 
 



42 

Distribution 
 
Aripiprazole is widely distributed throughout the body with an apparent volume of distribution 
of 4.9 l/kg, indicating extensive extravascular distribution. At therapeutic concentrations, aripiprazole 
and dehydro-aripiprazole are greater than 99% bound to serum proteins, binding primarily to albumin. 
 
Biotransformation 
 
Aripiprazole is extensively metabolised by the liver primarily by three biotransformation pathways: 
dehydrogenation, hydroxylation, and N-dealkylation. Based on in vitro studies, CYP3A4 and CYP2D6 
enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is 
catalysed by CYP3A4. Aripiprazole is the predominant medicinal product moiety in systemic 
circulation. At steady state, dehydro-aripiprazole, the active metabolite, represents about 40% of 
aripiprazole AUC in plasma. 
 
Elimination 
 
The mean elimination half-lives for aripiprazole are approximately 75 hours in extensive metabolisers 
of CYP2D6 and approximately 146 hours in poor metabolisers of CYP2D6. 
 
The total body clearance of aripiprazole is 0.7 ml/min/kg, which is primarily hepatic. 
 
Following a single oral dose of [14C]-labelled aripiprazole, approximately 27% of the administered 
radioactivity was recovered in the urine and approximately 60% in the faeces. Less than 1% 
of unchanged aripiprazole was excreted in the urine and approximately 18% was recovered unchanged 
in the faeces. 
 
Paediatric population 
The pharmacokinetics of aripiprazole and dehydro-aripiprazole in paediatric patients 10 to 17 years 
of age were similar to those in adults after correcting for the differences in body weights. 
 
Pharmacokinetics in special patient groups 
 
Elderly 
There are no differences in the pharmacokinetics of aripiprazole between healthy elderly and younger 
adult subjects, nor is there any detectable effect of age in a population pharmacokinetic analysis 
in schizophrenic patients. 
 
Gender 
There are no differences in the pharmacokinetics of aripiprazole between healthy male and female 
subjects nor is there any detectable effect of gender in a population pharmacokinetic analysis 
in schizophrenic patients. 
 
Smoking 
Population pharmacokinetic evaluation has revealed no evidence of clinically significant effects from 
smoking on the pharmacokinetics of aripiprazole. 
 
Race 
Population pharmacokinetic evaluation showed no evidence of race-related differences 
on the pharmacokinetics of aripiprazole. 
 



43 

Renal impairment 
The pharmacokinetic characteristics of aripiprazole and dehydro-aripiprazole were found to be similar 
in patients with severe renal disease compared to young healthy subjects. 
 
Hepatic impairment 
A single-dose study in subjects with varying degrees of liver cirrhosis (Child-Pugh Classes A, B, and 
C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of aripiprazole 
and dehydro-aripiprazole, but the study included only 3 patients with Class C liver cirrhosis, which 
is insufficient to draw conclusions on their metabolic capacity. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction 
and development. 
 
Toxicologically significant effects were observed only at doses or exposures that were sufficiently 
in excess of the maximum human dose or exposure, indicating that these effects were limited 
or of no relevance to clinical use. These included: dose-dependent adrenocortical toxicity (lipofuscin 
pigment accumulation and/or parenchymal cell loss) in rats after 104 weeks at 20 to 60 mg/kg/day 
(3 to 10 times the mean steady-state AUC at the maximum recommended human dose) and increased 
adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas in female rats 
at 60 mg/kg/day (10 times the mean steady-state AUC at the maximum recommended human dose). 
The highest non-tumorigenic exposure in female rats was 7 times the human exposure 
at the recommended dose. 
 
An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates 
of hydroxy metabolites of aripiprazole in the bile of monkeys after repeated oral dosing 
at 25 to 125 mg/kg/day (1 to 3 times the mean steady-state AUC at the maximum recommended 
clinical dose or 16 to 81 times the maximum recommended human dose based on mg/m2). However, 
the concentrations of the sulphate conjugates of hydroxy aripiprazole in human bile at the highest dose 
proposed, 30 mg per day, were no more than 6% of the bile concentrations found in the monkeys in 
the 39-week study and are well below (6%) their limits of in vitro solubility. 
 
In repeat-dose studies in juvenile rats and dogs, the toxicity profile of aripiprazole was comparable 
to that observed in adult animals, and there was no evidence of neurotoxicity or adverse reactions 
on development. 
 
Based on results of a full range of standard genotoxicity tests, aripiprazole was considered non-
genotoxic. Aripiprazole did not impair fertility in reproductive toxicity studies. Developmental 
toxicity, including dose-dependent delayed foetal ossification and possible teratogenic effects, were 
observed in rats at doses resulting in subtherapeutic exposures (based on AUC) and in rabbits at doses 
resulting in exposures 3 and 11 times the mean steady-state AUC at the maximum recommended 
clinical dose. Maternal toxicity occurred at doses similar to those eliciting developmental toxicity. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Lactose monohydrate 
Microcrystalline cellulose 
Crospovidone 



44 

Hydroxypropyl cellulose 
Silica colloidal anhydrous 
Croscarmellose sodium 
Acesulfame potassium 
Mango flavour 
Magnesium stearate 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
OPA/Alu/PVC/Alu foil blisters (Alu-Alu blister), carton box. 
Pack size: 14, 28 or 49 orodispersible tablets 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Aripiprazole Zentiva 10 mg orodispersible tablets 
 
EU/1/15/1009/021 
EU/1/15/1009/022 
EU/1/15/1009/023 
 
Aripiprazole Zentiva 15 mg orodispersible tablets 
 
EU/1/15/1009/024 
EU/1/15/1009/025 
EU/1/15/1009/026 



45 

 
Aripiprazole Zentiva 30 mg orodispersible tablets 
 
EU/1/15/1009/027 
EU/1/15/1009/028 
EU/1/15/1009/029 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 25 June 2015 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
  

http://www.ema.europa.eu/


46 

 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 

 
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
  



47 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
Zentiva SA 
50 Theodor Pallady Blvd. 
District 3, 032266 
Bucuresti 
Romania 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports  
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile 
or as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached. 

 
 
 
 
  



48 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



49 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



50 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 5 mg tablets 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 5 mg of aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
14 tablets 
28 tablets 
49 tablets 
56 tablets 
98 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 



51 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1009/001 
EU/1/15/1009/002 
EU/1/15/1009/003 
EU/1/15/1009/004 
EU/1/15/1009/005 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aripiprazole Zentiva 5 mg tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



52 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



53 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 5 mg tablets 
aripiprazole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



54 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 10 mg tablets 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 10 mg of aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
14 tablets 
28 tablets 
49 tablets 
56 tablets 
98 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 



55 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1009/006 
EU/1/15/1009/007 
EU/1/15/1009/008 
EU/1/15/1009/009 
EU/1/15/1009/010 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aripiprazole Zentiva 10 mg tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



56 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



57 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 10 mg tablets 
aripiprazole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



58 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 15 mg tablets 
aripiprazole 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 15 mg of aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
14 tablets 
28 tablets 
49 tablets 
56 tablets 
98 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 



59 

 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1009/011 
EU/1/15/1009/012 
EU/1/15/1009/013 
EU/1/15/1009/014 
EU/1/15/1009/015 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aripiprazole Zentiva 15 mg tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



60 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



61 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 15 mg tablets 
aripiprazole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



62 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 30 mg tablets 
aripiprazole 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 30 mg of aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
14 tablets 
28 tablets 
49 tablets 
56 tablets 
98 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 



63 

 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1009/016 
EU/1/15/1009/017 
EU/1/15/1009/018 
EU/1/15/1009/019 
EU/1/15/1009/020 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aripiprazole Zentiva 30 mg tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



64 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



65 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 30 mg tablets 
aripiprazole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



66 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 10 mg orodispersible tablets 
aripiprazole 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each orodipersible tablet contains 10 mg of aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Orodispersible tablet 
 
14 orodispersible tablets 
28 orodispersible tablets 
49 orodispersible tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 



67 

 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1009/021 
EU/1/15/1009/022 
EU/1/15/1009/023 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aripiprazole Zentiva 10 mg orodispersible tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN  



68 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 10 mg orodispersible tablets 
aripiprazole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



69 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 15 mg orodispersible tablets 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each orodipersible tablet contains 15 mg of aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Orodispersible tablet 
 
14 orodispersible tablets 
28 orodispersible tablets 
49 orodispersible tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



70 

9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1009/024 
EU/1/15/1009/025 
EU/1/15/1009/026 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aripiprazole Zentiva 15 mg orodispersible tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



71 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 15 mg orodispersible tablets 
aripiprazole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



72 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 30 mg orodispersible tablets 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each orodipersible tablet contains 30 mg of aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Orodispersible tablet 
 
14 orodispersible tablets 
28 orodispersible tablets 
49 orodispersible tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



73 

9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1009/027 
EU/1/15/1009/028 
EU/1/15/1009/029 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aripiprazole Zentiva 30 mg orodispersible tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



74 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aripiprazole Zentiva 30 mg orodispersible tablets 
aripiprazole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



75 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



76 

Package leaflet: Information for the user 
 

Aripiprazole Zentiva 5 mg tablets 
Aripiprazole Zentiva 10 mg tablets 
Aripiprazole Zentiva 15 mg tablets 
Aripiprazole Zentiva 30 mg tablets 

aripiprazole 
 

Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Aripiprazole Zentiva is and what it is used for 
2. What you need to know before you take Aripiprazole Zentiva 
3. How to take Aripiprazole Zentiva 
4. Possible side effects 
5. How to store Aripiprazole Zentiva 
6. Contents of the pack and other information 
 
 
1. What Aripiprazole Zentiva is and what it is used for 
 
Aripiprazole Zentiva contains the active substance aripiprazole and belong to a group of medicines 
called antipsychotics. 
It is used to treat adults and adolescents aged 15 years and older who suffer from a disease 
characterised by symptoms such as hearing, seeing or sensing things which are not there, 
suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with 
this condition may also feel depressed, guilty, anxious or tense. 
 
Aripiprazole Zentiva is used to treat adults and adolescents aged 13 years and older who suffer from 
a condition with symptoms such as feeling “high”, having excessive amounts of energy, needing much 
less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In adults 
it also prevents this condition from returning in patients who have responded to the treatment with 
Aripiprazole Zentiva. 
 
 
2. What you need to know before you take Aripiprazole Zentiva 
 
Do not take Aripiprazole Zentiva 
• if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed 

in section 6). 
 
Warnings and precautions 
Talk to your doctor before taking Aripiprazole Zentiva. 
Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor 
immediately if you are having any thoughts or feelings about hurting yourself. 



77 

 
Before treatment with Aripiprazole Zentiva, tell your doctor if you suffer from 
• high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts 

of urine, increase in appetite and feeling weak) or family history of diabetes 
• fits (seizures) since your doctor may want to monitor you more closely 
• involuntary, irregular muscle movements, especially in the face 
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular 

disease, stroke or “mini” stroke, abnormal blood pressure 
• blood clots, or family history of blood clots, as antipsychotics have been associated with 

formation of blood clots 
• past experience with excessive gambling. 
 
If you notice you are gaining weight, develop unusual movements, experience somnolence that 
interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell 
your doctor. 
 
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), 
you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke. 
 
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself. 
Suicidal thoughts and behaviours have been reported during aripiprazole treatment. 
 
Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, 
sweating, altered mental status, or very rapid or irregular heart beat. 
 
Tell your doctor if you or your family/carer notices that you are developing urges or cravings 
to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation 
to carry out certain activities that could harm yourself or others. These are called impulse control 
disorders and can include behaviours such as addictive gambling, excessive eating or spending, 
an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings. 
Your doctor may need to adjust or stop your dose. 
 
Aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in 
your ability to move and balance, which may lead to falls. Caution should be taken, particularly if you 
are an elderly patient or have some debility. 
 
Children and adolescents 
Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe 
and effective in these patients. 
 
Other medicines and Aripiprazole Zentiva 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines, including medicines obtained without a prescription. 
 
Blood pressure-lowering medicines: Aripiprazole Zentiva may increase the effect of medicines used to 
lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood 
pressure under control. 
 
Taking Aripiprazole Zentiva with some medicines may mean the doctor will need to change your dose 
of Aripiprazole Zentiva or the other medicines. It is especially important to mention the following 
to your doctor: 
• Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide) 



78 

• Antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, 
paroxetine, venlafaxine, St. Johnʼs Wort) 

• Antifungal medicines (such as ketoconazole, itraconazole) 
• Certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors 

e.g. indinavir, ritonavir) 
• Anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital) 
• Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin) 
 
These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Zentiva; 
if you get any unusual symptom taking any of these medicines together with Aripiprazole Zentiva, you 
should see your doctor. 
 
Medicines that increase the level of serotonin are typically used in conditions including depression, 
generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well 
as migraine and pain: 
• Triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety 

disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain 
• Selective-serotonin-reuptake-inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for 

depression, OCD, panic and anxiety 
• Other anti-depressants (such as venlafaxine and tryptophan) used in major depression 
• Tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness 
• St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression 
• Pain killers (such as tramadol and pethidine) used for pain relief 
• Triptans (such as sumatriptan and zolmitripitan) used for treating migraine 
 
These medicines may increase the risk of side effects; if you get any unusual symptom taking any 
of these medicines together with Aripiprazole Zentiva, you should see your doctor. 
 
Aripiprazole Zentiva with food, drink and alcohol 
This medicine can be taken regardless of meals. 
Alcohol should be avoided. 
 
Pregnancy, breast-feeding and fertility 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, 
ask your doctor for advice before taking this medicine. 
The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole 
Zentiva in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or 
weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops 
any of these symptoms you may need to contact your doctor. 
If you are taking Aripiprazole Zentiva, your doctor will discuss with you whether you should breast 
feed considering the benefit to you of your therapy and the benefit to your baby of breast feeding. 
You should not do both. Talk to your doctor about the best way to feed your baby if you are taking this 
medicine. 
 
Driving and using machines 
Dizziness and vision problems may occur during treatment with this medicine (see section 4). This 
should be considered in cases where full alertness is required, e.g. when driving a car or handling 
machines. 
 
Aripiprazole Zentiva contains lactose 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product. 

http://en.wikipedia.org/wiki/Major_depressive_disorder
http://en.wikipedia.org/wiki/Generalized_anxiety_disorder
http://en.wikipedia.org/wiki/Social_anxiety_disorder


79 

 
Aripiprazole Zentiva contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’. 
 
 
3. How to take Aripiprazole Zentiva 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The recommended dose for adults is 15 mg once a day. However your doctor may prescribe a lower 
or higher dose to a maximum of 30 mg once a day. 
 
Use in children and adolescents 
This medicinal product may be started at a low dose with the oral solution (liquid) form. The dose may 
be gradually increased to the recommended dose for adolescents of 10 mg once a day. However your 
doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day. 
 
If you have the impression that the effect of Aripiprazole Zentiva is too strong or too weak, talk 
to your doctor or pharmacist. 
 
Try to take Aripiprazole Zentiva at the same time each day. It does not matter whether you take it 
with or without food. Always take the tablet with water and swallow it whole. 
 
Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole Zentiva without first 
consulting your doctor. 
 
Aripiprazole Zentiva 10 mg, 30 mg tablets: The score line is not intended for breaking the tablet. 
 
If you take more Aripiprazole Zentiva than you should 
If you realise you have taken more Aripiprazole Zentiva than your doctor has recommended 
(or if someone else has taken some of your Aripiprazole Zentiva), contact your doctor right away. 
If you cannot reach your doctor, go to the nearest hospital and take the pack with you. 
Patients who have taken too much aripiprazole have experienced the following symptoms: 
• Rapid heartbeat, agitation/aggressiveness, problems with speech. 
• Unusual movements (especially of the face or tongue) and reduced level of consciousness. 
 
Other symptoms may include: 
• Acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, 
• Muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood 

pressure, abnormal rhythms of the heart. 
Contact your doctor or hospital immediately if you experience any of the above. 
 
If you forget to take Aripiprazole Zentiva 
If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one 
day. 
 
If you stop taking Aripiprazole Zentiva 
Do not stop your treatment just because you feel better. It is important that you carry on taking 
Aripiprazole Zentiva for as long as your doctor has told you to. 
 



80 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Common side effects (may affect up to 1 in 10 people): 
• diabetes mellitus, 
• difficulty sleeping, 
• feeling anxious, 
• feeling restless and unable to keep still, difficulty sitting still, 
• uncontrollable twitching, jerking or writhing movements, restless legs, 
• trembling, 
• headache, 
• tiredness, 
• sleepiness, 
• light-headedness, 
• shaking and blurred vision, 
• decreased number of or difficulty making bowel movements, 
• indigestion, 
• feeling sick, 
• more saliva in mouth than normal, 
• vomiting, 
• feeling tired. 
 
Uncommon side effects (may affect up to 1 in 100 people): 
• increased blood levels of the hormone prolactin, 
• too much sugar in the blood, 
• depression, 
• altered or increased sexual interest, 
• uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia), 
• muscle disorder causing twisting movements (dystonia), 
• double vision, 
• eye sensitivity to light, 
• fast heart beat, 
• a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting, 
• hiccups. 
 
The following side effects have been reported since the marketing of oral aripiprazole but the 
frequency for them to occur is not known: 
• low levels of white blood cells, 
• low levels of blood platelets, 
• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), 
• onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, 
• high blood sugar, 
• not enough sodium in the blood, 
• loss of appetite (anorexia), 
• weight loss, 
• weight gain, 



81 

• thoughts of suicide, suicide attempt and suicide; 
• feeling aggressive, 
• agitation, 
• nervousness, 
• combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and 

sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome), 
• seizure, 
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, 

clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), 
• speech disorder, 
• fixation of the eyeballs in one position, 
• sudden unexplained death, 
• life-threatening irregular heart beat, 
• heart attack, 
• slower heart beat, 
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in 

the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in 
breathing (if you notice any of these symptoms, seek medical advice immediately), 

• high blood pressure, 
• fainting, 
• accidental inhalation of food with risk of pneumonia (lung infection), 
• spasm of the muscles around the voice box, 
• inflammation of the pancreas, 
• difficulty swallowing, 
• diarrhoea, 
• abdominal discomfort, 
• stomach discomfort, 
• liver failure, 
• inflammation of the liver, 
• yellowing of the skin and white part of eyes, 
• reports of abnormal liver tests values; 
• skin rash, 
• skin sensitivity to light, 
• baldness, 
• excessive sweating, 
• abnormal muscle breakdown which can lead to kidney problems, 
• muscle pain, 
• stiffness, 
• involuntary loss of urine (incontinence), 
• difficulty in passing urine; 
• withdrawal symptoms in newborn babies in case of exposure during pregnancy, 
• prolonged and/or painful erection, 
• difficulty controlling core body temperature or overheating, 
• chest pain, 
• swelling of hands, ankles or feet, 
• in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin. 
• inability to resist the impulse, drive or temptation to perform an action that could be harmful 

to you or others, which may include: 
- strong impulse to gamble excessively despite serious personal or family consequences 
- altered or increased sexual interest and behaviour of significant concern to you or to 



82 

others, for example, an increased sexual drive 
- uncontrollable excessive shopping 
- binge eating (eating large amounts of food in a short time period) or compulsive eating 

(eating more food than normal and more than is needed to satisfy your hunger) 
- a tendency to wander away. 
Tell your doctor if you experience any of these behaviours; he/she will discuss ways 
of managing or reducing the symptoms. 
 

In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. 
In addition, cases of stroke or “mini” stroke have been reported. 
 
Additional side effects in children and adolescents 
Adolescents aged 13 years and older experienced side effects that were similar in frequency and type 
to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, 
and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, 
increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the 
limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common 
(greater than 1 in 100 patients). 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Aripiprazole Zentiva 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. 
The expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how 
to throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Aripiprazole Zentiva contains 
The active substance is aripiprazole. Each tablet contains 5 mg/10 mg/15 mg/30 mg of aripiprazole. 
The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, 
hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, magnesium stearate. 
 
What Aripiprazole Zentiva looks like and contents of the pack 
Aripiprazole Zentiva 5 mg are white to off-white round flat bevel edged uncoated tablets with ‘5’ 
debossed on one side and plain on the other side with diameter approx. 6 mm. 
 
Aripiprazole Zentiva 10 mg tablets are white to off-white round uncoated tablets with ‘10’ debossed 
on one side and snap tab breakline on the other side with diameter approx. 8 mm. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


83 

Aripiprazole Zentiva 15 mg tablets are white to off-white round flat bevel edged uncoated tablets with 
‘15’ debossed on one side and plain on the other side with diameter approx. 8.8 mm. 
 
Aripiprazole Zentiva 30 mg tablets are white to off-white capsule shaped uncoated tablets with ‘30’ 
debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm. 
 
Pack size: 14, 28, 49, 56, or 98 tablets 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
Manufacturer 
S.C. Zentiva S.A. 
50 Theodor Pallady Blvd. 
Bucharest 032266 
Romania 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Zentiva, k.s. 
Tél/Tel: +32 280 86 420 
PV-Belgium@zentiva.com 

Lietuva 
Zentiva, k.s. 
Tel: +370 52152025 
PV-Lithuania@zentiva.com 

България 
Zentiva, k.s. 
Тел: + 359 2 805 72 08 
PV-Bulgaria@zentiva.com 

Luxembourg/Luxemburg 
Zentiva, k.s. 
Tél/Tel: +352 208 82330 
PV-Luxembourg@zentiva.com 

Česká republika 
Zentiva, k.s. 
Tel: +420 267 241 111 
PV-Czech-Republic@zentiva.com 

Magyarország 
Zentiva, k.s. 
Tel.: +36 165 55 722 
PV-Hungary@zentiva.com 

Danmark 
Zentiva, k.s. 
Tlf: +45 787 68 400 
PV-Denmark@zentiva.com 

Malta 
Zentiva, k.s. 
Tel: +356 277 82 052 
PV-Malta@zentiva.com 

Deutschland 
Zentiva Pharma GmbH  
Tel: +49 (0) 800 53 53 010 
PV-Germany@zentiva.com 

Nederland 
Zentiva, k.s. 
Tel: +31 202 253 638 
PV-Netherlands@zentiva.com 

Eesti 
Zentiva, k.s. 
Tel: +372 52 70308 
PV-Estonia@zentiva.com 

Norge 
Zentiva, k.s. 
Tlf: +47 219 66 203 
PV-Norway@zentiva.com 



84 

Ελλάδα 
Zentiva, k.s. 
Τηλ: +30 211 198 7510 
PV-Greece@zentiva.com 

Österreich 
Zentiva, k.s. 
Tel: +43 720 778 877 
PV-Austria@zentiva.com 

España 
Zentiva, k.s. 
Tel: +34 931 815 250 
PV-Spain@zentiva.com 

Polska 
Zentiva Polska Sp. z o.o. 
Tel: + 48 22 375 92 00 
PV-Poland@zentiva.com 

France 
Zentiva France 
Tél: +33 (0) 800 089 219  
PV-France@zentiva.com 

Portugal 
Zentiva Portugal, Lda 
Tel: +351210601360 
PV-Portugal@zentiva.com 

Hrvatska 
Zentiva, k.s. 
Tel: +385 155 17 772 
PV-Croatia@zentiva.com 

România 
ZENTIVA S.A. 
Tel: +40 021.304.7597 
zentivaRO@zentiva.com 

Ireland 
Zentiva, k.s. 
Tel: +353 766 803 944 
PV-Ireland@zentiva.com 

Slovenija 
Zentiva, k.s. 
Tel: +386 360 00 408 
PV-Slovenia@zentiva.com 

Ísland 
Zentiva, k.s. 
Sími: +354 539 0650 
PV-Iceland@zentiva.com 

Slovenská republika 
Zentiva, a.s. 
Tel: +421 2 3918 3010 
PV-Slovakia@zentiva.com 

Italia 
Zentiva Italia S.r.l. 
Tel: +39-02-38598801 
PV-Italy@zentiva.com 

Suomi/Finland 
Zentiva, k.s. 
Puh/Tel: +358 942 598 648 
PV-Finland@zentiva.com 

Κύπρος 
Zentiva, k.s. 
Τηλ: +357 240 30 144 
PV-Cyprus@zentiva.com 

Sverige 
Zentiva, k.s. 
Tel: +46 840 838 822 
PV-Sweden@zentiva.com 

Latvija 
Zentiva, k.s. 
Tel: +371 67893939 
PV-Latvia@zentiva.com 

United Kingdom 
Zentiva Pharma UK Limited 
Tel: +44 (0) 845 372 7101 
PV-United-Kingdom@zentiva.com 

 
This leaflet was last revised in 
 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

http://www.ema.europa.eu/


85 

Package leaflet: Information for the user 
 

Aripiprazole Zentiva 10 mg orodispersible tablets 
Aripiprazole Zentiva 15 mg orodispersible tablets 
Aripiprazole Zentiva 30 mg orodispersible tablets 

aripiprazole 
 

Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Aripiprazole Zentiva is and what they are used for 
2. What you need to know before you take Aripiprazole Zentiva 
3. How to take Aripiprazole Zentiva 
4. Possible side effects 
5. How to store Aripiprazole Zentiva 
6. Contents of the pack and other information 
 
 
1. What Aripiprazole Zentiva is and what it is used for 
 
Aripiprazole Zentiva contains the active substance aripiprazole and belong to a group of medicines 
called antipsychotics. 
It is used to treat adults and adolescents aged 15 years and older who suffer from a disease 
characterised by symptoms such as hearing, seeing or sensing things which are not there, 
suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with 
this condition may also feel depressed, guilty, anxious or tense. 
 
Aripiprazole Zentiva is used to treat adults and adolescents aged 13 years and older who suffer from 
a condition with symptoms such as feeling “high”, having excessive amounts of energy, needing much 
less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In adults 
it also prevents this condition from returning in patients who have responded to the treatment with 
Aripiprazole Zentiva. 
 
 
2. What you need to know before you take Aripiprazole Zentiva 
 
Do not take Aripiprazole Zentiva 
• if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed 

in section 6). 
 
Warnings and precautions 
Talk to your doctor before taking Aripiprazole Zentiva. 
 
Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor 
immediately if you are having any thoughts or feelings about hurting yourself. 
 



86 

Before treatment with Aripiprazole Zentiva, tell your doctor if you suffer from 
• high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts 

of urine, increase in appetite and feeling weak) or family history of diabetes 
• fits (seizures) since your doctor may want to monitor you more closely 
• involuntary, irregular muscle movements, especially in the face 
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular 

disease, stroke or “mini” stroke, abnormal blood pressure 
• blood clots, or family history of blood clots, as antipsychotics have been associated with 

formation of blood clots 
• past experience with excessive gambling 
If you notice you are gaining weight, develop unusual movements, experience somnolence that 
interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell 
your doctor. 
 
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you 
or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke. 
 
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself. 
Suicidal thoughts and behaviours have been reported during aripiprazole treatment. 
 
Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, 
sweating, altered mental status, or very rapid or irregular heart beat. 
 
Tell your doctor if you or your family/carer notices that you are developing urges or cravings 
to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation 
to carry out certain activities that could harm yourself or others. These are called impulse control 
disorders and can include behaviours such as addictive gambling, excessive eating or spending, 
an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings. 
Your doctor may need to adjust or stop your dose. 
 
Aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in 
your ability to move and balance, which may lead to falls. Caution should be taken, particularly if you 
are an elderly patient or have some debility. 
 
Children and adolescents 
Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe 
and effective in these patients. 
 
Other medicines and Aripiprazole Zentiva 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines, including medicines obtained without a prescription. 
 
Blood pressure-lowering medicines: Aripiprazole Zentiva may increase the effect of medicines used to 
lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood 
pressure under control. 
 
Taking Aripiprazole Zentiva with some medicines may mean the doctor will need to change your dose 
of Aripiprazole Zentiva or the other medicines. It is especially important to mention the following 
to your doctor: 
• Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide) 
• Antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, 

paroxetine, venlafaxine, St. Johnʼs Wort) 



87 

• Antifungal medicines (such as ketoconazole, itraconazole) 
• Certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors 

e.g. indinavir, ritonavir) 
• Anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital) 
• Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin) 
 
These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Zentiva; 
if you get any unusual symptom taking any of these medicines together with Aripiprazole Zentiva 
tablets, you should see your doctor. 
 
Medicines that increase the level of serotonin are typically used in conditions including depression, 
generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well 
as migraine and pain: 
• Triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety 

disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain 
• Selective-serotonin-reuptake-inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for 

depression, OCD, panic and anxiety 
• Other anti-depressants (such as venlafaxine and tryptophan) used in major depression 
• Tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness 
• St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression 
• Pain killers (such as tramadol and pethidine) used for pain relief 
• Triptans (such as sumatriptan and zolmitripitan) used for treating migraine 
 
These medicines may increase the risk of side effects; if you get any unusual symptom taking any 
of these medicines together with Aripiprazole Zentiva, you should see your doctor. 
 
Aripiprazole Zentiva with food, drink and alcohol 
This medicine can be taken regardless of meals. 
Alcohol should be avoided. 
 
Pregnancy, breast-feeding and fertility 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine. 
The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole 
Zentiva in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or 
weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops 
any of these symptoms you may need to contact your doctor. 
 
If you are taking Aripiprazole Zentiva, your doctor will discuss with you whether you should breast 
feed considering the benefit to you of your therapy and the benefit to your baby of breast feeding. 
You should not do both. Talk to your doctor about the best way to feed your baby if you are taking this 
medicine. 
 
Driving and using machines 
Dizziness and vision problems may occur during treatment with this medicine (see section 4). This 
should be considered in cases where full alertness is required, e.g., when driving a car or handling 
machines. 
 
Aripiprazole Zentiva contains lactose 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product. 
 



88 

Aripiprazole Zentiva contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’. 
 
 
3. How to take Aripiprazole Zentiva 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The recommended dose for adults is 15 mg once a day. However your doctor may prescribe a lower 
or higher dose to a maximum of 30 mg once a day. 
 
Use in children and adolescents 
This medicinal product may be started at a low dose with the oral solution (liquid) form. The dose may 
be gradually increased to the recommended dose for adolescents of 10 mg once a day. However your 
doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day. 
 
If you have the impression that the effect of Aripiprazole Zentiva is too strong or too weak, talk 
to your doctor or pharmacist. 
 
Try to take Aripiprazole Zentiva at the same time each day. It does not matter whether you take it 
with or without food. 
 
Do not open the blister until ready to administer. Immediately upon opening the blister, using dry 
hands, remove the tablet and place the entire orodispersible tablet on the tongue. Tablet disintegration 
occurs rapidly in saliva. The orodispersible tablet can be taken with or without liquid. Alternatively, 
disperse the tablet in water and drink the resulting suspension. 
 
Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole Zentiva without first 
consulting your doctor. 
 
Aripiprazole Zentiva 10 mg, 30 mg orodispersible tablets: The score line is not intended for breaking 
the tablet. 
 
If you take more Aripiprazole Zentiva than you should 
If you realise you have taken more Aripiprazole Zentiva than your doctor has recommended (or if 
someone else has taken some of your Aripiprazole Zentiva), contact your doctor right away. If you 
cannot reach your doctor, go to the nearest hospital and take the pack with you. 
Patients who have taken too much aripiprazole have experienced the following symptoms: 
• Rapid heartbeat, agitation/aggressiveness, problems with speech. 
• Unusual movements (especially of the face or tongue) and reduced level of consciousness. 
 
Other symptoms may include: 
• Acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, 
• Muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood 

pressure, abnormal rhythms of the heart. 
 
Contact your doctor or hospital immediately if you experience any of the above. 
 



89 

If you forget to take Aripiprazole Zentiva 
If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one 
day. 
 
If you stop taking Aripiprazole Zentiva 
Do not stop your treatment just because you feel better. It is important that you carry on taking 
Aripiprazole Zentiva orodispersible tablets for as long as your doctor has told you to. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Common side effects (may affect up to 1 in 10 people): 
• diabetes mellitus, 
• difficulty sleeping, 
• feeling anxious, 
• feeling restless and unable to keep still, difficulty sitting still, 
• uncontrollable twitching, jerking or writhing movements, restless legs, 
• trembling, 
• headache, 
• tiredness, 
• sleepiness, 
• light-headedness, 
• shaking and blurred vision, 
• decreased number of or difficulty making bowel movements, 
• indigestion, 
• feeling sick, 
• more saliva in mouth than normal, 
• vomiting, 
• feeling tired. 
 
Uncommon side effects (may affect up to 1 in 100 people): 
• increased blood levels of the hormone prolactin, 
• too much sugar in the blood, 
• depression, 
• altered or increased sexual interest, 
• uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia), 
• muscle disorder causing twisting movements (dystonia), 
• double vision, 
• eye sensitivity to light, 
• fast heart beat, 
• a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting, 
• hiccups. 
 
The following side effects have been reported since the marketing of oral aripiprazole but 
the frequency for them to occur is not known: 
• low levels of white blood cells; 
• low levels of blood platelets, 



90 

• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), 
• onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, 
• high blood sugar, 
• not enough sodium in the blood, 
• loss of appetite (anorexia), 
• weight loss, 
• weight gain, 
• thoughts of suicide, suicide attempt and suicide; 
• feeling aggressive, 
• agitation, 
• nervousness, 
• combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and 

sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome), 
• seizure, 
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, 

clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), 
• speech disorder, 
• fixation of the eyeballs in one position, 
• sudden unexplained death, 
• life-threatening irregular heart beat, 
• heart attack, 
• slower heart beat, 
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness 

in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty 
in breathing (if you notice any of these symptoms, seek medical advice immediately), 

• high blood pressure, 
• fainting, 
• accidental inhalation of food with risk of pneumonia (lung infection), 
• spasm of the muscles around the voice box, 
• inflammation of the pancreas, 
• difficulty swallowing, 
• diarrhoea, 
• abdominal discomfort, 
• stomach discomfort, 
• liver failure, 
• inflammation of the liver, 
• yellowing of the skin and white part of eyes, 
• reports of abnormal liver test values, 
• skin rash, 
• skin sensitivity to light, 
• baldness, 
• excessive sweating, 
• abnormal muscle breakdown which can lead to kidney problems, 
• muscle pain, 
• stiffness, 
• involuntary loss of urine (incontinence), 
• difficulty in passing urine, 
• withdrawal symptoms in newborn babies in case of exposure during pregnancy, 
• prolonged and/or painful erection, 
• difficulty controlling core body temperature or overheating, 



91 

• chest pain, 
• swelling of hands, ankles or feet, 
• in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin. 
• inability to resist the impulse, drive or temptation to perform an action that could be harmful 

to you or others, which may include: 
- strong impulse to gamble excessively despite serious personal or family consequences 
- altered or increased sexual interest and behaviour of significant concern to you 

or to others, for example, an increased sexual drive 
- uncontrollable excessive shopping 
- binge eating (eating large amounts of food in a short time period) or compulsive eating 

(eating more food than normal and more than is needed to satisfy your hunger) 
- a tendency to wander away. 
Tell your doctor if you experience any of these behaviours; he/she will discuss ways 
of managing or reducing the symptoms. 

 
In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. 
In addition, cases of stroke or “mini” stroke have been reported. 
 
Additional side effects in children and adolescents 
Adolescents aged 13 years and older experienced side effects that were similar in frequency and type 
to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, 
and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, 
increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the 
limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common 
(greater than 1 in 100 patient). 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Aripiprazole Zentiva 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. 
The expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how 
to throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Aripiprazole Zentiva contains 
The active substance is aripiprazole. Each orodispersible tablet contains 10 mg/15 mg/30 mg 
of aripiprazole. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


92 

The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, 
hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, acesulfame potassium, 
mango flavour, magnesium stearate. 
 
What Aripiprazole Zentiva looks like and contents of the pack 
Aripiprazole Zentiva 10 mg orodispersible tablets are white to off-white round tablets debossed ‘10’ 
on one side and snap break line on other side with diameter approx. 7 mm. 
 
Aripiprazole Zentiva 15 mg orodispersible tablets are white to off-white round flat bevel edged tablets 
debossed ‘15’ on one side and plain on the other side with diameter approx. 8 mm. 
 
Aripiprazole Zentiva 30 mg orodispersible tablets are white to off-white round tablets debossed ‘30’ 
on one side and snap break line on the other side with diameter approx. 10.2 mm. 
 
Pack size: 14, 28 or 49 orodispersible tablets 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
Manufacturer 
S.C. Zentiva S.A. 
50 Theodor Pallady Blvd. 
Bucharest 032266 
Romania 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Zentiva, k.s. 
Tél/Tel: +32 280 86 420 
PV-Belgium@zentiva.com 

Lietuva 
Zentiva, k.s. 
Tel: +370 52152025 
PV-Lithuania@zentiva.com 

България 
Zentiva, k.s. 
Тел: + 359 2 805 72 08 
PV-Bulgaria@zentiva.com 

Luxembourg/Luxemburg 
Zentiva, k.s. 
Tél/Tel: +352 208 82330 
PV-Luxembourg@zentiva.com 

Česká republika 
Zentiva, k.s. 
Tel: +420 267 241 111 
PV-Czech-Republic@zentiva.com 

Magyarország 
Zentiva, k.s. 
Tel.: +36 165 55 722 
PV-Hungary@zentiva.com 

Danmark 
Zentiva, k.s. 
Tlf: +45 787 68 400 
PV-Denmark@zentiva.com 

Malta 
Zentiva, k.s. 
Tel: +356 277 82 052 
PV-Malta@zentiva.com 



93 

Deutschland 
Zentiva Pharma GmbH  
Tel: +49 (0) 800 53 53 010 
PV-Germany@zentiva.com 

Nederland 
Zentiva, k.s. 
Tel: +31 202 253 638 
PV-Netherlands@zentiva.com 

Eesti 
Zentiva, k.s. 
Tel: +372 52 70308 
PV-Estonia@zentiva.com 

Norge 
Zentiva, k.s. 
Tlf: +47 219 66 203 
PV-Norway@zentiva.com 

Ελλάδα 
Zentiva, k.s. 
Τηλ: +30 211 198 7510 
PV-Greece@zentiva.com 

Österreich 
Zentiva, k.s. 
Tel: +43 720 778 877 
PV-Austria@zentiva.com 

España 
Zentiva, k.s. 
Tel: +34 931 815 250 
PV-Spain@zentiva.com 

Polska 
Zentiva Polska Sp. z o.o. 
Tel: + 48 22 375 92 00 
PV-Poland@zentiva.com 

France 
Zentiva France 
Tél: +33 (0) 800 089 219  
PV-France@zentiva.com 

Portugal 
Zentiva Portugal, Lda 
Tel: +351210601360 
PV-Portugal@zentiva.com 

Hrvatska 
Zentiva, k.s. 
Tel: +385 155 17 772 
PV-Croatia@zentiva.com 

România 
ZENTIVA S.A. 
Tel: +40 021.304.7597 
zentivaRO@zentiva.com 

Ireland 
Zentiva, k.s. 
Tel: +353 766 803 944 
PV-Ireland@zentiva.com 

Slovenija 
Zentiva, k.s. 
Tel: +386 360 00 408 
PV-Slovenia@zentiva.com 

Ísland 
Zentiva, k.s. 
Sími: +354 539 0650 
PV-Iceland@zentiva.com 

Slovenská republika 
Zentiva, a.s. 
Tel: +421 2 3918 3010 
PV-Slovakia@zentiva.com 

Italia 
Zentiva Italia S.r.l. 
Tel: +39-02-38598801 
PV-Italy@zentiva.com 

Suomi/Finland 
Zentiva, k.s. 
Puh/Tel: +358 942 598 648 
PV-Finland@zentiva.com 

Κύπρος 
Zentiva, k.s. 
Τηλ: +357 240 30 144 
PV-Cyprus@zentiva.com 

Sverige 
Zentiva, k.s. 
Tel: +46 840 838 822 
PV-Sweden@zentiva.com 

Latvija 
Zentiva, k.s. 
Tel: +371 67893939 
PV-Latvia@zentiva.com 

United Kingdom 
Zentiva Pharma UK Limited 
Tel: +44 (0) 845 372 7101 
PV-United-Kingdom@zentiva.com 

 



94 

This leaflet was last revised in 
 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
  

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
{'Title': '1. what aripiprazole zentiva is and what it is used for', 'Section_Content': 'aripiprazole zentiva contains the active substance aripiprazole and belong to a group of medicines called antipsychotics. it is used to treat adults and adolescents aged 15 years and older who suffer from a disease characterised by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. people with this condition may also feel depressed, guilty, anxious or tense. aripiprazole zentiva is used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. in adults it also prevents this condition from returning in patients who have responded to the treatment with aripiprazole zentiva.', 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{'Title': '2. what you need to know before you take aripiprazole zentiva', 'Section_Content': 'do not take aripiprazole zentiva if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6). warnings and precautions talk to your doctor before taking aripiprazole zentiva. suicidal thoughts and behaviours have been reported during aripiprazole treatment. tell your doctor immediately if you are having any thoughts or feelings about hurting yourself. before treatment with aripiprazole zentiva, tell your doctor if you suffer from high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak) or family history of diabetes fits (seizures) since your doctor may want to monitor you more closely involuntary, irregular muscle movements, especially in the face cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots past experience with excessive gambling. if you notice you are gaining weight, develop unusual movements, experience somnolence that interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell your doctor. if you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke. tell your doctor immediately if you are having any thoughts or feelings about hurting yourself. suicidal thoughts and behaviours have been reported during aripiprazole treatment. tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat. tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. these are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings. your doctor may need to adjust or stop your dose. aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in your ability to move and balance, which may lead to falls. caution should be taken, particularly if you are an elderly patient or have some debility. children and adolescents do not use this medicine in children and adolescents under 13 years of age. it is not known if it is safe and effective in these patients. other medicines and aripiprazole zentiva tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. blood pressure-lowering medicines: aripiprazole zentiva may increase the effect of medicines used to lower the blood pressure. be sure to tell your doctor if you take a medicine to keep your blood pressure under control. taking aripiprazole zentiva with some medicines may mean the doctor will need to change your dose of aripiprazole zentiva or the other medicines. it is especially important to mention the following to your doctor: medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide) 78 antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, st. johnʼs wort) antifungal medicines (such as ketoconazole, itraconazole) certain medicines to treat hiv infection (such as efavirenz, nevirapine, an protease inhibitors e.g. indinavir, ritonavir) anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital) certain antibiotics used to treat tuberculosis (rifabutin, rifampicin) these medicines may increase the risk of side effects or reduce the effect of aripiprazole zentiva; if you get any unusual symptom taking any of these medicines together with aripiprazole zentiva, you should see your doctor. medicines that increase the level of serotonin are typically used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (ocd) and social phobia as well as migraine and pain: triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (ocd) and social phobia as well as migraine and pain selective-serotonin-reuptake-inhibitors (ssris) (such as paroxetine and fluoxetine) used for depression, ocd, panic and anxiety other anti-depressants (such as venlafaxine and tryptophan) used in major depression tricyclic\'s (such as clomipramine and amitriptyline) used for depressive illness st john\'s wort (hypericum perforatum) used as a herbal remedy for mild depression pain killers (such as tramadol and pethidine) used for pain relief triptans (such as sumatriptan and zolmitripitan) used for treating migraine these medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with aripiprazole zentiva, you should see your doctor. aripiprazole zentiva with food, drink and alcohol this medicine can be taken regardless of meals. alcohol should be avoided. pregnancy, breast-feeding and fertility if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. the following symptoms may occur in newborn babies, of mothers that have used aripiprazole zentiva in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. if your baby develops any of these symptoms you may need to contact your doctor. if you are taking aripiprazole zentiva, your doctor will discuss with you whether you should breast feed considering the benefit to you of your therapy and the benefit to your baby of breast feeding. you should not do both. talk to your doctor about the best way to feed your baby if you are taking this medicine. driving and using machines dizziness and vision problems may occur during treatment with this medicine (see section 4). this should be considered in cases where full alertness is required, e.g. when driving a car or handling machines. aripiprazole zentiva contains lactose if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. aripiprazole zentiva contains sodium this medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially \'sodium- free\'.', 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{'Title': '3. how to take aripiprazole zentiva', 'Section_Content': 'always take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure. the recommended dose for adults is 15 mg once a day. however your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day. use in children and adolescents this medicinal product may be started at a low dose with the oral solution (liquid) form. the dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. however your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day. if you have the impression that the effect of aripiprazole zentiva is too strong or too weak, talk to your doctor or pharmacist. try to take aripiprazole zentiva at the same time each day. it does not matter whether you take it with or without food. always take the tablet with water and swallow it whole. even if you feel better, do not alter or discontinue the daily dose of aripiprazole zentiva without first consulting your doctor. aripiprazole zentiva 10 mg, 30 mg tablets: the score line is not intended for breaking the tablet. if you take more aripiprazole zentiva than you should if you realise you have taken more aripiprazole zentiva than your doctor has recommended (or if someone else has taken some of your aripiprazole zentiva), contact your doctor right away. if you cannot reach your doctor, go to the nearest hospital and take the pack with you. patients who have taken too much aripiprazole have experienced the following symptoms: rapid heartbeat, agitation/aggressiveness, problems with speech. unusual movements (especially of the face or tongue) and reduced level of consciousness. other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart. contact your doctor or hospital immediately if you experience any of the above. if you forget to take aripiprazole zentiva if you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day. if you stop taking aripiprazole zentiva do not stop your treatment just because you feel better. it is important that you carry on taking aripiprazole zentiva for as long as your doctor has told you to. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'aripiprazole zentiva', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 25}, {'Text': '15', 'Type': 'NUMBER', 'BeginOffset': 170, 'EndOffset': 172}, {'Text': '30', 'Type': 'NUMBER', 'BeginOffset': 261, 'EndOffset': 263}, {'Text': 'this medicinal product', 'Type': 'TREATMENT', 'BeginOffset': 311, 'EndOffset': 333}, 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. common side effects (may affect up to 1 in 10 people): diabetes mellitus, difficulty sleeping, feeling anxious, feeling restless and unable to keep still, difficulty sitting still, uncontrollable twitching, jerking or writhing movements, restless legs, trembling, headache, tiredness, sleepiness, light-headedness, shaking and blurred vision, decreased number of or difficulty making bowel movements, indigestion, feeling sick, more saliva in mouth than normal, vomiting, feeling tired. uncommon side effects (may affect up to 1 in 100 people): increased blood levels of the hormone prolactin, too much sugar in the blood, depression, altered or increased sexual interest, uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia), muscle disorder causing twisting movements (dystonia), double vision, eye sensitivity to light, fast heart beat, a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting, hiccups. the following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known: low levels of white blood cells, low levels of blood platelets, allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, high blood sugar, not enough sodium in the blood, loss of appetite (anorexia), weight loss, weight gain, 81 thoughts of suicide, suicide attempt and suicide; feeling aggressive, agitation, nervousness, combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome), seizure, serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), speech disorder, fixation of the eyeballs in one position, sudden unexplained death, life-threatening irregular heart beat, heart attack, slower heart beat, blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately), high blood pressure, fainting, accidental inhalation of food with risk of pneumonia (lung infection), spasm of the muscles around the voice box, inflammation of the pancreas, difficulty swallowing, diarrhoea, abdominal discomfort, stomach discomfort, liver failure, inflammation of the liver, yellowing of the skin and white part of eyes, reports of abnormal liver tests values; skin rash, skin sensitivity to light, baldness, excessive sweating, abnormal muscle breakdown which can lead to kidney problems, muscle pain, stiffness, involuntary loss of urine (incontinence), difficulty in passing urine; withdrawal symptoms in newborn babies in case of exposure during pregnancy, prolonged and/or painful erection, difficulty controlling core body temperature or overheating, chest pain, swelling of hands, ankles or feet, in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin. inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include: - strong impulse to gamble excessively despite serious personal or family consequences - altered or increased sexual interest and behaviour of significant concern to you or to 82 others, for example, an increased sexual drive - uncontrollable excessive shopping - binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) - a tendency to wander away. tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms. in elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. in addition, cases of stroke or "mini" stroke have been reported. additional side effects in children and adolescents adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (greater than 1 in 100 patients). reporting of side effects if you get any side effects, talk to your doctor or pharmacist. this includes any 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{'Title': '5. how to store aripiprazole zentiva', 'Section_Content': None, 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': "what aripiprazole zentiva contains the active substance is aripiprazole. each tablet contains 5 mg/10 mg/15 mg/30 mg of aripiprazole. the other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, magnesium stearate. what aripiprazole zentiva looks like and contents of the pack aripiprazole zentiva 5 mg are white to off-white round flat bevel edged uncoated tablets with '5' debossed on one side and plain on the other side with diameter approx. 6 mm. aripiprazole zentiva 10 mg tablets are white to off-white round uncoated tablets with '10' debossed on one side and snap tab breakline on the other side with diameter approx. 8 mm. aripiprazole zentiva 15 mg tablets are white to off-white round flat bevel edged uncoated tablets with '15' debossed on one side and plain on the other side with diameter approx. 8.8 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