Yentreve
1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
YENTREVE 20 mg hard gastro-resistant capsules 
YENTREVE 40 mg hard gastro-resistant capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
YENTREVE 20 mg 
Each capsule contains 20 mg of duloxetine (as hydrochloride). 
 
Excipient(s) with known effect  
Each capsule may contain up to 37 mg sucrose. 
 
YENTREVE 40 mg 
Each capsule contains 40 mg of duloxetine (as hydrochloride).  
 
Excipient(s) with known effect  
Each capsule may contain up to 74 mg sucrose. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Hard gastro-resistant capsule. 
 
YENTREVE 20 mg 
Opaque blue body, imprinted with ‘20 mg’ and an opaque blue cap, imprinted with ‘9544’. 
 
YENTREVE 40 mg 
Opaque orange body, imprinted with ’40 mg’ and an opaque blue cap, imprinted with ‘9545’. 
 
 
4.  CLINICAL PARTICULARS 

 
4.1 Therapeutic indications 
 
YENTREVE is indicated for women for the treatment of moderate to severe Stress Urinary 
Incontinence (SUI). 
 
YENTREVE is indicated in adults. 
For further information see section 5.1. 
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended dose of YENTREVE is 40 mg twice daily without regard to meals. After 2-4 weeks 
of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of the 
therapy. Some patients may benefit from starting treatment at a dose of 20 mg twice daily for two 
weeks before increasing to the recommended dose of 40 mg twice daily. Dose escalation may 
decrease, though not eliminate, the risk of nausea and dizziness. 
 
However, limited data are available to support the efficacy of YENTREVE 20 mg twice daily. 
 



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The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo-controlled 
studies. The benefit of treatment should be re-assessed at regular intervals. 
 
Combining YENTREVE with a pelvic floor muscle training (PFMT) programme may be more 
effective than either treatment alone. It is recommended that consideration be given to concomitant 
PFMT. 
 
Hepatic impairment 
YENTREVE must not be used in women with liver disease resulting in hepatic impairment (see 
sections 4.3 and 5.2). 
 
Renal impairment 
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine 
clearance 30 to 80 ml/min). YENTREVE must not be used in patients with severe renal impairment 
(creatinine clearance <30 ml/min; see section 4.3). 
 
Paediatric population 
 
The safety and efficacy of duloxetine for the treatment of stress urinary incontinence has not been 
studied. No data are available. 
 
Special populations 
 
Elderly 
Caution should be exercised when treating the elderly. 
 
Discontinuation of treatment 
Abrupt discontinuation should be avoided. When stopping treatment with YENTREVE the dose 
should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of 
withdrawal reactions (see sections 4.4 and 4.8). If intolerable symptoms occur following a decrease in 
the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be 
considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate. 
 
Method of administration 
For oral use. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Liver disease resulting in hepatic impairment (see section 5.2). 
 
YENTREVE should not be used in combination with nonselective, irreversible monoamine oxidase 
inhibitors - MAOIs (see section 4.5).  
 
YENTREVE should not be used in combination with CYP1A2 inhibitors, like fluvoxamine, 
ciprofloxacin or enoxacin since the combination results in elevated plasma concentrations of 
duloxetine (see section 4.5). 
 
Severe renal impairment (creatinine clearance <30 ml/min) (see section 4.4). 
 
The initiation of treatment with YENTREVE is contraindicated in patients with uncontrolled 
hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 
4.8). 
 



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4.4 Special warnings and precautions for use 
 
Mania and seizures 
YENTREVE should be used with caution in patients with a history of mania or a diagnosis of bipolar 
disorder, and/or seizures. 
 
Serotonin syndrome 
As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may 
occur with duloxetine treatment, particularly with concomitant use of other serotonergic agents 
(including SSRIs, SNRIs tricyclic antidepressants or triptans), with agents that impair metabolism of 
serotonin such as MAOIs, or with antipsychotics or other dopamine antagonists that may affect the 
serotonergic neurotransmitter systems (see sections 4.3 and 4.5). 
 
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, 
coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular 
aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, 
vomiting, diarrhoea). 
 
If concomitant treatment with duloxetine and other serotonergic agents that may affect the 
serotonergic and/or dopaminergic neurotransmitter systems in clinically warranted, careful observation 
of the patient is advised, particularly during treatment initiation and dose increases. 
 
St John’s wort 
Adverse reactions may be more common during concomitant use of YENTREVE and herbal 
preparations containing St John’s wort (Hypericum perforatum). 
 
Mydriasis 
Mydriasis has been reported in association with duloxetine, therefore, caution should be used when 
prescribing duloxetine in patients with increased intraocular pressure, or those at risk of acute narrow-
angle glaucoma.  
 
Blood pressure and heart rate 
Duloxetine has been associated with an increase in blood pressure and clinically significant 
hypertension in some patients. This may be due to the noradrenergic effect of duloxetine. Cases of 
hypertensive crisis have been reported with duloxetine, especially in patients with pre-existing 
hypertension. Therefore, in patients with known hypertension and/or other cardiac disease, blood 
pressure monitoring is recommended, especially during the first month of treatment. Duloxetine 
should be used with caution in patients whose conditions could be compromised by an increased heart 
rate or by an increase in blood pressure. Caution should also be exercised when duloxetine is used 
with medicinal products that may impair its metabolism (see section 4.5). For patients who experience 
a sustained increase in blood pressure while receiving duloxetine either dose reduction or gradual 
discontinuation should be considered (see section 4.8). In patients with uncontrolled hypertension 
duloxetine should not be initiated (see section 4.3). 
 
Renal impairment 
Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on 
haemodialysis (creatinine clearance <30 ml/min). For patients with severe renal impairment, see 
section 4.3. See section 4.2 for information on patients with mild or moderate renal dysfunction.  
 
Haemorrhage  
There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal 
haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline 
reuptake inhibitors (SNRIs), including duloxetine. Duloxetine may increase the risk of postpartum 
haemorrhage (see section 4.6). Caution is advised in patients taking anticoagulants and/or medicinal 
products known to affect platelet function (e.g. NSAIDs or acetylsalicylic acid (ASA)), and in patients 
with known bleeding tendencies. 
 



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Discontinuation of treatment 
Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is 
abrupt (see section 4.8). In a clinical trial, adverse events seen on abrupt treatment discontinuation 
occurred in approximately 44% of patients treated with YENTREVE and 24% of patients taking 
placebo. 
 
The risk of withdrawal symptoms seen with SSRI’s and SNRI’s may be dependent on several factors 
including the duration and dose of therapy and the rate of dose reduction. The most commonly 
reported reactions are listed in section 4.8. Generally these symptoms are mild to moderate, however, 
in some patients they may be severe in intensity. They usually occur within the first few days of 
discontinuing treatment, but there have been very rare reports of such symptoms in patients who have 
inadvertently missed a dose. Generally these symptoms are self-limiting and usually resolve within 2 
weeks, though in some individuals they may be prolonged (2-3 months or more). It is therefore 
advised that duloxetine should be gradually tapered when discontinuing treatment over a period of no 
less than 2 weeks, according to the patient’s needs (see section 4.2). 
 
Hyponatraemia 
Hyponatraemia has been reported when administering YENTREVE, including cases with serum 
sodium lower than 110 mmol/l. Hyponatraemia may be due to a syndrome of inappropriate anti-
diuretic hormone secretion (SIADH). The majority of cases of hyponatraemia were reported in the 
elderly, especially when coupled with a recent history of, or condition pre-disposing to, altered fluid 
balance. Caution is required in patients at increased risk for hyponatraemia, such as elderly, cirrhotic, 
or dehydrated patients or patients treated with diuretics.  
 
Depression, suicidal ideation and behaviour 
Although YENTREVE is not indicated for the treatment of depression, its active ingredient 
(duloxetine) also exists as an antidepressant medicinal product. Depression is associated with an 
increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists 
until significant remission occurs. As improvement may not occur during the first few weeks or more 
of treatment, patients should be closely monitored until such improvement occurs. It is general clinical 
experience that the risk of suicide may increase in the early stages of recovery. Patients with a history 
of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to 
commencement of treatment are known to be at a greater risk of suicidal thoughts or suicidal 
behaviour, and should receive careful monitoring during treatment. A meta-analysis of placebo-
controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an 
increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 
years old. 
 
Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or 
early after treatment discontinuation (see section 4.8). Physicians should encourage patients to report 
any distressing thoughts or feelings or depressive symptoms at any time. If while on YENTREVE 
therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be 
sought, as depression is a serious medical condition. If a decision to initiate antidepressant 
pharmacological therapy is taken, the gradual discontinuation of YENTREVE is recommended (see 
section 4.2). 
 
Use in children and adolescents under 18 years of age 
YENTREVE should not be used in the treatment of children and adolescents under the age of 18 
years. Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility 
(predominantly aggression, oppositional behaviour and anger), were more frequently observed in 
clinical trials among children and adolescents treated with antidepressants compared to those treated 
with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be 
carefully monitored for the appearance of suicidal symptoms.  In addition, long-term safety data in 
children and adolescents concerning growth, maturation and cognitive and behavioural development 
are lacking. 
 



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Medicinal products containing duloxetine 
Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic 
pain, major depressive disorder, generalised anxiety disorder and stress urinary incontinence). The use 
of more than one of these products concomitantly should be avoided. 
 
Hepatitis/increased liver enzymes 
Cases of liver injury, including severe elevations of liver enzymes (>10 times upper limit of normal), 
hepatitis and jaundice have been reported with duloxetine (see section 4.8). Most of them occurred 
during the first months of treatment. The pattern of liver damage was predominantly hepatocellular. 
Duloxetine should be used with caution in patients treated with other medicinal products associated 
with hepatic injury. 
 
Akathisia/psychomotor restlessness 
The use of duloxetine has been associated with the development of akathisia, characterised by a 
subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability 
to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who 
develop these symptoms, increasing the dose may be detrimental. 
 
Sexual dysfunction 
Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) 
may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting 
sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRIs. 
 
Sucrose 
YENTREVE hard gastro-resistant capsules contain sucrose. Patients with rare hereditary problems of 
fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not 
take this medicine. 
 
Sodium 
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 
‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Monoamine oxidase inhibitors (MAOIs): Due to the risk of serotonin syndrome, duloxetine should not 
be used in combination with non-selective irreversible monoamine oxidase inhibitors (MAOIs), or 
within at least 14 days of discontinuing treatment with an MAOI. Based on the half-life of duloxetine, 
at least 5 days should be allowed after stopping YENTREVE before starting an MAOI (see section 
4.3). 
 
The concomitant use of YENTREVE with selective, reversible MAOIs, like moclobemide, is not 
recommended (see section 4.4). The antibiotic linezolid is a reversible non-selective MAOI and should 
not be given to patients treated with YENTREVE (see section 4.4). 
 
Inhibitors of CYP1A2: Because CYP1A2 is involved in duloxetine metabolism, concomitant use of 
YENTREVE with potent inhibitors of CYP1A2 is likely to result in higher concentrations of 
duloxetine. Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent 
plasma clearance of duloxetine by about 77% and increased AUC0-t 6-fold. Therefore YENTREVE 
should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see 
section 4.3).  
 
CNS medicinal products: Caution is advised when YENTREVE is taken in combination with other 
centrally acting medicinal products or substances, including alcohol and sedative medicinal products 
(e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).  
 
Serotonergic agents: In rare cases, serotonin syndrome has been reported in patients using 
SSRIs/SNRIs concomitantly with serotonergic agents. Caution is advisable if YENTREVE is used 



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concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine 
or amitriptyline, MAOIs like moclobemide or linezolid, St John’s wort (Hypericum perforatum) or 
triptans, tramadol, pethidine and tryptophan (see section 4.4). 
 
Effect of duloxetine on other medicinal products 
Medicinal products metabolised by CYP1A2: The pharmacokinetics of theophylline, a CYP1A2 
substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).  
 
Medicinal products metabolised by CYP2D6: Duloxetine is a moderate inhibitor of CYP2D6. When 
duloxetine was administered at a dose of 60 mg twice daily with a single dose of desipramine, a 
CYP2D6 substrate, the AUC of desipramine increased 3-fold. The co-administration of duloxetine 
(40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71 %, but does 
not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is 
recommended. Caution is advised if YENTREVE is co-administered with medicinal products that are 
predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as 
nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such 
as flecainide, propafenone and metoprolol). 
 
Oral contraceptives and other steroidal agents: Results of in vitro studies demonstrate that duloxetine 
does not induce the catalytic activity of CYP3A. Specific in vivo drug interaction studies have not 
been performed.  
 
Anticoagulants and antiplatelet agents: Caution should be exercised when duloxetine is combined 
with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding attributable 
to a pharmacodynamic interaction. Furthermore, increases in INR values have been reported when 
duloxetine was co-administered to patients treated with warfarin. However, concomitant 
administration of duloxetine with warfarin under steady state conditions, in healthy volunteers, as part 
of a clinical pharmacology study, did not result in a clinically significant change in INR from baseline 
or in the pharmacokinetics of R- or S-warfarin. 
 
Effects of other medicinal products on duloxetine 
Antacids and H2 antagonists: Co-administration of YENTREVE with aluminium- and magnesium-
containing antacids or with famotidine had no significant effect on the rate or extent of duloxetine 
absorption after administration of a 40 mg oral dose. 
 
Inducers of CYP1A2: Population pharmacokinetic studies analyses have shown that smokers have 
almost 50% lower plasma concentrations of duloxetine compared with non-smokers. 
 
4.6 Fertility, pregnancy and lactation  
 
Fertility 
In animal studies, duloxetine had no effect on male fertility, and effects in females were only evident 
at doses that caused maternal toxicity. 
 
Pregnancy  
Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine 
lower than the maximum clinical exposure (see section 5.3). 
 
Two large observational studies do not suggest an overall increased risk of major congenital 
malformation (one from the US including 2,500 exposed to duloxetine during the first trimester and 
one from the EU including 1,500 exposed to duloxetine during the first trimester). The analysis on 
specific malformations such as cardiac malformations shows inconclusive results. 
 
In the EU study, maternal exposure to duloxetine during late pregnancy (at any time from 20 weeks 
gestational age to delivery) was associated with an increased risk for preterm birth (less than 2-fold, 
corresponding to approximately 6 additional premature births per 100 women treated with duloxetine 



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late in pregnancy). The majority occurred between 35 and 36 weeks of gestation. This association was 
not seen in the US study. 
 
The US observational data have provided evidence of an increased risk (less than 2-fold) of 
postpartum haemorrhage following duloxetine exposure within the month prior to birth. 
 
Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late 
pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). 
Although no studies have investigated the association of PPHN to SNRI treatment, this potential risk 
cannot be ruled out with duloxetine taking into account the related mechanism of action (inhibition of 
the re-uptake of serotonin).  
 
As with other serotonergic medicinal products, discontinuation symptoms may occur in the neonate 
after maternal duloxetine use near term. Discontinuation symptoms seen with duloxetine may include 
hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures. The majority of 
cases have occurred either at birth or within a few days of birth. 
 
YENTREVE should be used in pregnancy only if the potential benefit justifies the potential risk to the 
foetus. Women should be advised to notify their physician if they become pregnant, or intend to 
become pregnant, during therapy.  
 
Breast feeding 
Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did 
not breast feed their children. The estimated daily infant dose on a mg/kg basis is approximately 
0.14% of the maternal dose (see section 5.2). As the safety of duloxetine in infants is not known, the 
use of YENTREVE while breast-feeding is not recommended. 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed. YENTREVE 
may be associated with sedation and dizziness. Patients should be instructed that if they experience 
sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating 
machinery. 
 
4.8 Undesirable effects  
 
a. Summary of the safety profile 
The most commonly reported adverse events in patients treated with YENTREVE in clinical trials in 
SUI and other lower urinary tract disorders were nausea, dry mouth fatigue and constipation. The data 
analysis of four 12-week, placebo-controlled clinical trials in patients with SUI, including 958 
duloxetine-treated and 955 placebo-treated patients, showed that the onset of the reported adverse 
events typically occurred in the first week of therapy. However, the majority of the most frequent 
adverse events were mild to moderate and resolved within 30 days of occurrence (e.g. nausea). 
 
b. Tabulated summary of adverse reactions 
Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled 
clinical trials. 
 
Table 1: Adverse reactions 
Frequency estimate: 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). 
 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
 

Very common Common Uncommon Rare Very Rare 
Infections and infestations 
  Laryngitis   



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Very common Common Uncommon Rare Very Rare 
Immune system disorders 
  Hyper-sensitivity 

disorder 
Anaphylactic 
reaction 

 

Endocrine disorders 
  Hypo-thyroidism   
Metabolism and nutrition disorders 
 Appetite 

decreased 
Dehydration Hyperglycaemia 

(reported 
especially in 
diabetic patients) 
Hyponatraemia 
SIADH6 

 

Psychiatric disorders 
  Insomnia  

Agitation 
Libido decreased 
Anxiety 
Sleep disorder 
 

Bruxism 
Disorientation 
Apathy 
Orgasm abnormal 
Abnormal dreams 

Suicidal 
behaviour5,6 
Suicidal 
ideation5,7 
Mania6 
Hallucinations 
Aggression and 
anger4,6 

 

Nervous system disorders 
 Headache 

Dizziness 
Lethargy 
Somnolence 
Tremor 
Paraesthesia 

Nervousness 
Disturbance in 
attention 
Dysgeusia 
Poor quality sleep 
 

Serotonin 
syndrome6 
Convulsions1,6 
Myoclonus 
Akathisia6 
Psychomotor 
restlessness6 
Extra-pyramidal 
symptoms6 
Dyskinesia 
Restless legs 
syndrome 

 

Eye disorders 
 Blurred vision Mydriasis 

Visual 
impairment 
Dry eye 

Glaucoma  

Ear and labyrinth disorders 
 Vertigo Tinnitus1  

Ear pain 
  

Cardiac disorders 
  Palpitations 

Tachycardia 
Supra-ventricular 
arrhythmia, 
mainly atrial 
fibrillation6 

 

Vascular disorders 
 Hypertension3,7 

Flushing 
Syncope2 
Blood pressure 
increase3 

Hypertensive 
crisis3 
Orthostatic 
hypotension2 
Peripheral 
coldness 

 

Respiratory, thoracic and mediastinal disorders 



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Very common Common Uncommon Rare Very Rare 
  Yawning  Throat tightness 

Epistaxis   
Interstitial lung 
disease10 
Eosinophilic 
pneumonia6 

 

Gastrointestinal disorders 
Nausea  
Dry mouth  
Constipation  

Diarrhoea  
Abdominal pain 
Vomiting  
Dyspepsia 

Gastrointestinal 
haemorrhage7 
Gastroenteritis 
Stomatitis 
Eructation  
Gastritis 
Dysphagia 
Flatulence  
Breath odour 

Haematochezia 
Microscopic 
colitis9 
 

 

Hepato-biliary disorders 
  Hepatitis3 

Elevated liver 
enzymes (ALT, 
AST, alkaline 
phosphatase) 
Acute liver injury 

Hepatic failure6  
Jaundice6 

 

Skin and subcutaneous tissue disorders 
 Sweating 

increased 
Rash 
Night sweats  
Urticaria  
Dermatitis 
contact 
Cold sweat 
Increased 
tendency to 
bruise 

Stevens-Johnson 
Syndrome6  
Angio-neurotic 
oedema6 
Photo-sensitivity 
reactions 

Cutaneous 
vasculitis 

Musculoskeletal and connective tissue disorders 
  Musculo-skeletal 

pain 
Muscle tightness 
Muscle spasm  
Trismus 

Muscle twitching  

Renal and urinary disorders 
  Urinary hesitation 

Dysuria 
Nocturia 
Pollakiuria 
Urine odour 
abnormal 

Urinary retention6 
Polyuria 
Urine flow 
decreased 
 

 

Reproductive system and breast disorders 
  Gynaecological 

haemorrhage  
Menopausal 
symptoms 
 

Menstrual 
disorder  
Galactorrhoea 
Hyperprolactinae
mia 
Postpartum 
haemorrhage6 

 

General disorders and administration site conditions 



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Very common Common Uncommon Rare Very Rare 
Fatigue  Asthenia 

Chills 
Chest pain7 
Falls8 
Feeling abnormal  
Feeling cold  
Thirst 
Malaise 
Feeling hot 

Gait disturbance  

Investigations 
  Weight decrease 

Weight increase 
Blood cholesterol 
increased 
Blood creatine 
phosphokinase 
increased 

Blood potassium 
increased 

 

 

1 Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation. 
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of 

treatment. 
3 See section 4.4. 
4 Cases of aggression and anger have been reported particularly early in treatment or after treatment 

discontinuation. 
5 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or 

early after treatment discontinuation (see section 4.4). 
6 Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in 

placebo-controlled clinical trials. 
7 Not statistically significantly different from placebo. 
8 Falls were more common in the elderly (≥65 years old). 
9 Estimated frequency based on all clinical trial data. 
10Estimated frequency based on placebo-controlled clinical trials. 
 
c. Description of selected adverse reactions 
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms. 
Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly 
in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, 
agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, 
hyperhydrosis and vertigo are the most commonly reported reactions. 
 
Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting, however, in 
some patients they may be severe and/or prolonged. It is therefore advised that when duloxetine 
treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see 
sections 4.2 and 4.4). 
 
The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in 
placebo-treated patients. No clinically significant differences were observed for QT, PR, QRS, or 
QTcB measurements between duloxetine-treated and placebo-treated patients. 
 
In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic 
pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine-
treated patients. HbA1c was stable in both duloxetine-treated and placebo-treated patients. In the 
extension phase of these studies, which lasted up to 52 weeks, there was an increase in HbA1c in both 
the duloxetine and routine care groups, but the mean increase was 0.3% greater in the duloxetine-
treated group. There was also a small increase in fasting blood glucose and in total cholesterol in 
duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care 
group.  
 



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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 
 
Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 
5400 mg were reported. Some fatalities have occurred, primarily with mixed overdoses, but also with 
duloxetine alone at a dose of approximately 1000 mg. Signs and symptoms of overdose (duloxetine 
alone or in combination with other medicinal products) included somnolence, coma, serotonin 
syndrome, seizures, vomiting and tachycardia.   
 
No specific antidote is known for duloxetine but if serotonin syndrome ensues, specific treatment 
(such as with cyproheptadine and/or temperature control) may be considered. A free airway should be 
established. Monitoring of cardiac and vital signs is recommended, along with appropriate 
symptomatic and supportive measures. Gastric lavage may be indicated if performed soon after 
ingestion or in symptomatic patients. Activated charcoal may be useful in limiting absorption. 
Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange 
perfusion are unlikely to be beneficial. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other antidepressants. ATC code: N06AX21. 
 
Mechanism of action 
Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor. It weakly 
inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic 
and adrenergic receptors.  
 
Pharmacodynamic effects 
In animal studies, increased levels of 5-HT and NE in the sacral spinal cord, lead to increased urethral 
tone via enhanced pudendal nerve stimulation to the urethral striated sphincter muscle only during the 
storage phase of the micturition cycle. A similar mechanism in women is believed to result in stronger 
urethral closure during urine storage with physical stress that could explain the efficacy of duloxetine 
in the treatment of women with SUI.  
 
Clinical efficacy and safety 
The efficacy of duloxetine 40 mg given twice daily in the treatment of SUI was established in four 
double-blind, placebo-controlled studies that randomised 1913 women (22 to 83 years) with SUI; of 
these, 958 patients were randomised to duloxetine and 955 to placebo. The primary efficacy measures 
were Incontinence Episode Frequency (IEF) from diaries and an incontinence specific quality of life 
questionnaire score (I-QOL). 
 
Incontinence Episode Frequency: In all four studies the duloxetine-treated group had a 50% or greater 
median decrease in IEF compared with 33% in the placebo-treated group. Differences were observed 
at each visit after 4 weeks (duloxetine 54% and placebo 22%), 8 weeks (52% and 29%), and 12 weeks 
(52% and 33%) of medication.  
 
In an additional study limited to patients with severe SUI, all responses with duloxetine were achieved 
within 2 weeks.  
 

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 13 

The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo-controlled 
studies. The clinical benefit of YENTREVE compared with placebo has not been demonstrated in 
women with mild SUI, defined in randomised trials as those with IEF < 14 per week. In these women, 
YENTREVE may provide no benefit beyond that afforded by more conservative behavioural 
interventions. 
 
Quality of Life: Incontinence Quality of Life (I-QOL) questionnaire scores were significantly 
improved in the duloxetine-treated patient group compared with the placebo-treated group (9.2 versus 
5.9 score improvement, p<0.001). Using a global improvement scale (PGI), significantly more women 
using duloxetine considered their symptoms of stress incontinence to be improved with treatment 
compared with women using placebo (64.6% versus 50.1%, p<0.001). 
 
YENTREVE and Prior Continence Surgery: There are limited data that suggest that the benefits of 
YENTREVE are not diminished in women with stress urinary incontinence who have previously 
undergone continence surgery. 
 
YENTREVE and Pelvic Floor Muscle Training (PFMT): During a 12-week blinded, randomised, 
controlled study, YENTREVE demonstrated greater reductions in IEF compared with either placebo 
treatment or with PFMT alone. Combined therapy (duloxetine + PFMT) showed greater improvement 
in both pad use and condition-specific quality of life measures than YENTREVE alone or PFMT 
alone. 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Yentreve in all subsets of the paediatric population in the treatment of stress urinary incontinence. See 
section 4.2 for information on paediatric use. 
 
5.2 Pharmacokinetic properties 
 
Duloxetine is administered as a single enantiomer. Duloxetine is extensively metabolised by oxidative 
enzymes (CYP1A2 and the polymorphic CYP2D6), followed by conjugation. The pharmacokinetics of 
duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, 
smoking status and CYP2D6 metaboliser status.  
 
Absorption: Duloxetine is well absorbed after oral administration with a Cmax occurring 6 hours post 
dose. The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%). Food 
delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the 
extent of absorption (approximately 11 %). These changes do not have any clinical significance.  
 
Distribution: Duloxetine is approximately 96% bound to human plasma proteins. Duloxetine binds to 
both albumin and alpha-l acid glycoprotein. Protein binding is not affected by renal or hepatic 
impairment. 
 
Biotransformation: Duloxetine is extensively metabolised and the metabolites are excreted principally 
in urine. Both cytochromes P450-2D6 and 1A2 catalyse the formation of the two major metabolites 
glucuronide conjugate of 4-hydroxy duloxetine and sulfate conjugate of 5-hydroxy 6-methoxy 
duloxetine. Based upon in vitro studies, the circulating metabolites of duloxetine are considered 
pharmacologically inactive. The pharmacokinetics of duloxetine in patients who are poor metabolisers 
with respect to CYP2D6 has not been specifically investigated. Limited data suggest that the plasma 
levels of duloxetine are higher in these patients. 
 
Elimination: The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours). 
After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/hr to 46 l/hr (mean of 
36 l/hr). After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/hr 
(mean 101 l/hr). 
 



 14 

Special populations 
Gender: Pharmacokinetic differences have been identified between males and females (apparent 
plasma clearance is approximately 50% lower in females). Based upon the overlap in the range of 
clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a 
lower dose for female patients.  
 
Age: Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) 
(AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude 
of these changes is not sufficient to justify adjustments to the dose. As a general recommendation, 
caution should be exercised when treating the elderly (see sections 4.2 and 4.4). 
 
Renal impairment: End stage renal disease (ESRD) patients receiving dialysis had 2-fold higher 
duloxetine Cmax and AUC values compared with healthy subjects. Pharmacokinetic data on duloxetine 
is limited in patients with mild or moderate renal impairment. 
 
Hepatic impairment: Moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of 
duloxetine. Compared with healthy subjects, the apparent plasma clearance of duloxetine was 79% 
lower, the apparent terminal half-life was 2.3 times longer, and the AUC was 3.7 times higher in 
patients with moderate liver disease. The pharmacokinetics of duloxetine and its metabolites have not 
been studied in patients with mild or severe hepatic insufficiency. 
 
Breast-feeding mothers: The disposition of duloxetine was studied in 6 lactating women who were at 
least 12-weeks postpartum. Duloxetine is detected in breast milk, and steady-state concentrations in 
breast milk are about one-fourth those in plasma. The amount of duloxetine in breast milk is 
approximately 7 µg/day while on 40 mg twice daily dosing. Lactation did not influence duloxetine 
pharmacokinetics.  
 
5.3 Preclinical safety data 
 
Duloxetine was not genotoxic in a standard battery of tests and was not carcinogenic in rats.  
Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat 
carcinogenicity study. The underlying mechanism and the clinical relevance are unknown.  Female 
mice receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and 
carcinomas at the high dose only (144 mg/kg/day), but these were considered to be secondary to 
hepatic microsomal enzyme induction. The relevance of this mouse data to humans is unknown. 
Female rats receiving duloxetine before and during mating and early pregnancy had a decrease in 
maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices 
and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at 
the most at maximum clinical exposure (AUC). In an embryotoxicity study in the rabbit, a higher 
incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels 
below the maximum clinical exposure (AUC). No malformations were observed in another study 
testing a higher dose of a different salt of duloxetine. In pre/postnatal toxicity study in the rat, 
duloxetine induced adverse behavioural effects in the offspring at systemic exposure levels below 
maximum clinical exposure (AUC).  
 
Studies in juvenile rats reveal transient effects on neurobehaviour, as well as significantly decreased 
body weight and food consumption; hepatic enzyme induction; and hepatocellular vacuolation at 45 
mg/kg/day. The general toxicity profile of duloxetine in juvenile rats was similar to that in adult rats. 
The no-adverse effect level was determined to be 20 mg/kg/day.  
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Capsule content 
Hypromellose 
Hypromellose acetate succinate 



 15 

Sucrose 
Sugar spheres 
Talc 
Titanium dioxide (E171) 
Triethyl citrate  
 
Capsule shell 
 
YENTREVE 20 mg 
Gelatin 
Sodium lauryl sulfate 
Titanium dioxide (E171) 
Indigo carmine (E132) 
Edible black ink 
 
Edible ink: 
Black iron oxide - synthetic (E172) 
Propylene glycol 
Shellac 
 
YENTREVE 40 mg 
Gelatin 
Sodium lauryl sulfate 
Titanium dioxide (E171) 
Indigo carmine (E132) 
Red iron oxide (E172) 
Yellow iron oxide (E172) 
Edible black ink 
 
Edible ink: 
Black iron oxide - synthetic (E172) 
Propylene glycol 
Shellac 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
Store in the original package in order to protect from moisture. Do not store above 30° C.  
 
6.5 Nature and contents of container 
 
Polyvinylchloride (PVC), polyethylene (PE), and polychlorotrifluoroethylene (PCTFE) blister sealed 
with an aluminium foil. 
 
YENTREVE 20 mg 
YENTREVE 20 mg is available in packs of 28, 56 and 98 hard gastro-resistant capsules. 
 
YENTREVE 40 mg 
YENTREVE 40 mg is available in packs of 28, 56, 98 and 140 hard gastro-resistant capsules and in a 
multipack containing 196 (2 packs of 98) hard gastro-resistant capsules. 



 16 

 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/04/280/001 
EU/1/04/280/002 
EU/1/04/280/003 
EU/1/04/280/004 
EU/1/04/280/005 
EU/1/04/280/006 
EU/1/04/280/007 
EU/1/04/280/008 

 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 11 August 2004 
Date of latest renewal: 24 June 2009 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicine is available on the European Medicines Agency (EMA) web 
site: http://www.ema.europa.eu 



 17 

  
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER(S) 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 

 



 18 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Lilly S.A.  
Avda. de la Industria Nº 30,  
28108 Alcobendas  
Madrid 
Spain 
 
 
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 in 
accordance with the requirements 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 (pharmacovililance or risk minimisation) milestone being reached. 
 

 
 
  



 19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



 20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



 21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTONS FOR 40 MG HARD GASTRO-RESISTANT CAPSULES 

 
1. NAME OF THE MEDICINAL PRODUCT 

 
YENTREVE 40 mg hard gastro-resistant capsules. 
Duloxetine  
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 40 mg of duloxetine (as hydrochloride) 
 
 

3. LIST OF EXCIPIENTS 
 
Contains sucrose 
See leaflet for further information 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 hard gastro-resistant capsules 
56 hard gastro-resistant capsules 
98 hard gastro-resistant capsules 
140 hard gastro-resistant capsules  
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before 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 
 
Store in the original package in order to protect from moisture. Do not store above 30°C. 
 
 



 22 

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 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/04/280/002(28 hard gastro-resistant capsules) 
EU/1/04/280/003 (56 hard gastro-resistant capsules) 
EU/1/04/280/004 (98 hard gastro-resistant capsules) 
EU/1/04/280/005 (140 hard gastro-resistant capsules)  
 
 

13. BATCH NUMBER 
 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 

 
16. INFORMATION IN BRAILLE 
 
YENTREVE 40 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



 23 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
MULTIPACK INNER CARTON FOR 40 MG HARD GASTRO-RESISTANT CAPSULES 
(WITHOUT BLUE BOX) 

 
1. NAME OF THE MEDICINAL PRODUCT 

 
YENTREVE 40 mg hard gastro-resistant capsules. 
Duloxetine 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 40 mg of duloxetine (as hydrochloride) 
 
 

3. LIST OF EXCIPIENTS 
 
Contains sucrose 
See leaflet for further information 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
98 hard gastro-resistant capsules. Component of a multipack, can’t be sold seperately. 
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before 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 
 
Store in the original package in order to protect from moisture. Do not store above 30 °C 
 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 



 24 

 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/04/280/006 
 
 

13. BATCH NUMBER 
 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
YENTREVE 40 mg 
  



 25 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
MULTIPACK-OUTER CARTON FOR 40 MG HARD GASTRO-RESISTANT CAPSULES 
(WITH BLUE BOX) 

 
1. NAME OF THE MEDICINAL PRODUCT 

 
YENTREVE 40 mg hard gastro-resistant capsules. 
Duloxetine 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 40 mg of duloxetine (as hydrochloride) 
 
 

3. LIST OF EXCIPIENTS 
 
Contains sucrose 
See leaflet for further information 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 196 (2 packs of 98 hard gastro-resistant capsules) 
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before 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 
 
Store in the original package in order to protect from moisture. Do not store above 30°C 
 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 



 26 

 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/04/280/006 
 
 

13. BATCH NUMBER 
 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
YENTREVE 40 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN: 
  



 27 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (40 mg hard gastro-
resistant capsules) 

 
1. NAME OF THE MEDICINAL PRODUCT 

 
YENTREVE 40 mg hard gastro-resistant capsules 
Duloxetine 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Lilly 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
  



 28 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTONS FOR 20 MG HARD GASTRO-RESISTANT CAPSULES 

 
1. NAME OF THE MEDICINAL PRODUCT 

 
YENTREVE 20 mg hard gastro-resistant capsules. 
Duloxetine  
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 20 mg of duloxetine (as hydrochloride) 
 
 

3. LIST OF EXCIPIENTS 
 
Contains sucrose 
See leaflet for further information 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
56 hard gastro-resistant capsules 
28 hard gastro-resistant capsules  
98 hard gastro-resistant capsules 
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the leaflet before 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 
 
Store in the original package in order to protect from moisture. Do not store above 30°C 
 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



 29 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/04/280/001 (56 hard gastro-resistant capsules) 
EU/1/04/280/007 (28 hard gastro-resistant capsules) 
EU/1/04/280/008 (98 hard gastro-resistant capsules) 
 
 

13. BATCH NUMBER 
 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
YENTREVE 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN:  
NN: 
  



 30 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (20 mg hard gastro-
resistant capsules) 

 
1. NAME OF THE MEDICINAL PRODUCT 

 
YENTREVE 20 mg hard gastro-resistant capsules 
Duloxetine 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Lilly 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
  



 31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



 32 

Package leaflet: information for the user 
 

YENTREVE 40 mg hard gastro-resistant capsules 
YENTREVE 20 mg hard gastro-resistant capsules 

Duloxetine (as hydrochloride) 
 

 
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 of the side effects talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. 
 
What is in this leaflet: 
1. What YENTREVE is and what it is used for 
2. What you need to know before you take YENTREVE 
3. How to take YENTREVE 
4. Possible side effects 
5. How to store YENTREVE 
6. Contents of the pack and other information 
 
 
1. What YENTREVE is and what it is used for 
 
YENTREVE contains the active substance duloxetine. YENTREVE increases the levels of serotonin 
and noradrenaline in the nervous system. 
 
YENTREVE is a medicine to be taken by mouth to treat Stress Urinary Incontinence (SUI) in women. 
 
Stress urinary incontinence is a medical condition in which patients have accidental loss or leakage of 
urine during physical exertion or activities such as laughing, coughing, sneezing, lifting, or exercise. 
 
YENTREVE is believed to work by increasing the strength of the muscle that holds back urine when 
you laugh, sneeze, or perform physical activities. 
 
The efficacy of YENTREVE is reinforced when combined with a training program called Pelvic Floor 
Muscle Training (PFMT). 
 
 
2.  What you need to know before you take YENTREVE 
 
DO NOT take YENTREVE if you: 
- are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6) 
- have liver disease 
- have severe kidney disease 
- are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase 

inhibitor (MAOI) (see ‘Other medicines and YENTREVE’) 
- are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which 

are used to treat some infections 
Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you 
should be taking YENTREVE. 
 



 33 

Warnings and Precautions 
The following are reasons why YENTREVE may not be suitable for you. Talk to your doctor before 
you take Yentreve if you: 
- are taking medicines to treat depression (see ‘Other medicines and YENTREVE’) 
- are taking St. John’s Wort, a herbal treatment (Hypericum perforatum) 
- have kidney disease 
- have had seizures (fits) 
- have had mania 
- suffer from bipolar disorder 
- have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) 
- have a history of bleeding disorders (tendency to develop bruises), especially if you are 

pregnant (see ‘Pregnancy and breast-feeding‘) 
- are at risk of low sodium levels (for example if you are taking diuretics, especially if you are 

elderly) 
- are currently being treated with another medicine which may cause liver damage. 
- are taking other medicines containing duloxetine (see ‘Other medicines and YENTREVE’) 
 
YENTREVE may cause a sensation of restlessness or an inability to sit or stand still. You should tell 
your doctor if this happens to you. 
 
Medicines like Yentreve (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see 
section 4). In some cases, these symptoms have continued after stopping treatment. 
 
Thoughts of suicide and worsening of depression or anxiety disorder  
Although YENTREVE is not indicated for the treatment of depression, its active ingredient 
(duloxetine) is used as an antidepressant medicine. If you are depressed and/or have anxiety disorders 
you can sometimes have thoughts of harming or killing yourself. These may be increased when first 
starting antidepressants, since these medicines all take time to work, usually about two weeks but 
sometimes longer. 
You may be more likely to think like this if you:  
- have previously had thoughts about killing or harming yourself 
- are a young adult. Information from clinical trials has shown an increased risk of suicidal 

behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an 
antidepressant 

 
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a 
hospital straight away. 
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety 
disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression 
or anxiety is getting worse, or if they are worried about changes in your behaviour. 
 
Children and adolescents under 18 years of age 
YENTREVE should not be used for children and adolescents under 18 years. Also, you should know 
that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts 
and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class 
of medicines. Also, the long-term safety effects concerning growth, maturation, and cognitive and 
behavioural development of YENTREVE in this age group have not yet been demonstrated. 
 
Other medicines and YENTREVE 
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines, including medicines obtained without a prescription.  
 
The main ingredient of YENTREVE, duloxetine, is used in other medicines for other conditions: 
• diabetic neuropathic pain, depression, anxiety and urinary incontinence 
Using more than one of these medicines at the same time should be avoided. Check with your doctor if 
you are already taking other medicines containing duloxetine. 
 



 34 

Your doctor should decide whether you can take YENTREVE with other medicines. Do not start or 
stop taking any medicines, including those bought without a prescription and herbal remedies, 
before checking with your doctor.  
 
You should also tell your doctor if you are taking any of the following: 
 
Monoamine oxidase inhibitors (MAOIs): You should not take YENTREVE if you are taking or have 
recently taken (within the last 14 days) an antidepressant medicine called a monoamine oxidase 
inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an 
antibiotic).  Taking a MAOI together with many prescription medicines, including YENTREVE, can 
cause serious or even life-threatening side effects. You must wait at least 14 days after you have 
stopped taking an MAOI before you can take YENTREVE. Also, you need to wait at least 5 days after 
you stop taking YENTREVE before you take a MAOI. 
 
Medicines that cause sleepiness: These include medicines prescribed by your doctor including 
benzodiazepines, strong painkillers, antipsychotics, phenobarbital and sedative antihistamines. 
 
Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as 
paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as 
clomipramine, amitriptyline), pethidine, St John’s Wort and MAOIs (such as moclobemide and 
linezolid). These medicines increase the risk of side effects; if you get any unusual symptom taking 
any of these medicines together with YENTREVE, you should see your doctor.  
 
Oral anticoagulants or antiplatelet agents: Medicines which thin the blood or prevent the blood from 
clotting. These medicines might increase the risk of bleeding. 
 
YENTREVE with food, drink and alcohol 
YENTREVE may be taken with or without food. You should take extra care if you drink alcohol while 
taking YENTREVE.  
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
• Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are 

taking YENTREVE. You should use YENTREVE only after discussing the potential benefits 
and any potential risks to your unborn child with your doctor. 

  
• Make sure your midwife and/or doctor knows you are on YENTREVE. When taken during 

pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called 
persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and 
appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If 
this happens to your baby you should contact your midwife and/or doctor immediately. 

 
• If you take YENTREVE near the end of your pregnancy, your baby might have some symptoms 

when it is born. These usually begin at birth or within a few days of your baby being born. 
These symptoms may include floppy muscles, trembling, jitteriness, not feeding properly, 
trouble with breathing and fits. If your baby has any of these symptoms when it is born, or you 
are concerned about your baby’s health, contact your doctor or midwife who will be able to 
advise you. 
 

• If you take YENTREVE near the end of your pregnancy there is an increased risk of excessive 
vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your 
doctor or midwife should be aware that you are taking duloxetine so they can advise you. 
 

• Available data from the use of YENTREVE during the first three months of pregnancy do not 
show an increased risk of overall birth defects in general in the child. If YENTREVE is taken 
during the second half of pregnancy, there may be an increased risk that the infant will be born 



 35 

early (6 additional premature infants for every 100 women who take YENTREVE in the second 
half of pregnancy), mostly between weeks 35 and 36 of pregnancy. 

 
• Tell your doctor if you are breast-feeding. The use of YENTREVE while breastfeeding is not 

recommended. You should ask your doctor or pharmacist for advice. 
 
Driving and using machines 
YENTREVE may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you 
know how YENTREVE affects you. 
 
YENTREVE contains sucrose 
YENTREVE contains sucrose. If you have been told by your doctor that you have an intolerance to 
some sugars, contact your doctor before taking this medicinal product.  
 
YENTREVE contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 
‘sodium-free’. 
 
 
3.  How to take YENTREVE 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.  
 
YENTREVE is for oral use. You should swallow your capsule whole with a drink of water. 
 
The recommended dose of YENTREVE is 40 mg twice a day (in the morning and late 
afternoon/evening). Your doctor may decide to start your treatment with 20 mg twice a day for two 
weeks before increasing the dose to 40 mg twice a day.  
 
To help you remember to take YENTREVE, you may find it easier to take it at the same times every 
day.  
 
Do not stop taking YENTREVE, or change your dose, without talking to your doctor. Treating your 
disorder properly is important to help you get better.  If it is not treated, your condition may not go 
away and may become more serious and difficult to treat. 
 
If you take more YENTREVE than you should 
Call your doctor or pharmacist immediately if you take more than the amount of YENTREVE 
prescribed by your doctor. Symptoms of overdose include sleepiness, coma, serotonin syndrome (a 
rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, 
feeling of being drunk, fever, sweating or rigid muscles), fits, vomiting and fast heart rate. 
 
If you forget to take YENTREVE 
If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the 
missed dose and take only a single dose as usual. Do not take a double dose to make up for a forgotten 
dose. Do not take more than the daily amount of YENTREVE that has been prescribed for you in one 
day. 
 
If you stop taking YENTREVE 
DO NOT stop taking your capsules without the advice of your doctor even if you feel better. If your 
doctor thinks that you no longer need YENTREVE he or she will ask you to reduce your dose over 2 
weeks.  
 



 36 

Some patients, who suddenly stop taking YENTREVE after more than 1 week of therapy, have had 
symptoms such as:  
• dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in 

the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, 
feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), 
shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or 
vertigo.  

These symptoms are usually not serious and disappear within a few days, but if you have symptoms 
that are troublesome you should ask your doctor for advice. 

 
If you have 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. These 
effects are normally mild to moderate and often disappear after a short time. 
 
Very common side effects (may affect more than 1 in 10 people) 
• feeling sick (nausea), dry mouth, constipation 
• fatigue 
 
Common side effects (may affect up to 1 in 10 people) 
• lack of appetite 
• trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty sleeping 
• headache, dizziness, feeling sluggish, feeling sleepy,  tremor, numbness, including numbness, 

pricking or tingling of the skin 
• blurred eyesight 
• feeling of dizziness or “spinning” (vertigo) 
• increased blood pressure, flushing 
• diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion 
• increased sweating  
• weakness, shivering 
 
Uncommon side effects (may affect up to 1 in 100 people) 
• throat inflammation that causes a hoarse voice 
• allergic reactions  
• decreased thyroid gland activity which can cause tiredness or weight gain  
• dehydration 
• grinding or clenching the teeth, feeling disorientated, lack of motivation, difficulty or failure to 

experience orgasm, unusual dreams 
• feeling nervous, difficulty concentrating, changes in sense of taste, poor sleep quality  
• large pupils (the dark centre of the eye), problems with eyesight, eyes feel dry  
• tinnitus (hearing sound in the ear when there is no external sound), ear pain 
• feeling the heart pumping in the chest, fast and/or irregular heart beat  
• fainting 
• increased yawning 
• vomiting blood, or black tarry stools (faeces), gastroenteritis, inflammation of the mouth, 

burping, difficulty swallowing, breaking wind, bad breath 
• inflammation of the liver that may cause abdominal pain and yellowing of the skin or whites of 

the eyes 
• (itchy) rash, night sweats, hives, cold sweats, increased tendency to bruise   
• muscle pain, muscle tightness, muscle spasm, contraction of the jaw muscle 
• difficulty to start urinating, painful urination, needing to pass urine during the night, frequent 

urination, abnormal urine odour  



 37 

• abnormal vaginal bleeding, menopausal symptoms 
• chest pain, feeling cold, thirst, feeling hot 
• weight loss, weight gain 
• Yentreve may cause effects that you may not be aware of, such as increases in liver enzymes or 

blood levels of potassium, creatine phosphokinase, sugar, or cholesterol  
 
Rare side effects (may affect up to 1 in 1000 people) 
• serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or 

lips  
• low levels of sodium in the blood (mostly in elderly people; the symptoms may include feeling 

dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are 
fainting, fits or falls), syndrome of inappropriate secretion of anti-diuretic hormone (SIADH)   

• suicidal behaviour, suicidal thoughts,  mania (over activity, racing thoughts and decreased need 
for sleep), hallucinations, aggression and anger 

• “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, 
clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, sudden 
involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or 
stand still, difficulty controlling movement e.g. lack of coordination or involuntary movements 
of the muscles, restless legs syndrome 

• increased pressure in the eye (glaucoma) 
• dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes 
• throat tightness, nose bleeds 
• coughing, wheezing and shortness of breath which may be accompanied by a high temperature 
• passing bright red blood in your stools, inflammation of the large intestine (leading to diarrhoea) 
• liver failure, yellowing of the skin or whites of the eyes (jaundice) 
• Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals), 

serious allergic reaction which causes swelling of the face or throat (angioedema), sensitivity to 
sunlight  

• muscle twitching  
• difficulty or inability to pass urine, needing to pass more urine than normal, having a decreased 

urine flow 
• abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or 

missed periods, abnormal production of breast milk 
• excessive vaginal bleeding shortly after birth (postpartum haemorrhage) 
• falls (mostly in elderly people), abnormal gait 
 
Very rare side effects (may affect up to 1 in 10,000 people) 
• inflammation of the blood vessels in the skin (cutaneous vasculitis) 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor of 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 YENTREVE 
 
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 carton. 
 
Store in the original package to protect from moisture. Do not store above 30°C. 
 

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


 38 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away of medicines you no longer use. These measures will help to protect the environment. 
 
 
6.  Contents of the pack and other information 
 
What YENTREVE contains 
The active substance is duloxetine.  
Each capsule contains 20 or 40 mg of duloxetine (as hydrochloride).  
 
The other ingredients are: 
Capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium 
dioxide (E171), triethyl citrate (See end of section 2 for further information on sucrose). 
Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), red iron 
oxide and yellow iron oxide, edible black ink. 
Edible ink: synthetic black iron oxide (E172), propylene glycol, shellac. 
 
What YENTREVE looks like and contents of the pack 
YENTREVE is a hard gastro-resistant capsule. Each capsule of YENTREVE contains pellets of 
duloxetine hydrochloride with a covering to protect them from stomach acid. 
 
YENTREVE is available in 2 strengths: 20 and 40 mg. 
The 40 mg capsules are orange and blue and are printed with ’40 mg’ and the code ‘9545’. 
The 20 mg capsules are blue and are printed with ’20 mg’ and the code ‘9544’. 
 
YENTREVE 40 mg is available in packs of 28, 56, 98, 140 and 196 (2 x 98) capsules. 
YENTREVE 20 mg is available in packs of 28, 56 and 98 capsules. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The 
Netherlands. 
Manufacturer: Lilly S.A., Avda. De la Industria, 30, 28108 Alcobendas, Madrid, Spain. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 

België/Belgique/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84  

Česká republika 
Eli Lilly ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S 
Tlf: +45 45 26 60 00 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 

Nederland 
Eli Lilly Nederland B.V. 
Tel: + 31-(0) 30 60 25 800 



 39 

 
Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6 817 280 
 

Norge 
Eli Lilly Norge A.S 
Tlf: +47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges.m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Spaly Bioquímica, S.A. 
Tel: + 34-91 623 17 32 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 
 

France 
Lilly France SAS 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351 21-4126600 
 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: +353-(0) 1 661 4377 

 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0)1 580 00 10 

Ísland 
Icepharma hf. 
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab 
Puh/Tel: +358-(0) 9 85 45 250 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0)8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: + 371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 
 

 
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. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) 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
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{'Title': '2. what you need to know before you take yentreve', 'Section_Content': "do not take yentreve if you: - are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6) - have liver disease - have severe kidney disease - are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (maoi) (see 'other medicines and yentreve') - are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections talk to your doctor if you have high blood pressure or heart disease. your doctor will tell you if you should be taking yentreve. warnings and precautions the following are reasons why yentreve may not be suitable for you. talk to your doctor before you take yentreve if you: - are taking medicines to treat depression (see 'other medicines and yentreve') - are taking st. john's wort, a herbal treatment (hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see 'pregnancy and breast-feeding') - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage. - are taking other medicines containing duloxetine (see 'other medicines and yentreve') yentreve may cause a sensation of restlessness or an inability to sit or stand still. you should tell your doctor if this happens to you. medicines like yentreve (so called ssris/snris) may cause symptoms of sexual dysfunction (see section 4). in some cases, these symptoms have continued after stopping treatment. thoughts of suicide and worsening of depression or anxiety disorder although yentreve is not indicated for the treatment of depression, its active ingredient (duloxetine) is used as an antidepressant medicine. if you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. these may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. you may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself - are a young adult. information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant if you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. you may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. you might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour. children and adolescents under 18 years of age yentreve should not be used for children and adolescents under 18 years. also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of yentreve in this age group have not yet been demonstrated. other medicines and yentreve please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. the main ingredient of yentreve, duloxetine, is used in other medicines for other conditions: diabetic neuropathic pain, depression, anxiety and urinary incontinence using more than one of these medicines at the same time should be avoided. check with your doctor if you are already taking other medicines containing duloxetine. your doctor should decide whether you can take yentreve with other medicines. do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor. you should also tell your doctor if you are taking any of the following: monoamine oxidase inhibitors (maois): you should not take yentreve if you are taking or have recently taken (within the last 14 days) an antidepressant medicine called a monoamine oxidase inhibitor (maoi). examples of maois include moclobemide (an antidepressant) and linezolid (an antibiotic). taking a maoi together with many prescription medicines, including yentreve, can cause serious or even life-threatening side effects. you must wait at least 14 days after you have stopped taking an maoi before you can take yentreve. also, you need to wait at least 5 days after you stop taking yentreve before you take a maoi. medicines that cause sleepiness: these include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and sedative antihistamines. medicines that increase the level of serotonin: triptans, tramadol, tryptophan, ssris (such as paroxetine and fluoxetine), snris (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, st john's wort and maois (such as moclobemide and linezolid). these medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with yentreve, you should see your doctor. oral anticoagulants or antiplatelet agents: medicines which thin the blood or prevent the blood from clotting. these medicines might increase the risk of bleeding. yentreve with food, drink and alcohol yentreve may be taken with or without food. you should take extra care if you drink alcohol while taking yentreve. pregnancy and breast-feeding if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking yentreve. you should use yentreve only after discussing the potential benefits and any potential risks to your unborn child with your doctor. make sure your midwife and/or doctor knows you are on yentreve. when taken during pregnancy, similar drugs (ssris) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (pphn), making the baby breathe faster and appear bluish. these symptoms usually begin during the first 24 hours after the baby is born. if this happens to your baby you should contact your midwife and/or doctor immediately. if you take yentreve near the end of your pregnancy, your baby might have some symptoms when it is born. these usually begin at birth or within a few days of your baby being born. these symptoms may include floppy muscles, trembling, jitteriness, not feeding properly, trouble with breathing and fits. if your baby has any of these symptoms when it is born, or you are concerned about your baby's health, contact your doctor or midwife who will be able to advise you. if you take yentreve near the end of your pregnancy there is an increased risk of excessive vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. your doctor or midwife should be aware that you are taking duloxetine so they can advise you. available data from the use of yentreve during the first three months of pregnancy do not show an increased risk of overall birth defects in general in the child. if yentreve is taken during the second half of pregnancy, there may be an increased risk that the infant will be born 35 early (6 additional premature infants for 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{'Title': '3. how to take yentreve', '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. yentreve is for oral use. you should swallow your capsule whole with a drink of water. the recommended dose of yentreve is 40 mg twice a day (in the morning and late afternoon/evening). your doctor may decide to start your treatment with 20 mg twice a day for two weeks before increasing the dose to 40 mg twice a day. to help you remember to take yentreve, you may find it easier to take it at the same times every day. do not stop taking yentreve, or change your dose, without talking to your doctor. treating your disorder properly is important to help you get better. if it is not treated, your condition may not go away and may become more serious and difficult to treat. if you take more yentreve than you should call your doctor or pharmacist immediately if you take more than the amount of yentreve prescribed by your doctor. symptoms of overdose include sleepiness, coma, serotonin syndrome (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, vomiting and fast heart rate. if you forget to take yentreve if you miss a dose, take it as soon as you remember. however, if it is time for your next dose, skip the missed dose and take only a single dose as usual. do not take a double dose to make up for a forgotten dose. do not take more than the daily amount of yentreve that has been prescribed for you in one day. if you stop taking yentreve do not stop taking your capsules without the advice of your doctor even if you feel better. if your doctor thinks that you no longer need yentreve he or she will ask you to reduce your dose over 2 weeks. some patients, who suddenly stop taking yentreve after more than 1 week of therapy, have had symptoms such as: dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo. these symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome you should ask your doctor for advice. if you have further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'yentreve', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 25}, {'Id': 2, 'BeginOffset': 246, 'EndOffset': 254, 'Score': 0.38237160444259644, 'Text': 'yentreve', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 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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. these effects are normally mild to moderate and often disappear after a short time. very common side effects (may affect more than 1 in 10 people) feeling sick (nausea), dry mouth, constipation fatigue common side effects (may affect up to 1 in 10 people) lack of appetite trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty sleeping headache, dizziness, feeling sluggish, feeling sleepy, tremor, numbness, including numbness, pricking or tingling of the skin blurred eyesight feeling of dizziness or "spinning" (vertigo) increased blood pressure, flushing diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion increased sweating weakness, shivering uncommon side effects (may affect up to 1 in 100 people) throat inflammation that causes a hoarse voice allergic reactions decreased thyroid gland activity which can cause tiredness or weight gain dehydration grinding or clenching the teeth, feeling disorientated, lack of motivation, difficulty or failure to experience orgasm, unusual dreams feeling nervous, difficulty concentrating, changes in sense of taste, poor sleep quality large pupils (the dark centre of the eye), problems with eyesight, eyes feel dry tinnitus (hearing sound in the ear when there is no external sound), ear pain feeling the heart pumping in the chest, fast and/or irregular heart beat fainting increased yawning vomiting blood, or black tarry stools (faeces), gastroenteritis, inflammation of the mouth, burping, difficulty swallowing, breaking wind, bad breath inflammation of the liver that may cause abdominal pain and yellowing of the skin or whites of the eyes (itchy) rash, night sweats, hives, cold sweats, increased tendency to bruise muscle pain, muscle tightness, muscle spasm, contraction of the jaw muscle difficulty to start urinating, painful urination, needing to pass urine during the night, frequent urination, abnormal urine odour 37 abnormal vaginal bleeding, menopausal symptoms chest pain, feeling cold, thirst, feeling hot weight loss, weight gain yentreve may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol rare side effects (may affect up to 1 in 1000 people) serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips low levels of sodium in the blood (mostly in elderly people; the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are fainting, fits or falls), syndrome of inappropriate secretion of anti-diuretic hormone (siadh) suicidal behaviour, suicidal thoughts, mania (over activity, racing thoughts and decreased need for sleep), hallucinations, aggression and anger "serotonin syndrome" (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome increased pressure in the eye (glaucoma) dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes throat tightness, nose bleeds coughing, wheezing and shortness of breath which may be accompanied by a high temperature passing bright red blood in your stools, inflammation of the large intestine (leading to diarrhoea) liver failure, yellowing of the skin or whites of the eyes (jaundice) stevens-johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals), serious allergic reaction which causes swelling of the face or throat (angioedema), sensitivity to sunlight muscle twitching difficulty or inability to pass urine, needing to pass more urine than normal, having a decreased urine flow abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, abnormal production of breast milk excessive vaginal bleeding shortly after birth (postpartum haemorrhage) falls (mostly in elderly people), abnormal gait very rare side effects (may affect up to 1 in 10,000 people) inflammation of the blood vessels in the skin (cutaneous vasculitis) reporting of side effects if you get any side effects, talk to your doctor of 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.', 'Entity_Recognition': [{'Text': 'yentreve', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all 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'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6639190912246704}]}, {'Text': 'abnormal gait very rare side effects', 'Type': 'PROBLEM', 'BeginOffset': 4309, 'EndOffset': 4345}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 4364, 'EndOffset': 4365}, {'Text': '10,000', 'Type': 'NUMBER', 'BeginOffset': 4369, 'EndOffset': 4375}, {'Text': 'inflammation of the blood vessels in the skin (cutaneous vasculitis', 'Type': 'PROBLEM', 'BeginOffset': 4384, 'EndOffset': 4451}, {'Id': 240, 'BeginOffset': 4466, 'EndOffset': 4478, 'Score': 0.9256863594055176, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7544457316398621}]}, {'Id': 241, 'BeginOffset': 4494, 'EndOffset': 4506, 'Score': 0.9213794469833374, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7769691944122314}]}, {'Id': 242, 'BeginOffset': 4570, 'EndOffset': 4582, 'Score': 0.9546017646789551, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.662693202495575}]}, {'Id': 243, 'BeginOffset': 4631, 'EndOffset': 4643, 'Score': 0.8566479086875916, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7004947662353516}]}, {'Id': 244, 'BeginOffset': 4697, 'EndOffset': 4708, 'Score': 0.3644017279148102, 'Text': 'appendix v.', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6069282293319702}]}, {'Id': 245, 'BeginOffset': 4722, 'EndOffset': 4734, 'Score': 0.853878915309906, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7344232201576233}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 4790, 'EndOffset': 4803}]}
{'Title': '5. how to store yentreve', 'Section_Content': '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 carton. store in the original package to protect from moisture. do not store above 30. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away of medicines you no longer use. these measures will help to protect the environment.', 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': "what yentreve contains the active substance is duloxetine. each capsule contains 20 or 40 mg of duloxetine (as hydrochloride). the other ingredients are: capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (e171), triethyl citrate (see end of section 2 for further information on sucrose). capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (e171), indigo carmine (e132), red iron oxide and yellow iron oxide, edible black ink. edible ink: synthetic black iron oxide (e172), propylene glycol, shellac. what yentreve looks like and contents of the pack yentreve is a hard gastro-resistant capsule. each capsule of yentreve contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid. yentreve is available in 2 strengths: 20 and 40 mg. the 40 mg capsules are orange and blue and are printed with '40 mg' and the code '9545'. the 20 mg capsules are blue and are printed with '20 mg' and the code '9544'. yentreve 40 mg is available in packs of 28, 56, 98, 140 and 196 (2 x 98) capsules. yentreve 20 mg is available in packs of 28, 56 and 98 capsules. not all pack sizes may be marketed.", 'Entity_Recognition': [{'Text': 'yentreve', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 47, 'EndOffset': 57, 'Score': 0.9983323216438293, 'Text': 'duloxetine', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.6602756977081299, 'RelationshipScore': 0.9999938011169434, 'RelationshipType': 'FORM', 'Id': 1, 'BeginOffset': 64, 'EndOffset': 71, 'Text': 'capsule', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.9316338300704956, 'RelationshipScore': 0.9997166991233826, 'RelationshipType': 'DOSAGE', 'Id': 2, 'BeginOffset': 81, 'EndOffset': 92, 'Text': '20 or 40 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '20', 'Type': 'NUMBER', 'BeginOffset': 81, 'EndOffset': 83}, {'Text': '40', 'Type': 'NUMBER', 'BeginOffset': 87, 'EndOffset': 89}, {'Id': 3, 'BeginOffset': 96, 'EndOffset': 106, 'Score': 0.9960824251174927, 'Text': 'duloxetine', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.6602756977081299, 'RelationshipScore': 0.9721704721450806, 'RelationshipType': 'FORM', 'Id': 1, 'BeginOffset': 64, 'EndOffset': 71, 'Text': 'capsule', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.9316338300704956, 'RelationshipScore': 0.934711217880249, 'RelationshipType': 'DOSAGE', 'Id': 2, 'BeginOffset': 81, 'EndOffset': 92, 'Text': '20 or 40 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 4, 'BeginOffset': 111, 'EndOffset': 124, 'Score': 0.9739797711372375, 'Text': 'hydrochloride', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 171, 'EndOffset': 183, 'Score': 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