Valdoxan
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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



 

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1 NAME OF THE MEDICINAL PRODUCT 
 
Valdoxan 25 mg film-coated tablets 
 
 
2 QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each film-coated tablet contains 25 mg of agomelatine. 
 
Excipient with known effect 
 
Each film-coated tablet contains 61.8 mg lactose (as monohydrate)  
 
For the full list of excipients, see section 6.1. 
 
 
3 PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet with blue imprint of company 
logo on one side. 
 
 
4 CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Valdoxan is indicated for the treatment of major depressive episodes in adults. 
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended dose is 25 mg once daily taken orally at bedtime.  
After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 
50 mg once daily, i.e. two 25 mg tablets, taken together at bedtime. 
 
Decision of dose increase has to be balanced with a higher risk of transaminases elevation. Any dose 
increase to 50 mg should be made on an individual patient benefit/risk basis and with strict respect of 
Liver Function Test monitoring. 
 
Liver function tests should be performed in all patients before starting treatment. Treatment should not 
be initiated if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4). 
During treatment transaminases should be monitored  periodically after around three weeks, six weeks 
(end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter 
when clinically indicated (see also section 4.4). Treatment should be discontinued if transaminases 
exceed 3 X upper limit of normal (see sections 4.3 and 4.4). 
When increasing the dosage, liver function tests should again be performed at the same frequency as 
when initiating treatment. 
 
Treatment duration 
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that 
they are free of symptoms. 
 
Switching therapy from SSRI/SNRI antidepressant to agomelatine 
Patients may experience discontinuation symptoms after cessation from an SSRI/ SNRI 
antidepressant. 



 

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The SmPC of the actual SSRI/SNRI should be consulted on how to withdraw the treatment to avoid 
this. Agomelatine can be started immediately while tapering the dosage of a SSRI//SNRI (see section 
5.1). 
 
Treatment discontinuation 
No dosage tapering is needed on treatment discontinuation. 
 
Special populations 
 
Elderly 
The efficacy and safety of agomelatine (25 to 50mg/day) have been established in elderly depressed 
patients (< 75years). No effect is documented  in patients ≥75 years. Therefore, agomelatine should 
not be used by patients in this age group (see sections 4.4 and 5.1). No dose adjustment is required in 
relation to age (see section 5.2). 
 
Renal impairment  
No relevant modification in agomelatine pharmacokinetic parameters in patients with severe renal 
impairment has been observed. However, only limited clinical data on the use of agomelatine in 
depressed patients with severe or moderate renal impairment with major depressive episodes is 
available. Therefore, caution should be exercised when prescribing agomelatine to these patients. 
 
Hepatic impairment  
Agomelatine is contraindicated in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2). 
 
Paediatric population  
The safety and efficacy of agomelatine in children from 2 years onwards for treatment of major 
depressive episodes have not yet been established. No data are available (see section 4.4). 
There is no relevant use of agomelatine in children from birth to 2 years for treatment of major 
depressive episodes. 
 
Method of administration 
 
For oral use. 
Valdoxan film-coated tablets may be taken with or without food. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Hepatic impairment (i.e. cirrhosis or active liver disease) or transaminases exceeding 3 X upper limit 
of normal (see sections 4.2 and 4.4). 
Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) (see section 4.5). 
 
4.4 Special warnings and precautions for use 
 
Monitoring of liver function 
 
Cases of liver injury, including hepatic failure (few cases were exceptionally reported with fatal 
outcome or liver transplantation in patients with hepatic risk factors), elevations of liver enzymes 
exceeding 10 times upper limit of normal, hepatitis and jaundice have been reported in patients treated 
with agomelatine in the post-marketing setting (see section 4.8). Most of them occurred during the 
first months of treatment. The pattern of liver damage is predominantly hepatocellular with increased 
serum transaminases, which usually return to normal levels on cessation of agomelatine.  
 
Caution should be exercised before starting treatment and close surveillance should be 
performed throughout the treatment period in all patients, especially if hepatic injury risk 
factors or concomitant medicinal products associated with risk of hepatic injury are present. 
 



 

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Before starting treatment  
Treatment with Valdoxan should only be prescribed after careful consideration of benefit and risk in 
patients with hepatic injury risk factors e.g.: 

-  obesity/overweight/non-alcoholic fatty liver disease, diabetes 
- alcohol use disorder and /or substantial alcohol intake  

and in patients receiving concomitant medicinal products associated with risk of hepatic injury.  
Baseline liver function tests should be undertaken in all patients and treatment should not be initiated 
in patients with baseline values of ALT and/or AST >3 X upper limit of normal (see section 4.3). 
Caution should be exercised when Valdoxan is administered to patients with pretreatment elevated 
transaminases (> the upper limit of the normal ranges and ≤3 times the upper limit of the normal 
range). 
 
• Frequency of liver function tests  
- before starting treatment 
- and then: 

- after around 3 weeks,  
- after around 6 weeks (end of acute phase), 
- after around 12 and 24 weeks (end of maintenance phase),  
- and thereafter when clinically indicated. 

- When increasing the dosage, liver function tests should again be performed at the same 
frequency as when initiating treatment. 
 

Any patient who develops increased serum transaminases should have his/her liver function tests 
repeated within 48 hours. 

 
During treatment period 
Valdoxan treatment should be discontinued immediately if: 

‐ patient develops symptoms or signs of potential liver injury (such as dark urine, light 
coloured stools, yellow skin/eyes, pain in the upper right belly, sustained new-onset and 
unexplained fatigue). 

‐ the increase in serum transaminases exceeds 3 X upper limit of normal. 
 
Following discontinuation of Valdoxan therapy liver function tests should be repeated until serum 
transaminases return to normal. 
 
Use in paediatric population  
 
Valdoxan is not recommended in the treatment of depression in patients under 18 years of age since 
safety and efficacy of Valdoxan have not been established in this age group. In clinical trials among 
children and adolescents treated with other antidepressants, suicide-related behaviour (suicide attempt 
and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) 
were more frequently observed compared to those treated with placebo (see section 4.2). 
 
Elderly 
No effect of agomelatine is documented in patients ≥75 years, therefore agomelatine should not be 
used by patients in this age group (see also sections 4.2 and 5.1). 
 
Use in elderly with dementia 
 
Valdoxan should not be used for the treatment of major depressive episodes in elderly patients with 
dementia since the safety and efficacy of Valdoxan have not been established in these patients. 
 
Bipolar disorder/ mania / hypomania 
 
Valdoxan should be used with caution in patients with a history of bipolar disorder, mania or 
hypomania and should be discontinued if a patient develops manic symptoms (see section 4.8). 



 

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Suicide/suicidal thoughts 
 
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 
ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or 
suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-
controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed an 
increased risk of suicidal behaviour with antidepressants compared to placebo, in patients less than 25 
years old. 
Close supervision of patients and in particular those at high risk should accompany treatment 
especially in early treatment and following dose changes. Patients (and caregivers of patients) should 
be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and 
unusual changes in behaviour and to seek medical advice immediately if these symptoms present. 
 
Combination with CYP1A2 inhibitors (see sections 4.3 and 4.5)  
 
Caution should be exercised when prescribing Valdoxan with moderate CYP1A2 inhibitors (e.g. 
propranolol, enoxacin) which may result in increased exposure of agomelatine. 
 
Lactose intolerance 
 
Valdoxan contains lactose. Patients with rare hereditary problems of galactose intolerance, total 
lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
 
Level of sodium 
 
Valdoxan contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Potential interactions affecting agomelatine 
 
Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/19 
(10%). Medicinal products that interact with these isoenzymes may decrease or increase the 
bioavailability of agomelatine.  
Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of 
agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure. 
Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e.g. fluvoxamine, 
ciprofloxacin) is contraindicated. 
Combination of agomelatine with oestrogens (moderate CYP1A2 inhibitors) results in a several fold 
increased exposure of agomelatine. While there was no specific safety signal in the 800 patients 
treated in combination with oestrogens, caution should be exercised when prescribing agomelatine 
with other moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) until more experience has been 
gained (see section 4.4). 
Rifampicin an inducer of all three cytochromes involved in the metabolism of agomelatine may 
decrease the bioavailability of agomelatine. 
Smoking induces CYP1A2 and has been shown to decrease the bioavailability of agomelatine, 
especially in heavy smokers (> 15 cigarettes/day) (see section 5.2). 
 
Potential for agomelatine to affect other medicinal products 
 



 

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In vivo, agomelatine does not induce CYP450 isoenzymes. Agomelatine inhibits neither CYP1A2 in 
vivo nor the other CYP450 in vitro. Therefore, agomelatine will not modify exposure to medicinal 
products metabolised by CYP 450. 
 
 
Other medicinal products 
 
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which 
could be prescribed concomitantly with Valdoxan in the target population was found in phase I 
clinical trials: benzodiazepines, lithium, paroxetine, fluconazole and theophylline.  
 
Alcohol 
 
The combination of agomelatine and alcohol is not advisable. 
 
Electroconvulsive therapy (ECT) 
 
There is no experience of concurrent use of agomelatine with ECT. Animal studies have not shown 
proconvulsant properties (see section 5.3). Therefore, clinical consequences of ECT performed 
concomitantly with agomelatine treatment, are considered to be unlikely. 
 
Paediatric population 
 
Interaction studies have only been performed in adults. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of 
agomelatine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with 
respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 
5.3). As a precautionary measure, it is preferable to avoid the use of Valdoxan during pregnancy.  
 
Breast-feeding 
 
It is not known whether agomelatine/metabolites are excreted in human milk. Available 
pharmacodynamic/toxicological data in animals have shown excretion of agomelatine/metabolites in 
milk (see section 5.3). A risk to the newborns/infants cannot be excluded. A decision must be made 
whether to discontinue breast-feeding or to discontinue/abstain from Valdoxan therapy taking into 
account the benefit of breast feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
 
Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility (see section 
5.3). 
 
4.7 Effects on ability to drive and use machines 
 
 Agomelatine has minor influence on the ability to drive and use machines.Considering that dizziness 
and somnolence are common adverse reactions, patients should be cautioned about their ability to 
drive or operate machines. 
 
4.8 Undesirable effects  
 
Summary of the safety profile 
 



 

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Adverse reactions were usually mild or moderate and occurred within the first two weeks of treatment. 
The most common adverse reactions were headache, nausea and dizziness. 
These adverse reactions were usually transient and did not generally lead to cessation of therapy.  
 
Tabulated list of adverse reactions 
 
The below table gives the adverse reactions observed from placebo-controlled and active-controlled 
clinical trials. 
Adverse reactions are listed below using the following convention: 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), not known (cannot be estimated from the available data). The frequencies have not been 
corrected for placebo. 
 
 

System organ class Frequency Preferred Term 
Psychiatric disorders Common Anxiety 

Abnormal dreams* 
Uncommon Suicidal thoughts or behaviour (see section 

4.4) 
Agitation and related symptoms* (such as 
irritability and restlessness) 
Aggression* 
Nightmares* 
Mania/hypomania* 
These symptoms may also be due to the 
underlying disease (see section 4.4). 

 Confusional state* 
Rare Hallucinations* 

Nervous system 
disorders 

Very common Headache 
Common Dizziness 

Somnolence 
Insomnia 

Uncommon Migraine 
Paraesthesia 
Restless leg syndrome* 

Rare Akathisia* 
Eye disorders Uncommon Blurred vision 
Ear and labyrinth 
disorders 

Uncommon Tinnitus* 

Gastrointestinal 
Disorders 
 

Common Nausea 
Diarrhoea 
Constipation 
Abdominal pain 
Vomiting* 

Hepato- biliary 
disorders 

Common Increased ALT and/or AST (in clinical trials, 
increases >3 times the upper limit of the 
normal range for ALT and/or AST were seen 
in 1.2% of patients on agomelatine 25 mg 
daily and 2.6 % on agomelatine 50 mg daily 
vs. 0.5% on placebo). 

Uncommon Increased gamma-glutamyltransferase* 
(GGT)(>3 times the upper limit of the normal 
range 

Rare Hepatitis 
Increased alkaline phosphatase* 



 

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(>3 times the upper limit of the normal range)  
Hepatic failure*(1) 
Jaundice* 

Skin and subcutaneous 
tissue disorders 

Uncommon Hyperhidrosis 
Eczema 
Pruritus* 
Urticaria* 

Rare Erythematous rash 
Face oedema and angioedema* 

Musculoskeletal and 
connective tissue 
disorders 

Common Back pain 

Uncommon Myalgia* 

Renal and urinary 
disorders 

Rare Urinary retention* 

General disorders and 
administration site 
conditions 

Common Fatigue  

Investigations Common Weight increased *  
Uncommon  Weight decreased* 

* Frequency estimated from clinical trials for adverse reactions detected from spontaneous report 
(1) Few cases were exceptionally reported with fatal outcome or liver transplantation in patients with 
hepatic risk factors. 
 
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 
 
Symptoms 
 
There is limited experience with agomelatine overdose. Experience with agomelatine in overdose has 
indicated that epigastralgia, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or 
malaise have been reported.  
One person having ingested 2,450 mg agomelatine, recovered spontaneously without cardiovascular 
and biological abnormalities. 
 
Management 
 
No specific antidotes for agomelatine are known. Management of overdose should consist of treatment 
of clinical symptoms and routine monitoring. Medical follow-up in a specialised environment is 
recommended. 
 
 
5 PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties  
 
Pharmacotherapeutic group: Psychoanaleptics, other antidepressants, ATC-code: N06AX22 
 
Mechanism of action 
 

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Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist. Binding 
studies indicate that agomelatine has no effect on monoamine uptake and no affinity for α, β 
adrenergic, histaminergic, cholinergic, dopaminergic and benzodiazepine receptors. 
Agomelatine resynchronises circadian rhythms in animal models of circadian rhythm disruption. 
Agomelatine increases noradrenaline and dopamine release specifically in the frontal cortex and has 
no influence on the extracellular levels of serotonin.  
 
Pharmacodynamic effects 
 
Agomelatine has shown an antidepressant-like effect in animal models of depression (learned 
helplessness test, despair test, chronic mild stress) as well as in models with circadian rhythm 
desynchronisation and in models related to stress and anxiety.  
In humans, agomelatine has positive phase shifting properties; it induces a phase advance of sleep, 
body temperature decline and melatonin onset. 
 
Clinical efficacy and safety 
 
The efficacy and safety of agomelatine in major depressive episodes have been studied in a clinical 
programme including 7,900 patients treated with agomelatine.  
Ten placebo controlled trials have been performed to investigate the short term efficacy of 
agomelatine in major depressive disorder in adults, with fixed dose and/or dose up-titration. At the end 
of treatment (over 6 or 8 weeks), significant efficacy of agomelatine 25-50 mg was demonstrated in 6 
out of the ten short-term double-blind placebo-controlled trials. Primary endpoint was change in 
HAMD-17 score from baseline. Agomelatine failed to differentiate from placebo in two trials where 
the active control, paroxetine or fluoxetine showed assay sensitivity. Agomelatine was not compared 
directly with paroxetine and fluoxetine as these comparators where added in order to ensure assay 
sensitivity of the trials. In two other trials, it was not possible to draw any conclusions because the 
active controls, paroxetine or fluoxetine, failed to differentiate from placebo. However, in these 
studies it was not allowed to increase the start dose of either agomelatine, paroxetine or fluoxetine 
even if the response was not adequate. 
Efficacy was also observed in more severely depressed patients (baseline HAM-D ≥ 25) in all positive 
placebo-controlled trials. 
Response rates were statistically significantly higher with agomelatine compared with placebo. 
Superiority (2 trials) or non-inferiority (4 trials) has been shown in six out of seven efficacy trials in 
heterogeneous populations of depressed adult patients versus SSRI/SNRI (sertraline, escitalopram, 
fluoxetine, venlafaxine or duloxetine) The anti-depressive effect was assessed with the HAMD-17 
score either as primary or secondary endpoint. 
The maintenance of antidepressant efficacy was demonstrated in a relapse prevention trial. Patients 
responding to 8/10-weeks of acute treatment with open-label agomelatine 25-50 mg once daily were 
randomised to either agomelatine 25-50 mg once daily or placebo for further 6-months. 
Agomelatine 25-50 mg once daily demonstrated a statistically significant superiority compared to 
placebo (p=0.0001) on the primary outcome measure, the prevention of depressive relapse, as 
measured by time to relapse. The incidence of relapse during the 6-months double-blind follow up 
period was 22% and 47% for agomelatine and placebo, respectively. 
 
Agomelatine does not alter daytime vigilance and memory in healthy volunteers. In depressed 
patients, treatment with agomelatine 25 mg increased slow wave sleep without modification of REM 
(Rapid Eye Movement) sleep amount or REM latency. Agomelatine 25 mg also induced an advance of 
the time of sleep onset and of minimum heart rate. From the first week of treatment, onset of sleep and 
the quality of sleep were significantly improved without daytime clumsiness as assessed by patients.  
 
In a specific sexual dysfunction comparative trial with remitted depressed patients, there was a 
numerical trend (not statistically significant) towards less sexual emergent dysfunction than 
venlafaxine for Sex Effects Scale (SEXFX) drive arousal or orgasm scores on agomelatine. The 
pooled analysis of trials using the Arizona Sexual Experience Scale (ASEX) showed that agomelatine 



 

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was not associated with sexual dysfunction. In healthy volunteers agomelatine preserved sexual 
function in comparison with paroxetine. 
 
Agomelatine had neutral effect on heart rate and blood pressure in clinical trials. 
 
In a trial designed to assess discontinuation symptoms by the Discontinuation Emergent Signs and 
Symptoms (DESS) check-list in patients with remitted depression, agomelatine did not induce 
discontinuation syndrome after abrupt treatment cessation. 
Agomelatine has no abuse potential as measured in healthy volunteer studies on a specific visual 
analogue scale or the Addiction Research Center Inventory (ARCI) 49 check-list. 
A placebo-controlled 8-week trial of agomelatine 25-50mg/day in elderly depressed patients (≥ 65 
years, N=222, of which 151 on agomelatine) demonstrated a statistically significant difference of 2.67 
points on HAM-D total score, the primary outcome. Responder rate analysis favoured agomelatine. No 
improvement was observed in very elderly patients (≥75 years, N= 69, of which 48 on agomelatine). 
Tolerability of agomelatine in elderly patients was comparable to that seen in the younger adults. 
 
A specific controlled, 3-week trial has been conducted in patients suffering from major depressive 
disorder and insufficiently improved with paroxetine (a SSRI) or venlafaxine (a SNRI). When 
treatment was switched from these antidepressants to agomelatine, discontinuation symptoms arose 
after cessation of the SSRI or SNRI treatment, either after abrupt cessation or gradual cessation of the 
previous treatment. These discontinuation symptoms may be confounded with a lack of early benefit 
of agomelatine. 
The percentage of patients with at least one discontinuation symptom one week after the SSRI/SNRI 
treatment stop, was lower in the long tapering group (gradual cessation of the previous SSRI/SNRI 
within 2 weeks) than in the short tapering group (gradual cessation of the previous SSRI/SNRI within 
1 week) and in the abrupt substitution group (abrupt cessation): 56.1%, 62.6 % and 79.8% 
respectively.  
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
agomelatine in one or more subsets of the paediatric population in the treatment of major depressive 
episodes (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption and bioavailability 
 
Agomelatine is rapidly and well (≥ 80%) absorbed after oral administration. Absolute bioavailability is 
low (< 5% at the therapeutic oral dose) and the interindividual variability is substantial. The 
bioavailability is increased in women compared to men. The bioavailability is increased by intake of 
oral contraceptives and reduced by smoking. The peak plasma concentration is reached within 1 to 2 
hours. 
 
In the therapeutic dose-range, agomelatine systemic exposure increases proportionally with dose. At 
higher doses, a saturation of the first-pass effect occurs. 
Food intake (standard meal or high fat meal) does not modify the bioavailability or the absorption rate. 
The variability is increased with high fat food. 
 
Distribution 
 
Steady state volume of distribution is about 35 l and plasma protein binding is 95% irrespective of the 
concentration and is not modified with age and in patients with renal impairment but the free fraction 
is doubled in patients with hepatic impairment. 
 
Biotransformation 
 



 

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Following oral administration, agomelatine is rapidly metabolised mainly via hepatic CYP1A2; 
CYP2C9 and CYP2C19 isoenzymes are also involved but with a low contribution. 
The major metabolites, hydroxylated and demethylated agomelatine, are not active and are rapidly 
conjugated and eliminated in the urine. 
 
Elimination 
 
Elimination is rapid, the mean plasma half-life is between 1 and 2 hours and the clearance is high 
(about 1,100 ml/min) and essentially metabolic. 
Excretion is mainly (80%) urinary and in the form of metabolites, whereas unchanged compound 
recovery in urine is negligible. 
Kinetics are not modified after repeated administration. 
 
Renal impairment 
 
No relevant modification of pharmacokinetic parameters in patients with severe renal impairment has 
been observed (n=8, single dose of 25 mg), but caution should be exercised in patients with severe or 
moderate renal impairment as only limited clinical data are available in these patients (see section 4.2).  
 
Hepatic impairment 
 
In a specific study involving cirrhotic patients with chronic mild (Child-Pugh type A) or moderate 
(Child-Pugh type B) liver impairment, exposure to agomelatine 25 mg was substantially increased (70-
times and 140-times, respectively), compared to matched volunteers (age, weight and smoking habit) 
with no liver failure (see section 4.2, 4.3 and 4.4). 
 
Elderly 
 
In a pharmacokinetic study in elderly patients (≥ 65 years), it was showed that at a dose of 25 mg the 
mean AUC and mean Cmax were about 4-fold and 13-fold higher for patients ≥ 75 years old 
compared to patients < 75 years old. The total number of patients receiving 50 mg was too low to draw 
any conclusions. No dose adaptation is required in elderly patients. 
 
Ethnic groups 
 
There is no data on the influence of race on agomelatine pharmacokinetics. 
 
5.3 Preclinical safety data 
 
In mice, rats and monkeys sedative effects were observed after single and repeated administration at 
high doses. 
In rodents, a marked induction of CYP2B and a moderate induction of CYP1A and CYP3A were seen 
from 125 mg/kg/day whereas in monkeys the induction was slight for CYP2B and CYP3A at 
375 mg/kg/day. No hepatotoxicity was observed in rodents and monkeys in the repeat dose toxicity 
studies. 
Agomelatine passes into the placenta and foetuses of pregnant rats. 
Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility, 
embryofoetal development and pre- and post natal development. 
A battery of in vitro and in vivo standard genotoxicity assays concludes to no mutagenic or clastogenic 
potential of agomelatine. 
 
In carcinogenicity studies agomelatine induced an increase in the incidence of liver tumours in the rat 
and the mouse, at a dose at least 110-fold higher than the therapeutic dose. Liver tumours are most 
likely related to enzyme induction specific to rodents. The frequency of benign mammary 
fibroadenomas observed in the rat was increased with high exposures (60-fold the exposure at the 
therapeutic dose) but remains in the range of that of controls. 
 



 

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Safety pharmacology studies showed no effect of agomelatine on hERG (human Ether à-go-go 
Related Gene) current or on dog Purkinje cells action potential. Agomelatine did not show 
proconvulsive properties at ip doses up to 128 mg/kg in mice and rats. 
 
No effect of agomelatine on juvenile animals behavioural performances, visual and reproductive 
function were observed. There were mild non dose dependent decreases in body weight related to the 
pharmacological properties and some minor effects on male reproductive tract without any impairment 
on reproductive performances. 
 
 
6 PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients  
 
Tablet core 
 
Lactose monohydrate 
Maize starch 
Povidone (K30) 
Sodium starch glycolate type A 
Stearic acid  
Magnesium stearate  
Silica, colloidal anhydrous  
 
Film-coating 

 
Hypromellose  
Yellow iron oxide (E172) 
Glycerol  
Macrogol (6000) 
Magnesium stearate  
Titanium dioxide (E171) 
 
Printing ink containing shellac, propylene glycol and indigo carmine aluminium lake (E132). 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Aluminium/PVC blister packed in cardboard boxes. 
Calendar packs containing 14, 28, 56, 84 and 98 film-coated tablets. 
Calendar packs of 100 film-coated tablets for hospital use. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements for disposal. 



 

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7 MARKETING AUTHORISATION HOLDER 
 
Les Laboratoires Servier 
50, rue Carnot 
92284 Suresnes cedex 
France 
 
 
8 MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/08/499/002 
EU/1/08/499/003 
EU/1/08/499/005 
EU/1/08/499/006 
EU/1/08/499/007 
EU/1/08/499/008 
 
 
9 DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation : 19 February 2009 
Date of latest renewal : 12 December 2018 
 
 
10 DATE OF REVISION OF THE TEXT 
 
MM/YYYY 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/.  
 

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


 

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ANNEX II 
 

A.  MANUFACTURERS 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 



 

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A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, France 
Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co. Wicklow, Ireland 
Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul. Annopol 6B - 03-236 Warszawa, Poland 
Laboratorios Servier, S.L, Avda. de los Madroños, 33 -28043 Madrid, Spain 
 
The printed package leaflet of the medicinal product must state the name and address of the manufacturer 
responsible for the release of the concerned batch. 
 
 
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 (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal.  
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

• Risk management plan (RMP) 
 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 
authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

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

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

 
• Additional risk minimisation measures 

The Marketing Authorisation Holder shall agree the format and content of the physician’s guide to 
prescribing with the National Competent Authority prior to launch in the Member State.  
 



 

16 

The Marketing Authorisation Holder shall ensure that at launch and after launch all physicians who are 
expected to prescribe or use Valdoxan are provided with the updated educational material containing the 
following: 
• The Summary of Product Characteristics; 
• The Physician’s guide to prescribing, including a liver monitoring scheme. 
 
The Physician’s guide to prescribing should contain the following key messages: 
• The need to inform patients about the potential risk of transaminases elevations,the risk of liver 
injury and interactions with potent CYP 1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin);  
• The need to perform liver function tests in all patients before starting treatment and periodically 
thereafter around three, six (end of acute phase), twelve and twenty four weeks (end of maintenance 
phase), and thereafter when clinically indicated;  
• The need to perform liver function tests at the same frequency as at treatment initiation in all 
patients where the dosage is increased;  
• Guidance in case of clinical symptoms of hepatic dysfunction; 
• Guidance in case of liver function test abnormality;  
• Caution should be exercised when therapy is administered to patients with pretreatment elevated 
transaminases (> the upper limit of the normal ranges and < 3 times the upper limit of the normal range); 
• Caution should be exercised when therapy is prescribed for patients with hepatic injury risk 
factors e.g. obesity/overweight/non-alcoholic fatty liver disease, diabetes, alcohol use disorder and /or 
substantial alcohol intake or concomitant medicinal products associated with risk of hepatic injury;  
• Contra-indication in patients with hepatic impairment (i.e. cirrhosis or active liver disease); 
• Contraindication in patients with transaminases exceeding 3 X upper limit of normal;  
• Contra-indication in patients receiving concomitantly potent CYP1A2 inhibitors. 
 
 
The Marketing Authorisation Holder shall agree the format and content of the patient booklet with the 
National Competent Authority in the Member State. 
 
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use 
Valdoxan, are provided with patient booklets to be distributed to their patients being prescribed this 
medicine. 
 
The Patient’s Booklet should contain the following key messages: 

• Information about the risk of hepatic reactions and clinical signs of liver problems 
• A guidance on the scheme of hepatic monitoring  
• A blood tests appointments reminder.  

 



 

17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 

18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 

19 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Valdoxan 25 mg film-coated tablets 
agomelatine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 25 mg of agomelatine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
28 film-coated tablets 
56 film-coated tablets 
84 film-coated tablets 
98 film-coated tablets 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 



 

20 

 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Les Laboratoires Servier 
50, rue Carnot 
92284 Suresnes cedex 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
[EU/1/08/499/002] 14 film-coated tablets 
[EU/1/08/499/003] 28 film-coated tablets 
[EU/1/08/499/005] 56 film-coated tablets 
[EU/1/08/499/006] 84 film-coated tablets 
[EU/1/08/499/007] 98 film-coated tablets 
[EU/1/08/499/008] 100 film-coated tablets 
  
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Valdoxan 25 mg 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 



 

21 

 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 
 
 



 

22 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Valdoxan 25 mg tablets 
agomelatine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Les Laboratoires Servier 
 
 
3. EXPIRY DATE 
 
EXP 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Mon. 
Tue. 
Wed. 
Thu. 
Fri. 
Sat. 
Sun. 



 

23 

 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 

24 

 
Package leaflet: Information for the patient 

 
 

Valdoxan 25 mg film-coated tablets 
agomelatine 

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

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

not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Valdoxan is and what it is used for 
2. What you need to know before you take Valdoxan 
3. How to take Valdoxan  
4. Possible side effects 
5 How to store Valdoxan 
6. Contents of the pack and other information 
 
 
1.  What Valdoxan is and what it is used for 
 
Valdoxan contains the active ingredient agomelatine. It belongs to a group of medicines called 
antidepressants. You have been given Valdoxan to treat your depression. 
Valdoxan is used in adults. 
 
Depression is a continuing disturbance of mood that interferes with everyday life. The symptoms of 
depression vary from one person to another, but often include deep sadness, feelings of worthlessness, loss 
of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, 
changes in weight. 
The expected benefits of Valdoxan are to reduce and gradually remove the symptoms related to your 
depression. 
 
 
2. What you need to know before you take Valdoxan 
 
Do not take Valdoxan 
- if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section 

6).  
- if your liver does not work properly (hepatic impairment). 
- if you are taking fluvoxamine (another medicine used in the treatment of depression) or 

ciprofloxacin (an antibiotic). 
 

 
Warnings and precautions 
There could be some reasons why Valdoxan may not be suitable for you:  



 

25 

- If you are taking medicines known to affect the liver. Ask your doctor for advice on which medicine 
that is. 

- If you are obese or overweight, ask your doctor for advice. 
- If you are diabetic, ask your doctor for advice. 
- If you have increased levels of liver enzymes before treatment, your doctor will decide if Valdoxan 

is right for you. 
- If you have bipolar disorder, have experienced or if you develop manic symptoms (a period of 

abnormally high excitability and emotions) talk to your doctor before you start taking this medicine 
or before you continue with this medicine (see also under “Possible side effects” in section 4). 

- If you are suffering from dementia, your doctor will make an individual evaluation of whether it is 
right for you to take Valdoxan. 
 

During your treatment with Valdoxan : 
 
What to do to avoid potential serious liver problems 
- Your doctor should have checked that your liver is working properly before starting the 

treatment. Some patients may get increased levels of liver enzymes in their blood during treatment 
with Valdoxan.  Therefore follow-up tests should take place at the following time points:  
 

 before initiation 
or 

dose increase 

around 
3 weeks 

around 
6 weeks 

around 
12 weeks 

around 
24 weeks 

Blood tests      
 

Based on the evaluation of these tests your doctor will decide whether you should receive or 
continue using Valdoxan (see also under “How to take Valdoxan” in section 3). 

 
 

Be vigilant about signs and symptoms that your liver may not be working properly 
- If you observe any of these signs and symptoms of liver problems: unusual darkening of the 

urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, unusual fatigue 
(especially associated with other symptoms listed above), seek urgent advice from a doctor 
who may advise you to stop taking Valdoxan. 

 
Effect of Valdoxan is not documented in patients aged 75 years and older. Valdoxan should therefore not 
be used in these patients. 
 
Thoughts of suicide and worsening of your depression 
If you are depressed 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. 
- if you are a young adult. Information from clinical trials has shown an increased risk of suicidal 
behaviour in young adults (aged less than 25 years) with psychiatric conditions who were being 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.  
 



 

26 

You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this 
leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are 
worried about changes in your behaviour. 
 
Children and adolescents 
Valdoxan should not be used in children and adolescents (under 18 years old).  
 
Other medicines and Valdoxan 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
 
You should not take Valdoxan together with certain medicines (see also under “Do not take Valdoxan” in 
section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an 
antibiotic) can modify the expected dose of agomelatine in your blood. 
Make sure to tell your doctor if you are taking any of the following medicines: propranolol (a beta-blocker 
used in the treatment of hypertension), enoxacin (antibiotic)  
 
Make sure to tell your doctor if you are smoking more than15 cigarettes/day. 
 
Valdoxan with alcohol 
It is not advisable to drink alcohol while you are being treated with Valdoxan. 
 
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. 
 
Breastfeeding should be discontinued if you take Valdoxan.  
 
Driving and using machines 
You might experience dizziness or sleepiness which could affect your ability to drive or operate machines. 
Make sure that your reactions are normal before driving or operating machines. 
 
Valdoxan contains lactose 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicine. 
 
Valdoxan contains sodium 
Valdoxan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 
 
 
3. How to take Valdoxan 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or 
pharmacist if you are not sure.  
 
The recommended dose of Valdoxan is one tablet (25 mg) at bedtime. In some cases, your doctor may 
prescribe a higher dose (50 mg), i.e. two tablets to be taken together at bedtime.  
 
Method of administration 
Valdoxan is for oral use. You should swallow your tablet with a drink of water. Valdoxan can be taken 
with or without food. 
 



 

27 

Duration of treatment 
Valdoxan starts to act on symptoms of depression in most depressed people within two weeks of starting 
treatment. 
Your depression should be treated for a sufficient period of at least 6 months to ensure that you are free of 
symptoms. 
Your doctor may continue to give you Valdoxan when you are feeling better to prevent your depression 
from returning. 
 
If you have trouble with your kidneys, your doctor will make an individual evaluation of whether it is safe 
for you to take Valdoxan. 
 
Surveillance of the liver function (see also section 2): 
Your doctor will run laboratory tests to check that your liver is working properly before starting treatment 
and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks.  
If your doctor increase the dose to 50mg, laboratory tests should be performed at this initiation and then 
periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks. Thereafter tests 
will be taken if the doctor finds it necessary. 
You must not use Valdoxan if your liver does not work properly.  
 
How to switch from an antidepressant medicine (SSRI/SNRI) to Valdoxan? 
If your doctor changes your previous antidepressant medicine from an SSRI or SNRI to Valdoxan, he/she 
will advise you on how you should discontinue your previous medicine when starting Valdoxan. 
You may experience discontinuation symptoms related to stopping of your previous medicine for a few 
weeks, even if the dose of your previous antidepressant medicine is decreased gradually.  
Discontinuation symptoms include: dizziness, numbness, sleep disturbances, agitation or anxiety, 
headaches, feeling sick, being sick and shaking. These effects are usually mild to moderate and disappear 
spontaneously within a few days.  
If Valdoxan is initiated while tapering the dosage of the previous medicine, possible discontinuation 
symptoms should not be confounded with a lack of early effect of Valdoxan. 
You should discuss with your doctor on the best way of stopping your previous antidepressant medicine 
when starting Valdoxan. 
 
If you take more Valdoxan than you should 
If you have taken more Valdoxan than you should, or if for example a child has taken medicine by 
accident, contact your doctor immediately. 
The experience of overdoses with Valdoxan is limited but reported symptoms include pain in the upper 
part of the stomach, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise. 
 
If you forget to take Valdoxan 
Do not take a double dose to make up for a forgotten dose. Just carry on with the next dose at the usual 
time. 
The calendar printed on the blister containing the tablets should help you remembering when you last took 
a tablet of Valdoxan. 
 
If you stop taking Valdoxan  
Do not stop taking your medicine without the advice of your doctor even if you feel better. 
 
If you have any further questions on the use of this product, please ask your doctor or pharmacist. 
 
 



 

28 

4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Most side effects are mild or moderate. They usually occur within the first two weeks of the treatment and 
are usually temporary. 
 
These side effects include: 
- Very common side effects (may affect more than 1 in 10 people) : headache 
- Common side effects (may affect up to 1 in 10 people): dizziness, sleepiness (somnolence), 

difficulty in sleeping (insomnia), feeling sick (nausea), diarrhoea, constipation, abdominal pain, 
back pain, tiredness, anxiety, abnormal dreams, increased levels of liver enzymes in your blood, 
vomiting, weight increased. 

- Uncommon side effects (may affect up to 1 in 100 people): migraine, pins and needles in the fingers 
and toes (paraesthesia), blurred vision, restless legs syndrome (a disorder that is characterized by an 
uncontrollable urge to move the legs), ringing in the ears, excessive sweating (hyperhidrosis), 
eczema, pruritus, urticaria (hives), agitation, irritability, restlessness, aggressive behaviour, 
nightmares, mania/hypomania (see also under “Warnings and precautions” in section 2), suicidal 
thoughts or behaviour,confusion, weight decreased, muscle pain. 

- Rare side effects (may affect up to 1 in 1,000 people): serious skin eruption (erythematous rash), 
face oedema (swelling) and angioedema (swelling of the face, lips, tongue and/or throat that may 
cause difficulty in breathing or swallowing), hepatitis, yellow coloration of the skin or the whites of 
the eyes (jaundice), hepatic failure*, hallucinations, inability to remain still (due to physical and 
mental unrest), inability to completely empty the bladder. 
 

* Few cases resulting in liver transplantation or death have been reported. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store Valdoxan 
 
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 and blister. The expiry date 
refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 
away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Valdoxan contains 
- The active substance is agomelatine. Each film-coated tablet contains 25 mg of agomelatine. 

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


 

29 

- The other ingredients are:  
• lactose monohydrate, maize starch, povidone (K30), sodium starch glycolate type A, 

stearic acid, magnesium stearate, colloidal anhydrous silica,hypromellose, glycerol, 
macrogol (6000), yellow iron oxide (E172) and titanium dioxide (E171). 

• printing ink : shellac, propylene glycol and indigo carmine aluminium lake (E132) 
 
What Valdoxan looks like and contents of the pack 
Valdoxan 25 mg film-coated tablets (tablet) are oblong, orange-yellow with a blue imprint of ‘company 
logo’ on one side. 
Valdoxan 25 mg film-coated tablets are available in calendar blisters. Packs contain 14, 28, 56, 84 or 98 
tablets. Packs of 100 film-coated tablets are also available for hospital use.  
Not all pack sizes may be marketed. 
 
 
Marketing Authorisation Holder 
Les Laboratoires Servier 
50, rue Carnot 
92284 Suresnes cedex - France 
 
Manufacturer 
Les Laboratoires Servier Industrie 
905, route de Saran 
45520 Gidy 
France 
 
Servier (Ireland) Industries Ltd 
Gorey road 
Arklow – Co. Wicklow – Ireland 
 
Anpharm Przedsiebiorstwo Farmaceutyczne S.A.  
03-236 Warszawa  
ul. Annopol 6B  
Poland 
 
Laboratorios Servier, S.L. 
Avda. de los Madroños, 33 
28043 Madrid 
Spain 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
S.A. Servier Benelux N.V. 
Tel: +32 (0)2 529 43 11 
 

Lietuva 
UAB “SERVIER PHARMA” 
Tel: +370 (5) 2 63 86 28 

България 
Сервие Медикал ЕООД 
Тел.: +359 2 921 57 00 
 

Luxembourg/Luxemburg 
S.A. Servier Benelux N.V. 
Tel: +32 (0)2 529 43 11 
 



 

30 

Česká republika 
Servier s.r.o. 
Tel: +420 222 118 111 

Magyarország 
Servier Hungaria Kft. 
Tel: +36 1 238 7799 
 

Danmark 
Servier Danmark A/S 
Tlf: +45 36 44 22 60 
 

Malta 
V.J. Salomone Pharma Ltd  
Tel: + 356 21 22 01 74 
   

Deutschland 
Servier Deutschland GmbH 
Tel: +49 (0)89 57095 01 
 

Nederland 
Servier Nederland Farma B.V. 
Tel: +31 (0)71 5246700 
 

Eesti 
Servier Laboratories OÜ  
Tel:+ 372 664 5040 
 

Norge 
Servier Danmark A/S 
Tlf: +45 36 44 22 60 
 

Eλλάδα 
ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ 
Τηλ: +30 210 939 1000 
 

Österreich 
Servier Austria GmbH 
Tel: +43 (1) 524 39 99 
 

España 
Laboratorios Servier S.L. 
Tel: +34 91 748 96 30 
 

Polska 
Servier Polska Sp. z o.o. 
Tel: +48 (0) 22 594 90 00 

France 
Les Laboratoires Servier 
Tel: +33 (0)1 55 72 60 00 
 

Portugal 
Servier Portugal, Lda 
Tel.: +351 21 312 20 00 

Hrvatska 
Servier Pharma, d. o. o. 
Tel.: +385 (0)1 3016 222 
 

România 
Servier Pharma SRL 
Tel: +4 021 528 52 80 
 

Ireland 
Servier Laboratories (Ireland) Ltd. 
Tel: +353 (0)1 663 8110 
 

Slovenija 
Servier Pharma d. o. o.  
Tel.: +386 (0)1 563 48 11 

Ísland 
Servier Laboratories 
c/o Icepharma hf 
Sími: +354 540 8000 
 

Slovenská republika 
Servier Slovensko spol. s r.o. 
Tel.:+421 (0) 2 5920 41 11 

Italia 
Servier Italia S.p.A. 
Tel: +39 06 669081 

Suomi/Finland 
Servier Finland Oy 
P. /Tel: +358 (0)9 279 80 80 
 

Κύπρος 
C.A. Papaellinas Ltd. 
Τηλ: +357 22741741 
 

Sverige 
Servier Sverige AB 
Tel : +46 (0)8 522 508 00 
 

Latvija 
SIA Servier Latvia 

United Kingdom 
Servier Laboratories Ltd 



 

31 

Tel: +371 67502039 
 

Tel: +44 (0)1753 666409 

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

 

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

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
{'Title': '1. what valdoxan is and what it is used for', 'Section_Content': 'valdoxan contains the active ingredient agomelatine. it belongs to a group of medicines called antidepressants. you have been given valdoxan to treat your depression. valdoxan is used in adults. depression is a continuing disturbance of mood that interferes with everyday life. the symptoms of depression vary from one person to another, but often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, changes in weight. the expected benefits of valdoxan are to reduce and gradually remove the symptoms related to your depression.', 'Entity_Recognition': [{'Text': 'valdoxan', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 0, 'EndOffset': 8, 'Score': 0.5399103760719299, 'Text': 'valdoxan', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'the active ingredient agomelatine', 'Type': 'TREATMENT', 'BeginOffset': 18, 'EndOffset': 51}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 78, 'EndOffset': 87}, {'Id': 18, 'BeginOffset': 95, 'EndOffset': 110, 'Score': 0.6645447015762329, 'Text': 'antidepressants', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Id': 2, 'BeginOffset': 132, 'EndOffset': 140, 'Score': 0.8198797702789307, 'Text': 'valdoxan', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'your depression', 'Type': 'PROBLEM', 'BeginOffset': 150, 'EndOffset': 165}, {'Id': 3, 'BeginOffset': 167, 'EndOffset': 175, 'Score': 0.6769064664840698, 'Text': 'valdoxan', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 6, 'BeginOffset': 195, 'EndOffset': 205, 'Score': 0.9864869117736816, 'Text': 'depression', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.7555298209190369}]}, {'Text': 'a continuing disturbance of mood', 'Type': 'PROBLEM', 'BeginOffset': 209, 'EndOffset': 241}, {'Text': 'the symptoms', 'Type': 'PROBLEM', 'BeginOffset': 278, 'EndOffset': 290}, {'Id': 9, 'BeginOffset': 294, 'EndOffset': 304, 'Score': 0.982131838798523, 'Text': 'depression', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6825541853904724}]}, {'Id': 10, 'BeginOffset': 356, 'EndOffset': 368, 'Score': 0.7713848948478699, 'Text': 'deep sadness', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.954375147819519}]}, {'Id': 11, 'BeginOffset': 370, 'EndOffset': 395, 'Score': 0.9445808529853821, 'Text': 'feelings of worthlessness', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9699109196662903}]}, {'Id': 12, 'BeginOffset': 397, 'EndOffset': 437, 'Score': 0.9842760562896729, 'Text': 'loss of interest in favourite activities', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9004263877868652}]}, {'Id': 13, 'BeginOffset': 439, 'EndOffset': 457, 'Score': 0.977268397808075, 'Text': 'sleep disturbances', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9807841777801514}]}, {'Id': 14, 'BeginOffset': 459, 'EndOffset': 487, 'Score': 0.9124935269355774, 'Text': 'feeling of being slowed down', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9428419470787048}]}, {'Id': 15, 'BeginOffset': 501, 'EndOffset': 508, 'Score': 0.9975705742835999, 'Text': 'anxiety', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9535297155380249}]}, {'Id': 16, 'BeginOffset': 510, 'EndOffset': 527, 'Score': 0.9171901941299438, 'Text': 'changes in weight', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7367785573005676}]}, {'Id': 4, 'BeginOffset': 554, 'EndOffset': 562, 'Score': 0.5795325636863708, 'Text': 'valdoxan', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'the symptoms', 'Type': 'PROBLEM', 'BeginOffset': 598, 'EndOffset': 610}, {'Text': 'your depression', 'Type': 'PROBLEM', 'BeginOffset': 622, 'EndOffset': 637}]}
{'Title': '2. what you need to know before you take valdoxan', 'Section_Content': 'do not take valdoxan - if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section 6). - if your liver does not work properly (hepatic impairment). - if you are taking fluvoxamine (another medicine used in the treatment of depression) or ciprofloxacin (an antibiotic). warnings and precautions there could be some reasons why valdoxan may not be suitable for you: 25 - if you are taking medicines known to affect the liver. ask your doctor for advice on which medicine that is. - if you are obese or overweight, ask your doctor for advice. - if you are diabetic, ask your doctor for advice. - if you have increased levels of liver enzymes before treatment, your doctor will decide if valdoxan is right for you. - if you have bipolar disorder, have experienced or if you develop manic symptoms (a period of abnormally high excitability and emotions) talk to your doctor before you start taking this medicine or before you continue with this medicine (see also under "possible side effects" in section 4). - if you are suffering from dementia, your doctor will make an individual evaluation of whether it is right for you to take valdoxan. during your treatment with valdoxan : what to do to avoid potential serious liver problems - your doctor should have checked that your liver is working properly before starting the treatment. some patients may get increased levels of liver enzymes in their blood during treatment with valdoxan. therefore follow-up tests should take place at the following time points: before initiation or dose increase around 3 weeks around 6 weeks around 12 weeks around 24 weeks blood tests based on the evaluation of these tests your doctor will decide whether you should receive or continue using valdoxan (see also under "how to take valdoxan" in section 3). be vigilant about signs and symptoms that your liver may not be working properly - if you observe any of these signs and symptoms of liver problems: unusual darkening of the urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, unusual fatigue (especially associated with other symptoms listed above), seek urgent advice from a doctor who may advise you to stop taking valdoxan. effect of valdoxan is not documented in patients aged 75 years and older. valdoxan should therefore not be used in these patients. thoughts of suicide and worsening of your depression if you are depressed 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. - if you are a young adult. information from clinical trials has shown an increased risk of suicidal behaviour in young adults (aged less than 25 years) with psychiatric conditions who were being 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 and ask them to read this leaflet. you might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour. children and adolescents valdoxan should not be used in children and adolescents (under 18 years old). other medicines and valdoxan tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. you should not take valdoxan together with certain medicines (see also under "do not take valdoxan" in section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an antibiotic) can modify the expected dose of agomelatine in your blood. make sure to tell your doctor if you are taking any of the following medicines: propranolol (a beta-blocker used in the treatment of hypertension), enoxacin (antibiotic) make sure to tell your doctor if you are smoking more than15 cigarettes/day. valdoxan with alcohol it is not advisable to drink alcohol while you are being treated with valdoxan. 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. breastfeeding should be discontinued if you take valdoxan. driving and using machines you might experience dizziness or sleepiness which could affect your ability to drive or operate machines. make sure that your reactions are normal before driving or operating machines. valdoxan contains lactose if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. valdoxan contains sodium valdoxan contains less than 1 mmol 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{'Title': '3. how to take valdoxan', 'Section_Content': 'always take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure. the recommended dose of valdoxan is one tablet (25 mg) at bedtime. in some cases, your doctor may prescribe a higher dose (50 mg), i.e. two tablets to be taken together at bedtime. method of administration valdoxan is for oral use. you should swallow your tablet with a drink of water. valdoxan can be taken with or without food. duration of treatment valdoxan starts to act on symptoms of depression in most depressed people within two weeks of starting treatment. your depression should be treated for a sufficient period of at least 6 months to ensure that you are free of symptoms. your doctor may continue to give you valdoxan when you are feeling better to prevent your depression from returning. if you have trouble with your kidneys, your doctor will make an individual evaluation of whether it is safe for you to take valdoxan. surveillance of the liver function (see also section 2): your doctor will run laboratory tests to check that your liver is working properly before starting treatment and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks. if your doctor increase the dose to 50mg, laboratory tests should be performed at this initiation and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks. thereafter tests will be taken if the doctor finds it necessary. you must not use valdoxan if your liver does not work properly. how to switch from an antidepressant medicine (ssri/snri) to valdoxan? if your doctor changes your previous antidepressant medicine from an ssri or snri to valdoxan, he/she will advise you on how you should discontinue your previous medicine when starting valdoxan. you may experience discontinuation symptoms related to stopping of your previous medicine for a few weeks, even if the dose of your previous antidepressant medicine is decreased gradually. discontinuation symptoms include: dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking. these effects are usually mild to moderate and disappear spontaneously within a few days. if valdoxan is initiated while tapering the dosage of the previous medicine, possible discontinuation symptoms should not be confounded with a lack of early effect of valdoxan. you should discuss with your doctor on the best way of stopping your previous antidepressant medicine when starting valdoxan. if you take more valdoxan than you should if you have taken more valdoxan than you should, or if for example a child has taken medicine by accident, contact your doctor immediately. the experience of overdoses with valdoxan is limited but reported symptoms include pain in the upper part of the stomach, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise. if 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{'Title': '4. possible side effects', 'Section_Content': None, 'Entity_Recognition': None}
{'Title': '5 how to store valdoxan', 'Section_Content': None, 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': "what valdoxan contains - the active substance is agomelatine. each film-coated tablet contains 25 mg of agomelatine. - the other ingredients are: lactose monohydrate, maize starch, povidone (k30), sodium starch glycolate type a, stearic acid, magnesium stearate, colloidal anhydrous silica,hypromellose, glycerol, macrogol (6000), yellow iron oxide (e172) and titanium dioxide (e171). printing ink : shellac, propylene glycol and indigo carmine aluminium lake (e132) what valdoxan looks like and contents of the pack valdoxan 25 mg film-coated tablets (tablet) are oblong, orange-yellow with a blue imprint of 'company logo' on one side. valdoxan 25 mg film-coated tablets are available in calendar blisters. packs contain 14, 28, 56, 84 or 98 tablets. packs of 100 film-coated tablets are also available for hospital use. not all pack sizes may be marketed.", 'Entity_Recognition': [{'Text': 'valdoxan', 'Type': 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