Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284, Suresnes cedex, France
Valdoxan is indicated for the treatment of major depressive episodes in adults.
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.
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms.
Patients may experience discontinuation symptoms after cessation from an SSRI/ SNRI antidepressant.
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).
No dosage tapering is needed on treatment discontinuation.
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).
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.
Agomelatine is contraindicated in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
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.
For oral use.
Valdoxan film-coated tablets may be taken with or without food.
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.
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.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
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.
No special requirements for disposal.
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