Pays: Singapour
Langue: anglais
Source: HSA (Health Sciences Authority)
Agomelatine
SERVIER (S) PTE LTD
N06AX22
25 mg
TABLET, FILM COATED
Agomelatine 25 mg
ORAL
Prescription Only
LES LABORATOIRES SERVIER INDUSTRIE [LSI]
ACTIVE
2010-02-26
PACKAGE INSERT VALDOXAN 25 MG 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: lactose monohydrate 61.84 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet [tablet]. Orange-yellow, oblong, film-coated tablet with blue imprint of company logo on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes in adults Valdoxan is indicated 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. Liver function tests should be performed in all patients : at initiation of treatment, and then 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). 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. Valdoxan tablets may be taken with or without food. _Paediatric population :_ The safety and efficacy of Valdoxan in children aged below 18 years have not been established. No data are available. (see section 4.4). _Elderly patients: _ Efficacy has not been clearly demonstrated in the elderly ( ≥ 65 years). Only limited clinical data is availa Lire le document complet
PACKAGE INSERT VALDOXAN 25 MG 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 Servier logo on one side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Valdoxan is indicated for the treatment of: - major depressive episodes (MDE); - generalised anxiety disorder (GAD). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 25 mg once daily taken orally at bedtime. 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 - 2 weeks after treatment initiation in major depressive episode; - 4 weeks after treatment initiation in generalized anxiety disorder. 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 should be treated for a s Lire le document complet