阿戈美拉汀产品总结.pdf

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1 NAME OF THE MEDICINAL PRODUCT Thymanax 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 4.2 Posology and method of administration 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 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). Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms. Thymanax tablets may be taken with or without food. Children and adolescents: Thymanax is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy (see section 4.4). Elderly patients: Efficacy has not been clearly demonstrated in the elderly (≥ 65 years). Only limited clinical data is available on the use of Thymanax in elderly patients ≥ 65 years old with major depressive episodes. Therefore, caution should be exercised when prescribing Thymanax to these patients (see section 4.4). Patients with renal impairment: No relevant modification in agomelatine pharm