Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AGOMELATINE
SERVIER MALAYSIA SDN BHD
AGOMELATINE
28Tablet Tablets
LES LABS SERVIER INDUSTRIE
_Consumer Medication Information Leaflet (RIMUP)_ VALDOXAN 25MG FILM-COATED TABLETS _Agomelatine 25mg _ 1 WHAT IS IN THIS LEAFLET 1. What is Valdoxan used for 2. How Valdoxan works 3. Before you take Valdoxan 4. How to take Valdoxan 5. While you are taking Valdoxan 6. Side effects 7. Storage and Disposal of Valdoxan 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT VALDOXAN IS USED FOR You have been given Valdoxan to treat your depression or generalised anxiety disorder. 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. Generalised anxiety disorder is a chronic feeling of anxiety or nervousness with sleep disorders, and physical symptoms such as fatigue and muscle tension. HOW VALDOXAN WORKS Valdoxan contains the active ingredient agomelatine. It belongs to a group of medicines called antidepressants. The expected benefits of Valdoxan are to reduce and gradually remove the symptoms related to your depression or generalised anxiety disorder. BEFORE YOU TAKE VALDOXAN - _When you must not use it _ DO NOT TAKE VALDOXAN - if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section 8). - 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). - _ _ _ _ _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. - _Before you start to take it _ WARNINGS AND PRECAUTIONS There could be some reasons why Valdoxan may not b Lugege kogu dokumenti
__________________________________________________________________________________ Final PI_Valdoxan_08.07.2022 1 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; - 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 generalised 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 whe Lugege kogu dokumenti