Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Agomelatine
McDermott Laboratories Ltd., T/A Gerard Laboratories
N06AX22
Agomelatine
25 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
agomelatine
Marketed
2018-10-26
22 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AGOMELATINE MYLAN 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 Agomelatine Mylan is and what it is used for 2. What you need to know before you take Agomelatine Mylan 3. How to take Agomelatine Mylan 4. Possible side effects 5 How to store Agomelatine Mylan 6. Contents of the pack and other information 1. WHAT AGOMELATINE MYLAN IS AND WHAT IT IS USED FOR Agomelatine Mylan contains the active ingredient agomelatine. It belongs to a group of medicines called antidepressants and you have been given this medicine to treat your depression. Agomelatine Mylan 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 Agomelatine Mylan is to reduce and gradually remove the symptoms related to your depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGOMELATINE MYLAN DO NOT TAKE AGOMELATINE MYLAN - 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 PRECAUT Läs hela dokumentet
Health Products Regulatory Authority 17 November 2023 CRN00D6XD Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Agomelatine Mylan 25 mg film‐coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film‐coated tablet contains agomelatine‐citric acid co‐crystal equivalent to 25 mg of agomelatine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film‐coated tablet (Tablet) Yellow, oblong, biconvex, film‐coated tablet, 9.0 mm long by 4.5 mm wide. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Agomelatine Mylan is indicated in adults for the treatment of major depressive episodes. 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 (LFT) 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 Läs hela dokumentet