Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Agomelatine
Accord Healthcare Ireland Ltd.
N06AX22
Agomelatine
25 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
agomelatine
Not marketed
2018-12-21
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AGOMELATINE ACCORD 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 Accord is and what it is used for 2. What you need to know before you take Agomelatine Accord 3. How to take Agomelatine Accord 4. Possible side effects 5 How to store Agomelatine Accord 6. Contents of the pack and other information 1. WHAT AGOMELATINE ACCORD IS AND WHAT IT IS USED FOR Agomelatine Accord contains the active ingredient agomelatine. It belongs to a group of medicines called antidepressants and you have been given Agomelatine Accord to treat your depression. Agomelatine Accord 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 and changes in weight. The expected benefits of Agomelatine Accord are to reduce and gradually remove the symptoms related to your depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGOMELATINE ACCORD DO NOT TAKE AGOMELATINE ACCORD - 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). W Lire le document complet
Health Products Regulatory Authority 27 January 2023 CRN00DD4C Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Agomelatine Accord 25 mg film‐coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film‐coated tablet contains agomelatine‐citric acid equivalent to 25 mg of agomelatine Excipient with known effect: Each tablet contains 0.2 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film‐coated tablet. Yellow, oblong, biconvex film‐coated tablets 9.0 mm long, 4.5 mm wide 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. Agomelatine Accord 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. 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/riskbasis 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 Lire le document complet