Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Agomelatine
Les Laboratoires Servier
N06AX22
Agomelatine
Psychoanaleptics,
Depressive Disorder, Major
Treatment of major depressive episodes in adults.,
Revision: 24
Authorised
2009-02-19
_ _ 23 _ _ B. PACKAGE LEAFLET _ _ 24 _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VALDOXAN 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 Valdoxan is and what it is used for 2. What you need to know before you take Valdoxan 3. How to take Valdoxan 4. Possible side effects 5 How to store Valdoxan 6. Contents of the pack and other information 1. WHAT VALDOXAN IS AND WHAT IT IS USED FOR Valdoxan contains the active ingredient agomelatine. It belongs to a group of medicines called antidepressants. You have been given Valdoxan to treat your depression. Valdoxan 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 Valdoxan are to reduce and gradually remove the symptoms related to your depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALDOXAN DO NOT TAKE VALDOXAN - 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 PRECAUTIONS There could be some reasons why Valdoxan may not be suitable fo Pročitajte cijeli dokument
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ 2 _ _ 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. 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 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 SSR Pročitajte cijeli dokument