Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
SERTRALINE HYDROCHLORIDE
Actavis Group PTC ehf
N06AB06
SERTRALINE HYDROCHLORIDE
50 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors
Authorised
2008-01-11
PACKAGE LEAFLET: INFORMATION FOR THE USER SERTRALINE ACTAVIS 50 MG FILM-COATED TABLETS SERTRALINE ACTAVIS 100 MG FILM-COATED TABLETS Sertraline 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 SERTRALINE ACTAVIS IS AND WHAT IT IS USED FOR. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE SERTRALINE ACTAVIS. 3 HOW TO TAKE SERTRALINE ACTAVIS. 4 POSSIBLE SIDE EFFECTS. 5 HOW TO STORE SERTRALINE ACTAVIS. 6 CONTENTS OF THE PACK AND OTHER INFORMATION. 1 WHAT SERTRALINE ACTAVIS IS AND WHAT IT IS USED FOR Sertraline Actavis contains the active substance sertraline. Sertraline is one of a group of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders. SERTRALINE ACTAVIS CAN BE USED TO TREAT: • Depression and prevention of recurrence of depression (in adults). • Obsessive compulsive disorder (OCD) (in adults and children and adolescents aged 6-17 years old). Depression is a clinical illness with symptoms like feeling sad, unable to sleep properly or to enjoy life as you used to. OCD is an illness linked to anxiety with symptoms like being constantly troubled by persistent ideas (obsessions) that make you carry out repetiti Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sertraline Actavis 50 mg Film-coated tablet. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50mg Sertraline (as hydrochloride) Excipients with known effect: Each tablet contains 79.65mg of lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, scored, oval biconvex, embossed with `L` on one side The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sertraline is indicated for the treatment of: Major depressive episodes. Prevention of recurrence of major depressive episodes. Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Initial treatment_ _Depression and OCD_ Sertraline treatment should be started at a dose of 50 mg/day. _Titration_ _Depression and OCD_ Patients not responding to a 50 mg dose may benefit from dose increases. Dose changes should be made in steps of 50 mg at intervals of at least one week, up to a maximum of 200 mg/day. Changes in dose should not be made more frequently than once per week given the 24-hour elimination half life of sertraline. The onset of therapeutic effect may be seen within 7 days. However, longer periods are usually necessary to demonstrate therapeutic response, especially in OCD. _Maintenance_ Dosage during long-term therapy should be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response. _Depression_ HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 29/07/2015_ _CRN 21643 Baca dokumen lengkap