Country: Malta
Lingwa: Ingliż
Sors: Medicines Authority
SERTRALINE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
N06AB06
SERTRALINE 100 mg
FILM-COATED TABLET
SERTRALINE 100 mg
POM
PSYCHOANALEPTICS
Withdrawn
2007-12-27
SERTRALIN ACTAVIS Film-coated tablets Sertraline 50mg, 100mg PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Sertralin Actavis is and what it is used for 2. Before you take Sertralin Actavis 3. How to take Sertralin Actavis 4. Possible side effects 5. How to store Sertralin Actavis 6. Further information. 1. WHAT SERTRALIN ACTAVIS IS AND WHAT IT IS USED FOR Sertralin Actavis belongs to the group of antidepressant medicines (also called selective serotonin reuptake inhibitors, SSRIs). Sertralin Actavis is used in the treatment of: - Depressive illnesses (major depressive episodes) - Obsessive-compulsive disorders (obsessive-compulsive thoughts and obsessive-compulsive actions) - Panic attacks with or without agoraphobia - Psychological reactions after a mentally stressful event (post-traumatic stress syndrome) - Anxiety when dealing with other people (social phobia). 2. BEFORE YOU TAKE SERTRALIN ACTAVIS DO NOT TAKE SERTRALIN ACTAVIS - if you are allergic (hypersensitive) to sertraline or any of the other ingredients of Sertralin Actavis - if you are taking medicines that belong to the group of MAO inhibitors including selegiline (for Parkinson‘s disease) and moclobemide (for depression) - if you are taking medicines containing pimozide - If you suffer from severe hepatic impairment. TAKE SPECIAL CARE WITH SERTRALIN ACTAVIS - if you have recently finished treatment with medicines that belong to the group of MAO inhibitors (e Aqra d-dokument sħiħ
Page 1 of 15 SUMMARY OF THE PRODUCT CHARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT _Sertralin Actavis 50 mg film-coated tablets_ _ _ _Sertralin Actavis 100 mg film-coated tablets_ 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION _Sertralin Actavis 50 mg film-coated tablets: _ Each film-coated tablet contains 50 mg sertraline (as hydrochloride). Excipient: 79,65 mg lactose monohydrate/film-coated tablet. _Sertralin Actavis 100 mg film-coated tablets: _ Each film-coated tablet contains 100 mg sertraline (as hydrochloride). Excipient: 159,3 mg lactose monohydrate/film-coated tablet. For a full list of excipients, see 6.1. 3 P HARMACEUTICAL F ORM Film-coated tablet _ _ _Sertralin Actavis 50 mg film-coated tablets_ _ _ White, oval, biconvex, film-coated tablets, scored on one side, other side with “L”markings _ _ _Sertralin Actavis 100 mg film-coated tablets_ _ _ White, round, biconvex, film-coated tablets, scored on one side, other side with “C” markings. The tablet can be divided into equal halves. 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. Following a satisfactory response, Sertralin Actavis can be given preventively against relapse or further depressive episodes. Treatment of obsessive compulsive disorder. Panic syndrome with or without agoraphobia. Post-traumatic stress disorder. Social phobia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults _ _ _ _Major depressive episodes _ The usual daily dose is 50 mg sertraline. Page 2 of 15 If required, the dose can be increased to 100 mg sertraline/day. The maximum daily dose is 200 mg sertraline. If dose increments are required, these should be made in steps of 50 mg at minimum intervals of 1 week. Dose changes should not be performed more than once per week due to elimination half-life of sertraline over 24 hours. During long term therap Aqra d-dokument sħiħ