Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
SERTRALINE HYDROCHLORIDE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
N06AB06
SERTRALINE HYDROCHLORIDE 50 mg
FILM-COATED TABLET
SERTRALINE HYDROCHLORIDE 50 mg
POM
PSYCHOANALEPTICS
Authorised
2017-07-26
PACKAGE LEAFLET: INFORMATION FOR THE USER SERTRALINE AUROBINDO 50 MG FILM-COATED TABLETS SERTRALINE AUROBINDO 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 Aurobindo is and what it is used for 2. What you need to know before you take Sertraline Aurobindo 3. How to take Sertraline Aurobindo 4. Possible side effects 5. How to store Sertraline Aurobindo 6. Contents of the pack and other information 1. WHAT SERTRALINE AUROBINDO IS AND WHAT IT IS USED FOR Sertraline Aurobindo 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 AUROBINDO CAN BE USED TO TREAT: • Depression and prevention of recurrence of depression (in adults). • Social anxiety disorder (in adults). • Post traumatic stress disorder (PTSD) (in adults). • Panic disorder (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 and Panic disorders are illnesses linked to anxiety with symptoms like being constantly troubled by persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions). PTSD is a condition that can occur after a very emotionally traumatic experience, and has some symptoms that are similar t Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sertraline Aurobindo 50 mg film-coated tablets Sertraline Aurobindo 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablets contains sertraline hydrochloride equivalent to 50 mg sertraline Each film-coated tablets contains sertraline hydrochloride equivalent to 100 mg sertraline For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet. _Sertraline Aurobindo 50 mg_ _film-coated tablets _ White coloured, biconvex, capsule shaped film coated tablets, debossed with ‘A’ on one side and with a score line in between ‘8’ and ‘1’ on the other side. The Size is: Approx. 10.5mm X 4.3mm. The tablet can be divided into equal doses. _ _ _Sertraline Aurobindo 100 mg_ _film-coated tablets _ White coloured, biconvex, capsule shaped film coated tablets, debossed with ‘A’ on one side and ‘82’ on the other side. The Size is: Approx. 13.3mm X 5.3mm] 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sertraline is indicated for the treatment of: Major depressive episodes. Prevention of recurrence of major depressive episodes. Panic disorder, with or without agoraphobia. Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years. Social anxiety disorder. Post traumatic stress disorder (PTSD) 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. _Panic Disorder, PTSD, and Social Anxiety Disorder _ Therapy should be initiated at 25 mg/day. After one week, the dose should be increased to 50 mg once daily. This dosage regimen has been shown to reduce the frequency of early treatment emergent side effects characteristic of panic disorder. _Titration _ _Depression, OCD, Panic Disorder, Social Anxiety Disorder and PTSD _ 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 a Leggi il documento completo