Valsts: Nīderlande
Valoda: holandiešu
Klimata pārmaiņas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SERTRALINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; SERTRALINE
Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN
N06AB06
SERTRALINEHYDROCHLORIDE COMPOSITION corresponding to ; SERTRALINE
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; METHYLCELLULOSE (E 461) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Sertraline
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); METHYLCELLULOSE (E 461); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2014-01-17
SERTRALINE APOTEX 50 MG FILM-COATED TABLETS SERTRALINE APOTEX 100 MG FILM-COATED TABLETS MODULE 1.3 Product Information Version: 29.06.2021 MODULE 1.3.1 Package Leaflet Replaces : 28.11.2020 1 PACKAGE LEAFLET: INFORMATION FOR THE USER SERTRALINE APOTEX 50 MG FILM-COATED TABLETS SERTRALINE APOTEX 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 is and what it is used for 2. What you need to know before you take Sertraline 3. How to take Sertraline 4. Possible side effects 5. How to store Sertraline 6. Contents of the pack and other information 1. WHAT SERTRALINE IS AND WHAT IT IS USED FOR Sertraline contains the active ingredient sertraline. Sertraline is one of a group of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). These medicines are used to treat depression and/ or anxiety disorders. Sertraline 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, children and adolescents aged 6-17 years old). Depression is a clinical illness with symptoms like feeling sad, unable to sleep properly or unable to enjoy life as you used to. SERTRALINE APOTEX 50 MG FILM-COATED TABLETS SERTRALINE APOTEX 100 MG FILM-COATED TABLETS MODULE 1.3 Product Information Version: 29.06.2021 MODULE 1.3.1 Package Leaflet Replaces : 28.11.2020 2 Obs Izlasiet visu dokumentu
SERTRALINE APOTEX 50 MG FILM-COATED TABLETS SERTRALINE APOTEX 100 MG FILM-COATED TABLETS MODULE 1.3 Product Information Version: 29.06.2021 MODULE 1.3.1 Summary of Product Characteristics Replaces : 28.11.2020 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sertraline Apotex 50 mg film-coated tablets Sertraline Apotex 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Sertraline Apotex 50 mg film-coated tablets:_ Each film-coated tablet contains sertraline hydrochloride equivalent to 50 mg sertraline. _Sertraline Apotex 100 mg film-coated tablets:_ Each film-coated tablet 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 50mg film-coated tablets are 4 x 8 mm bluish purple oval scored film coated tablets engraved “APO” on one side, “SE” bisect “50” on the other side. Sertraline 100mg film-coated tablets are 5 x 10 mm yellow oval scored film coated tablets engraved “APO” on one side, “SER” bisect “100” on the other side. The tablet can be divided 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. 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 SERTRALINE APOTEX 50 MG FILM-COATED TABLETS SERTRALINE APOTEX 100 MG FILM-COATED TABLETS MODULE 1.3 Product Information Version: 29.06.2021 MODULE 1.3.1 Summary of Product Characteristics Replaces : 28.11.2020 2 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 b Izlasiet visu dokumentu