Šalis: Nyderlandai
kalba: olandų
Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SERTRALINEHYDROCHLORIDE 55,95 mg/stuk SAMENSTELLING overeenkomend met ; SERTRALINE 50 mg/stuk
Pfizer B.V. Rivium Westlaan 142 2909 LD CAPELLE A/D IJSSEL
N06AB06
SERTRALINEHYDROCHLORIDE 55,95 mg/stuk SAMENSTELLING overeenkomend met ; SERTRALINE 50 mg/stuk
Filmomhulde tablet
CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYETHYLEENGLYCOL (E 1521) ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Sertraline
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); HYPROMELLOSE (E 464); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYETHYLEENGLYCOL (E 1521); POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);
2012-10-08
Package leaflet NLD 23C21 1 NLD 23C21 PACKAGE LEAFLET: INFORMATION FOR THE USER ENORE 50 MG FILMOMHULDE TABLETTEN ENORE 100 MG FILMOMHULDE TABLETTEN 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 Enore is and what it is used for. 2. What you need to know before you take Enore. 3. How to take Enore. 4. Possible side effects. 5. How to store Enore. 6. Contents of the pack and other information. 1. WHAT ENORE IS AND WHAT IT IS USED FOR Enore 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. Enore 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 to depression and anxiety. Social anxiety disorder (social phobia) is an illne Perskaitykite visą dokumentą
Samenvatting van de productkenmerken NLD 23C21 1 NLD 23C21 SAMENVATTING VAN DE PRODUCTKENMERKEN 1. NAME OF THE MEDICINAL PRODUCT Enore 50 mg filmomhulde tabletten Enore 100 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sertraline 50 mg film-coated tablets: Each film-coated tablet contains sertraline hydrochloride equivalent to 50 mg sertraline. Sertraline 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 Sertraline 50 mg film-coated tablets are white, capsular shaped, film-coated scored tablets marked “ZLT 50” or “LTL 50” or “SER 50” on one side and ‘PFIZER’ on the other. The tablet can be divided into equal doses. Sertraline 100 mg film-coated tablets are white, capsular shaped, film-coated tablets marked “ZLT 100” or “LTL 100” or “SER 100” on one side and ‘PFIZER’ on the other. 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. _ _ Samenvatting van de productkenmerken NLD 23C21 2 _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 cha Perskaitykite visą dokumentą