Χώρα: Κύπρος
Γλώσσα: Ελληνικά
Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
SERTRALINE HYDROCHLORIDE
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
N06AB06
SERTRALINE
50MG
FILM COATED TABLETS
SERTRALINE HYDROCHLORIDE (8000002128) 55,9MG
ORAL USE
Εθνική Διαδικασία
SERTRALINE
Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 28 TABS IN BLISTER(S) (310025809) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή
PACKAGE LEAFLET : INFORMATION FOR THE USER TRENEL 50 MG FILM-COATED TABLETS TRENEL 100 MG FILM-COATED TABLETS Sertraline 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. See section 4. IN THIS LEAFLET: 1. What Trenel is and what it is used for 2. Before you take Trenel 3. How to take Trenel 4. Possible side effects 5. How to store Trenel 6. Further information 1. WHAT TRENEL IS AND WHAT IT IS USED FOR Trenel contains the active ingredient 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. TRENEL 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 illness linked to anxiety. It is characterised by feelings of intense anxiety or distress in social situations (for example: talking to strangers, sp Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Trenel 50 mg Film-coated tablets Trenel 100 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For 50 mg strength: Each film-coated tablet contains 55.9 mg sertraline hydrochloride corresponding to 50.0 mg of sertraline base. Excipient(s) with known effect: each tablet contains 79.65 mg of lactose monohydrate. For 100 mg strength: Each film-coated tablet contains 111.8 mg sertraline hydrochloride corresponding to 100.0 mg of sertraline base. Excipient(s) with known effect: each tablet contains 159.3 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. For 50 mg strength: White oval biconvex, 10x5 mm, coated tablets, scored on one side, on other side with “L” markings. For 100 mg strength: White, round biconvex, 10 mm, coated tablets, scored on one side, other side with “C” markings. 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 1 Sertraline should be administered once daily, either in the morning or evening. Sertraline tablet can be administered with or without food. _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 Διαβάστε το πλήρες έγγραφο