País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sertraline hydrochloride
Tillomed Laboratories Ltd
N06AB06
Sertraline hydrochloride
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030300; GTIN: 5024655002702
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 Tablets are and what they are used for 2. What you need to know before you take Sertraline Tablets 3. How to take Sertraline Tablets 4. Possible side effects 5. How to store Sertraline Tablets 6. Contents of the pack and other information 1. WHAT SERTRALINE TABLETS ARE AND WHAT THEY ARE USED FOR This medicine is one of a group of antidepressant or anti-obsessional drugs called the Selective Serotonin Reuptake Inhibitors (SSRIs). Sertraline is used to treat depression and prevention of recurrence of depression, Panic disorder, Obsessive Compulsive Disorder (OCD), Social anxiety disorder or Post Traumatic Stress Disorder (PTSD). It is also used to treat OCD in children and adolescents aged 6 - 17 years old. Your doctor has decided that this medicine is suitable for treating your illness. Depression is a clinical illness. If you have been feeling sad, tearful, unable to sleep properly or to enjoy life as you used to, Sertraline Tablets may help you to feel better. It may also help treat the anxiety which may accompany your depression. If you are not sure why you are on these tablets, ask your doctor. OCD and Panic disorders are illnesses linked to anxiety. If you have been constantly troubled by persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions) Sertraline Tablets may help you. If you are not sure why you are on these tablets, ask your doctor. PTSD is a condition that can occur after a very emotio Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sertraline 50 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Sertraline hydrochloride equivalent to 50 mg sertraline. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Film coated tablets. 50 mg white, oblong, biconvex, film-coated tablet with score line on one face. 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 50 mg and 100 mg Tablets should be given as a single daily dose either in the morning or evening. Sertraline Tablets can be administered with or without food. Sertraline tablets are for oral administration only ADULTS: _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 at least one week, up to a maximum of 200 mg/day. Changes in dose should not be made more frequently than once per week given the 24-hour elimination half life of sertraline. The onset of therapeutic effect may be seen within 7 days. However, longer periods are usually necessary to demonstrate therapeutic response, especially in OCD. _Maintenance _ Dosage during long-term therapy should be kept at the lowest effective level, with subsequent a Leer el documento completo