Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SERTRALINE HYDROCHLORIDE
Ranbaxy Ireland Limited
100 Milligram
Film Coated Tablet
2011-10-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bellsert 100mg film – coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of sertraline as sertraline hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White film-coated caplet shaped tablet embossed with “100” on one side and break-line on the other side. 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 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 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 Read the complete document