BELLSERT Film Coated Tablet 100 Milligram
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
06-05-2024
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Ingredient activ:
SERTRALINE HYDROCHLORIDE
Disponibil de la:
Ranbaxy Ireland Limited
Dozare:
100 Milligram
Forma farmaceutică:
Film Coated Tablet
Data de autorizare:
2011-10-07
Caracteristicilor produsului
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
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