Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paroxetine hydrochloride hemihydrate
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
Paroxetine hydrochloride hemihydrate
30Tablet Tablets
Bora Pharmaceutical Services Inc.
Consumer Medication Information Leaflet (RiMUP) SEROXAT CR TABLET Paroxetine hydrochloride hemihydrate (12.5 mg, 25mg) 1 What is in this leaflet 1. What SEROXAT CR is used for 2. How SEROXAT CR works 3. Before you use SEROXAT CR 4. How to use SEROXAT CR 5. While you are using it 6. Side Effects 7. Storage and Disposal of SEROXAT CR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision What SEROXAT CR is used for In adults aged 18 years and over, SEROXAT CR is used to treat: Depression A severe form of premenstrual syndrome (premenstrual dysphoric disorder), symptoms include depression, severe mood changes, irritability Panic attacks, including those caused by a fear of open spaces (agoraphobia) Anxiety caused by situations such as socialising or performance These conditions can occur when the amount of a substance called serotonin in the brain is reduced. How SEROXAT CR works The active ingredient in SEROXAT CR is paroxetine which belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Paroxetine works by increasing serotonin levels in the brain. Before you use SEROXAT CR - When you must not use it Do not use SEROXAT CR: If you are allergic (hypersensitive) to paroxetine or any other ingredients of SEROXAT CR (see section Product Description). If you are taking or have recently taken (within the last two weeks) medicines for depression called monoamine oxidase inhibitors (MAOIs). If you are taking or have recently taken (within the last two weeks) an antibiotic called linezolid. If you are taking or have recently taken (within the last two weeks) a medicine called methylthioninium chloride (methylene blue). If you are taking medicines called thioridazine or pimozide (usually used to treat schizophrenia). If you think any of these apply to you, don’t take SEROXAT CR until you have checked with your doctor. - Before you start to use it Before you take SEROXAT CR your doctor needs to know: If you have ever Lees het volledige document
CONFIDENTIAL [GSK logo] SEROXAT CR PAROXETINE HYDROCHLORIDE HEMIHYDRATE QUALITATIVE AND QUANTITATIVE COMPOSITION _SEROXAT CR_ 12.5 mg tablets: Yellow, round, biconvex tablets with GSK engraved on one side and 12.5 on the other side. _SEROXAT CR_ 25 mg tablets: Pink, round, biconvex tablets with GSK engraved on one side and 25 on the other side. Each _SEROXAT _ CR (controlled release) tablet contains paroxetine hydrochloride hemihydrate equivalent to 12.5 mg or 25 mg paroxetine free base. CLINICAL INFORMATION INDICATIONS • ADULTS MAJOR DEPRESSIVE DISORDER: _SEROXAT _ CR tablets are indicated for the treatment of major depressive disorder (MDD). PANIC DISORDER: _SEROXAT _ CR tablets have been shown to be effective in the treatment of panic disorder with or without agoraphobia. PREMENSTRUAL DYSPHORIC DISORDER: _SEROXAT _ CR tablets are indicated for the treatment of premenstrual dysphoric disorder (PMDD). Paroxetine has not been evaluated beyond 3 menstrual cycles in controlled clinical trials for the treatment of PMDD. SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA: _SEROXAT _ CR tablets have been shown to be effective in the treatment of Social Anxiety Disorder/Social Phobia. The effectiveness of _SEROXAT _ CR tablets in the long-term treatment of Social Anxiety Disorder/Social Phobia has not been evaluated. Therefore, if _SEROXAT _ CR tablets are to be administered for extended periods in the treatment of Social Anxiety Disorder/Social CONFIDENTIAL Phobia, the physician should periodically re-evaluate the long-term usefulness of _SEROXAT _ CR for the individual patient. • CHILDREN AND ADOLESCENTS (LESS THAN 18 YEARS) ALL INDICATIONS: _SEROXAT _ CR is not indicated for use in children or adolescents aged less than 18 years ( _see _ _Warnings and Precautions_ ). The efficacy of _SEROXAT _ CR tablets has not been studied in children or adolescents aged less than 18 years; however, controlled clinical studies with _SEROXAT _ IR (immediate release) tablets in children and adolescents with major depressive disorder failed t Lees het volledige document