Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paroxetine hydrochloride hemihydrate
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
Paroxetine hydrochloride hemihydrate
30Tablet Tablets
GLAXOSMITHKLINE 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 Preberite celoten dokument
CONFIDENTIAL [GSK logo] SEROXAT CR Paroxetine hydrochloride hemihydrate QUALITATIVE AND QUANTITATIVE COMPOSITION Each SEROXAT CR (controlled release) tablet contains paroxetine hydrochloride hemihydrate equivalent to 12.5 mg or 25 mg paroxetine free base. PHARMACEUTICAL FORM 12.5 mg tablets: Yellow, round, biconvex tablets with GSK engraved on one side and 12.5 on the other side. 25 mg tablets: Pink, round, biconvex tablets with GSK engraved on one side and 25 on the other side. CLINICAL PARTICULARS 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. Preberite celoten dokument