Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
Paroxetine HCl Hemihydrate 14.25mg equv. to Paroxetin HCl
GLAXOSMITHKLINE PTE LTD
N06AB05
12.5 mg
TABLET, EXTENDED RELEASE
Paroxetine HCl Hemihydrate 14.25mg equv. to Paroxetin HCl 12.5 mg
ORAL
Prescription Only
Bora Pharmaceutical Services Inc.
ACTIVE
2004-08-30
1 SEROXAT™ CR PAROXETINE HYDROCHLORIDE QUALITATIVE AND QUANTITATIVE COMPOSITION _SEROXAT_ CR tablets 12.5 mg and 25 mg contain paroxetine hydrochloride equivalent to 12.5 mg and 25 mg paroxetine free base, respectively. PHARMACEUTICAL FORM _12.5 mg tablets:_ Yellow, with GSK engraved on one side and 12.5 on the other side. _25 mg tablets:_ Pink, 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. _SEROXAT_ CR has not been systematically evaluated beyond 12 weeks in controlled clinical trials and the physician who elects to use _SEROXAT_ CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patients. PREMENSTRUAL DYSPHORIC DISORDER: _SEROXAT_ CR tablets are indicated for the treatment of premenstrual dysphoric disorder (PMDD). The effectiveness of _SEROXAT_ CR in long-term use, i.e. for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use _SEROXAT_ CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient._ _ SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA: _SEROXAT_ CR Tablets are indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia. The effectiveness of _SEROXAT_ CR tablets in the long-term treatment of Social Anxiety Disorder/Social Phobia, i.e. for more than 12 weeks, has not been evaluated in adequate and well-controlled trials. Therefore, the physician who elects to prescribe _SEROXAT_ CR 2 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the ind Przeczytaj cały dokument
1 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 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). _SEROXAT_ CR has not been systematically evaluated beyond 12 weeks in controlled clinical trials and the physician who elects to use _SEROXAT_ CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patients. PREMENSTRUAL DYSPHORIC DISORDER: _SEROXAT_ CR tablets are indicated for the treatment of premenstrual dysphoric disorder (PMDD). The effectiveness of _SEROXAT_ CR in long-term use, i.e. for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use _SEROXAT_ CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. _ _ SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA: _SEROXAT_ CR tablets are indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia. The effectiveness of _SEROXAT_ CR tablets in the long-term treatment of Social Anxiety Disorder/Social Phobia, i.e. for more than 12 weeks, has not been evaluated in adequate and well-controlled trials. Therefore, the physician who elects to prescribe _SEROXAT_ CR 2 for extended periods should periodically re-evaluate the long-term usefulness of the drug 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 Prec Przeczytaj cały dokument