Երկիր: Սինգապուր
Լեզու: անգլերեն
Աղբյուրը: HSA (Health Sciences Authority)
Paroxetine Hydrochloride Hemihydrate 22.8 mg eqv paroxetine
GLAXOSMITHKLINE PTE LTD
N06AB05
20 mg
TABLET, FILM COATED
Paroxetine Hydrochloride Hemihydrate 22.8 mg eqv paroxetine 20 mg
ORAL
Prescription Only
GlaxoSmithKline Pharmaceuticals S.A.
ACTIVE
1992-06-09
1 SEROXAT PAROXETINE HYDROCHLORIDE QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains paroxetine hydrochloride equivalent to 20 mg paroxetine free base. PHARMACEUTICAL FORM _20 mg tablets:_ White, film-coated, oval-shaped biconvex tablet debossed with ‘20’ on one side and a break bar on the other. CLINICAL PARTICULARS INDICATIONS ADULTS DEPRESSION: Treatment of symptoms of depressive illness of all types including reactive and severe depression and depression accompanied by anxiety. Following an initial satisfactory response, continuation with _SEROXAT_ therapy is effective in preventing relapse of Depression. ANXIETY DISORDERS: Treatment of symptoms and prevention of relapse of Obsessive Compulsive Disorder (OCD). Treatment of symptoms and prevention of relapse of Panic Disorder With or Without Agoraphobia. Treatment of Social Anxiety Disorder/Social Phobia. Treatment of symptoms and prevention of relapse of Generalised Anxiety Disorder. Treatment of Post-Traumatic Stress Disorder. CHILDREN AND ADOLESCENTS (LESS THAN 18 YEARS) ALL INDICATIONS: _SEROXAT_ is not indicated for use in children or adolescents aged less than 18 years (_see _ _Warnings and Precautions_). Controlled clinical studies in children and adolescents with major depressive disorder failed to demonstrate efficacy, and do not support the use of _SEROXAT_ in the treatment of depression in this population_ _(_see Warnings and Precautions_). The safety and efficacy of _SEROXAT_ in children aged less than 7 years has not been studied. 2 DOSAGE AND ADMINISTRATION ADULTS For oral administration. It is recommended that _SEROXAT_ be administered once daily in the morning with food. The tablets should be swallowed rather than chewed. As with all antidepressant drugs, dosage should be reviewed and adjusted if Կարդացեք ամբողջական փաստաթուղթը
1 SEROXAT PAROXETINE HYDROCHLORIDE HEMIHYDRATE QUALITATIVE AND QUANTITATIVE COMPOSITION _SEROXAT_ 20 mg tablets: White, film-coated, oval shaped, biconvex tablets with a break line on one side. Each _SEROXAT _ tablet contains paroxetine hydrochloride hemihydrate equivalent to 20 mg paroxetine free base. CLINICAL INFORMATION INDICATIONS ADULTS MAJOR DEPRESSIVE DISORDER: _SEROXAT_ is indicated for the treatment of major depressive disorder (MDD). Results of studies in which patients received _SEROXAT_ treatment for up to one year indicate that _SEROXAT_ is effective in preventing the relapse of depressive symptoms. ANXIETY DISORDERS: Treatment of symptoms and prevention of relapse of Obsessive Compulsive Disorder (OCD). Treatment of symptoms and prevention of relapse of Panic Disorder With or Without Agoraphobia. Treatment of Social Anxiety Disorder/Social Phobia. Treatment of symptoms and prevention of relapse of Generalised Anxiety Disorder. Treatment of Post-Traumatic Stress Disorder. CHILDREN AND ADOLESCENTS (LESS THAN 18 YEARS) ALL INDICATIONS: _SEROXAT_ is not indicated for use in children or adolescents aged less than 18 years ( _see _ _Warnings and Precautions_ ). Controlled clinical studies in children and adolescents with major depressive disorder failed to demonstrate efficacy, and do not support the use of _SEROXAT_ in the treatment of depression in this population _ _ ( _see Warnings and Precautions_ ). 2 The safety and efficacy of _SEROXAT_ in children aged less than 7 years has not been studied. DOSAGE AND ADMINISTRATION Pharmaceutical form: film-coated tablet ADULTS For oral administration. It is recommended that _SEROXAT_ be administered once daily in the morning with food. Tablets: _ _ The tablets should be swallowed rather than chewed. The 20 mg tablets have functional break lines to allow for breaking the tablets in half to yield 10 mg doses if needed. As with all antidepressant drugs, dosage should be reviewed and adjusted if necessary within 2 to 3 weeks of initiation of therapy and thereafter Կարդացեք ամբողջական փաստաթուղթը