Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
FLUOXETINE HYDROCHLORIDE
Astellas Pharma Co. Ltd
FLUOXETINE HYDROCHLORIDE
20 Base Milligrams
Capsules Hard
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-01-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Affex 20 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Fluoxetine 20 mg (as Fluoxetine Hydrochloride). Excipients: Contains Soya Lecithin For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard A hard, gelatin capsule with a light-green opaque cap and a yellow opaque body. The capsule is marked ‘F20’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Major depressive episodes._ _Obsessive-compulsive disorder._ _Bulimia nervosa: _Affex is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration to adults only. MAJOR DEPRESSIVE EPISODES: Adults and the elderly: 20mg/day to 60mg/day. A dose of 20mg/day is recommended as the initial dose. Although there may be an increased potential for undesirable effects at higher doses, a dose increase may be considered after three weeks if there is no response. In agreement with the consensus statement of the WHO, antidepressant medication should be continued for at least six months. OBSESSIVE-COMPULSIVE DISORDER (OCD): Adults and the elderly: 20 mg/day to 60 mg/day. A dose of 20 mg/day is recommended as the initial dose. Although there may be an increased potential for side effects at higher doses, a dose increase maybe considered after two weeks if there is no response. If no improvement is observed within ten weeks, treatment with fluoxetine should be reconsidered. If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis. While there are no systematic studies to answer the question of how long to continue fluoxetine treatment, OCD i Belgenin tamamını okuyun