Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
FLUOXETINE HYDROCHLORIDE
PCO Manufacturing
N06AB03
20mg
Capsules
Adults Major depressive episodes Obsessive compulsive disorder Bulimia nervosa:Prozac is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity
1996-10-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prozac 20 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg of fluoxetine (as hydrochloride). For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. _Product imported from France, Italy , Spain & the Czech Republic.:_ Hard capsules with pale yellow body and green cap, printed with ‘Lilly 3105’ on each part. _Product imported from the UK:_ Hard capsules with pale yellow body and green cap, printed ‘Prozac’ on the body and ‘20 mg’ on the cap. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults o Major depressive episodes. o Obsessive compulsive disorder. o Bulimia nervosa: Prozac is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity. Children and adolescents aged 8 years and above, moderate to severe major episodes, if depression is unresponsive to psychological therapy after 4-6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration to adults only. _MAJOR DEPRESSIVE EPISODES_ Adults and the elderly: the recommended dose is 20mg daily. Dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically. Although there may be an increased potential for undesirable effects at higher doses, in some patients, with insufficient response to 20mg, the dose may be increased gradually up to a maximum of 60mg (see section 5.1). Dosage adjustment should be made carefully on an individual basis, to maintain the patients at the lowest effective d Preberite celoten dokument