Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
FLUOXETINE HYDROCHLORIDE
Eli Lilly and Company Limited
N06AB03
60mg
Capsule
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
1994-02-09
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prozac 60mg hard capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains fluoxetine hydrochloride equivalent to 60mg of fluoxetine. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules. The capsules are yellow, printed 3109. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 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 appropriate. Although there may be an increased potential for undesirable effects at higher doses, in some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 60 mg (see section 5.1, Pharmacodynamic properties). Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. _Obsessive-compulsive disorder:_ Adults and the elderly: The recommended dose is 20mg daily. Although there may be an increased potential for side undesirable effects at higher doses, in some patients, if after two weeks there is insufficient response to 20mg, the dose may be increased gradually up to a maximum of 60mg. IRISH MEDICINES BOARD ________________________________________________________________________________ Прочитайте повний документ