País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
FLUOXETINE
IPS Healthcare Limited
FLUOXETINE
20 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-03-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prozac 20mg hard capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules. _Product imported from the UK:_ The capsules are green and yellow, printed 'Lilly 3105'. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. Children and adolescents aged 8 years and above: Moderate to severe major depressive episode, 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. _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. IRISH MEDICINES BOARD _______ Leer el documento completo