Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
FLUOXETINE HYDROCHLORIDE
Milpharm Limited
20 MG/5ml
Oral Solution
2011-01-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluoxetine Aurobindo 20 mg/5 ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of oral solution contains 20mg of fluoxetine (as hydrochloride). Excipients: Contains 3 g of sucrose per 5 ml dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. A clear, colorless, peppermint flavored liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ADULTS:_ Major depressive episodes. Obsessive-compulsive disorder. Bulimia nervosa: Fluoxetine 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 20mg, the dose may be increased gradually up to a maximum of 60mg (see section 5.1). 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 dis Lees het volledige document