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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
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