PROZAC 20 Milligram Capsules Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-06-2024
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Active ingredient:
FLUOXETINE
Available from:
IPS Healthcare Limited
INN (International Name):
FLUOXETINE
Dosage:
20 Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2013-03-28
Summary of Product characteristics
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
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