FLUTAMIDE Tablets 250 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-04-2023
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Active ingredient:
FLUTAMIDE
Available from:
TAD Pharma GmbH
Dosage:
250 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2002-12-06
Summary of Product characteristics
License
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Flutamide 250mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 250mg flutamide.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Slightly yellow, round, biplane tablet with the imprint ‘F 250’.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Treatment of advanced prostatic carcinoma in which suppression of testosterone effects is indicated: as initial treatment
in combination with an LHRH agonist; as adjunctive therapy in patients already receiving LHRH agonist therapy; in
surgically castrated patients; in the treatment of patients who have not responded to other forms of hormonal
manipulation or in patients who cannot tolerate such treatment.
4.2 Posology and method of administration
One 250mg tablet three times daily at 8 hour intervals.
When used as initial treatment with an LHRH agonist, a greater reduction in the incidence and severity of the LHRH
agonist flare reaction may be achieved if Flutamide 250mg Tablets are introduced before rather than concomitantly
with the LHRH agonist. It is, therefore, recommended that treatment with Flutamide 250mg Tablets, one tablet three
times daily, should
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