CASODEX Film Coated Tablet 50 Milligram
Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
SPC
(SPC)
07-05-2024
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active_ingredient:
BICALUTAMIDE
MAH:
Profind Wholesale Ltd.
dosage:
50 Milligram
pharmaceutical_form:
Film Coated Tablet
authorization_date:
2010-11-12
SPC
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Casodex 50mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of bicalutamide.
Excipients: Contains lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Italy:_
Round, white, biconvex tablets marked with "Cdx 50" on one face and a logo on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in combination with
LHRH
analogue therapy or surgical castration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adult males including the elderly: One tablet (50mg) once a day. Treatment with Casodex should be started at the
same time as treatment with an
LHRH
analogue or surgical castration.
Children: Casodex is contraindicated in children.
Renal Impairment: No dosage adjustment is necessary for patients with renal impairment.
Hepatic Impairment: No dosage adjustment is necessary for patients with mild hepatic impairment. Increased
accumulation may occur in patients with moderate to severe hepatic impairment (_see section 4.4, Special warnings and_
_precautions for use_).
4.3 CONTRAINDICATIONS
Casodex is contra-indicated in females and children (see section 4.6).
Casodex must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any of
the excipients of this product.
Co-administration of terfenadine, astemizole or cisapride with Casodex is contraindicated (see section 4.5)
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Initiation of treatment should be under the direct supervision of a specialist.
Casodex is extensively metabolised in the liver. Data suggests that its elimination may be slower in subjects with
severe hepatic imp
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