CASODEX 150 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BICALUTAMIDE

Available from:

ASTRA ZENECA (ISRAEL) LTD

ATC code:

L02BB03

Pharmaceutical form:

TABLETS

Composition:

BICALUTAMIDE 150 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ASTRA ZENECA UK LIMITED

Therapeutic group:

BICALUTAMIDE

Therapeutic area:

BICALUTAMIDE

Therapeutic indications:

In patients with locally advanced prostate cancer (T3 - T4 any N M0 T1 -T2 N+ M0) Casodex 150 mg is indicated as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy. The management of patients with locally advanced non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable.

Authorization date:

2010-09-30

Summary of Product characteristics

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קדבנ
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רשואמ ןולע
:
טסוגוא
2011
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been
checked and approved.” Date of approval in August 2011:
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Casodex 150 mg Film-coated Tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg Bicalutamide (INN)
For excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet. White.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Patients with locally advanced prostate cancer (T3-T4, any N, M0;
T1-T2, N+, M0), Casodex
150mg is indicated as immediate therapy either alone or as adjuvant to
treatment by radical
prostatectomy or radiotherapy. (See section Pharmacodynamic
properties).
Casodex 150 mg is also indicated for the management of patients with
locally advanced, non-
metastatic prostate cancer for whom surgical castration or other
medical intervention is not
considered appropriate or acceptable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adult males including the elderly: The dosage is one 150 mg tablet to
be taken orally once a
day.
Casodex 150 mg should be taken continuously for at least 2 years or
until disease progression.
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 Special warnings and precautions for use ).
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2
4.3
CONTRAINDICATIONS
Casodex 150 mg is contraindicated in females and children (see Section
Pregnanacy and
lactation).
Casodex 150 mg must not be given to any patient who has shown a
hypersensitivity to the
active substance or any of the excipients.
Co-administration of terfenadine, astemizole or cisapride with Casodex
is contraindicated (see
Se