CASODEX 50 MG

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

BICALUTAMIDE

MAH:

TARO INTERNATIONAL LTD, ISRAEL

ATC_code:

L02BB03

pharmaceutical_form:

TABLETS

composition:

BICALUTAMIDE 50 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

CORDEN PHARMA GMBH, GERMANY

therapeutic_group:

BICALUTAMIDE

therapeutic_area:

BICALUTAMIDE

therapeutic_indication:

For the treatment of advanced prostate cancer in combination with LHRH analog therapy or surgical castration.

authorization_date:

2021-12-31

PIL

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor's prescription only
Casodex
®
50 mg
Tablets
Composition:
Each tablet contains:
bicalutamide 50 mg
Inactive ingredients and allergens: see section 2 under ‘Important
information
about some of this medicine’s ingredients’, and section 6
‘Further information'.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains concise information about the medicine. If you
have
further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not
pass it on to others. It may harm them even if it seems to you that
their
ailment is similar.
This medicine is not intended for women or children, including
pregnant or
breast-feeding women.
1.
WHAT IS THE MEDICINE INTENDED FOR?
For treatment of prostate cancer.
Therapeutic group:
An anti-androgenic agent that interferes with some of the activities
of andro-
gens (male hormones) within the body.
2.
BEFORE USING THE MEDICINE
Do not use the medicine if:
•
you are sensitive (allergic) to the active ingredient bicalutamide or
to any
of the other ingredients of this medicine (please refer to section 6 -
Further
Information).
•
you are already taking a medicine called cisapride or certain
anti-histamine
medicines (terfenadine, astemizole).
Special warnings regarding use of Casodex
Before starting treatment with Casodex, tell the doctor if:
•
You are suffering from a heart or blood vessel problem, including
heart
rhythm disorders (arrhythmia), or if you are being treated with medi-
cines for any of these problems. The risk of heart rhythm problems can
increase when using Casodex.
•
You are taking blood thinners or medicines to prevent blood clots.
•
You are suffering from liver problems.
•
You are suffering from diabetes and are taking "LHRH analogs",
including
goserelin, buserelin, leuprorelin and triptorelin.
If you go to the hospital, tell

SPC

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CASODEX 50 MG TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Casodex 50 mg Tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg bicalutamide (INN).
Excipient(s) with known effect:
Each tablet contains 61 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White film-coated tablet.
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
POSOLOGY
Adult males including the elderly: one tablet (50 mg) once a day.
Treatment with Casodex should be started at least 3 days before
commencing treatment with
an LHRH analogue, or at the same time as surgical castration.
Paediatric population: Casodex is contraindicated for use in children
(see section 4.5)
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).
4.3
CONTRAINDICATIONS
Casodex is contra-indicated in females and children (see section 4.6).
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Co-administration of terfenadine, astemizole or cisapride with Casodex
is contra-indicated
(see section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Initiation of treatment should be under the direct supervision of a
specialist.
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Casodex is extensively metabolised in the liver. Data suggests that
its elimination may be
slower in subjects with severe hepatic impairment and this could lead
to increased
accumulation of Casodex. Therefore, Casodex should be used with
caution in patients with
moderate to severe hepatic impairment.
Periodic liver function testing should be considered due to the
possibility of hepatic changes.
The majority of changes are expected to occur within