CASODEX TABLET 50MG

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

BICALUTAMIDE

Доступна з:

ASTRAZENECA SDN. BHD.

ІПН (Міжнародна Ім'я):

BICALUTAMIDE

Одиниць в упаковці:

28Tablet Tablets

Виробник:

Corden Pharma GmbH

інформаційний буклет

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CASODEX
® TABLET 50MG
BICALUTAMIDE (50MG)
1
WHAT IS IN THIS LEAFLET
1.
What Casodex is used for
2.
How Casodex works
3.
Before you use Casodex
4.
How to use Casodex
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Casodex
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT CASODEX IS USED FOR
Casodex is used to treat prostate
cancer.
HOW CASODEX WORKS
Casodex contains a medicine
called bicalutamide. This belongs
to a group of medicines called
‘anti-androgens’.
Casodex is used to treat prostate
cancer.
It works by blocking the effects of
male hormones such as
testosterone.
BEFORE YOU USE CASODEX_ _
_- When you must not use it _
DO NOT TAKE CASODEX IF:
•
You are allergic
(hypersensitive) to
bicalutamide or any of the
other ingredients of this
medicine.
•
You are already taking a
medicine called cisapride or
certain anti-histamine
medicines (terfenadine or
astemizole).
•
You are a woman.
Do not take Casodex if any of the
above apply to you. If you are not
sure, talk to your doctor or
pharmacist before taking Casodex.
Casodex must not be given to
children.
_- Before you start to use it _
Check with your doctor or
pharmacist before taking Casodex
if:
•
You have any of the
following: any heart of blood
vessel conditions, including
heart rhythm problems
(arrhythmia), or are being
treated with medicines for
these conditions. The risk of
heart rhythm problems may
be increased when using
Casodex.
•
You are taking blood thinners
or medicines to prevent blood
clots.
•
You have problems with your
liver.
•
You have diabetes and are
already taking an ‘LHRH
analogue’. These include
goserelin, buserelin,
leuprorelin and triptorelin.
•
You go into hospital, tell the
medical staff that you are
taking Casodex.
•
You are taking Casodex, you
and/or your partner should
use birth control while you
are taking Casodex and for
130 days after stopping
Casodex. Talk to your doctor
if

Характеристики продукта

CASODEX
® 50 MG
_Bicalutamide _
Film coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg bicalutamide (INN).
PHARMACEUTICAL FORM
White film-coated tablet.
THERAPEUTIC INDICATIONS
Treatment
of
advanced
prostate
cancer
in
combination
with
luteinizing-hormone
releasing
hormone (LHRH) analogue therapy or surgical castration.
POSOLOGY AND METHOD OF ADMINISTRATION
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.
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’).
Paediatric
population:
Casodex
is
contraindicated
for
use
in
children
(see
section
‘Contraindications’).
CONTRAINDICATIONS
Casodex
is
contraindicated
in
females
and
children
(see
section
‘Fertility, Pregnancy
and
lactation’).
Hypersensitivity to the active substance or to any of the excipients
listed in the section ‘List of
Excipients’.
Co-administration of terfenadine, astemizole or cisapride with Casodex
is contraindicated (see
section ‘Interaction with other medicinal products and other forms
of interaction’).
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 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 wi