Bicalutamide 50mg Film-coated Tablets

Country: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

BICALUTAMIDE

থেকে পাওয়া:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

এটিসি কোড:

L02BB03

INN (International Name):

BICALUTAMIDE 50 mg

ফার্মাসিউটিকাল ফর্ম:

FILM-COATED TABLET

রচনা:

BICALUTAMIDE 50 mg

প্রেসক্রিপশন টাইপ:

POM

Therapeutic area:

ENDOCRINE THERAPY

অনুমোদন অবস্থা:

Withdrawn

অনুমোদন তারিখ:

2010-07-22

তথ্য লিফলেট

Page
1
of
6
PACKAGE LEAFLET: INFORMATION FOR THE USER
BICALUTAMIDE 50 MG FILM-COATED TABLETS
BICALUTAMIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Bicalutamide Tablets are and what they are used for
2. What you need to know before you take Bicalutamide Tablets
3. How to take Bicalutamide Tablets
4. Possible side effects
5. How to store Bicalutamide Tablets
6. Contents of the pack and other information
1.
WHAT BICALUTAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Bicalutamide Tablets contain a medicine called bicalutamide. This
belongs to a group of medicines
called“anti-androgens”.
•
Bicalutamide Tablet is used to treat prostate cancer.
•
It works by blocking the effects of male hormones such as
testosterone.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BICALUTAMIDE TABLETS
DO NOT TAKE BICALUTAMIDE TABLETS:
•
If you are allergic to bicalutamide or any of the other ingredients of
this medicine (listed in section 6).
•
If you are a woman
•
If you are already taking a medicine called cisapride or certain
anti-histamine medicines (terfenadine
or astemizole).
Do not take Bicalutamide tablets if any of the above apply to you. If
you are not sure, talk to your doctor
or pharmacist before taking Bicalutamide tablets.
Bicalutamide tablets must not be given to children.
Page
2
of
6
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Bicalutamide tablets.
•
if you have any of the following: Any heart or blood vessel
conditions, including heart rhythm
problems

পণ্য বৈশিষ্ট্য

Page
1
of
8
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Bicalutamide 50 mg Film-coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg Bicalutamide.
Excipients with known effect:
Each tablet contains 56mg of Lactose monohydrate.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film-coated tablet. (tablets).
White to off white, round biconvex, film-coated tablet debossed ‘B
50’ on one side and plain on
other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in combination with
luteinizing-hormone releasing hormone
(LHRH) analogue therapy or surgical castration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adult males including the elderly: one tablet (50mg) once a day.
Treatment with Bicalutamide Tablets 50mg should be started at least 3
days before commencing
treatment with an LHRH analogue, or at the same time as surgical
castration.
_ _
_Paediatric population_
:
Bicalutamide is contraindicated for use in children(see section 4.3 ).
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
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Use in females, children and adolescents is contraindicated (see
section 4.6).
Co-administration of terfenadine, astemizole or cisapride with
Bicalutamide 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.
Page
2
of
8
Bicalutamide 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
bicalutamide. Therefore