Bicalutamide 50mg Film-coated Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

BICALUTAMIDE

Tilgængelig fra:

Accord Healthcare Limited

ATC-kode:

L02BB03

INN (International Name):

BICALUTAMIDE

Lægemiddelform:

FILM-COATED TABLET

Sammensætning:

BICALUTAMIDE 50 mg

Recept type:

POM

Terapeutisk område:

ENDOCRINE THERAPY

Autorisation status:

Authorised

Autorisation dato:

2010-07-22

Indlægsseddel

Page
1
of
5
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 is and what it is 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 TABLET IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group: Hormone antagonists and related agents,
anti-androgens.
Bicalutamide is used for the treatment of advanced prostatic
carcinoma. It is taken together with
a drug known as a luteinising hormone-releasing hormone (LHRH)
analogue - an additional
hormone treatment - or with accompanying surgical removal of the
testicles.
Bicalutamide is one of a group of medicines known as the non-steroidal
antiandrogens. The
active substance bicalutamide blocks the undesired effect of the male
sex hormones (androgens)
and inhibits cell growth in the prostate in this way.
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, adolescent or child

If you are taking of terfenadine or astemizole (for hay fever or
allergy) or cisapride (for
stomach disorders) with Bicalutamide Tablets 50mg.
Bicalutamide tablets must not be taken by woman or children.
WARNI

Produktets egenskaber

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.
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 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 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.
Children and adolescents: Bicalutamide is not indicated in children
and adolescents.
Renal impairment: no dosage adjustment is necessary for patients with
renal impairment.
There is no experience with the use of bicalutamide in patients with
severe renal impairment
(creatinine clearance < 30ml/min) (see section 4.4).
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 bicalutamide 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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Initiation of treatment should be under the direct supervision of a
specialist.
Page
2
of
8
As there is no experience with the use of bicalutamide in patients
with severe renal
impairment (creatinine clearance < 30/min), bicalutamide should only
be used with cauti