Bicalutamide Fair-Med 50 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bicalutamide

Available from:

Fairmed Healthcare GmbH

ATC code:

L02BB; L02BB03

INN (International Name):

Bicalutamide

Dosage:

50 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Anti-androgens; bicalutamide

Authorization status:

Not marketed

Authorization date:

2012-09-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
BICALUTAMIDE FAIR-MED 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.
_ _
WHAT IS IN THIS LEAFLET
1.
What Bicalutamide Fair-Med is and what it is used for
2.
What you need to know before you take Bicalutamide Fair-Med
3.
How to take Bicalutamide Fair-Med
4.
Possible side effects
5.
How to store Bicalutamide Fair-Med
6.
Contents of the pack and other information
1.
WHAT BICALUTAMIDE FAIR-MED IS AND WHAT IT IS USED FOR
Bicalutamide Fair-Med contains a medicine called bicalutamide. This
belongs to a group of
medicines called ‘anti-androgens’. It works by blocking the effect
of the male sex hormones
(androgens) and inhibits cell growth in the prostate.
Bicalutamide Fair-Med is used to treat advanced prostate cancer. It is
taken together with an
additional hormone treatment (called LHRH analogue) or with
accompanying surgical
removal of the testicles.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BICALUTAMIDE FAIR-MED
DO NOT TAKE BICALUTAMIDE FAIR-MED:

if you are allergic to bicalutamide or any of the other ingredients of
this medicine
(listed in Section 6).

if you are already taking a medicine called cisapride or certain
anti-histamine
medicines (terfenadine or astemizole).

if you are a woman.
Do not take Bicalutamide Fair-Med if any of the above apply to you. If
you are not sure, talk
to your doctor or pharmacist before taking Bicalutamide Fair-Med.
Bicalutamide Fair-Med must not be given to children and adolescents.
WARNINGS AND PRECAUTIONS
Talk

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bicalutamide Fair-Med 50mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg Bicalutamide
Excipient(s) with known effect: Each tablet contains 62.7 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex, film coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bicalutamide Fair-Med is indicated for the 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 (50 mg) once a day.
Route: Oral use.
The tablets should be swallowed whole with liquid.
Treatment with Bicalutamide Fair-Med 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 Fair-Med is contraindicated 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 < 30 ml/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 the active substance or to any of the excipients
listed in section 6.1.
Bicalutamide Fair-Med is contraindicated in females, children and
adolescents (see section 4.6).
Co-administration of terfenadine, astemizole or cisapride with
bicalutamide is contraindicated (see section 4.5).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Initiation of treatment should be under the direct supervision of a
specialist and subsequently patients should be kept
under regular surveillance.
Bicalutamide is extensively metabolised