Bicalutamide Fair-Med 50mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BICALUTAMIDE

Available from:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

ATC code:

L02BB03

INN (International Name):

BICALUTAMIDE 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

BICALUTAMIDE 50 mg

Prescription type:

POM

Therapeutic area:

ENDOCRINE THERAPY

Authorization status:

Withdrawn

Authorization date:

2012-08-07

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, tal

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 
1 
NAME OF THE MEDICINAL PRODUCT 
Bicalutamide Fair-Med 50 mg 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