Bicalutamide 150mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bicalutamide

Available from:

Teva UK Ltd

ATC code:

L02BB03

INN (International Name):

Bicalutamide

Dosage:

150mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030402; GTIN: 5017007042815

Patient Information leaflet

PAGE 1: FRONT FACE (INSIDE OF REEL)
Top of page cut-off to middle of registration mark: 21mm. Registration
Pitch: 210mm -0.45mm (Sheet depth / cut-off length: 210mm)
Pharma code 756
(Main)
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.
1. What Bicalutamide is and what it is used for
2. What you need to know before you take Bicalutamide
3. How to take Bicalutamide
4. Possible side effects
5. How to store Bicalutamide
6. Contents of the pack and other information
WHAT BICALUTAMIDE IS AND WHAT IT IS USED FOR
Bicalutamide contains a medicine called bicalutamide.
This belongs to a group of medicines called
‘anti-androgens’.
•
Bicalutamide is used to treat prostate cancer
•
It works by blocking the effects of male hormones such
as testosterone.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BICALUTAMIDE
DO NOT TAKE BICALUTAMIDE
•
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 containing medicine called
cisapride or certain antihistamine medicines
(terfenadine or astemizole)
Bicalutamide must not be given to children.
Do not take Bicalutamide if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before
taking Bicalutamide.
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Bicalutamide
•
if you have problems with your liver. Your doctor may do
blood tests before and during your treatment with
Bicalutamide.
•
if you have any of the following: any heart or blood

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bicalutamide 150 mg film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 150 mg bicalutamide.
Excipient with known effect: One film-coated tablet contains 169.68 mg
lactose
monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Bicalutamide 150 mg film-coated tablets are round, biconvex, white, 10
mm in
diameter, with “B 150” printed on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bicalutamide 150 mg is indicated either alone or as adjuvant to
radical prostatectomy
or radiotherapy in patients with locally advanced prostate cancer at
high risk for
disease progression (see section 5.1).
Bicalutamide 150 mg is also indicated for the management of patients
with locally
advanced, non-metastatic prostate cancer for whom surgical castration
or other
medical intervention is not considered appropriate or acceptable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adult males including the elderly: _
One tablet daily.
The tablet should be swallowed whole with liquid.
Bicalutamide 150 mg tablets should be taken continuously for at least
2 years
or until disease progression.
_Paediatric population _
Bicalutamide is not indicated in children and adolescents.
_Renal impairment _
No dose adjustment is necessary for patients with renal impairment.
_Hepatic impairment _
No dose adjustment is necessary for patients with mild hepatic
impairment.
The medicinal product may accumulate in patients with moderate to
severe
hepatic impairment (see section 4.4.).
4.3
CONTRAINDICATIONS
Bicalutamide is contraindicated in females and children (see section
4.6).
Bicalutamide must not be given to any patient who has shown a
hypersensitivity
reaction to the active substance or to any of the excipients listed in
section 6.1.
Co-administration of terfenadine, astemizole or cisapride with
Bicalutamide is
contraindicated (see section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS F