Bicalutamide 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bicalutamide

Available from:

Waymade Healthcare Plc

ATC code:

L02BB03

INN (International Name):

Bicalutamide

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030402

Patient Information leaflet

Package leaflet: Information for the user
BICALUTAMIDE 50 MG 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 I
N THIS LEAFLET:
1.
What Bicalutamide 50 mg Tablets are and what they are used for
2.
What you need to know before you take Bicalutamide 50 mg Tablets
3.
How to take Bicalutamide 50 mg Tablets
4.
Possible side effects
5.
How to store Bicalutamide 50 mg Tablets
6.
Contents of the pack and other information
1.
WHAT BICALUTAMIDE 50 MG TABLETS ARE AND WHAT THEY ARE USED FOR
Bicalutamide 50 mg Tablets
contains a medicine called bicalutamide. This belongs to a group of
medicines called ‘anti-androgens’.
•
Bicalutamide 50 mg Tablets are 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 50 MG TABLETS
DO NOT TAKE BICALUTAMIDE 50 MG TABLETS:
•
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 50 mg Tablets if any of the above apply to
you. If you are not sure,
talk to your doctor or pharmacist before taking Bicalutamide 50 mg
Tablets.
Bicalutamide must not be given to children.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Bicalutamide 50 mg
Tablets:
•
if you have any of the following: any heart or blood vessel
condi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bicalutamide 50 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg bicalutamide.
Each tablet contains 61 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White round, biconvex film-coated tablet embossed ‘B50’ 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
should
be
started
at
least
3
days
before
commencing treatment with an LHRH analogue, or at the same time as
surgical castration.
Children: Bicalutamide is contra-indicated in children.
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
Bicalutamide is contra-indicated in females and children.
Bicalutamide must not be given to any patient who has shown a
hypersensitivity reaction to its use or to any excipients of this
product.
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
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,
bicalutamide
should be used with caution in patients with moderate to severe
hepatic
impairment.
Periodic liver function testing should be considered due to the
possibility of
hepatic changes. The majority of