Bicalutamide 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bicalutamide

Available from:

Consilient Health Ltd

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; GTIN: 5391512450595

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 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg bicalutamide
Excipient(s) with known effect:
Each tablet contains 56.6 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex, 7mm diameter. Marked ‘B 50’ on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in combination with
luteinizing-hormone
releasing hormone (LHRH) analogue therapy or surgical castration.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adult males including the elderly: one tablet (50 mg) once a day.
Treatment with Bicalutamide 50 mg should be started at least 3 days
before
commencing treatment with an LHRH analogue, or at the same time as
surgical
castration.
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).
Paediatric population: Bicalutamide is contraindicated for use in
children (see
section 4.3).
4.3
CONTRAINDICATIONS
Bicalutamide 50 mg is contraindicated in females and children (see
section 4.6).
Hypersensitivity 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 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