Bicalutamide 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bicalutamide

Available from:

Zentiva Pharma UK 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: 5000283653226

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CASODEX
®
BICALUTAMIDE 50MG TABLETS 50MG TABLETS /
(BICALUTAMIDE)
This product is available using any of the above names but will be
referred to as
Casodex throughout the following:
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 IN THIS LEAFLET:
1. What Casodex is and what it is used for
2. What you need to know before you take Casodex
3. How to take Casodex
4. Possible side effects
5. How to store Casodex
6. Contents of the pack and other information
1. WHAT CASODEX IS AND WHAT IT IS USED FOR
Casodex contains a medicine called bicalutamide. This belongs to a
group of medicines
called ‘anti-androgens’.
•
Casodex is 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 CASODEX
DO NOT TAKE CASODEX:
•
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 Casodex if any of the above apply to you. If you are not
sure, talk to your
doctor or pharmacist before taking Casodex.
Casodex must not be given to children.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Casodex:
•
if you have any of the following:
any heart or blood vessel conditions, including heart rhythm problems
(arrhythmia),
or are being treated with medicines for these condit

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