Bicalutamide 50mg Film-coated Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Bicalutamide

Verfügbar ab:

Accord Healthcare Limited

ATC-Code:

L02BB; L02BB03

INN (Internationale Bezeichnung):

Bicalutamide

Dosierung:

50 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Anti-androgens; bicalutamide

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2008-12-08

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
BICALUTAMIDE 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. See section 4
WHAT IS IN THIS LEAFLET:
1. What Bicalutamide Tablets are and what they are used for
2. What you need to know before you take Bicalutamide Tablets
3. How to take Bicalutamide Tablets
4. Possible side effects
5. How to store Bicalutamide Tablets
6. Contents of the pack and other information
1. WHAT BICALUTAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Bicalutamide Tablets contain a medicine called bicalutamide. This
belongs to a group of medicines
called“anti-androgens”.

Bicalutamide Tablet 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 BICALUTAMIDE TABLETS
DO NOT TAKE BICALUTAMIDE TABLETS:

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 a medicine called cisapride or certain
anti-histamine medicines (terfenadine
or astemizole).
Do not take Bicalutamide tablets if any of the above apply to you. If
you are not sure, talk to your
doctor or pharmacist before taking Bicalutamide tablets.
Bicalutamide tablets must not be given to children.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Bicalutamide tablets.

if you have any of the following: Any heart or blood vessel
conditions, including heart rhythm
problems (arrhythmia), or are bein

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bicalutamide 50mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg Bicalutamide.
Excipients with known effect:
Each tablet contains 56mg of Lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, round biconvex, film-coated tablet debossed ‘B
50’ on one side and plain on other 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 (50mg) once a day.
TREATMENT WITH BICALUTAMIDE TABLETS 50MG SHOULD BE STARTED AT LEAST 3
DAYS BEFORE COMMENCING TREATMENT WITH
AN LHRH ANALOGUE, OR AT THE SAME TIME AS SURGICAL CASTRATION.
_PAEDIATRIC POPULATION_:
BICALUTAMIDE IS CONTRAINDICATED FOR USE IN CHILDREN(SEE SECTION 4.3 ).
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 < 30ml/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.
Use in females, children and adolescents is contraindicated (see
section 4.6).
Co-administration of terfenadine, astemizole or cisapride with
Bicalutamide is contra-indicated(see section 4.5).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Initiation of treatment should be under the direct supervision of a
specialist.
As there is no experience with the use of bicalutamide in patients
with severe renal impairment (creatinine clearance