Bicalutamide 50mg Film-coated tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Bicalutamide

Tilgængelig fra:

Fresenius Kabi Deutschland GmbH

ATC-kode:

L02BB; L02BB03

INN (International Name):

Bicalutamide

Dosering:

50 milligram(s)

Lægemiddelform:

Film-coated tablet

Terapeutisk område:

Anti-androgens; bicalutamide

Autorisation status:

Not marketed

Autorisation dato:

2011-01-28

Indlægsseddel

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 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
1.
WHAT BICALUTAMIDE IS AND WHAT IT IS USED FOR
Bicalutamide 50 mg film-coated tablets 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BICALUTAMIDE
DO NOT TAKE BICALUTAMIDE:
•
if you are allergic to bicalutamide or any of the other ingredient 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 if any of the above apply to you. If you are
not sure, talk to
your doctor or pharmacist before taking bicalutamide.
Bicalutamide must not be given to children.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking bicalutamide:
•
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
conditions.
The risk of heart rhythm problems may be in

Produktets egenskaber

Health Products Regulatory Authority
05 April 2019
CRN008RTZ
Page 1 of 6
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.
Excipient(s) with known effect:
Each tablet contains 88.93 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off white, circular, film coated biconvex tablets of 7 mm,
debossed with ‘DB01’ 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 older people: one tablet (50 mg) 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.
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.
4.3 CONTRAINDICATIONS
Bicalutamide is contraindicated in female 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).
Health Products Regulatory Authority
05 April 2019
CRN008RTZ
Page 2 of 6
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Initiation of treatment should be under the direct supervision of a
specialistBicalutamide is extensively metabolised in the liver.
Data suggests that its elimination may be slower in subjects with
severe hepat