Bicalutamide 50 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bicalutamide

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

L02BB; L02BB03

INN (International Name):

Bicalutamide

Dosage:

50 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Anti-androgens; bicalutamide

Authorization status:

Marketed

Authorization date:

2008-12-08

Patient Information leaflet

NL/H/4559/001/II/026 + NL/H/4559/001/IA/031, ver 00, JUL 2023
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”.
These drugs block a number of the effects of the male sex hormone
androgen in the body. One of the effects
of androgen is that it stimulates tumour growth. Anti-androgens
inhibit tumour growth.
This medicine is used to inhibit growth of a tumour on the prostate
and to improve quality of life (palliative
treatment).
This medicine is only prescribed for men with inoperable metastatic
prostate cancer in whom the testes
have been fully or partially removed or who are using an LHRH agonist
(a type of medicine that inhibits
formation of testosterone by the body).
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 (including women who are pregnant or
breast-feeding)
•
If you are

Summary of Product characteristics

Health Products Regulatory Authority
13 September 2023
CRN00DTQW
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.
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 <30 ml /
min).
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.
Theoretically, a dosage of 1 tablet every other day could be
considered in this case, however there is no experience of this (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 o