Bicalutamide 150 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bicalutamide

Available from:

Fresenius Kabi Oncology Plc

ATC code:

L02BB; L02BB03

INN (International Name):

Bicalutamide

Dosage:

150 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Anti-androgens; bicalutamide

Authorization status:

Not marketed

Authorization date:

2011-11-25

Patient Information leaflet

Ver.: 05
Last modified: 30 June 2016 4:51 PM
Times New Roman 10 pt
BICALUTAMIDE 150MG-PACK INSERT-BORDON-GBR+IRL
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PACKAGE LEAFLET: INFORMATION FOR THE USER
BICALUTAMIDE 150 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 150 mg is and what it is used for
2. What you need to know before you take Bicalutamide 150 mg
3. How to take Bicalutamide 150 mg
4. Possible side effects
5. How to store Bicalutamide 150 mg
6. Contents of the pack and other information
1. WHAT BICALUTAMIDE 150 MG IS AND WHAT IT IS USED FOR
Bicalutamide 150 mg film-coated tablets (called Bicalutamide 150 mg
throughout this leaflet) contains a medicine called bicalutamide. This
belongs to a group of medicines called ‘anti-androgens’.
Anti-androgens act
against the effects of androgens (male sex hormones).
• It 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 150 MG
DO NOT TAKE BICALUTAMIDE 150 MG:
• 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 150 mg if any of the above appl

Summary of Product characteristics

Health Products Regulatory Authority
11 January 2019
CRN008L57
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bicalutamide 150 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg bicalutamide.
Excipient(s) with known effect
Each 150 mg film-coated tablet contains 266.79 mg 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, debossed
with ‘DB04’ on
one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bicalutamide 150 mg tablets are indicated either alone or as adjuvant
to radical
prostatectomy or radiotherapy in patients with locally advanced
prostate cancer at
high risk for disease progression (see section 5.1).
Bicalutamide 150 mg tablets are also indicated for the management of
patients with
locally advanced, non-metastatic prostate cancer for whom surgical
castration or
other medical intervention is not considered appropriate or
acceptable.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adult males including the elderly: The dosage is one 150 mg tablet to
be taken orally
once a day.
Bicalutamide 150 mg tablets should be taken continuously for at least
2 years or until
disease progression.
Renal impairment: No dosage adjustment is necessary for patients with
renal
impairment.
Health Products Regulatory Authority
11 January 2019
CRN008L57
Page 2 of 11
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
Bicalutamide is contraindicated in females and children (see section
4.6).
Hypersensitivity to bicalutamide 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