Bicalutamide Teva 50 mg film-coated tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Bicalutamide

זמין מ:

Teva Pharma B.V.

קוד ATC:

L02BB; L02BB03

INN (שם בינלאומי):

Bicalutamide

כמות:

50 milligram(s)

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

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

איזור תרפויטי:

Anti-androgens; bicalutamide

מצב אישור:

Marketed

תאריך אישור:

2007-05-18

עלון מידע

BICALUTAMIDE 50MG FILM-COATED TABLETS
CZ/H/133/01/MR
ie-pil-clean-bicalutamide-teva-pa0749-032-001
1
PATIENT LEAFLET: INFORMATION FOR THE USER
BICALUTAMIDE TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Bicalutamide Teva
3.
How to take Bicalutamide Teva
4.
Possible side effects
5.
How to store Bicalutamide Teva
6.
Contents of the pack and other information
1.
WHAT BICALUTAMIDE TEVA IS AND WHAT IT IS USED FOR
Bicalutamide contains a medicine called bicalutamide. This belongs to
a group of medicines called
‘anti-androgens’.
•
Bicalutamide Teva 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 TEVA
DO NOT TAKE BICALUTAMIDE TEVA
•
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 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 Teva:
•
if you have any of the following: any heart or blood vessel
conditions, including heart rhythm

מאפייני מוצר

Health Products Regulatory Authority
25 May 2022
CRN00CMF4
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bicalutamide Teva 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg bicalutamide
Excipient with known effect:
Each tablet contains 33.25 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
White to off-white biconvex film-coated tablets, debossed with "93" on
one side and "220" on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in combination with luteinising
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 daily a
day.
Treatment with Bicalutamide Teva should be started the same time as
treatment with an LHRH analogue or 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 Teva is contraindicated for use in children (see section
4.3).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Bicalutamide Teva is contraindicated in females and children (see
section 4.6).
Co-administration of terfenadine, astemizole or cisapride with
Bicalutamide Teva 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.
Health Products Regulatory Authority
25 May 2022
CRN00CMF4
Page 2 of 6
Bicalutamide is extensively metabolised in the liver. Data suggest
that its elimination may be slower in subjects with severe
hepatic impairment, and this could lead to i