BICALUTAMIDE ACTAVIS 50 Milligram Film Coated Tablet

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

BICALUTAMIDE

متاح من:

Actavis Group PTC ehf

ATC رمز:

L02BB03

INN (الاسم الدولي):

BICALUTAMIDE

جرعة:

50 Milligram

الشكل الصيدلاني:

Film Coated Tablet

نوع الوصفة الطبية :

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

المجال العلاجي:

Anti-androgens

الوضع إذن:

Authorised

تاريخ الترخيص:

2014-11-07

نشرة المعلومات

BICALUTAMIDE ACTAVIS 50 MG FILM-COATED TABLETS 

PA1380/153/1 

IE-PIL-V002 

CRN: 2169445 

PACKAGE LEAFLET: INFORMATION FOR THE USER  

BICALUTAMIDE ACTAVIS 50 MG FILM-COATED TABLETS 

bicalutamide 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Actavis is and what it is used for  
2. 
What you need to know before you use Bicalutamide Actavis  
3. 
How to use Bicalutamide Actavis  
4. 
Possible side effects  
5. 
How to store Bicalutamide Actavis  
6. 
Contents of the pack and other information  

1. 
WHAT BICALUTAMIDE ACTAVIS IS AND WHAT IT IS USED FOR  

The growth of prostatic tumours is dependent on
stimulation by male hormones (androgens). 
Bicalutamide Actavis contains the active substance bicalutamide,
which prevents this stimulation. 
Bicalutamide Actavis is used in adult males in the
treatment of advanced prostate cancer in 
combination with a type of medicine called
LHRH analogues or surgical castration.  

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BICALUTAMIDE ACTAVIS  

DO NOT USE BICALUTAMIDE ACTAVIS  
- 
if you are allergic to bicalutamide or any of the
other ingredients of this medicine (listed in 
section 6). 
- 
if you are a woman or a child 
- 
if you are already taking any medicine containing te

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bicalutamide Actavis 50mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 50 mg bicalutamide.
Excipient with known effect: One tablet contains 56.56 mg lactose
monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Bicalutamide Actavis 50 mg film-coated tablets are round, biconvex,
white, 7 mm in diameter, with “B 50” printed on
one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in combination with LHRH
analogue therapy or surgical castration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adult males including the elderly: one film-coated tablet (50 mg)
daily with or without food.
Treatment with Bicalutamide Actavis 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 not indicated in children and adolescents
_Renal impairment_
No dose adjustment is necessary for patients with renal impairment.
_Hepatic impairment_
No dose adjustment is necessary for patients with mild hepatic
impairment. The medicinal product may accumulate in
patients with moderate to severe hepatic impairment (see section
4.4.).
4.3 CONTRAINDICATIONS
Bicalutamide Actavis is contraindicated in females and children (see
section 4.6).
Bicalutamide Actavis must not be given to any patient who has shown a
hypersensitivity reaction to the active
substance or to any of the excipients listed in section 6.1.
Co-administration of terfenadine, astemizole or cisapride with
Bicalutamide Actavis is contraindicated (see section
4.5).
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