Bicalutamide 150mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Bicalutamide

Διαθέσιμο από:

Accord-UK Ltd

Φαρμακολογική κατηγορία (ATC):

L02BB03

INN (Διεθνής Όνομα):

Bicalutamide

Δοσολογία:

150mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 08030402; GTIN: 5012617016867

Φύλλο οδηγιών χρήσης

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Details
BICALUTAMIDE 150MG 28 FILM-COATED TABLETS PIL - UK
Black
Text Free area
BBBA1763
C.Grant
21/02/18
28/02/18
C.Grant
160x270
9pt
IL/Intas Pharmaceuti-
cals, Ltd.
21/02/18
27/02/2018
03
Version 2
01.11.2017
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 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 tablets are a medicine containing the active
substance 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
ingredients of this medicine (listed i

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bicalutamide 150 mg film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 150 mg bicalutamide.
Excipient with known effect: One film-coated tablet contains 169.68 mg
lactose
monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Bicalutamide 150 mg film-coated tablets are round, biconvex, white, 10
mm in
diameter, with “B 150” printed on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bicalutamide 150 mg is 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 is 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: _
One tablet daily.
The tablet should be swallowed whole with liquid.
Bicalutamide 150 mg tablets should be taken continuously for at least
2 years
or until disease progression.
_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 is contraindicated in females and children (see section
4.6).
Bicalutamide 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 is
contraindicated (see section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS F