Bicalutamide 150mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Bicalutamide

Հասանելի է:

Zentiva Pharma UK Ltd

ATC կոդը:

L02BB03

INN (Միջազգային անվանումը):

Bicalutamide

Դոզան:

150mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 08030402; GTIN: 5000283653233

Տեղեկատվական թերթիկ

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).
BICALUTAMIDE 150 MG FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
150mg
film-coated
Tablets
(called
bicalutamide throughout this leaflet) belong to a group of
medicines
called
anti-androgens.
Anti-androgens
act
against the effects of male sex hormones (androgens) in
the body.
Bicalutamide is used in adult men for the treatment of
prostate cancer without metastases, when castration or
other
types
of
treatment
are
not
appropriate
or
acceptable.
It may be used in combination with radiotherapy or
prostate surgery in early treatment programmes.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE BICALUTAMIDE
DO NOT TAKE BICALUTAMIDE
•
if you are allergic to the active substance or to any of the
other ingredients of this medicine (listed in section 6)
•
if you take terfenadine or astemizole (for hay fever or
allergy) or cisapride (for stomach problems)
•
Bicalutamide
should
not
be
given
to
women,
including pregnant women or nursing mothers or to
children or adolescents.
WARNINGS AND PRECAUTIONS
Talk
to
your
doctor
or
pharmacist
before
taking
bicalutamide
•
IF THE LIVER IS MODERATELY OR SEVERELY IMPAIRED.
The drug should only be taken after your doctor has
carefu

Ապրանքի հատկությունները

OBJECT 1
BICALUTAMIDE 150MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 25-Aug-2015 | Zentiva
1. Name of the medicinal product
Bicalutamide 150 mg film-coated Tablets
2. Qualitative and quantitative composition
Each tablet contains 150 mg of bicalutamide.
Excipients with known effect: One tablet contains 181.32 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White, round, biconvex film-coated tablet, with the inscription “BCM
150“ in one 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
One 150 mg tablet once a day.
The tablets should be swallowed whole with liquid.
Bicalutamide 150 mg tablets should be taken continuously for at least
2 years or until disease progression.
Children and adolescents
Bicalutamide is contraindicated 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.
Increased accumulation may occur in patients with moderate to severe
hepatic impairment (see section
4.4).
4.3 Contraindications
• Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1.
• Bicalutamide is contraindicated in women and children (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