Bicalutamide 50mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Bicalutamide

Saadav alates:

Crescent Pharma Ltd

ATC kood:

L02BB03

INN (Rahvusvaheline Nimetus):

Bicalutamide

Annus:

50mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 08030402; GTIN: 5017123282133

Infovoldik

JP62 A
JP62 A
PATIENT INFORMATION LEAFLET
TAKING OTHER
MEDICINES
BICALUTAMIDE 50 MG TABLETS
You should tell your doctor if you are taking or have taken any of the
following
medicines
(bicalutamide
)
as they may interact with your Bicalutamide
Tablets:
The name of this medicine is Bicalutamide 50 mg Tablets, which will be
referred to as
•
oral anticoagulants (such as warfarin) used to thin the
blood
Bicalutamide Tablets throughout this leaflet.
•
calcium channel blockers (such as verapamil or diltiazem) used to
treat high
blood
pressure or some heart
conditions
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
cimetidine (used to treat
ulcers)
•
Keep this leaflet. You may need to read it again.
•
ketoconazole (used to treat fungal
infections)
•
If you have further questions, please ask your doctor or pharmacist.
•
ciclosporin (used to suppress the immune system following transplant
surgery).
•
This medicine has been prescribed for you personally and you should
not pass it
on
to others. It may harm them, even if their symptoms are the same as
yours.
It may still be all right for you to take Bicalutamide Tablets and
your doctor will be able
to
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this
decide what is suitable for
you.
leaflet, please tell your doctor or pharmacist.
See section 4
Please tell your doctor or pharmacist if you are taking or have
recently taken any
other
medicines, including medicines obtained without a
prescription.
IN THIS LEAFLET:
PREGNANCY AND
BREAST-FEEDING
1. What Bicalutamide Tablets are and what they are used for.
Women must not take Bicalutamide
Tablets.
2. Before you take Bicalutamide
Tablets.
3. How to take Bicalutamide Tablets.
DRIVING AND USING
MACHINES
4. Possible side effects.
Some people may occasionally feel drowsy when taking Bicalutamide
Tablets. If
this
5. How to store Bicalutamide Tablets.
happens to you, you should exercise caution if you drive or operate
machinery.
6. Further informatio

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bicalutamide 50 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg bicalutamide.
Each tablet contains 61 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White round, biconvex film-coated tablet embossed ‘B50’ on one
side and
plain on other 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 tablet (50mg) once a day.
Treatment
with
bicalutamide
should
be
started
at
least
3
days
before
commencing treatment with an LHRH analogue, or at the same time as
surgical castration.
Children: Bicalutamide is contra-indicated in children.
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).
4.3
CONTRAINDICATIONS
Bicalutamide is contra-indicated in females and children.
Bicalutamide must not be given to any patient who has shown a
hypersensitivity reaction to its use or to any excipients of this
product.
Co-administration of terfenadine, astemizole or cisapride with
bicalutamide is
contra-indicated.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Initiation of treatment should be under the direct supervision of a
specialist
Bicalutamide is extensively metabolised in the liver. Data suggests
that its
elimination may be slower in subjects with severe hepatic impairment
and this
could lead to increased accumulation of bicalutamide. Therefore,
bicalutamide
should be used with caution in patients with moderate to severe
hepatic
impairment.
Periodic liver function testing should be considered due to the
possibility of
hepatic changes. The majority of