Bicalutamide 150mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Bicalutamide

Предлага се от:

A A H Pharmaceuticals Ltd

АТС код:

L02BB03

INN (Международно Name):

Bicalutamide

дозиране:

150mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 08030402; GTIN: 5025903007661

Листовка

bicalutamide150mg-cpl-0002/v2017.05
PACKAGE LEAFLET: INFORMATION FOR THE USER
BICALUTAMIDE 150MG 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 Tablets are and what they are used for
2.
What you need to know before you take Bicalutamide Tablets
3.
How to take Bicalutamide Tablets
4.
Possible side effects
5.
How to store Bicalutamide Tablets
6.
Contents of the pack and other information
1.
WHAT BICALUTAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR
The full name of your medicine is Bicalutamide 150mg Film-coated
tablets, but within the
leaflet it will be referred to as Bicalutamide Tablets.
Bicalutamide Tablets contain a medicine called bicalutamide. This
belongs to a group of
medicines called ‘anti-androgens’.
• Bicalutamide Tablets are 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 TABLETS
DO NOT TAKE BICALUTAMIDE TABLETS:
• if you are a woman.
• 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).
Bicalutamide Tablets must not be given to children.
Do not take Bicalutamide Tablets if any of the above apply to you. If
you are not sure, talk to
your doctor or pharmacist before taking Bicalutamide Tablets.
WARNINGS AND PRECAUTIONS
Talk to your docto

Данни за продукта

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