Casodex 50mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Bicalutamide

Dostupné z:

AstraZeneca UK Ltd

ATC kód:

L02BB03

INN (Medzinárodný Name):

Bicalutamide

Dávkovanie:

50mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 08030402; GTIN: 5000455005921

Príbalový leták

_S0585 LEAFLET Casodex 20210406 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
CASODEX
® 50MG TABLETS
(bicalutamide)
Your medicine is known as Casodex 50mg Tablets but will be
referred to as Casodex throughout the following patient information
leaflet.
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 Casodex is and what it is used for
2.
What you need to know before you take Casodex
3.
How to take Casodex
4.
Possible side effects
5.
How to store Casodex
6.
Contents of the pack and other information
1. WHAT CASODEX IS AND WHAT IT IS USED FOR
Casodex contains a medicine called bicalutamide. This belongs to a
group of medicines called ‘anti-androgens’.

Casodex 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 CASODEX
DO NOT TAKE CASODEX:

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).

if you are a woman.
Do not take Casodex if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Casodex.
Casodex must not be given to children.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Casodex:

if you have any of the following: any heart or blood vessel
conditions, including heart rhythm problems (arrhythmia), or are
being treated with

Súhrn charakteristických

OBJECT 1
CASODEX 50 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 20-Feb-2018 | AstraZeneca
UK Limited
1. Name of the medicinal product
Casodex 50 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each tablet contains 50 mg bicalutamide (INN)
Excipient(s) with known effect:
Each tablet contains 61 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
White film-coated tablet.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of advanced prostate cancer in combination with
luteinizing-hormone releasing hormone
(LHRH) analogue therapy or surgical castration.
4.2 Posology and method of administration
Posology
Adult males including the elderly: one tablet (50 mg) once a day.
Treatment with Casodex should be started at least 3 days before
commencing treatment with an LHRH
analogue, or at the same time as surgical castration.
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).
Paediatric population: Casodex is contraindicated for use in children
(see section 4.3).
4.3 Contraindications
Casodex is contraindicated in females and children (see section 4.6).
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Co-administration of terfenadine, astemizole or cisapride with Casodex
is contraindicated (see section
4.5).
4.4 Special warnings and precautions for use
Initiation of treatment should be under the direct supervision of a
specialist.
Casodex 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 Casodex.
Therefore, Casodex should be used with caution in patients with
moderate to severe hepatic impairment.
Periodic liver func