CASODEX 50 Milligram Film Coated Tablet

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

BICALUTAMIDE

Dostopno od:

LTT Pharma Limited

Koda artikla:

L02BB03

INN (mednarodno ime):

BICALUTAMIDE

Odmerek:

50 Milligram

Farmacevtska oblika:

Film Coated Tablet

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Terapevtsko območje:

Anti-androgens

Status dovoljenje:

Authorised

Datum dovoljenje:

2017-01-20

Navodilo za uporabo

CASODEX 50 MG FILM-COATED TABLETS
(bicalutamide)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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:
What Casodex is and what is it used for
What you need to know before you take Casodex
How to take Casodex
Possible side effects
How to store Casodex
Contents of the pack and other information
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 together with other treatments to treat prostate
cancer.
*
It works by blocking the effects of male hormones such as
testosterone.
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
medicines for these conditions. The risk of heart rhythm problems may
be
increased when using Casodex.
*
if you have problems with your liver.
*
if you have diabetes and are

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Casodex 50mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50mg of bicalutamide.
Excipient(s) with known effect:
lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Greece_
Round, white, biconvex tablet intagliated with “CdX50” on one face
and a logo on the reverse.
4 CLINICAL PARTICULARS
As per PA0970/004/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0970/004/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core
Lactose Monohydrate,
Magnesium Stearate
Polyvidone
Sodium Starch Glycolate
Film-coating
Hypromellose
Macrogol 300
Titanium Dioxide
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_4_
_/_
_0_
_1_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_8_
_3_
_1_
_3_
_6_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30ºC.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips. Pack size 28
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
Any unused medicinal product or waste materi