Cosudex

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Bicalutamide 150mg

Saatavilla:

AstraZeneca Limited

INN (Kansainvälinen yleisnimi):

Bicalutamide 150 mg

Annos:

150 mg

Lääkemuoto:

Film coated tablet

Koostumus:

Active: Bicalutamide 150mg Excipient: Hypromellose Lactose monohydrate Macrogol 300 Magnesium stearate Povidone Purified water   Sodium starch glycolate Titanium dioxide

Kpl paketissa:

Blister pack, PVC/Al 28 tablets, 28 tablets

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

AstraZeneca UK Ltd

Tuoteyhteenveto:

Package - Contents - Shelf Life: Blister pack, PVC/Al 28 tablets - 28 tablets - 48 months from date of manufacture stored at or below 30°C

Valtuutus päivämäärä:

2002-01-03

Pakkausseloste

Cosudex® CMI 310717
Copyright
1(5)
COSUDEX
®
BICALUTAMIDE 50 MG TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
COSUDEX. It does not contain
all the information that is known about COSUDEX.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking COSUDEX
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT COSUDEX IS USED FOR
COSUDEX 50 mg is used to treat prostate cancer.
COSUDEX is an anti-androgen medicine. Androgens such as testosterone
are natural male sex
hormones. In some types of prostate cancer, androgens may help the
cancer cells to grow. By
blocking these hormones, COSUDEX may slow or stop the growth of cancer
cells.
COSUDEX 50 mg will be used in combination with other medicines to
treat your cancer.
COSUDEX should only be taken by men.
Follow all directions given to you by your doctor. They may differ
from the information in this leaflet.
Your doctor may prescribe this medicine for another use. Ask your
doctor if you want more
information.
COSUDEX is not addictive.
COSUDEX is only available with a doctor’s prescription.
BEFORE YOU USE COSUDEX
_WHEN YOU MUST NOT USE IT _
COSUDEX MUST NOT BE TAKEN BY WOMEN, INCLUDING PREGNANT WOMEN OR
MOTHERS WHO ARE BREAST
FEEDING. Women are not normally treated with COSUDEX.
DO NOT TAKE COSUDEX IF YOU ARE ALLERGIC TO BICALUTAMIDE OR ANY OTHER
INGREDIENTS IN COSUDEX.
DO NOT GIVE COSUDEX TO CHILDREN. There is no experience of its use in
children.
DO NOT TAKE COSUDEX AFTER THE USE BY (EXPIRY) DATE PRINTED ON THE
PACK. It may have no effect at
all or an unexpected effect if you take it after the expiry date.
DO NOT USE COSUDEX IF THE PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
DO NOT USE IT TO TREAT ANY OTHER COMPLAINTS UNLESS

Valmisteyhteenveto

C
OSUDEX
Data Sheet 310717
Copyright
DATA SHEET
1.
PRODUCT NAME
C
OSUDEX
50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 50 mg bicalutamide.
C
OSUDEX
50 mg is a white film-coated tablet impressed with CDX50 on one side
and a
logo on the other.
3.
PHARMACEUTICAL FORM
Film coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in combination with GnRH
luteinizing-hormone
releasing hormone (LHRH) agonist therapy or surgical castration.
Prevention of disease flare associated with the use of LHRH agonists.
4.2
DOSE AND METHOD OF ADMINISTRATION
AS COMBINATION THERAPY IN ADULT MALES INCLUDING THE ELDERLY
One tablet (50 mg) once a day.
Treatment with C
OSUDEX
should be started at the same time as treatment with a GnRH
(LHRH) agonist or surgical castration.
CHILDREN
C
OSUDEX
is contraindicated in children.
USE IN ADULT MALES WITH RENAL IMPAIRMENT
No dosage adjustment is necessary for patients with renal impairment.
USE IN ADULT MALES WITH 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
C
OSUDEX
is contraindicated in females and children.
C
OSUDEX
must not be given to any patient who has shown a hypersensitivity
reaction to
the active substance or to any of the excipients.
C
OSUDEX
Data Sheet 310717
Copyright
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bicalutamide is extensively metabolised in the liver. Data suggest
that its elimination may be
slower
in
subjects
with
severe
hepatic
impairment
and
this
could
lead
to
increased
accumulation of bicalutamide. Therefore, C
OSUDEX
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.
Severe hepatic changes and hepatic failure have been observed rarely
with C
OSUDEX
,
and fatal outcomes