ZolaCos CP

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Goserelin acetate 3.8mg equivalent to 3.6 mg goserelin;  ; Bicalutamide 50mg;  

Available from:

AstraZeneca Limited

INN (International Name):

Goserelin acetate 3.8 mg (equivalent to 3.6 mg goserelin)

Dosage:

3.6mg + 50mg pack

Pharmaceutical form:

Combination

Composition:

Active: Goserelin acetate 3.8mg equivalent to 3.6 mg goserelin   Excipient: Polyglactin Active: Bicalutamide 50mg   Excipient: Hypromellose Lactose Macrogol 300 Magnesium stearate Povidone Sodium starch glycolate Titanium dioxide

Units in package:

Blister pack, PVC/Al, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

AstraZeneca UK Ltd

Therapeutic indications:

ZOLACOS CP is indicated for the treatment of advanced prostate cancer and prevention of disease flare associated with the use of LHRH agonists.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 28 tablets - 5 years from date of manufacture stored at or below 30°C - Combination pack, Sample 1 x 3.6 mg Zoladex depot implant + 28 Cosudex tablets - 1 U - 36 months from date of manufacture stored at or below 25°C - Combination pack, 1 x 3.6 mg Zoladex depot implant + 28 Cosudex tablets - 1 U - 36 months from date of manufacture stored at or below 25°C - Syringe, depot implant, pre-filled single dose - 1 implants - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2008-05-21

Patient Information leaflet

ZolaCos CP CMI 010817
Copyright
1(6)
ZOLACOS CP
®
COSUDEX® (BICALUTAMIDE) AND ZOLADEX® (GOSERELIN) COMBINATION PACK.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
ZOLACOS CP. It does not
contain all the information that is known about ZOLACOS CP.
It does not take the place of talking to your doctor or pharmacist.
Your pharmacist or doctor has
weighed the risks of you taking ZOLACOS CP against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT ZOLACOS CP IS USED FOR
ZOLACOS CP combination therapy is the brand name for packs containing
ZOLADEX (goserelin)
3.6mg subcutaneous implant plus COSUDEX (bicalutamide) 50mg tablets.
ZOLACOS CP is used to treat advanced prostate cancer in men. It is not
a cure for prostate cancer.
Bicalutamide tablets can also be used to treat disease flare
associated with previous goserelin
therapy.
ZOLACOS CP is a combination pack consisting of an anti-androgen
(COSUDEX) medicine and a
Luteinising Hormone Releasing Hormone (LHRH) agonist (ZOLADEX).
Androgens such as testosterone are natural male sex hormones. In some
types of prostate cancer,
androgens may help the cancer cells to grow.
LHRH agonists reduce the level of testosterone in men. ZOLACOS CP
interferes with some of the
actions of these hormones.
ZOLACOS CP 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.
ZOLACOS CP is not addictive. ZOLACOS CP is only available with a
doctor’s prescription.
BEFORE YOU USE ZOLACOS CP
_WHEN YOU MUST NOT USE IT _
DO NOT USE ZOLACOS CP IF YOU ARE A WOMAN OR A CHILD.
DO NOT USE ZOLACOS CP IF YOU ARE ALLERGIC TO BICALUTAMIDE, GOSERELIN
OR ANY OF THE OTHER
INGREDIENTS IN ZOLACOS CP.
Do not t

Summary of Product characteristics

Z
OLA
C
OS
CP Data Sheet 010817
Copyright
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Z
OLA
C
OS
CP
3.6 mg + 50 mg Combination pack
Z
OLA
C
OS
CP
10.8 mg + 50 mg Combination pack
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Z
OLA
C
OS
CP is a combination therapy containing Zoladex (goserelin) 3.6 mg or
10.8 mg
subcutaneous implant plus Cosudex (bicalutamide) 50 mg tablets.
BICALUTAMIDE
C
OSUDEX
50 mg is a white film-coated tablet containing 50 mg bicalutamide and
is
impressed with CDX50 on one side and a logo on the other.
GOSERELIN
A sterile, white to cream coloured cylindrical implant in which
goserelin acetate (equivalent to
3.6 mg or 10.8 mg of peptide base) is dispersed in a biodegradable
matrix. It is supplied in a
single dose syringe applicator. The SafeSystem
TM
incorporates a protective needle sleeve
that
automatically
locks
in
place
following
administration
of
the
implant
to
aid
in
the
prevention of needle stick injury.
3.
PHARMACEUTICAL FORM
Combination pack.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Z
OLA
C
OS
CP
is indicated for the treatment of advanced prostate cancer and
prevention of
disease flare associated with the use of
luteinizing-hormone releasing hormone
(LHRH)
agonists.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULT MALES INCLUDING THE ELDERLY
BICALUTAMIDE (Cosudex): One tablet (50 mg) once a day.
Treatment with Cosudex should be started at the same time as treatment
with Zoladex.
GOSERELIN (Zoladex): One 3.6 mg implant of goserelin every 28 days or
one 10.8 mg implant
of goserelin every 3 months, injected subcutaneously into the anterior
abdominal wall.
Z
OLA
C
OS
CP Data Sheet 010817
Copyright
2
CHILDREN
Z
OLA
C
OS
CP
is contraindicated in children.
RENAL AND HEPATIC IMPAIRMENT
No dosage adjustment is necessary for patients with renal or hepatic
impairment.
Increased accumulation of bicalutamide may occur in patients with
moderate to severe
hepatic impairment (see WARNINGS AND PRECAUTIONS).
METHOD OF ADMINISTRATION
GOSERELIN (ZOLADEX)
For correct administration of Z
OLADEX
, see inst