ZolaCos CP Combination Goserelin 10.8mg (as Acetate) Implant Syringe and Bicalutamide 50mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

goserelin, Quantity: 10.8 mg

Available from:

AstraZeneca Pty Ltd

INN (International Name):

Bicalutamide,Goserelin

Pharmaceutical form:

Implant

Composition:

Excipient Ingredients: polyglactin

Administration route:

Subcutaneous

Units in package:

1 x single syringe + 28 tablets, 1 x single syringe + 84 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of advanced prostate cancer. Bicalutamide is also indicated for the prevention of disease flare associated with initial goserelin treatment

Product summary:

Visual Identification: White to cream-coloured cylindrical pieces of rigid polymeric material.;

Authorization status:

Licence status A

Authorization date:

2006-12-01

Patient Information leaflet

ZOLACOS CP™
_bicalutamide & goserelin_
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.
All medicines have risks and
benefits. Your doctor will have
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
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ZOLACOS CP IS
FOR
ZOLACOS CP combination therapy
is the brand name for packs
containing ZOLADEX (goserelin)
3.6mg or 10.8mg 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.
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 USE ZOLACOS CP IF YOU
ARE TAKING CISAPRIDE OR THE
ANTIHISTAMINES, TERFENADINE AND
ASTEMIZOLE.
DO NOT USE Z

Summary of Product characteristics

1 of 15
AUSTRALIAN PRODUCT INFORMATION
ZOLACOS
® CP (BICALUTAMIDE AND GOSERELIN) TABLETS AND
IMPLANT
1
NAME OF THE MEDICINE
Bicalutamide and goserelin acetate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each COSUDEX (bicalutamide) tablet contains 50 mg bicalutamide are
white film coated tablets
impressed with CDX50 on one side and an arrow shaped logo on the other
side.
Bicalutamide is a fine white to off-white powder. At 37°C it is
practically insoluble in water
(4.6 mg/litre), acid (4.6 mg/litre at pH 1) and alkali (3.7 mg/litre
at pH 8). In organic solvents it is
slightly soluble in ethanol, sparingly soluble in methanol and freely
soluble in acetone and
tetrahydrofuran.
ZOLADEX (goserelin) implants contain goserelin acetate in an amount
equivalent to 3.6 mg or 10.8
mg of goserelin base.
Excipients with known effect: Each COSUDEX tablet contains lactose
monohydrate. For the full
list of excipients for COSUDEX and ZOLACOS, see Section 6.1 List of
excipients.
3
PHARMACEUTICAL FORM
COSUDEX film-coated tablets are white and are impressed with CDX50 on
one side and an arrow
shaped logo on the other side.
ZOLADEX is a sterile white to cream coloured cylindrical implant.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of advanced prostate cancer.
Bicalutamide is also indicated for the prevention of disease flare
associated with initial goserelin
treatment.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULT MALES INCLUDING THE ELDERLY
_BICALUTAMIDE _
One tablet (50 mg) once a day.
Treatment with COSUDEX 50 mg should be started at the same time as
treatment with a GnRH
agonist.
_GOSERELIN _
Caution should be taken while inserting ZOLADEX into the interior
abdominal wall due to the
proximity of underlying inferior epigastric artery and its branches.
2 of 15
Use extra care when administering ZOLADEX to patients with a low BMI
and/or who are receiving
full anticoagulation medication (see Section 4.4 Special warnings and
precautions for use).
One 3.6 mg implant of goserelin every 28 days or one 10.8 mg impl