Zoladex 3.6 mg implant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Goserelin

Available from:

AstraZeneca AB

ATC code:

L02AE; L02AE03

INN (International Name):

Goserelin

Dosage:

3.6 milligram(s)

Pharmaceutical form:

Implant

Therapeutic area:

Gonadotropin releasing hormone analogues; goserelin

Authorization status:

Marketed

Authorization date:

1999-02-02

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLADEX
 3.6 MG IMPLANT
goserelin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Zoladex is and what it is used for
2.
What you need to know before you use Zoladex
3.
How to use Zoladex
4.
Possible side effects
5.
How to store Zoladex
6.
Contents of the pack and other information
Most of the information in this leaflet applies to both men and women.
•
Where information only applies to men, it is shown by the heading
INFORMATION FOR MEN
.
•
Where information only applies to women, it is shown by the heading
INFORMATION FOR
WOMEN
.
1. WHAT ZOLADEX IS AND WHAT IT IS USED FOR
Zoladex contains a medicine called goserelin. This belongs to a group
of medicines called
‘LHRH analogues’.
USE OF ZOLADEX BY MEN
In men, Zoladex is used to treat prostate cancer. It works by reducing
the amount of
‘testosterone’ (a hormone) that is produced by your body.
USE OF ZOLADEX BY WOMEN
In women, Zoladex is used to:
•
Treat breast cancer.
•
Treat a condition called ‘endometriosis’. This is where cells
normally only found in the
lining of the womb (uterus) are found elsewhere in your body (normally
on other structures
near the womb).
•
Treat benign growths in the womb called ‘uterine fibroids’.
•
Make the lining of the womb thinner before you have an operation on
your womb.
•
Help treat infertility (together with other medicines). It helps to
control the release of eggs
from the ovaries.
In women, Zoladex works

Summary of Product characteristics

Health Products Regulatory Authority
20 June 2019
CRN009400
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoladex 3.6 mg Implant
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Goserelin acetate equivalent to 3.6 mg goserelin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Implant
White to cream-coloured cylindrical implant in a pre-filled syringe.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(i) Prostate Cancer: Zoladex 3.6mg is indicated in the management of
prostate cancer suitable for hormonal manipulation.
(ii) Breast cancer: Zoladex 3.6mg is indicated in the management of
breast cancer in pre and perimenopausal women suitable
for hormonal manipulation.
(iii) Endometriosis: In the management of endometriosis, Zoladex 3.6mg
alleviates symptoms, including pain, and reduces the
size and number of endometrial lesions.
(iv) Uterine fibroids: In the management of fibroids, Zoladex 3.6mg
shrinks the lesions, improves the patient’s haematological
status and reduces symptoms, including pain. It is used as an adjunct
to surgery to facilitate the operative technique and
reduce operative blood loss.
(v) Endometrial Thinning: Use as an endometrial thinning agent prior
to endometrial ablation. As a prethinning agent Zoladex
3.6mg should be administered as two depots, four weeks apart, with
surgery planned for between zero and two weeks after the
second depot injection.
(vi) Assisted Reproduction: Pituitary downregulation in preparation
for superovulation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults:
One 3.6 mg depot of Zoladex injected subcutaneously into the anterior
abdominal wall every 28 days
Elderly:
No dosage adjustment is necessary in the elderly
Renal Impairment:
No dosage adjustment is necessary for patients with renal impairment
Hepatic Impairment:
No dosage adjustment is necessary for patients with hepatic impairment
Assisted Reproduction:
Once pituitary downregulation has been achieved with Zoladex 3.6 mg,
superovulation and oocyte
ret