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ZOLADEX LA 10.8MG INJECTION

Active substance: GOSERELIN ACETATE

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ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

ZOLADEX® LA 10.8mg INJECTION/
ZOLADEX® 10.8mg INJECTION
(Goserelin)
Patient Information Leaflet

This product is known as the above names but will be referred to as Zoladex LA in this leaflet.
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor, nurse or pharmacist.
In this leaflet:
1. What Zoladex LA is and what it is used for
2. Before you are given Zoladex LA
3. How Zoladex LA will be given
4. Possible side effects
5. How to store Zoladex LA
6. Further information
1. What Zoladex LA is and what it is used for
Zoladex LA contains a medicine called goserelin. This belongs to a group of medicines called ‘LHRH
analogues’.
Zoladex LA is used to treat prostate cancer. It works by reducing the amount of ‘testosterone’ (a hormone)
that is produced by your body. Zoladex LA is a long-acting form of Zoladex and it is given every 12 weeks.

WARNING!

Zoladex LA should not be given to children.

There have been reports of depression in patients taking Zoladex LA which may be severe. If you are taking
Zoladex LA and develop depressed mood, inform your doctor.

DATE:
01/07/13
DATE OF PROOF:

Driving and using machines
Zoladex LA is not likely to affect you being able to drive or use any tools or machines.




6464/0750A

DT
ARTWORKER:

Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines.
This includes medicines that you buy without a prescription and herbal medicines.

CODE:

Q.A.
APPROVED:
05-0440

CUSTOMER: Waymade
PRODUCT: Zoladex la 10.8mg injection

PRE-PRESS NO.:

Medicines of this type can cause a reduction in bone calcium (thinning of bones).
If you go into hospital, tell the medical staff that you are having Zoladex LA.

3. How Zoladex LA will be given
The Zoladex LA 10.8 mg will be injected under the skin on your stomach every 12 weeks. This will
be done by your doctor or nurse.
It is important that you keep having Zoladex LA treatment, even if you are feeling well.
Keep having this treatment until your doctor decides that it is time for you to stop.

Your next appointment
• You should be given a Zoladex LA injection every 12 weeks.
• Always remind the doctor or nurse to set up an appointment for your next injection.
• If you are given an appointment for your next injection which is earlier or later than 12 weeks from
your last injection, tell your doctor or nurse.
• If it has been more than 12 weeks since your last injection, contact your doctor or nurse so that you
can receive your injection as soon as possible.
4. Possible side effects
Like all medicines, Zoladex LA can cause side effects, although not everybody gets them.
Allergic reactions:
These are rare. The symptoms can include sudden onset of:
• Rash, itching or hives on the skin.
• Swelling of the face, lips or tongue or other parts of the body.
• Shortness of breath, wheezing or trouble breathing.
If this happens to you, see a doctor straight away.

Colour
Swatch

Black

WARNING!

Take special care with Zoladex LA
Check with your doctor or nurse before you have Zoladex LA if:
• You have problems passing urine (water) or problems with your back.
• You have diabetes.
• You have high blood pressure.
• You have any condition that affects the strength of your bones, especially if you are a heavy drinker,
a smoker, have a family history of osteoporosis (a condition that affects the strength of your bones)
or take anticonvulsants (medicines for epilepsy or fits) or corticosteroids (steroids).

DATE:

CUSTOMER
APPROVED:

2. Before you are given Zoladex LA
Do not have Zoladex LA if:
• You are allergic (hypersensitive) to goserelin or any of the other ingredients of this medicine (listed in
Section 6: Further information).
• You are a woman.
Do not have Zoladex LA if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist
before having Zoladex LA.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

PROOF HISTORY:
v.1 - waymade - 01/07/13

Leaflet Flat Size = 148 x 317
April 2012

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000A

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Do not be concerned by this list of possible side effects. You may not get any of them.




5. How to store Zoladex LA
Zoladex LA 10.8mg injection/Zoladex 10.8mg injection should be stored at a temperature below
25°C in its original container.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use after the expiry date printed on the carton or labelled pack.
You may be given a prescription and asked to collect your injection from the pharmacy and keep it
until you see your doctor. Keep it in the original package, do not break the seal.
If this injection is not required, please take it back to the pharmacist for safe disposal. Only keep the
injection if your doctor tells you to.
If the injection becomes discoloured or shows any other signs of deterioration, you should consult
your pharmacist who will advise you what to do.

Zoladex LA 10.8mg injection/Zoladex 10.8mg injection is available as a prefilled SafeSystem™ single dose
syringe applicator with a protective sleeve.
DATE:

POM

PL No: 6464/0750

01/07/13
DATE OF PROOF:

This product is manufactured by AstraZeneca UK Limited, Macclesfield, Cheshire, England and is procured
from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 01.07.2013

6464/0750A

ZOLADEX and SafeSystem trademarks are the property of ASTRAZENECA

CODE:

DT
ARTWORKER:

CUSTOMER: Waymade
PRODUCT: Zoladex la 10.8mg injection

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

6. Further information
Your medicine is called Zoladex LA 10.8mg injection/Zoladex 10.8mg injection.
It contains a sterile white to cream coloured, cylindrical long acting sustained release depot which contains
the active ingredient, Goserelin acetate, equivalent to 10.8mg of goserelin and also contains Lactide-glycolide
co-polymer which is an inactive substance.

Colour
Swatch

Black

WARNING!




DATE:

CUSTOMER
APPROVED:



WARNING!

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor, nurse or pharmacist.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

PROOF HISTORY:
v.1 - waymade - 01/07/13

Leaflet Flat Size = 148 x 317
April 2012

27mm

Other possible side effects:
• Pain in your lower back or problems passing urine. If this happens, talk to your doctor.
• Bone pain at the beginning of treatment. If this happens, talk to your doctor.
• Hot flushes and sweating.
• A reduced sex drive and impotence.
• Thinning of your bones.
• Rises in blood sugar levels.
• Tingling in your fingers or toes.
• Skin rashes.
• Hair loss.
• Weight gain.
• Pain, bruising, bleeding, redness or swelling where Zoladex LA is injected.
• Pain in the joints.
• Reduced heart function or heart attack.
• Changes in blood pressure.
• Swelling and tenderness of your breasts.
• Changes in your mood (including depression).
• Changes in your blood.
• Liver problems.
• A blood clot in your lungs causing chest pain or shortness of breath.
• Inflammation of the lungs. The symptoms may be like pneumonia (such as feeling short of breath
and coughing).
• Psychiatric problems called psychotic disorders which may include hallucinations (seeing, feeling or
hearing things that are not there), disordered thoughts and personality changes. This is very rare.
• The development of a tumour of the pituitary gland in your head or, if you already have a tumour in
your pituitary gland, Zoladex LA may make the tumour bleed or collapse.
These effects are very rare. Pituitary tumours can cause severe headaches, feeling or being sick,
loss of eyesight and becoming unconscious.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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