Zoladex LA 10.8mg

• 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.

1. What Zoladex LA is and what it is used for
2. What you need to know before you use Zoladex LA
3. How to use Zoladex LA
4. Possible side effects
5. How to store Zoladex LA
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.

In men, Zoladex LA is used to treat prostate cancer. It works by reducing the amount of ‘testosterone’ (a hormone) that is produced by your body.

In women, Zoladex LA is used to:

• Treat early and advanced breast cancer that is hormone dependent.

In women, Zoladex LA works by reducing the amount of ‘oestrogen’ (a hormone) that is produced by your body.

• if you are allergic to goserelin or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breast-feeding (see the section on ‘Pregnancy and breast-feeding’ below).

Do not have Zoladex LA if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before having Zoladex LA.

If you go into hospital, tell the medical staff that you are having Zoladex LA.

Talk to your doctor, pharmacist or nurse before using Zoladex LA:

• if you have high blood pressure.
• if you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Zoladex LA.
• If 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), have a poor diet or take anticonvulsants (medicines for epilepsy or fits) or corticosteroids (steroids).

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

Medicines of this type can cause a reduction in bone calcium (thinning of bones).

Zoladex LA should not be given to children.

Information for men

Talk to your doctor, pharmacist or nurse before using Zoladex:

• if you have problems passing urine (water) or problems with your back.
• if you have diabetes.

Information for women

• Worsening of the symptoms of your breast cancer at the beginning of treatment. This can include an increase in pain or an increase in the size of the affected tissue. These effects do not usually last long and they usually go away as treatment with Zoladex LA is continued. However, if the symptoms continue or you are uncomfortable, talk to your doctor.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines.

Zoladex LA might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).

• Do not have Zoladex if you are pregnant or breast-feeding.
• Do not have Zoladex if you are trying to get pregnant (unless Zoladex is being used as part of a treatment for infertility).
• Do not use ‘the pill’ (oral contraceptives) while you are having Zoladex. Use barrier methods of contraception, such as the condom or diaphragm (cap).

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

• 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.

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.

Injection site injury (including damage to blood vessels in the abdomen) has been reported following injection of Zoladex LA. In very rare cases this has caused severe bleeding. Contact your doctor immediately if you experience any of the following symptoms:

• Abdominal pain.
• Abdominal distension.
• Shortness of breath.
• Dizziness.
• Low blood pressure and/or any altered levels of consciousness.

Very common (may affect more than 1 in 10 people)

• Hot flushes and sweating. Occasionally these side effects may continue for some time (possibly months) after stopping Zoladex.
• A reduced sex drive and impotence.
• Pain, bruising, bleeding, redness or swelling where Zoladex LA is injected.

Common (may affect up to 1 in 10 people)

• 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.
• Temporary worsening of symptoms of your cancer at the beginning of treatment.
• Thinning of your bones.
• Rises in blood sugar levels.
• Tingling in your fingers or toes.
• Skin rashes.
• Hair loss.
• Weight gain.
• 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).

Very rare (may affect up to 1 in 10,000 people)

• 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.

Not known (frequency cannot be estimated from the available data)

• Changes in your blood.
• Liver problems including jaundice.
• 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).
• Changes in ECG (QT prolongation).
• Memory impairment.

Information for men

The following side effects can happen in men:

Very common (may affect more than 1 in 10 people)

• Impotence.

Common (may affect up to 1 in 10 people)

• 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.
• Reduced heart function or heart attack.
• Swelling and tenderness of your breasts.
• Rises in blood sugar levels.

Information for women

The following side effects can happen in women:

Very common (may affect more than 1 in 10 people)

• Dryness of the vagina.
• A change in breast size.
• Acne has been reported very commonly (often within one month of starting treatment).

Common (may affect up to 1 in 10 people)

• Headaches.

Rare (may affect up to 1 in 1,000 people)

• Small cysts (swellings) on the ovaries which can cause pain. These usually disappear without treatment.
• Some women enter the menopause early during treatment with Zoladex LA, and their periods do not return when Zoladex LA treatment is stopped.

Not known (frequency cannot be estimated from the available data)

• Bleeding from the vagina. This is most likely to happen in the first month after starting Zoladex LA and should stop on its own. However, if it continues or you are uncomfortable, talk to your doctor.
• A slight increase in the symptoms of fibroids, such as pain.

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

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is goserelin. Each Zoladex LA 10.8 mg Implant contains 10.8 mg of goserelin.

The other ingredient is lactide/glycolide copolymer which is an inactive substance.

Zoladex LA 10.8 mg Implant comes as an implant (a very small pellet) in a pre-filled syringe, ready to be used by the doctor or nurse.

Zoladex LA 10.8 mg Implant is produced in packs of one implant (injection).