The following side effects can happen in men or women:

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. 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.

Other possible side effects:

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.
• Pain, bruising, bleeding, redness or swelling where Zoladex is injected.

Common (may affect up to 1 in 10 people)

• Thinning of your bones.
• Tingling in your fingers or toes.
• Skin rashes.
• Hair loss.
• Weight gain.
• Pain in the joints.
• Changes in blood pressure.
• 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 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.
• 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).

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, and their periods do not return when Zoladex 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 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.

When Zoladex is used to treat endometriosis, uterine fibroids, infertility or for thinning of the uterus lining, the following side effects can also happen:

• Changes in body hair.
• Dry skin.
• Putting on weight.
• Raised levels of a fatty substance known as cholesterol in your blood. This would be seen in a blood test.
• Inflammation of the vagina and discharge from the vagina.
• Nervousness.
• Disturbed sleep and tiredness.
• Swelling of the feet and ankles.
• Muscle pain.
• Sudden painful muscle tightness (cramp) in your legs.
• Stomach complaints, feeling sick or being sick, diarrhoea and constipation.
• Changes to your voice.
• When used to treat uterine fibroids, a slight increase in the symptoms of fibroids, such as pain.

When Zoladex is used to treat breast cancer, the following can happen:

• 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 is continued. However, if the symptoms continue or you are uncomfortable, talk to your doctor.
• Changes in the amount of calcium in your blood. The signs may include feeling very sick, being sick a lot or being very thirsty. If this happens to you, talk to your doctor as he or she may need to do blood tests.

When Zoladex is used to treat infertility with another medicine called gonadotrophin, the following can happen:

• It can have too much of an effect on your ovaries. You may notice stomach pain, swelling of your stomach, and feeling or being sick. If this happens, tell your doctor straight away.

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

Reporting of side effects

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. By reporting side effects you can help provide more information on the safety of this medicine.