Suprefact 1 mg/ml Injection solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Suprefact Injection is and what it is used for
2. What you need to know before you use Suprefact Injection
3. How to use Suprefact Injection
4. Possible side effects
5. How to store Suprefact Injection
6. Contents of the pack and other information

• if you are allergic to buserelin acetate, any of the other similar medicines such as goserelin or any of the other ingredients of this medicine (listed in section 6).
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• if you have had an operation to remove your testicles.
• if you have a tumour that is not affected by changes in hormone levels.
• This medicine is intended for men only.
  Another presentation is available for women. It is important that these medicines are not used during pregnancy or breast-feeding.

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Suprefact Injection.

Talk to your doctor before using Suprefact Injection.

Especially take care with Suprefact Injection and check with your doctor or pharmacist before using this medicine:

• if you have depression. There have been reports of depression in patients using Suprefact Injection which may be severe. If you are using Suprefact Injection and develop depressed mood, inform your doctor.
• if you have high blood pressure. Your blood pressure must be checked regularly.
• if you have diabetes. You should check your blood glucose levels regularly.
• if you have metabolic bone disease or have additional risk factors for osteoporosis such as chronic alcohol abuse, smoking, a family history of osteoporosis or are on long term therapy with anticonvulsants or corticosteroids.
• 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 Suprefact Injection.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Suprefact Injection.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking the following:

• medicines for diabetes
• medicines for heart rhythm problems:
  Suprefact Injection 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).

This medicine is intended for use in men. However, there is another type of this medicine which can be used in women. Women should not use either type of this medicine if they are pregnant or breast-feeding.

You may feel dizzy, drowsy or have blurred eyesight while using this medicine. If this happens, do not drive or use any tools or machines.

This medicine contains 5 mg benzyl alcohol in each dosage unit (0,5 ml) which is equivalent to 10 mg/ml solution.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.

Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor.

Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist.

Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress by testing your blood at regular intervals and check the medicine you are given. Always ask if you are not sure why you are getting a dose of medicine.

If you give yourself more Suprefact Injection than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

The following effects may occur when using too much Suprefact Injection: feeling weak, headache, feeling nervous, hot flushes, feeling dizzy, feeling sick, stomach pain, swelling of the legs and breast pain. You may also have pain, bleeding or hardening of the skin at the site of injection.

Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you do think you have missed a dose, tell your doctor or nurse.

If you are injecting this medicine yourself and you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

Keep using Suprefact Injection until your doctor tells you to stop. This is important in helping treat your tumour.

Using Suprefact Injection may affect the results of some blood tests. In particular, Suprefact Injection can change the level of liver enzymes and fats in the blood (lipids) shown up in blood tests. If you are going to have a blood test, it is important to tell your doctor you are using Suprefact Injection.

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 buserelin as buserelin acetate.
  Each 1 ml of solution contains 1 mg of buserelin, equivalent to 1,05 mg buserelin acetate.
• The other ingredients are sodium chloride, sodium dihydrogen phosphate, sodium hydroxide, benzyl alcohol and water for injection.

Suprefact Injection is a clear, colourless, sterile solution.

Suprefact Injection is available in packs containing two multidose vials. Each vial contains 5.5 mg of solution.

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