Active ingredient
- buserelin acetate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 04425/0268.
Suprefact Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
Suprefact® 1mg/ml Injection
Buserelin acetate
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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
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
1. What Suprefact Injection is and what it is used for
Suprefact Injection contains a medicine called buserelin acetate. This belongs to a group of medicines called gonadotropin releasing hormone analogues. This is a synthetic version of a hormone that occurs naturally in the body. It works by lowering the production of sex hormones.
It is used to treat prostate cancer by lowering the amount of the hormone ‘testosterone’.
2. What you need to know before you use Suprefact Injection
Before using Suprefact, your doctor should assess your risk of developing diseases of heart and blood vessels (cardiovascular disease), diabetes mellitus and anaemia. If you develop any of the above, you should be monitored and treated accordingly.
Do not use this medicine and tell your doctor if:
Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Suprefact Injection.
Take special care with Suprefact Injection
Check with your doctor or pharmacist before using your medicine if:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Suprefact Injection.
Warnings and precautions
Please tell your doctor if you have any of the following:
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.
Other medicines and Suprefact Injection
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Suprefact Injection can affect the way some other medicines work. Also some medicines can affect the way Suprefact Injection works.
In particular, tell your doctor or pharmacist if you are taking the following:
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).
Pregnancy and breast-feeding
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.
Driving and using machines
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.
Important information about some of the ingredients of Suprefact Injection
Suprefact injection contains:
3. How to use Suprefact Injection
Suprefact Injection is normally given by a doctor or nurse. This is because it needs to be given as an injection underneath the skin (subcutaneous injection).
How much Suprefact Injection is given
If you are not sure why you are being given Suprefact Injection or have any questions about how much Suprefact Injection is being given to you, speak to your doctor or nurse.
If you have more Suprefact Injection than you should
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.
The following effects may occur: 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.
If you miss a dose of Suprefact 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.
If you stop having Suprefact Injection.
Keep using Suprefact Injection until your doctor tells you to stop. This is important in helping treat your tumour.
Blood Tests
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 have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Suprefact can cause side effects, although not everybody gets them.
Stop using Suprefact and see a doctor or go to a hospital straight away if;
Tell your doctor straight away if you notice any of the following serious side effects:
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
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 at: 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.
5. How to store Suprefact Injection
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Suprefact Injection after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Once opened use within 15 days.
Do not store above 25°C. Do not freeze.
Keep the vials in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Suprefact Injection contains
What Suprefact Injection looks like and contents of the pack
Suprefact Injection is available in boxes containing two multidose vials. Each vial contains 5.5 milligrams of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in July 2019
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