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 can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 04425/0279.
Suprefact Nasal Spray
PACKAGE LEAFLET: INFORMATION FOR THE USER
Suprefact® 100 micrograms
Nasal Spray Solution
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 Nasal Spray is and what it is used for
2. What you need to know before you use Suprefact Nasal Spray
3. How to use Suprefact Nasal Spray
4. Possible side effects
5. How to store Suprefact Nasal Spray
6. Contents of the pack and other information
1. What Suprefact Nasal Spray is and what it is used for
Suprefact Nasal Spray 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 Nasal Spray
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 take 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 Nasal Spray.
Take special care with Suprefact Nasal Spray
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 Nasal Spray.
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 Nasal Spray.
Other medicines and Suprefact Nasal Spray
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 Nasal Spray can affect the way some other medicines work. Also some medicines can affect the way Suprefact Nasal Spray works. In particular, tell your doctor or pharmacist if you are taking the following:
Suprefact Nasal Spray 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 Nasal Spray
Suprefact Nasal Spray contains benzalkonium chloride. This may cause difficulty breathing, wheezing or tightness in the chest (bronchospasm).
3. How to use Suprefact Nasal Spray
Always use Suprefact Nasal Spray exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Using this medicine
How to use Suprefact Nasal Spray:
1. Preparing the spray
2. If you are using the spray for the first time
3. Using the spray
4. After using the spray
How much Suprefact Nasal Spray to use:
Treatment of Prostate Cancer:
If you use more Suprefact Nasal Spray than you should
If you use more Suprefact Nasal Spray 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 used. 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.
If you forget to use Suprefact Nasal Spray
If 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 using Suprefact Nasal Spray.
Keep using Suprefact Nasal Spray until your doctor tells you to stop. If you stop, your prostate cancer may get worse.
Blood Tests
Using Suprefact Nasal Spray may affect the results of some blood tests. In particular, Suprefact Nasal Spray 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 Nasal Spray.
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
United Kingdom
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
By reporting side effects you can help provide more information on the safety of this medicine.
Malta
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Suprefact Nasal Spray
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Suprefact Nasal Spray after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.
Store below 25 °C. Do not freeze.
Once opened the product should be used within 1 week. Any remaining spray should be disposed of after this time.
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 Nasal Spray contains
What Suprefact Nasal Spray looks like and contents of the pack
Suprefact Nasal Spray is available in boxes containing four bottles and four spray pumps. Each bottle contains 10 grams of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
This package contains a metered dose nebulizer
CE0123
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 November 2014.
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