Active ingredient
- mercaptamine bitartrate
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: PLGB 08829/0190.
PROCYSBI 25 mg and 75 mg gastro-resistant hard capsules
Package leaflet: Information for the user
PROCYSBI 25 mg gastro-resistant hard capsules
PROCYSBI 75 mg gastro-resistant hard capsules
Cysteamine (mercaptamine bitartrate)
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 PROCYSBI is and what it is used for
2. What you need to know before you take PROCYSBI
3. How to take PROCYSBI
4. Possible side effects
5. How to store PROCYSBI
6. Contents of the pack and other information
1. What PROCYSBI is and what it is used for
PROCYSBI contains the active substance cysteamine (also known as mercaptamine) and is taken for the treatment of nephropathic cystinosis in children and adults. Cystinosis is a disease affecting how the body functions, with an abnormal accumulation of the amino acid cystine in various organs of the body such as the kidney, eye, muscle, pancreas, and brain. Cystine build-up causes kidney damage and excretion of excess amounts of glucose, proteins, and electrolytes. Different organs are affected at different ages.
PROCYSBI is a medicine that reacts with cystine to decrease its level within the cells. Cysteamine therapy should be initiated promptly after confirmation of the diagnosis of cystinosis to achieve maximum benefit.
2. What you need to know before you take PROCYSBI
Do not take PROCYSBI:
Warnings and precautions
Talk to your doctor or pharmacist before taking PROCYSBI.
Other medicines and PROCYSBI
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If your doctor prescribes bicarbonate, do not take it at the same time as PROCYSBI; take bicarbonate at least one hour before or at least one hour after the medicine.
PROCYSBI with food and drink
For at least 1 hour before and 1 hour after taking PROCYSBI try to avoid meals, which are rich in fat or proteins as well as any food or liquid that could decrease the acidity in your stomach, like milk or yogurt. If this is not possible, you can eat a small amount (about 100 grams) of food (preferably carbohydrates e.g. bread, pasta, fruits) during the hour before and after taking PROCYSBI.
Take the capsule with an acidic drink (such as orange juice or any acidic juice) or water. For children and patients who have problems to swallow, please refer to section 3 How to take PROCYSBI – Method of administration.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not use this medicine if you are pregnant, particularly during the first trimester. If you are a woman planning a pregnancy or become pregnant, seek immediate advice from your doctor about stopping therapy with this medicine as continued treatment may be harmful to the unborn baby.
Do not use this medicine if you are breastfeeding (see section 2 under “Do not take PROCYSBI”).
Driving and using machines
This medicine may cause some drowsiness. When starting therapy, you should not drive, use machines, or engage in other dangerous activities until you know how the medicine affects you.
PROCYSBI contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free.”
3. How to take PROCYSBI
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for you or your child will depend on your or your child’s age and weight. The targeted maintenance dose is 1.3 g/m2/day.
Dosing schedule
Take this medicine two times a day, every 12 hours. To get the most benefit from this medicine, try to avoid meals and dairy products for at least 1 hour before and 1 hour after PROCYSBI dosing. If this is not possible, you can eat a small amount (about 100 grams) of food (preferably carbohydrates e.g. bread, pasta, fruits) during the hour before and after PROCYSBI administration.
It is important to take PROCYSBI in a consistent way over time.
Do not increase or decrease the amount of medicine without your doctor’s approval.
The total usual dose should not exceed 1.95 g/m2/day.
Duration of treatment
Treatment with PROCYSBI should continue life-long, as instructed by your doctor.
Method of administration
You should take this medicine only by mouth.
In order for this medicine to work correctly, you must do the following:
If you take more PROCYSBI than you should
You should contact your doctor or the hospital emergency department immediately if you have taken more PROCYSBI than you should. You may become drowsy.
If you forget to take PROCYSBI
If you missed a dose of medicine, you should take it as soon as possible. However, if it is within 4 hours of the next dose, skip the missed dose and go back to the regular dosing schedule.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or nurse straight away if you notice any of the following side effects – you may need urgent medical treatment:
If any of the following side effects occur, please contact your doctor immediately. Since some of these side effects are serious, ask your doctor to explain their warning signs.
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
The other side effects listed below are given with an estimation of the frequency with which they may occur with PROCYSBI.
Very common side effects (may affect more than 1 in 10 people):
Common side effects:
Uncommon side effects:
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom:
or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland:
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store PROCYSBI
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton and the bottle label after EXP. The expiry date refers to the last day of that month.
Do not take this medicine if the foil seal has been open for more than 30 days. Discard the open bottle and use a new bottle.
Store in a refrigerator (2°C-8°C). Do not freeze. After opening do not store above 25°C. Keep the container tightly closed in order to protect from light and moisture.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What PROCYSBI contains
What PROCYSBI looks like and contents of the pack
Marketing Authorisation Holder
Republic of Ireland & United Kingdom (Northern Ireland):
Great Britain:
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 07/2021
Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema. europa.eu.
CP0062-7
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG
0800 009 2329
+44 (0)1748 827 271
+44 (0) 161 488 5555