Active ingredient
- deferiprone
Legal Category
POM: Prescription only medicine
P: Pharmacy
POM: Prescription only medicine
P: Pharmacy
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 08829/0198.
Ferriprox 500 mg film-coated tablets
Package leaflet: Information for the user
Ferriprox® 500 mg film-coated tablets
deferiprone
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Ferriprox is and what it is used for
2. What you need to know before you take Ferriprox
3. How to take Ferriprox
4. Possible side effects
5. How to store Ferriprox
6. Contents of the pack and other information
1. What Ferriprox is and what it is used for
Ferriprox contains the active substance deferiprone. Ferriprox is an iron chelator, a type of medicine that removes excess iron from the body.
Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
2. What you need to know before you take Ferriprox
Do not take Ferriprox
Warnings and precautions
Your doctor will also ask you to come in for tests to monitor body iron load. In addition he or she might ask you to undergo liver biopsies.
Other medicines and Ferriprox
Do not take medicines known to cause neutropenia or agranulocytosis (see “Do not take Ferriprox”). Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Do not take aluminium-based antacids at the same time as taking Ferriprox.
Please consult with your doctor or pharmacist before taking vitamin C with Ferriprox.
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant or if you are trying to become pregnant. This medicine could seriously harm your baby. You must use effective contraception while you are taking Ferriprox. Ask your doctor which method is best for you. If you become pregnant while taking Ferriprox, stop taking the medicine immediately and tell your doctor.
Do not use Ferriprox if you are breast-feeding. Please refer to the patient card attached to the carton.
Driving and using machines
Not relevant.
3. How to take Ferriprox
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The amount of Ferriprox that you take will depend on your weight. The usual dose is 25 mg/kg, 3 times per day, for a total daily dose of 75 mg/kg. The total daily dose should not exceed 100 mg/kg. Take your first dose in the morning. Take your second dose midday. Take your third dose in the evening. Ferriprox can be taken with or without food; however, you may find it easier to remember to take Ferriprox if you take it with your meals.
If you take more Ferriprox than you should
There are no reports of acute overdose with Ferriprox. If you have accidentally taken more than the prescribed dose, you should contact your doctor.
If you forget to take Ferriprox
Ferriprox will be most effective if you do not miss any doses. If you do miss one dose take it as soon as you remember and take your next dose at its regularly scheduled time. If you miss more than one dose do not take a double dose to make up for forgotten individual doses, just continue with your normal schedule. Do not change your daily dose without first talking to your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effect of Ferriprox is a very low white blood cell (neutrophil) count. This condition, known as severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken Ferriprox in clinical studies. A low white blood cell count can be associated with a serious and potentially life-threatening infection. Report immediately to your doctor any symptoms of infection such as: fever, sore throat or flu-like symptoms.
Very common side effects (may affect more than 1 in 10 people):
If you experience nausea or vomiting, it may help to take your Ferriprox with some food. Discoloured urine is a very common effect and is not harmful.
Common side effects (may affect up to 1 in 10 people):
Not known (frequency cannot be estimated from the available data):
Events of joint pain and swelling ranged from mild pain in one or more joints to severe disability. In most cases, the pain disappeared while patients continued taking Ferriprox.
Neurological disorders (such as tremors, walking disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who had been voluntarily prescribed more than double the maximum recommended dose of 100 mg/kg/day for several years and have also been observed in children with standard doses of deferiprone. The children recovered from these symptoms after Ferriprox discontinuation.
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
Ireland
United Kingdom
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 Ferriprox
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 label after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ferriprox contains
The active substance is deferiprone. Each 500 mg tablet contains 500 mg deferiprone.
The other ingredients are:
tablet core: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica
coating: hypromellose, macrogol, titanium dioxide
What Ferriprox looks like and contents of the pack
White to off-white, capsule-shaped, film-coated tablet imprinted “APO” bisect “500” on one side, plain on the other. The tablet is 7.1 mm x 17.5 mm x 6.8 mm and scored. The tablet can be divided into equal halves. Ferriprox is packaged in bottles of 100 tablets.
Marketing Authorisation Holder:
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 01-2022.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
CP0071-2
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG
0800 009 2329
+44 (0)1748 827 271
+44 (0) 161 488 5555