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
Ferriprox® 500 mg film-coated tablets
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
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.
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.
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.
Ferriprox may cause harm to unborn babies when used by pregnant women. Ferriprox must not be used during pregnancy unless clearly necessary. If you are pregnant or you become pregnant during treatment with Ferriprox, get medical advice immediately.
Both female and male patients are recommended to take special precautions in their sexual activity if there is any possibility for pregnancy to occur: Women of childbearing potential are recommended to use effective contraception during treatment with Ferriprox and for 6 months after the last dose. Men are recommended to use effective contraception during treatment and for 3 months after the last dose. This should be discussed with your doctor.
Do not use Ferriprox if you are breast-feeding. Please refer to the patient card attached to the carton.
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.
There are no reports of acute overdose with Ferriprox. If you have accidentally taken more than the prescribed dose, you should contact your doctor.
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.
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.
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
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.
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 ºC.
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.
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
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.
Ireland & United Kingdom (Northern Ireland):
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 09-2022.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.