What is a Patient Information Leaflet and why is it useful?

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.

Ferriprox 1000 mg film-coated tablets

Package leaflet: Information for the user

Ferriprox 1000 mg film-coated tablets

Deferiprone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • Attached to this leaflet you will find a patient/carer reminder card. You should detach, complete, read the card carefully and carry it with 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 a medicine that removes 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

  • if you are allergic to deferiprone or any of the other ingredients of this medicine (listed in section 6).
  • if you have a history of repeated episodes of neutropenia (low white blood cell (neutrophil) count).
  • if you have a history of agranulocytosis (very low white blood cell (neutrophil) count).
  • if you are currently taking medicines known to cause neutropenia or agranulocytosis (see “Other medicines and Ferriprox”).
  • if you are pregnant or breast-feeding.

Warnings and precautions

  • the most serious side effect that may occur while taking 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. Because white blood cells help to fight infection, a low neutrophil count may place you at risk of developing a serious and potentially life-threatening infection. To monitor for neutropenia, your doctor will ask you to have a blood test (to check your white blood cell count) performed regularly, as frequently as every week, while you are being treated with Ferriprox. It is very important for you to keep all of these appointments. Please refer to the patient/carer reminder card attached to this leaflet. Report immediately to your doctor any symptoms of infection such as fever, sore throat or flu-like symptoms.
  • if you are HIV positive or if your kidney or liver function is impaired, your doctor may recommend additional tests.

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 while 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/carer reminder card attached to this leaflet.

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):

  • abdominal pain
  • nausea
  • vomiting
  • reddish/brown discolouration of urine

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):

  • low white blood cell count (agranulocytosis and neutropenia)
  • headache
  • diarrhoea
  • increase in liver enzymes
  • fatigue
  • increase in appetite

Not known (frequency cannot be estimated from the available data):

  • allergic reactions including skin rash or hives

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:

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

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.

Do not store above 30°C. Keep the bottle tightly closed in order to protect from moisture. After first opening use within 50 days.

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 1000 mg tablet contains 1000 mg deferiprone.

The other ingredients are:

Tablet core: Methylcellulose, crospovidone, magnesium stearate.

Coating: Hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide.

What Ferriprox looks like and contents of the pack

Ferriprox 1000 mg tablets are white to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other. The tablets are scored and breakable in half. Ferriprox is packaged in bottles of 50 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Apotex Europe B.V.
Archimedesweg 2
2333 CN Leiden
Netherlands

Manufacturing Authorisation Holder:

Apotex Nederland B.V.
Archimedesweg 2
2333 CN Leiden
Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Swedish Orphan Biovitrum Ltd
Tel: + 44 1223 891854

This leaflet was last revised in 07/2017.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

PATIENT/CARER REMINDER CARD

Important Safety Reminders for Patients taking Ferriprox (deferiprone)

Prescribing doctor:

Phone No:

FOR WOMEN OF CHILD BEARING AGE

Do not take Ferriprox if you are pregnant or if you are trying to become pregnant. If taken during pregnancy, Ferriprox may seriously harm the unborn 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 take Ferriprox if you are breast-feeding.

MONITORING YOUR WHITE BLOOD CELL COUNT WITH FERRIPROX

There is a small chance that you may develop agranulocytosis (very low white blood cell count) while taking Ferriprox, which may lead to a serious infection. Even though agranulocytosis only affects 1 to 2 out of 100 users, it is important to monitor your blood on a regular basis.

Make sure you do the following:

1. Have your blood monitored on a weekly basis.
2. Contact your doctor immediately if you develop a fever, sore throat or flu like symptoms