Ferriprox - patient leaflet, side effects, dosage

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

• – 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 card attached to the carton. If you get any symptoms of infection such as fever, sore throat or flu-like symptoms, immediately seek medical attention. Your white blood cell count must be checked within 24 hours in order to detect potential agranulocytosis.

• – if you are human immunodeficiency virus (HIV) positive or if your liver or kidney function is severely 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 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):

• – 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.

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:

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Manufacturer:

Eurofins PROXY Laboratories B.V.

Archimedesweg 25

2333 CM Leiden

Netherlands

This leaflet was last revised in.

Other sources of information

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