Ferriprox 500 mg comprimidos con cubierta pelicular

Patient Information Leaflet

Ferriprox 500 mg, Film-Coated Tablets

deferiprone

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

• Keep this leaflet, as you may need to read it again.

• If you are unsure about anything, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

• The box contains a patient reminder card. You must detach, complete and read this card carefully and keep it with you. Give this patient reminder card to your doctor if you experience symptoms of infection such as fever, sore throat or flu-like symptoms.

Ferriprox contains the active ingredient deferiprone. Ferriprox is an iron chelator, a type of medication that removes excess iron from the body.

Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with beta thalassemia major when the current chelating treatment is contraindicated or inappropriate.

Do not take Ferriprox

• If you are allergic to deferoxamine or any of the other components of this medication (listed in section 6).

• If you have a history of repeated episodes of neutropenia (low white blood cell count (neutrophils)).

• If you have a history of agranulocytosis (very low white blood cell count (neutrophils)).

• If you are currently taking medications that are known to cause neutropenia or agranulocytosis (see the section “Use of other medications and Ferriprox”).

• If you are pregnant or breastfeeding.

Warnings and precautions

• The most serious adverse effect that can occur while taking Ferriprox is a very low white blood cell count (neutrophils). This condition, known as agranulocytosis or severe neutropenia, has occurred in 1 to 2 of every 100 people who have taken Ferriprox in clinical studies. Since white blood cells help fight infections, a low neutrophil count can put you at risk of developing a potentially life-threatening and serious infection. To monitor neutropenia, your doctor will ask you to have regular blood tests (to check your white blood cell count), weekly, while you are receiving treatment with Ferriprox. It is very important that you attend all of these appointments. See the patient information leaflet attached to the box. If you experience any symptoms of infection such as fever, sore throat, or flu-like symptoms, seek medical attention immediately. Your leucocyte count should be checked within 24 hours to detect possible agranulocytosis.

• If you have tested positive for the human immunodeficiency virus (HIV) or if your liver or kidney function is severely impaired, your doctor may recommend additional tests.

Your doctor will also ask you to have tests to monitor your iron body load. Additionally, they may ask you to undergo liver biopsies.

Other medications and Ferriprox

Do not take medications that are known to cause neutropenia or agranulocytosis (see the section “Do not take Ferriprox”). Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those obtained without a prescription.

Do not take aluminum-based antacids at the same time as taking Ferriprox.

Consult your doctor or pharmacist before taking vitamin C with Ferriprox.

Pregnancy and breastfeeding

Ferriprox may cause harm to the fetus when used by pregnant women. Ferriprox should not be used during pregnancy unless clearly necessary. If you are pregnant or become pregnant during treatment with Ferriprox, see your doctor immediately.

Both male and female patients are advised to take special precautions in their sexual activity if there is any possibility of pregnancy: Women of childbearing age are advised to use effective contraceptive methods during treatment with Ferriprox and for 6 months after the last dose. Men are advised to use effective contraceptive methods during treatment and for 3 months after the last dose. Discuss this with your doctor.

Do not take Ferriprox if you are breastfeeding. See the patient information leaflet attached to the box.

Driving and operating machinery

Not applicable.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. The amount of Ferriprox you take will depend on your weight. The usual dose is 25 mg/kg, taken three times a day, for a total daily dose of 75 mg/kg. The total daily dose should not exceed 100 mg/kg. Take the first dose in the morning, the second dose at midday, and the third dose at night. Ferriprox can be taken with or without food; however, you may find it easier to remember to take Ferriprox if you do so with meals.

If you take more Ferriprox than you should

No reports of acute overdose cases with Ferriprox have been reported. If you have accidentally taken a higher dose than prescribed, you should contact your doctor.

If you forget to take Ferriprox

Ferriprox will be more effective if you do not forget any doses. If you forget a dose, take it as soon as you remember, and take the next one at the usual time. If you forget to take more than one dose, do not take a double dose to make up for the missed doses, continue with the next dose at the usual time. Do not change your daily dose without first speaking with your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most serious side effect of Ferriprox is a very low white blood cell count (neutrophils). This condition, known as agranulocytosis or severe neutropenia, has occurred in 1 to 2 out of 100 people who have taken Ferriprox during clinical trials. A low white blood cell count can be associated with a severe and potentially life-threatening infection. Inform your doctor immediately if you have 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 urine color.

If you have nausea or vomiting, it may be helpful to take Ferriprox with a small amount of food. The urine color 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;
• diarrhea;

• increase in liver enzymes;
• fatigue;

• increased appetite.

Unknown frequency(cannot be estimated from available data):

• allergic reactions, such as hives or itching.

Episodes of joint pain and swelling varied 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, difficulty walking, double vision, involuntary muscle contractions, motor coordination problems) have been observed in children who, voluntarily, had been prescribed more than double the recommended dose of 100 mg/kg/day for several years. These disorders have also been observed in children taking standard doses of deferoxamine. Children stopped experiencing these symptoms after stopping Ferriprox administration.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F (30°C).

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Ferriprox

The active ingredient is deferiprone. Each 500mg tablet contains 500mg of deferiprone.

The other components are:

core:microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica.

coating:hypromellose, macrogol, titanium dioxide.

Appearance of the product and contents of the packaging

Coated tablet, white or off-white in color, in capsule shape, with “APO” and “500” printed on one side and smooth on the other. The tablet has dimensions of 7.1mmx17.5mmx6.8mm and is scored. The tablet can be divided into equal doses.

Ferriprox is packaged in bottles of 100 tablets.

Marketing Authorization Holder:

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Responsible for manufacturing:

Eurofins PROXY Laboratories B.V.

Archimedesweg 25

2333 CM Leiden

Netherlands

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet: September 2022

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.