FERRIPROX 500 mg FILM-COATED TABLETS

Introduction

Prospective: Information for the User

Ferriprox 500 mg, Film-Coated Tablets

Deferiprone

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

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

• If you have any doubts, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

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

• The box includes a patient card. You should peel off, fill in, and read this patient card carefully and carry it with you. Give this patient card to your doctor if you experience symptoms of infection such as fever, sore throat, or flu-like symptoms.

Contents of the Prospectus

1. What is Ferriprox and what is it used for
2. What you need to know before taking Ferriprox
3. How to take Ferriprox
4. Possible side effects
5. Storage of Ferriprox

1. Package contents and additional information

1. What is Ferriprox and what is it used for

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 current chelation therapy is contraindicated or inadequate.

2. What you need to know before taking Ferriprox

Do not take Ferriprox

• if you are allergic to deferiprone 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).

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

• if you are currently taking medications that are known to cause neutropenia or agranulocytosis (see the section "Do not take 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. This condition, known as agranulocytosis or severe neutropenia, has occurred in 1 to 2 out of every 100 people who have taken Ferriprox in clinical trials. Since white blood cells help fight infections, a low neutrophil count can put you at risk of developing a potentially life-threatening infection. To monitor neutropenia, your doctor will ask you to have a blood test (to check your white blood cell count) regularly, with a frequency of once a week, while receiving treatment with Ferriprox. It is very important that you attend all these appointments. Consult the patient card 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 white blood cell 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.

Additionally, your doctor will ask you to undergo tests to monitor your body's iron load. You may also be asked 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 recently used, or may need to use any other medication, including those purchased without a prescription.

Do not take aluminum-based antacids at the same time as you are 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, consult your doctor immediately.

Both female and male 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. You should discuss this with your doctor.

Do not take Ferriprox if you are breastfeeding. Consult the patient card attached to the box.

Driving and using machines

Not applicable.

3. How to take Ferriprox

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of 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, 3 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 noon, and the third dose in the evening. Ferriprox can be taken with or without food; however, it may be easier to remember to take Ferriprox if you take it with meals.

If you take more Ferriprox than you should

There are no reports of acute overdose cases with Ferriprox. If you have accidentally taken a higher dose than prescribed, contact your doctor.

If you forget to take Ferriprox

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

4. Possible side effects

Like all medications, this medication 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. This condition, known as agranulocytosis or severe neutropenia, has occurred in 1 to 2 out of every 100 people who have taken Ferriprox during clinical trials. A low white blood cell count can be associated with a serious and potentially life-threatening infection. Inform your doctor immediately if you experience 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;

• red/brown discoloration of urine.

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

• increased liver enzymes;
• fatigue;

• increased appetite.

Frequency not known(cannot be estimated from the available data):

• allergic reactions, such as rash or hives.

Episodes 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 to take Ferriprox.

Neurological disorders (such as tremors, difficulty walking, double vision, involuntary muscle contractions, motor coordination problems) have been observed in children who were voluntarily prescribed more than twice the recommended dose of 100 mg/kg/day for several years. Such disorders have also been observed in children with standard doses of deferiprone. The children stopped experiencing these symptoms after discontinuing Ferriprox.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish Medicines Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ferriprox

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

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

Do not store above 30°C.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Ferriprox

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

The other ingredients are:

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

coating:hypromellose, macrogol, titanium dioxide.

Appearance of the product and package contents

Film-coated tablet, white or almost white, capsule-shaped, with "APO" and "500" printed on one side and smooth on the other. The tablet has dimensions of 7.1 mm x 17.5 mm x 6.8 mm 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

Manufacturer:

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:

Date of the last revision of this prospectus: September 2022

Other sources of information

Detailed information about this medication is available on the European Medicines Agency website http://www.ema.europa.eu.