Prospect: information for the user

Ferriprox 100 mg/ml oral solution

deferiprona

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

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

• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

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

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

1. What you need to know before starting to take Ferriprox
2. How to take Ferriprox
3. Possible adverse effects

1. Storage of Ferriprox
2. Contents of the package and additional information

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 inadequate.

Do not take Ferriprox

• if you are allergic to deferoxamine or any of the other ingredients in 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 out of 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. Consult the patient 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.

Additionally, your doctor will ask you to attend tests to monitor your iron body load. Your doctor may also 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.

It is recommended that both male and female patients take special precautions in their sexual activity if there is any possibility of pregnancy: It is recommended that women of childbearing age use effective contraceptive methods during treatment with Ferriprox and for 6 months after the last dose. It is recommended that men 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. Consult the patient leaflet attached to the box.

Driving and operating machinery

Not applicable.

Ferriprox oral solution contains the yellow-orange colorant S (E110)

The yellow-orange colorant S (E110) is a coloring agent that may cause allergic reactions.

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, three times a day, to take a total daily dose of 75 mg/kg. The total daily dose should not exceed 100 mg/kg. Use the graduated cup to measure the prescribed volume by your doctor. Take the first dose in the morning, the second dose at noon, 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 dose. If you forget to take one, 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 compensate for the missed doses, follow 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.

This condition, known as agranulocytosis or severe neutropenia, has occurred in 1 to 2out of every 100people 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;
• increased liver enzymes;
• fatigue;
• increased appetite.

Unknown frequency(cannot be estimated from available data):

• allergic reactions, such as hives or itching.

The 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 100mg/kg/day for several years. These disorders have also been observed in children receiving standard doses of deferoxamine. Children stopped experiencing these symptoms after discontinuing Ferriprox administration.

Reporting of 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 Medicinal Products 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.

After opening the packaging for the first time, use the product within 35 days. Do not store at a temperature above 30°C. Store in the original packaging to protect from light.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Ferriprox

The active ingredient is deferiprona. Each milliliter of oral solution contains 100 mg of deferiprona.

The other components are: purified water; hydroxyethylcellulose; glycerol (E422); concentrated hydrochloric acid (to adjust the pH); artificial cherry flavor; peppermint oil; yellow orange S (E110); sucralose (E955). See section2. “Ferriprox oral solution contains the colorant yellow orangeS (E110)”.

Appearance of the product and contents of the packaging

Transparent liquid, orange-red in color. Ferriprox is packaged in 250ml or 500ml bottles.

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 European Medicines Agency websitehttp://www.ema.europa.eu.