Ferriprox 100 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ferriprox 100 mg/ml oral solution

deferiprone

Read all of 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 have any questions, ask your doctor or pharmacist.

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

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

• A patient card is attached to the pack. You must detach, complete and carefully read this patient card and carry it with you. Hand in this patient card to your doctor if you develop symptoms of infection such as fever, sore throat or flu-like symptoms.

Contents of the leaflet

1. What Ferriprox is and what it is used for

2. What you need to know before taking 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 deferiprona. 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 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 to 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 section “Other medicines and Ferriprox”).

• if you are pregnant or breastfeeding.

Warnings and precautions

• The most serious adverse effect that may occur while taking Ferriprox is a very low count of white blood cells (neutrophils). This condition, known as agranulocytosis or severe neutropenia, has occurred in 1 to 2 out of every 100 people who took Ferriprox in clinical studies. Since white blood cells help fight infections, a low neutrophil count may put you at risk of developing a potentially life-threatening and serious infection. To monitor for neutropenia, your doctor will ask you to have a blood test (to check your white blood cell count) regularly, on a weekly basis, while you are receiving Ferriprox treatment. It is very important that you attend all of these appointments. See the patient card included in the package. 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 must be checked within 24 hours to detect possible agranulocytosis.

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

Additionally, your doctor will ask you to undergo tests to monitor your body iron levels. Your doctor may also request that you undergo liver biopsies.

Other medicines and Ferriprox

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

Do not take aluminium-containing antacids at the same time as Ferriprox. Consult your doctor or pharmacist before taking vitamin C with Ferriprox.

Pregnancy and breastfeeding

Ferriprox may cause harm to the fetus when used in pregnant women. Ferriprox must not be used during pregnancy unless clearly necessary. If you are pregnant or become pregnant while being treated with Ferriprox, contact your doctor immediately.

Both female and male patients are advised to take special precautions regarding sexual activity if there is any possibility of pregnancy: Women of childbearing potential are advised to use effective contraception during treatment with Ferriprox and for 6 months after the last dose. Men are advised to use effective contraception 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. Refer to the patient card included in the package.

Driving and use of machinery

Not applicable.

Ferriprox oral solution contains the colouring agent sunset yellow FCF (E110)

Sunset yellow FCF (E110) is a colouring agent which may cause allergic reactions.

3. How to take Ferriprox

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. The amount of Ferriprox you take will depend on your body weight. The usual dose is 25 mg/kg, taken three times a day, resulting in 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 volume prescribed by your doctor. Take the first dose in the morning, the second at midday, and the third in the evening. Ferriprox may be taken with or without food; however, you may find it 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 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 forget a dose, take it as soon as you remember, and then take the next dose at the usual time. If you forget 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 talking to your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

This disorder, known as agranulocytosis or severe neutropenia, occurred in 1 to 2 out of every 100 people who took Ferriprox during clinical trials. A low white blood cell count may be associated with a serious and potentially life-threatening infection. Immediately inform your doctor if you experience any signs 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 help to take Ferriprox with a small amount of food. Urine discoloration 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 available data):

• allergic reactions, such as rash or hives.

Episodes of joint pain and swelling ranged from mild discomfort in one or more joints to severe disability. In most cases, the pain resolved 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 were intentionally prescribed more than double the recommended dose of 100 mg/kg/day for several years. Such disorders have also been observed in children receiving standard doses of deferiprone. Children stopped experiencing these symptoms after discontinuation of Ferriprox.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

After first opening the container, use the product within 35 days. Do not store above 30 °C. Keep in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its container. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ferriprox

The active substance is deferiprone. Each ml of oral solution contains 100 mg of deferiprone.

The other components are: purified water; hydroxyethylcellulose; glycerol (E422); concentrated hydrochloric acid (to adjust pH); artificial cherry flavour; peppermint oil; Orange Yellow S (E110); sucralose (E955). See section 2. “Ferriprox oral solution contains the colouring agent Orange Yellow S (E110)”.

Nature of the product and contents of the container

Reddish-orange transparent liquid. Ferriprox is packaged in 250 ml or 500 ml bottles.

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

The Netherlands

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: September 2022

Other sources of information

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