FERRIPROX 100 mg/mL ORAL SOLUTION

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, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• The carton contains 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 develop symptoms of infection such as fever, sore throat or flu-like symptoms.

Contents of the pack

1. What is Ferriprox and what is it used for

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

1. Storage of Ferriprox
2. Contents of the pack and other information

1. What is Ferriprox and what is it 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 beta-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 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 side 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 you are receiving treatment with Ferriprox. It is very important that you attend all these appointments. See the patient card attached to the carton. If you develop 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.

Also, your doctor will ask you to have tests to monitor your iron burden. Additionally, your doctor may ask you to undergo liver biopsies.

Other medicines and Ferriprox

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

Do not take aluminium-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 unborn child 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 potential 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. See the patient card attached to the carton.

Driving and using machines

Not applicable.

Ferriprox oral solution contains the colouring agent orange yellow S (E110)

Orange yellow S (E110) is a colouring agent that may cause allergic reactions.

3. How to take Ferriprox

Follow exactly the administration instructions of this medicine given 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, 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 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 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 dose. If you miss a dose, take it as soon as you remember, and take the next one 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, continue with the next dose at the usual time. Do not change your daily dose without talking to your doctor first.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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. Tell 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;
• red/brown discoloration of urine.

If you have nausea or vomiting, it may be helpful to take Ferriprox with a little 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;
• diarrhoea;
• increase in 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, muscle contractions, 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 having these symptoms after discontinuing Ferriprox.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via 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 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 carton after EXP. The expiry date is the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ferriprox contains

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

The other ingredients are: purified water; hydroxyethylcellulose; glycerol (E422); concentrated hydrochloric acid (for pH adjustment); 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)”.

Appearance and packaging

Transparent, orange-red liquid. Ferriprox is available 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

Netherlands

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet: September 2022

Other sources of information

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