• 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.
• Provided in the folding box, you will find a patient card. You should complete and read the card carefully and carry it with you. Provide this card to your doctor if you develop infection symptoms such as a fever, sore throat or flu-like symptoms.

1. What Deferiprone Lipomed is and what it is used for
2. What you need to know before you take Deferipone Lipomed
3. How to take Deferiprone Lipomed
4. Possible side effects
5. How to store Deferiprone Lipomed
6. Contents of the pack and other information

• 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 (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 “Other medicines and Deferiprone Lipomed”);
• if you are pregnant or breast-feeding.

The most serious side effect that may occur while taking Deferiprone Lipomed is a very low white blood cell (neutrophil) count. This condition, known as severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken deferiprone in clinical trials. Because white blood cells help to fight infection, a low neutrophil count may place you at risk of developing a serious and potentially life-threatening infection. To monitor for neutropenia, your doctor will ask you to have a blood test (to check your white blood cell count) performed regularly, as frequently as every week, while you are being treated with Deferiprone Lipomed. It is very important for you to keep all of these appointments. Please refer to the patient card provided in the folding box. If you get any symptoms of infection such as fever, sore throat or flu-like symptoms, immediately seek medical attention. Your white blood cell count must be checked within 24 hours in order to detect potential agranulocytosis.

If you are HIV positive or if your liver or kidney function is severely impaired, your doctor may recommend additional tests.

Your doctor will also ask you to come in for tests to monitor body iron load. In addition, he or she might ask you to undergo liver biopsies.

Talk to your doctor or pharmacist before taking Deferiprone Lipomed.

Do not take medicines known to cause neutropenia or agranulocytosis (see “Do not take Deferiprone Lipomed”). Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Do not take aluminium-based antacids at the same time as taking Deferiprone Lipomed.

Please consult with your doctor or pharmacist before taking vitamin C with Deferiprone Lipomed.

Deferiprone Lipomed may cause harm to unborn babies when used by pregnant women. Deferiprone Lipomed must not be used during pregnancy unless clearly necessary. If you are pregnant or you become pregnant during treatment with Deferiprone Lipomed, get medical advice immediately.

Both female and male patients are recommended to take special precautions in their sexual activity if there is any possibility for pregnancy to occur. Women of childbearing potential are recommended to use effective contraception during treatment with Deferiprone Lipomed and for 6 months after the last dose. Men are recommended to use effective contraception during treatment and for 3 months after the last dose. This should be discussed with your doctor.

Do not use Deferiprone Lipomed if you are breast-feeding. Please refer to the patient card provided in the folding box.

This medicine has no or negligible influence on the ability to drive and use machinery.

This medicine contains less than 1 mmol sodium (23 mg) per tablet and that is to say essentially ‘sodium-free’.

There are no reports of acute overdose with deferiprone. If you have accidentally taken more than the prescribed dose, you should contact your doctor.

Deferiprone Lipomed will be most effective if you do not miss any doses. If you do miss one dose take it as soon as you remember and take your next dose at its regularly scheduled time. If you miss more than one dose do not take a double dose to make up for forgotten individual doses, just continue with your normal schedule. Do not change your daily dose without first talking to your doctor.

In post-marketing experience with deferiprone, neurological disorders (such as tremors, walking disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who had been voluntarily prescribed more than double the maximum recommended dose of 100 mg/kg/day for several years and have also been observed in children with standard doses of deferiprone. They recovered from these symptoms after discontinuation of deferiprone.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is deferiprone. Each film-coated tablet contains 500 mg deferiprone.

The other ingredients are:

Tablet core: hypromellose, croscarmellose sodium (see section 2 “Deferiprone Lipomed contains sodium”), silica, colloidal anhydrous, microcrystalline cellulose, magnesium stearate

Coating: hypromellose, macrogol 6 000, titanium dioxide

Deferiprone Lipomed 500 mg film-coated tablets are white to off-white, glossy surface, oval film-coated tablets. The tablets are scored and breakable in half. Deferiprone Lipomed is packaged in blisters. One pack contains 100 film-coated tablets.