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Deferiprone Lipomed - patient leaflet, side effects, dosage

Contains active substance :

ATC code:

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Sources: Original PDF (ema.europa.eu)

Patient leaflet - Deferiprone Lipomed

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Deferiprone Lipomed 500 mg film-coated tablets 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.

  • – Provided in the folding box, you will find a patient/carer reminder 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.

What is in this leaflet

  • 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

1. What Deferiprone Lipomed is and what it is used for

Deferiprone Lipomed contains the active substance deferiprone. Deferiprone Lipomed is an iron chelator, a type of medicine that removes excess iron from the body.

Deferiprone Lipomed is used to treat iron overload caused by frequent blood transfusions in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.

2. What you need to know before you take Deferiprone Lipomed

Do not take Deferiprone Lipomed

  • – 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;

Warnings and precautions

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 studies. 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/carer reminder 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.

Other medicines and 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.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or if you are trying to become pregnant. This medicine could seriously harm your baby. You must use effective contraception while you are taking Deferiprone Lipomed. Ask your doctor which method is best for you. If you become pregnant while taking Deferiprone Lipomed, stop taking the medicine immediately and tell your doctor.

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

Driving and using machines

Not relevant.

Deferiprone Lipomed contains sodium

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

3. How to take Deferiprone Lipomed

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The amount of Deferiprone Lipomed that you take will depend on your weight. The usual dose is 25 mg/kg, 3 times per day, for a total daily dose of 75 mg/kg. The total daily dose should not exceed 100 mg/kg. Take your first dose in the morning. Take your second dose midday. Take your third dose in the evening. Deferiprone Lipomed can be taken with or without food; however, you may find it easier to remember to take Deferiprone Lipomed if you take it with your meals.

If you take more Deferiprone Lipomed than you should

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

If you forget to take Deferiprone Lipomed

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.

4. Possible side effects

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

The most serious side effect of 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 studies. A low white blood cell count can be associated with a serious and potentially life-threatening infection. Report immediately to your doctor 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 discoloration of urine

If you experience nausea or vomiting, it may help to take your Deferiprone Lipomed with some food. Discolored 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

  • – increase in appetite

Not known (frequency cannot be estimated from the available data):

  • – allergic reactions including skin rash or hives

5. How to store Deferiprone Lipomed

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

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Deferiprone Lipomed contains

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

The other ingredients are:

Tablet core: hypromellose, croscarmellose sodium, silica, colloidal anhydrous, microcrystalline cellulose, magnesium stearate

Coating: hypromellose, macrogol 6000, titanium dioxide

What Deferiprone Lipomed looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

Lipomed GmbH

Hegenheimer Strasse 2

79576 Weil am Rhein

Germany

Phone number: +49 7621 1693 472

Fax number: +49 7621 1693 474

Electronic mail:

This leaflet was last revised in.

Detailed information on this medicine is available on the European Medicines Agency web site:.

26

Sources: Original PDF (ema.europa.eu)

The drug is classified in the ATC tree:

V VARIOUS DRUG CLASSES IN ATC

V03 ALL OTHER THERAPEUTIC PRODUCTS

V03A ALL OTHER THERAPEUTIC PRODUCTS

V03AC Iron chelating agents

V03AC02 deferiprone

Frequently Asked Questions

What is Deferiprone Lipomed used for?

Deferiprone Lipomed is primarily used to treat iron overload in patients with thalassemia or other conditions that require frequent blood transfusions. It helps reduce excess iron in the body.

How does Deferiprone Lipomed work?

Deferiprone works by binding to excess iron in the bloodstream, which is then excreted through urine. This helps prevent damage to organs caused by iron overload.

What should I do if I miss a dose of Deferiprone Lipomed?

If you miss a dose of Deferiprone Lipomed, take it as soon as you remember unless it’s almost time for your next dose. Do not double up on doses.

Can I take Deferiprone Lipomed with food?

It is recommended to take Deferiprone Lipomed on an empty stomach to improve absorption. However, if you experience stomach upset, consult your doctor about taking it with food.

What are the common side effects of Deferiprone Lipomed?

Common side effects include nausea, vomiting, abdominal pain, and changes in taste. Always report any side effects to your healthcare provider.

Can children take Deferiprone Lipomed?

Yes, Deferiprone Lipomed can be prescribed to children under specific conditions. The dosage will be adjusted based on their weight and medical condition.

Can I drink alcohol while taking Deferiprone Lipomed?

It is best to avoid alcohol while taking Deferiprone Lipomed as it may increase the risk of liver damage. Consult your doctor for personalized advice.

How long will I need to take Deferiprone Lipomed?

The duration of treatment with Deferiprone Lipomed varies based on individual needs, but it usually continues until iron levels are adequately managed. Your doctor will monitor your progress.

Are there any interactions with other medications?

Yes, certain medications may interact with Deferiprone Lipomed, including antacids and some antibiotics. Always inform your healthcare provider about all medicines you're taking.

What should I do if I experience severe side effects from Deferiprone Lipomed?

If you experience severe side effects such as high fever, unusual bruising, or signs of liver problems like yellowing eyes or dark urine, seek medical attention immediately.

Is there a specific way to store Deferiprone Lipomed at home?

Store Deferiprone Lipomed at room temperature away from moisture and heat. Keep it out of reach of children.

Can pregnant or breastfeeding women use Deferiprone Lipomed?

Pregnant or breastfeeding women should consult their doctor before using Deferiprone Lipomed as its safety has not been established in these populations.

What kind of monitoring do I need while on Deferiprone Lipomed?

Regular blood tests are required to monitor iron levels and liver function while taking Deferiprone Lipomed. Your doctor will schedule these assessments accordingly.

Can I stop taking Deferiprone Lipomed suddenly?

Do not stop taking Deferiprone Lipomed without consulting your doctor as this can lead to a rebound increase in iron levels.

What is the recommended dosage for adults using Deferiprone Lipomed?

The typical adult dosage of Deferiprone Lipomed is 75 mg/kg/day, divided into three doses taken every eight hours. Your doctor will determine the exact dosage based on your needs.

Are there any lifestyle changes I should consider while using Deferiprone Lipomed?

It's advisable to maintain a balanced diet and avoid iron-rich foods or supplements during treatment with Deferiprone Lipomed unless otherwise directed by your healthcare provider.

How can I find help if I'm experiencing anxiety about my treatment with Deferiprone Lipomed?

If you're feeling anxious about your treatment, consider speaking with your healthcare provider or a mental health professional who can provide support and coping strategies.

Does insurance usually cover the cost of Deferiprone Lipomed?

Many insurance plans cover the cost of prescription medications like Deferiprone Lipomed, but it's best to check with your specific plan for coverage details.

Are there alternative treatments for iron overload besides Deferiprone?

Other treatments for iron overload include other chelating agents like deferasirox and desferrioxamine. Discuss alternatives with your healthcare provider based on your individual case.