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.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– 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.
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– 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.
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– 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
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1. What Deferiprone Lipomed is and what it is used for
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2. What you need to know before you take Deferipone Lipomed
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3. How to take Deferiprone Lipomed
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4. Possible side effects
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5. How to store Deferiprone Lipomed
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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
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– if you are allergic to deferiprone or any of the other ingredients of this medicine (listed in section 6);
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– if you have a history of repeated episodes of neutropenia (low white blood cell (neutrophil) count);
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– if you have a history of agranulocytosis (very low white blood cell (neutrophil) count);
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– if you are currently taking medicines known to cause neutropenia or agranulocytosis (see “Other medicines and Deferiprone Lipomed”);
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– 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):
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– abdominal pain
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– nausea
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– vomiting
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– 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):
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– low white blood cell count (agranulocytosis and neutropenia)
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– headache
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– diarrhoea
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– increase in liver enzymes
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– fatigue
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– increase in appetite
Not known (frequency cannot be estimated from the available data):
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– 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:.
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