Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Deferiprone
Lipomed GmbH
V03AC02
deferiprone
All other therapeutic products
Iron Overload; beta-Thalassemia
Deferiprone Lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.Deferiprone Lipomed in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload justifies rapid or intensive correction.
Revision: 7
Authorised
2018-09-19
22 B. PACKAGE LEAFLET 23 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 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 Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Deferiprone Lipomed 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg deferiprone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white, glossy surface, oval film-coated tablet. The tablet is 8.2 mm x 17.2 mm x 6.7 mm and scored. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Deferiprone Lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate. Deferiprone Lipomed in combination with another chelator (see section 4.4) is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia. Posology Deferiprone is usually given as 25 mg/kg body weight, orally, three times a day for a total daily dose of 75 mg/kg body weight. Dose per kilogram body weight should be calculated to the nearest half tablet. See tables below for recommended doses for body weights at 10 kg increments. To obtain a dose of about 75 mg/kg/day, use the number of tablets suggested in the following tables for the body weight of the patient. Sample body weights at 10 kg increments are listed. _DOSE TABLE FOR DEFERIPRONE LIPOMED 500 MG FILM-COATED TABLETS_ BODY WEIGHT (KG) TOTAL DAILY DOSE (MG) DOSE (MG, THREE TIMES/DAY) NUMBER OF TABLETS (THREE TIMES/DAY) 20 1 500 500 1.0 30 2 250 750 1.5 40 3 000 1 000 2.0 50 3 750 1 250 2.5 60 4 500 1 500 3.0 70 5 250 1 750 3.5 80 6 000 2 000 4.0 90 6 750 2 250 4.5 3 A total daily dose above Læs hele dokumentet