Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Deferiprone
Swedish Orphan Biovitrum Ltd
V03AC02
Deferiprone
1gram
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 0771313210850
1 PACKAGE LEAFLET: INFORMATION FOR THE USER FERRIPROX 1000 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. − Attached to this leaflet you will find a patient/carer reminder card. You should detach, complete, read the card carefully and carry it with you. WHAT IS IN THIS LEAFLET: 1. What Ferriprox is and what it is used for 2. What you need to know before you take Ferriprox 3. How to take Ferriprox 4. Possible side effects 5. How to store Ferriprox 6. Contents of the pack and other information 1. WHAT FERRIPROX IS AND WHAT IT IS USED FOR Ferriprox contains the active substance deferiprone. Ferriprox is a medicine that removes iron from the body. Ferriprox 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 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 (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 Ferriprox”). − if you are pregnant or breast-feeding. WARNINGS AND PRECAUTIONS − the most serious side effect that may occur while taking Ferriprox is a very low white bl Read the complete document
OBJECT 1 FERRIPROX 500 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 09-Aug-2017 | Swedish Orphan Biovitrum Ltd 1. Name of the medicinal product Ferriprox 500 mg film-coated tablets Ferriprox 1000 mg film-coated tablets 2. Qualitative and quantitative composition Ferriprox 500 mg film-coated tablets Each tablet contains 500 mg deferiprone. Ferriprox 1000 mg film-coated tablets Each tablet contains 1000 mg deferiprone. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Ferriprox 500 mg film-coated tablets White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other. The tablet is scored. The tablet can be divided into equal halves. Ferriprox 1000 mg film-coated tablets White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other. The tablet is scored. The tablet can be divided into equal halves. 4. Clinical particulars 4.1 Therapeutic indications Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate. Ferriprox 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 Read the complete document