Country: Malta
Language: English
Source: Medicines Authority
DEFERASIROX
BioOrganics BV Microweg 22, 6545CM Nijmegen, Netherlands
V03AC03
DEFERASIROX 360 mg
FILM-COATED TABLET
DEFERASIROX 360 mg
POM
ALL OTHER THERAPEUTIC PRODUCTS
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2019-10-23
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER DEFERASIROX BIOORGANICS 90 MG FILM-COATED TABLETS DEFERASIROX BIOORGANICS 180 MG FILM-COATED TABLETS DEFERASIROX BIOORGANICS 360 MG FILM-COATED TABLETS Deferasirox 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 only for you or your child. 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. WHAT IS IN THIS LEAFLET 1. What Deferasirox BioOrganics is and what it is used for 2. What you need to know before you take Deferasirox BioOrganics 3. How to take Deferasirox BioOrganics 4. Possible side effects 5. How to store Deferasirox BioOrganics 6. Contents of the pack and other information 1. WHAT DEFERASIROX BIOORGANICS IS AND WHAT IT IS USED FOR Deferasirox BioOrganics contains an active substance called deferasirox. It is an iron chelator which is a medicine used to remove the excess iron from the body (also called iron overload). It traps and removes excess iron which is then excreted mainly in the stools. WHAT [PRODUCT NAME] IS USED FOR Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)). However, repeated blood transfusions can cause a build-up of excess iron. This is because blood contains iron and your body does not have a natural way to remove the excess iron you get with your blood transfusions. In patients with non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over time, mainly due to increased absorption of dietary iron in response to low blood cell counts. Over time, the excess iron can Read the complete document
Page 1 of 21 1. NAME OF THE MEDICINAL PRODUCT Deferasirox BioOrganics 90 mg film-coated tablets Deferasirox BioOrganics 180 mg film-coated tablets Deferasirox BioOrganics 360 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 90 mg deferasirox. Excipient(s) with known effect Each film-coated tablet contains 1.16 mg lactose monohydrate. Each film-coated tablet contains 180 mg deferasirox. Excipient(s) with known effect Each film-coated tablet contains 1.54 mg lactose monohydrate. Each film-coated tablet contains 360 mg deferasirox. Excipient(s) with known effect Each film-coated tablet contains 3.08 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Light blue, oval biconvex film-coated tablet, approximately 10 mm long by 6 mm wide and debossed with ‘D7FX’ on one side and ‘90’ on the other. Medium blue, oval biconvex film-coated tablet, approximately 13 mm long by 7 mm wide and debossed with ‘D7FX’ on one side and ‘180’ on the other. Blue, oval biconvex film-coated tablet, approximately 15 mm long by 9 mm wide and debossed with ‘D7FX’ on one side and ‘360’ on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Deferasirox BioOrganics is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older. Deferasirox BioOrganics is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: - in paediatric patients with beta thalassaemia major with iron overload due to frequent blood Page 2 of 21 transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years, - in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cel Read the complete document