Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Deferasirox
Pharmathen S.A.
V03AC03
Deferasirox
Film-coated tablet
deferasirox
2022-02-04
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DEFERASIROX PHARMATHEN 90 MG FILM COATED TABLETS DEFERASIROX PHARMATHEN 180 MG FILM COATED TABLETS DEFERASIROX PHARMATHEN 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 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. WHAT IS IN THIS LEAFLET 1. What Deferasirox Pharmathen is and what it is used for 2. What you need to know before you take Deferasirox Pharmathen 3. How to take Deferasirox Pharmathen 4. Possible side effects 5. How to store Deferasirox Pharmathen 6. Contents of the pack and other information 1. WHAT DEFERASIROX PHARMATHEN IS AND WHAT IT IS USED FOR WHAT DEFERASIROX PHARMATHEN IS Deferasirox Pharmathen 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 DEFERASIROX PHARMATHEN 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 Lire le document complet
Health Products Regulatory Authority 20 September 2023 CRN00D10P Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Deferasirox Pharmathen 90 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 90 mg deferasirox. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Light blue, oval, biconvex film-coated tablet, engraved with "90" on one side, with the following dimensions: length 11.0±0.1 mm, width 4.4±0.1 mm and thickness 3.5±0.2 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Deferasirox / Pharmathen 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 / Pharmathen 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 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 cells) aged 2 years and older, in adult and paediatric patients with other anaemias aged 2 years and older. Deferasirox / Pharmathen is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Deferasirox Pharmathen should be initiated and maintained by physicians experienced in the treatment of chronic iron overload. POSOLOGY _Transfusional iron overload_ It is recommended that treatment be started after the transfusion of approxim Lire le document complet