Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
LENALIDOMIDE
Gedeon Richter Plc Gyomroi ut 19-21 1103 Budapest, Hungary
L04AX04
LENALIDOMIDE 20 mg
HARD CAPSULE
LENALIDOMIDE 20 mg
POM
IMMUNOSUPPRESSANTS
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2020-08-18
Page 1 of 13 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Lenalidomide Gedeon Richter 2.5 mg hard capsules Lenalidomide Gedeon Richter 5 mg hard capsules Lenalidomide Gedeon Richter 7.5 mg hard capsules Lenalidomide Gedeon Richter 10 mg hard capsules Lenalidomide Gedeon Richter 15 mg hard capsules Lenalidomide Gedeon Richter 20 mg hard capsules Lenalidomide Gedeon Richter 25 mg hard capsules lenalidomide 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 Lenalidomide Gedeon Richter is and what it is used for 2. What you need to know before you take Lenalidomide Gedeon Richter 3. How to take Lenalidomide Gedeon Richter 4. Possible side effects 5. How to store Lenalidomide Gedeon Richter 6. Contents of the pack and other information 1. WHAT LENALIDOMIDE GEDEON RICHTER IS AND WHAT IT IS USED FOR WHAT LENALIDOMIDE GEDEON RICHTER IS Lenalidomide Gedeon Richter contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. WHAT LENALIDOMIDE GEDEON RICHTER IS USED FOR Lenalidomide Gedeon Richter is used in adults for: - Multiple myeloma - Myelodysplastic syndromes - Mantle cell lymphoma - Follicular lymphoma MULTIPLE MYELOMA Multiple myeloma is a type of cancer which affects a certain kind of white blood cell, called the plasma cell. These cells collect in the bone marrow and divide, becoming out of control. This can damage the bones and kidneys. Multiple myeloma generally cannot be cured. However, the signs and symptoms can be gr Citiți documentul complet
Page 1 of 59 1. NAME OF THE MEDICINAL PRODUCT Lenalidomide Gedeon Richter 2.5 mg hard capsules Lenalidomide Gedeon Richter 5 mg hard capsules Lenalidomide Gedeon Richter 7.5 mg hard capsules Lenalidomide Gedeon Richter 10 mg hard capsules Lenalidomide Gedeon Richter 15 mg hard capsules Lenalidomide Gedeon Richter 20 mg hard capsules Lenalidomide Gedeon Richter 25 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lenalidomide Gedeon Richter 2.5 mg hard capsules Each capsule contains 2.5 mg of lenalidomide. Excipient with known effect: Each capsule contains 53.5 mg of lactose and 0.0274 mg Allura red AC (E129). Lenalidomide Gedeon Richter 5 mg hard capsules Each capsule contains 5 mg of lenalidomide. Excipient with known effect: Each capsule contains 107 mg of lactose and 0.0277 mg Sunset yellow FCF (E110). Lenalidomide Gedeon Richter 7.5 mg hard capsules Each capsule contains 7.5 mg of lenalidomide. Excipient with known effect: Each capsule contains 160.5 mg of lactose and 0.023 mg Sunset yellow FCF (E110). Lenalidomide Gedeon Richter 10 mg hard capsules Each capsule contains 10 mg of lenalidomide. Excipient with known effect: Each capsule contains 214 mg of lactose, 0.0436 mg tartrazine (E102), 0.0119 mg Sunset yellow FCF (E110) and 0.0153 mg Allura red AC (E129). Lenalidomide Gedeon Richter 15 mg hard capsules Each capsule contains 15 mg of lenalidomide. Excipient with known effect: Each capsule contains 120 mg of lactose, 0.0032 mg tartrazine (E102) and 0.0058 mg Allura red AC (E129). Lenalidomide Gedeon Richter 20 mg hard capsules Each capsule contains 20 mg of lenalidomide. Excipient with known effect: Each capsule contains 160 mg of lactose and 0.0011 mg Allura red AC (E129). Lenalidomide Gedeon Richter 25 mg hard capsules Each capsule contains 25 mg of lenalidomide. Excipient with known effect: Each capsule contains 200 mg of lactose. For the full list of excipients, see section 6.1. Page 2 of 59 3. PHARMACEUTICAL FORM Hard capsule. Lenalidomide Gedeon Richter 2.5 mg hard capsules A dark blue opa Citiți documentul complet