Riik: Malta
keel: inglise
Allikas: Malta Medicines Authority
LENALIDOMIDE
Lotus Support Services S.R.L. 47 Theodor Pallady Blvd. 2nd Office, Entrance B, 1st Floor 3rd District Bucharest, Romania
L04AX04
LENALIDOMIDE 5 mg
HARD CAPSULE
LENALIDOMIDE 5 mg
POM
IMMUNOSUPPRESSANTS
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2020-08-12
Page 1 of 15 _ _ PACKAGE LEAFLET Page 2 of 15 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Lenalidomide Lotus 2.5 mg hard capsules Lenalidomide Lotus 5 mg hard capsules Lenalidomide Lotus 7.5 mg hard capsules Lenalidomide Lotus 10 mg hard capsules Lenalidomide Lotus 15 mg hard capsules Lenalidomide Lotus 20 mg hard capsules Lenalidomide Lotus 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 Lotus is and what it is used for 2. What you need to know before you take Lenalidomide Lotus 3. How to take Lenalidomide Lotus 4. Possible side effects 5. How to store Lenalidomide Lotus 6. Contents of the pack and other information 1. WHAT LENALIDOMIDE LOTUS IS AND WHAT IT IS USED FOR WHAT LENALIDOMIDE LOTUS IS Lenalidomide Lotus contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. WHAT LENALIDOMIDE LOTUS IS USED FOR Lenalidomide Lotus is used in adults for: - Multiple myeloma - 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 greatly reduced or disappear for a period of time. This is called a ‘response’. Page 3 of 15 Newly diagnosed multiple myeloma in patients who have had a bone ma Lugege kogu dokumenti
Page 1 of 62 _ _ SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 62 1. NAME OF THE MEDICINAL PRODUCT Lenalidomide Lotus 2.5 mg hard capsules Lenalidomide Lotus 5 mg hard capsules Lenalidomide Lotus 7.5 mg hard capsules Lenalidomide Lotus 10 mg hard capsules Lenalidomide Lotus 15 mg hard capsules Lenalidomide Lotus 20 mg hard capsules Lenalidomide Lotus 25 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lenalidomide Lotus 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. Lenalidomide Lotus 5 mg hard capsules Each capsule contains 5 mg of lenalidomide. Excipient with known effect: Each capsule contains 107 mg of lactose. Lenalidomide Lotus 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. Lenalidomide Lotus 10 mg hard capsules Each capsule contains 10 mg of lenalidomide. Excipient with known effect: Each capsule contains 214 mg of lactose. Lenalidomide Lotus 15 mg hard capsules Each capsule contains 15 mg of lenalidomide. Excipient with known effect: Each capsule contains 120 mg of lactose. Lenalidomide Lotus 20 mg hard capsules Each capsule contains 20 mg of lenalidomide. Excipient with known effect: Each capsule contains 160 mg of lactose. Lenalidomide Lotus 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 3 of 62 3. PHARMACEUTICAL FORM Hard capsule. Lenalidomide Lotus 2.5 mg hard capsules A dark blue opaque cap and light orange opaque body, capsule shell size No. 4, 14-15 mm, imprinted in black ink with “LP” on the cap and “637” on the body and filled with white powder. Lenalidomide Lotus 5 mg hard capsules A green opaque cap and light brown opaque body, capsule shell size No. 2, 18-19 mm, imprinted in black ink with “LP” on the cap and “638” on the body and filled with whit Lugege kogu dokumenti