Land: Malta
Språk: engelsk
Kilde: Medicines Authority
LENALIDOMIDE
Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
L04AX04
LENALIDOMIDE 15 mg
HARD CAPSULE
LENALIDOMIDE 15 mg
POM
IMMUNOSUPPRESSANTS
Withdrawn
2018-08-10
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LENALIDOMIDE TEVA 10 MG HARD CAPSULES LENALIDOMIDE TEVA 15 MG HARD CAPSULES LENALIDOMIDE TEVA 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 Teva is and what it is used for 2. What you need to know before you take Lenalidomide Teva 3. How to take Lenalidomide Teva 4. Possible side effects 5. How to store Lenalidomide Teva 6. Contents of the pack and other information 1. WHAT LENALIDOMIDE TEVA IS AND WHAT IT IS USED FOR WHAT LENALIDOMIDE TEVA IS Lenalidomide Teva contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. Lenalidomide Teva is used in adults for Multiple myeloma. 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’. Newly diagnosed multiple myeloma – in patients who have had a bone marrow transplant Lenalidomide Teva is used on its own as maintenance therapy after patients have recovered enough following a bone marrow transplant. Newly diagnosed multiple myeloma – in patients who cannot have a bone marrow transplant Lenalidomide Teva is taken with other medic Les hele dokumentet
Page 1 of 43 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lenalidomide Teva 10 mg hard capsules Lenalidomide Teva 15 mg hard capsules Lenalidomide Teva 25 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lenalidomide Teva 10 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 10 mg of lenalidomide. Lenalidomide Teva 15 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 15 mg of lenalidomide. Lenalidomide Teva 25 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 25 mg of lenalidomide. Excipients with known effect: Lenalidomide Teva 10 mg hard capsules: Each capsule contains 0.9 mg of sodium. Lenalidomide Teva 15 mg hard capsules: Each capsule contains 1.35 mg of sodium. Lenalidomide Teva 25 mg hard capsules: Each capsule contains 2.25 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Lenalidomide Teva 10 mg hard capsules Hard, non-transparent capsules, size “2” (approximately 18 mm in length), imprinted in black with ‘10’ on ivory body and with green cap, containing off-white to pale yellow or beige powder or compressed powder. Lenalidomide Teva 15 mg hard capsules Hard, non-transparent capsules, size “1” (approximately 19.4 mm in length), imprinted in black with ‘15’ on white body and with blue cap, containing off-white to pale yellow or beige powder or compressed powder. Lenalidomide Teva 25 mg hard capsules Hard, non-transparent capsules, size “0” (approximately 21.7 mm in length), imprinted in black with ‘25’ on white body and with white cap, containing off-white to pale yellow or beige powder or compressed powder. Page 2 of 43 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Multiple myeloma Lenalidomide Teva as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Len Les hele dokumentet