Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
temozolomide
Sun Pharmaceutical Industries Europe B.V.
L01AX03
temozolomide
Antineoplastic agents
Glioma; Glioblastoma
Temozolomide Sun is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Revision: 19
Authorised
2011-07-13
48 B. PACKAGE LEAFLET 49 PACKAGE LEAFLET: INFORMATION FOR THE USER TEMOZOLOMIDE SUN 5 MG HARD CAPSULES TEMOZOLOMIDE SUN 20 MG HARD CAPSULES TEMOZOLOMIDE SUN 100 MG HARD CAPSULES TEMOZOLOMIDE SUN 140 MG HARD CAPSULES TEMOZOLOMIDE SUN 180 MG HARD CAPSULES TEMOZOLOMIDE SUN 250 MG HARD CAPSULES temozolomide 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Temozolomide SUN is and what it is used for 2. What you need to know before you take Temozolomide SUN 3. How to take Temozolomide SUN 4. Possible side effects 5. How to store Temozolomide SUN 6. Contents of the pack and other information 1. WHAT TEMOZOLOMIDE SUN IS AND WHAT IT IS USED FOR Temozolomide SUN contains a medicine called temozolomide. This medicine is an antitumour agent. Temozolomide SUN is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme. Temozolomide SUN is at first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment). - in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide SUN is used in these tumours if they return or get worse after standard treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE SUN DO NOT TAKE TEMOZOLOMIDE SUN - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6). - if you have had an allergic reaction to dacarbazine ( Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Temozolomide SUN 5 mg hard capsules Temozolomide SUN 20 mg hard capsules Temozolomide SUN 100 mg hard capsules Temozolomide SUN 140 mg hard capsules Temozolomide SUN 180 mg hard capsules Temozolomide SUN 250 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 mg hard capsules Each hard capsule contains 5 mg temozolomide. Excipient with known effect Each hard capsule contains 30.97 mg of lactose. 20 mg hard capsules Each hard capsule contains 20 mg temozolomide. Excipient with known effect Each hard capsule contains 18.16 mg of lactose. 100 mg hard capsules Each hard capsule contains 100 mg temozolomide. Excipient with known effect Each hard capsule contains 90.801 mg of lactose. 140 mg hard capsules Each hard capsule contains 140 mg temozolomide. Excipient with known effect Each hard capsule contains 127.121 mg of lactose. 180 mg hard capsules Each hard capsule contains 180 mg temozolomide. Excipient with known effect Each hard capsule contains 163.441 mg of lactose. 250 mg hard capsules Each hard capsule contains 250 mg temozolomide. Excipient with known effect Each hard capsule contains 227.001 mg of lactose. For the full list of excipients, see section 6.1. 3 3. PHARMACEUTICAL FORM 5 mg hard capsule (capsule) Hard gelatin capsules, with white opaque cap and body, imprinted in green ink. The cap is imprinted with ‘890’. The body is imprinted with ‘5 mg’ and two stripes. 20 mg hard capsule (capsule) Hard gelatin capsules, with white opaque cap and body, imprinted in yellow ink. The cap is imprinted with ‘891’. The body is imprinted with ’20 mg’ and two stripes. 100 mg hard capsule (capsule) Hard gelatin capsules, with white opaque cap and body, imprinted in pink ink. Thw cap is imprinted with ‘892’. The body is imprinted with ‘100 mg’ and two stripes. 140 mg hard capsule (capsule) Hard gelatin capsules, with white opaque cap and body, imprinted in blue ink. The cap is imprinted with ‘929’. The b Lestu allt skjalið