Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
temozolomide
Teva B.V.
L01AX03
temozolomide
Antineoplastic agents
Glioma; Glioblastoma
For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.For the treatment of 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: 21
Authorised
2010-01-28
47 B. PACKAGE LEAFLET 48 PACKAGE LEAFLET: INFORMATION FOR THE USER TEMOZOLOMIDE TEVA 5 MG HARD CAPSULES TEMOZOLOMIDE TEVA 20 MG HARD CAPSULES TEMOZOLOMIDE TEVA 100 MG HARD CAPSULES TEMOZOLOMIDE TEVA 140 MG HARD CAPSULES TEMOZOLOMIDE TEVA 180 MG HARD CAPSULES TEMOZOLOMIDE TEVA 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 Teva is and what it is used for 2. What you need to know before you take Temozolomide Teva 3. How to take Temozolomide Teva 4. Possible side effects 5. How to store Temozolomide Teva 6. Contents of the pack and other information 1. WHAT TEMOZOLOMIDE TEVA IS AND WHAT IT IS USED FOR Temozolomide Teva contains a medicine called temozolomide. This medicine is an antitumour agent. Temozolomide Teva is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme. Temozolomide Teva is 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 Teva is used in these tumours if they return or get worse after standard treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE TEVA DO NOT TAKE TEMOZOLOMIDE TEVA - 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 Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Temozolomide Teva 5 mg hard capsules Temozolomide Teva 20 mg hard capsules Temozolomide Teva 100 mg hard capsules Temozolomide Teva 140 mg hard capsules Temozolomide Teva 180 mg hard capsules Temozolomide Teva 250 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Temozolomide Teva 5 mg hard capsules Each hard capsule contains 5 mg temozolomide. _Excipient with known effect _ Each hard capsule contains 87 mg of lactose. Temozolomide Teva 20 mg hard capsules Each hard capsule contains 20 mg temozolomide. _Excipients with known effect _ Each hard capsule contains 72 mg of lactose and sunset yellow FCF (E110). Temozolomide Teva 100 mg hard capsules Each hard capsule contains 100 mg temozolomide. _Excipient with known effect _ Each hard capsule contains 84 mg of lactose. Temozolomide Teva 140 mg hard capsules Each hard capsule contains 140 mg temozolomide. _Excipient with known effect _ Each hard capsule contains 117 mg of lactose. Temozolomide Teva 180 mg hard capsules Each hard capsule contains 180 mg temozolomide. _Excipient with known effect _ Each hard capsule contains 150 mg of lactose. Temozolomide Teva 250 mg hard capsules Each hard capsule contains 250 mg temozolomide. _Excipient with known effect _ Each hard capsule contains 209 mg of lactose. For the full list of excipients, see section 6.1. 3 3. PHARMACEUTICAL FORM Hard capsule. Temozolomide Teva 5 mg hard capsules The hard capsules have a white opaque body and cap with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body. Each capsule is approximately 16 mm in length. Temozolomide Teva 20 mg hard capsules The hard capsules have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body. Each capsule is approximately 18 mm in length. Temozolomide Teva 100 mg hard capsules The hard capsules have a white opaque body and cap with two stripes in pink ink on the cap and with “T 100 Přečtěte si celý dokument