Country: Malta
Language: English
Source: Medicines Authority
TEMOZOLOMIDE
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
L01AX03
TEMOZOLOMIDE 180 mg
HARD CAPSULE
TEMOZOLOMIDE 180 mg
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2013-02-21
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ TEMOZOLOMIDE FAIR-MED 5 MG HARD CAPSULES TEMOZOLOMIDE FAIR-MED 20 MG HARD CAPSULES TEMOZOLOMIDE FAIR-MED 100 MG HARD CAPSULES TEMOZOLOMIDE FAIR-MED 140 MG HARD CAPSULES TEMOZOLOMIDE FAIR-MED 180 MG HARD CAPSULES TEMOZOLOMIDE FAIR-MED 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 FAIR-MED is and what it is used for 2. What you need to know before you use Temozolomide FAIR-MED 3. How to use Temozolomide FAIR-MED 4. Possible side effects 5. How to store Temozolomide FAIR-MED 6. Contents of the pack and other information 1. WHAT TEMOZOLOMIDE FAIR-MED IS AND WHAT IT IS USED FOR Temozolomide FAIR-MED contains a medicine called temozolomide. This medicine is an antitumour agent. Temozolomide FAIR-MED is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme. Temozolomide FAIR-MED 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 FAIR-MED is used in these tumours if they return or get worse after standard treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TEMOZOLOMIDE FAIR-MED DO NOT USE TEMOZOLOMIDE FAIR-MED - if you are allergic to temozolomide or any of the other ingredients of this medicine (lis Read the complete document
Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Temozolomide FAIR-MED 5 mg hard capsules Temozolomide FAIR-MED 20 mg hard capsules Temozolomide FAIR-MED 100 mg hard capsules Temozolomide FAIR-MED 140 mg hard capsules Temozolomide FAIR-MED 180 mg hard capsules Temozolomide FAIR-MED 250 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 5 mg temozolomide. Each hard capsule contains 20 mg temozolomide. Each hard capsule contains 100 mg temozolomide. Each hard capsule contains 140 mg temozolomide. Each hard capsule contains 180 mg temozolomide. Each hard capsule contains 250 mg temozolomide. Excipient with known effect: Each 5 mg hard capsule contains 399.3mg mg of anhydrous lactose. Each 20 mg hard capsule contains 384.3 mg of anhydrous lactose. Each 100 mg hard capsule contains 61.7 mg of anhydrous lactose. Each 140 mg hard capsule contains 86.4 mg of anhydrous lactose. Each 180 mg hard capsule contains 111.1 mg of anhydrous lactose. Each 250 mg hard capsule contains 154.3 mg of anhydrous lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. 5 mg: The hard gelatin capsules are size 0 and have a green opaque cap/white opaque body with 5 printed in black ink on the body. 20 mg: The hard gelatin capsules are size 0 and have an orange opaque cap /white opaque body with 20 printed in black ink on the body. 100 mg: The hard gelatin capsules are size 0 and have a purple opaque cap /white opaque body with 100 printed in black ink on the body 140 mg: The hard gelatin capsules are size 0 and have a blue opaque cap /white opaque body with 140 printed in black ink on the body 180 mg: The hard gelatin capsules are size 0 and have a chocolate brown opaque cap /white opaque body with 180 printed in black ink on the body 250 mg: The hard gelatin capsules size 0 and white opaque cap /white opaque body with 250 printed in black ink on the body Page 2 of 21 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Temozolomide FA Read the complete document