Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
afatinib
Boehringer Ingelheim International GmbH
L01XE13
afatinib
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung
Giotrif as monotherapy is indicated for the treatment ofEpidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.
Revision: 15
Authorised
2013-09-25
46 B. PACKAGE LEAFLET 47 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GIOTRIF 20 MG FILM-COATED TABLETS afatinib 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 any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. WHAT IS IN THIS LEAFLET 1. What GIOTRIF is and what it is used for 2. What you need to know before you take GIOTRIF 3. How to take GIOTRIF 4. Possible side effects 5. How to store GIOTRIF 6. Contents of the pack and other information 1. WHAT GIOTRIF IS AND WHAT IT IS USED FOR GIOTRIF is a medicine which contains the active substance afatinib. It works by blocking the activity of a group of proteins called the ErbB family (including EGFR [epidermal growth factor receptor or ErbB1], HER2 [ErbB2], ErbB3 and ErbB4). These proteins are involved in the growth and spread of cancer cells, and can be affected by changes (mutations) in the genes that produce them. By blocking the activity of these proteins this medicine can inhibit growth and spread of cancer cells. This medicine is used on its own to treat adult patients with a specific type of cancer of the lung (non-small cell lung cancer): that is identified by a change (mutation) in the gene for EGFR. GIOTRIF can be prescribed to you as your first treatment or if prior chemotherapy treatment has been insufficient. of squamous type if prior chemotherapy treatment has been insufficient. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GIOTRIF DO NOT TAKE GIOTRIF - if you are allergic to afatinib or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or p Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT GIOTRIF 20 mg film-coated tablets GIOTRIF 30 mg film-coated tablets GIOTRIF 40 mg film-coated tablets GIOTRIF 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION GIOTRIF 20 mg film-coated tablets One film-coated tablet contains 20 mg afatinib (as dimaleate). _Excipient with known effect_ One film-coated tablet contains 118 mg lactose (as monohydrate). GIOTRIF 30 mg film-coated tablets One film-coated tablet contains 30 mg afatinib (as dimaleate). _Excipient with known effect_ One film-coated tablet contains 176 mg lactose (as monohydrate). GIOTRIF 40 mg film-coated tablets One film-coated tablet contains 40 mg afatinib (as dimaleate). _Excipient with known effect_ One film-coated tablet contains 235 mg lactose (as monohydrate). GIOTRIF 50 mg film-coated tablets One film-coated tablet contains 50 mg afatinib (as dimaleate). _Excipient with known effect_ One film-coated tablet contains 294 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). GIOTRIF 20 mg film-coated tablets White to yellowish, round, biconvex and bevel-edged film-coated tablet debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other. GIOTRIF 30 mg film-coated tablets Dark blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other. GIOTRIF 40 mg film-coated tablets Light blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other. GIOTRIF 50 mg film-coated tablets Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GIOTRIF as monotherapy is indicated for the treatment of Epidermal Growth Facto Lestu allt skjalið