Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Etoposide
CHEPLAPHARM Arzneimittel GmbH
L01CB; L01CB01
Etoposide
100 milligram(s)
Capsule, soft
Podophyllotoxin derivatives; etoposide
Marketed
1981-09-08
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VEPESID™ 50 mg and 100 mg capsules, soft Etoposide 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 VEPESID is and what it is used for 2. What you need to know before you take VEPESID 3. How to take VEPESID 4. Possible side effects 5. How to store VEPESID 6. Contents of the pack and other information 1. WHAT VEPESID IS AND WHAT IT IS USED FOR The name of this medicine is VEPESID. Each capsule contains etoposide 50 mg or 100 mg as the active ingredient. Etoposide belongs to the group of medicines called cytostatics which are used in the treatment of cancer. VEPESID is used in the treatment of certain types of cancers in adults: - testicular cancer - small cell lung cancer - cancer of the blood (acute myeloid leukaemia) - tumour in the lymphatic system (Hodgkin’s lymphoma, non-Hodgkin’s lymphoma) - ovarian cancer The exact reason why you have been prescribed VEPESID capsules is best discussed with your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VEPESID DO NOT TAKE VEPESID: • If you are allergic to etoposide, sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217) or any of the other ingredients of this medicine (listed in section 6). • If you have recently been given a live vaccine, including yellow fever vaccine. • If you are breast-feeding or planning to breast-feed. If any of the above affects you, or if you are unsure if they do, tell your doctor who will be able to advise you. WARNINGS AND PRECAUTIONS Tal Přečtěte si celý dokument
Health Products Regulatory Authority 27 February 2024 CRN00F327 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT VEPESID 100 mg capsule, soft 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg etoposide Excipients with known effect: Each 100 mg capsule, soft contains: - 1.22 mg of sodium ethyl parahydroxybenzoate (E215) and - 0.61 mg of sodium propyl parahydroxybenzoate (E217). For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft. Opaque pink, oval, soft gelatin capsule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RECURRENT OR REFRACTORY TESTICULAR CANCER VEPESID is indicated in combination with other approved chemotherapeutic agents for the treatment of recurrent or refractory testicular cancer in adults. SMALL CELL LUNG CANCER VEPESID is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults. HODGKIN’S LYMPHOMA VEPESID is indicated in combination with other approved chemotherapeutic agents for the second line treatment of Hodgkin’s lymphoma in adults. NON-HODGKIN’S LYMPHOMA VEPESID is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory non-Hodgkin’s lymphoma in adults. ACUTE MYELOID LEUKAEMIA VEPESID is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory acute myeloid leukaemia in adults. OVARIAN CANCER VEPESID is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ovarian cancer in adults. VEPESID is indicated for the treatment of platinum-resistant/refractory epithelial ovarian cancer in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION VEPESID capsules should only be administered and monitored under the supervision of a qualified physician experienced in the use of anti-neoplastic medicinal products (see section 4.4). Health Products Regulatory Authority 27 February Přečtěte si celý dokument