Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ETOPOSIDE
Bristol-Myers Squibb (Holdings) Limited
L01CB01
ETOPOSIDE
100 Milligram
Capsules, Soft
Product subject to prescription which may not be renewed (A)
Podophyllotoxin derivatives
Transfer Pending
1981-09-08
ARTWORK PDF 1.5 ISSUE DATE 26-10-17 OPERATOR RI001 DRAFT 03 SEPARATIONS: BLACK PRODUCT CODE: 3000961A2 PRODUCT NAME: INS VEPESID CAP COUNTRY: IRLANDA BARCODE TYPE: 2/5 MEASURES (mm): 140X330 (140X165) FONT TYPE: ARIAL NARROW WGL Size: 8,5 - Spacing: 9 v.02.1-2017 Corden Pharma S.p.A. FRONT 053234 053234 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 or any of the other ingredients of this medicine (listed in section 6). • If you have recently been given a live vaccine, includin Read the complete document
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 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _5_ _/_ _1_ _1_ _/_ _2 Read the complete document