VEPESID 50 mg Milligram Capsule
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
29-11-2017
Summary of Product characteristics
(SPC)
29-11-2017
Active ingredient:
ETOPOSIDE
Available from:
Bristol-Myers Squibb (Holdings) Limited
ATC code:
L01CB01
INN (International Name):
ETOPOSIDE
Dosage:
50 mg Milligram
Pharmaceutical form:
Capsule
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Podophyllotoxin derivatives
Authorization status:
Transfer Pending
Authorization date:
1983-10-10
Patient Information leaflet
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
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
VEPESID 50 mg capsule, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg etoposide
Excipients with known effect:
Each 50 mg capsule, soft contains:
0.93 mg of sodium ethyl parahydroxybenzoate (E215) and
0.47 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
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