VEPESID 50 mg capsule, soft

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Etoposide

Available from:

Bristol-Myers Squibb Pharmaceuticals uc

ATC code:

L01CB; L01CB01

INN (International Name):

Etoposide

Dosage:

50 mg milligram(s)

Pharmaceutical form:

Capsule

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Podophyllotoxin derivatives; etoposide

Authorization status:

Marketed

Authorization date:

1983-10-10

Patient Information leaflet

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, 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
Talk to your doctor or pharmacist before taking VEPESID
-
if you have any INFECTIONS.
-

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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