VEPESID 50 mg capsule, soft

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Etoposide

Fáanlegur frá:

CHEPLAPHARM Arzneimittel GmbH

ATC númer:

L01CB; L01CB01

INN (Alþjóðlegt nafn):

Etoposide

Skammtar:

50 milligram(s)

Lyfjaform:

Capsule, soft

Lækningarsvæði:

Podophyllotoxin derivatives; etoposide

Leyfisstaða:

Marketed

Leyfisdagur:

1983-10-10

Upplýsingar fylgiseðill

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

Vara einkenni

Health Products Regulatory Authority
27 February 2024
CRN00F327
Page 1 of 11
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
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 20