Vepesid 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Etoposide

Available from:

Neon Healthcare Ltd

ATC code:

L01CB01

INN (International Name):

Etoposide

Dosage:

50mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010400; GTIN: 5012712005209

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 cytostatic 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

OBJECT 1
VEPESID SOFT CAPSULES 50 MG
Summary of Product Characteristics Updated 06-Dec-2017 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
VEPESID 50 mg capsule, soft
VEPESID 100 mg capsule, soft
2. Qualitative and quantitative composition
Each capsule contains 50 mg etoposide
Each capsule contains 100 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).
Each 100 mg capsule, soft contains:
• 1.22 mg of sodium ethyl parahydroxybenzoate (E215) and
• 0.61 mg of sodium propyl parahydroxybenzoate (E217).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, Soft
Opaque pink
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 on