VEPESID etoposide 100mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

etoposide, Quantity: 100 mg

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: iron oxide red; Gelatin; purified water; glycerol; sodium propyl hydroxybenzoate; citric acid; sodium ethyl hydroxybenzoate; titanium dioxide; macrogol 400

Administration route:

Oral

Units in package:

10 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1 - small cell carcinoma of the lung 2 - acutre monocytic and myelomoncytic leukaemia 3 - Hodgkins disease 4 - Non-Hodgkins lymphoma INDICATIONS AS AT 5 OCTOBER 2000: In the treatment of: 1. Small cell carcinoma of the lung. 2. Acute monocytic and myelomonocytic leukaemia. 3. Hodgkin's disease. 4. Non-Hodgkin's lymphoma.

Product summary:

Visual Identification: Opaque, pink, oval, soft gelatin capsules diameter 10mm, length 24mm; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-07-12

Patient Information leaflet

VEPESID
®
1
VEPESID
®
_etoposide (e-TOE-poe-side) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VEPESID. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking VEPESID
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT VEPESID IS USED
FOR
VEPESID is used to treat lung
cancer, leukaemia (blood cancer) and
cancer of the lymph glands.
VEPESID contains ETOPOSIDE, an
anti-cancer medicine. It interferes
with the development of cells and
causes cell death, particularly in
cancer cells.
VEPESID may be used alone or in
combination with other medicines to
treat cancer. Your doctor will inform
you if this is necessary.
Your doctor may have prescribed
VEPESID for another reason. Ask
your doctor if you have any questions
about why VEPESID was prescribed
for you.
BEFORE YOU ARE GIVEN
VEPESID
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT TAKE VEPESID IF YOU HAVE
AN ALLERGY TO VEPESID, OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET, UNLESS YOU HAVE
DISCUSSED IT WITH YOUR DOCTOR.
Symptoms of an allergic reaction
may include:
•
chills/fever
•
fast heart beat
•
difficulty in breathing, shortness
of breath
•
dizziness or lightheadedness
DO NOT TAKE VEPESID IF YOU HAVE,
OR HAVE HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS, UNLESS YOU
HAVE DISCUSSED IT WITH YOUR DOCTOR:
•
liver problems
•
kidney problems
•
your immune system is not
working properly (you get a lot of
infections requiring treatment
with antibiotics)
•
a blood disorder with a reduced
number of white blood cells
•
a blood disorder in which there is
a decreased number of red blood
cells
•
a blood disorder with a low blood
platelet count
•
lowered immunity due to
treatment with medicines such as

Summary of Product characteristics

VEPESID PI V7.0
1
AUSTRALIAN PRODUCT INFORMATION - VEPESID
(ETOPOSIDE)
1
NAME OF MEDICINE
Etoposide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VEPESID capsules contain 50 or 100 mg etoposide.
Excipients with known effect:
Each 50 mg capsule contains 930 mcg of sodium ethyl hydroxybenzoate
and 470 mcg sodium
propyl hydroxybenzoate.
Each 100 mg capsule contains 1.22 mg of sodium ethyl hydroxybenzoate
and 610 mcg sodium
propyl hydroxybenzoate.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Opaque, pink, soft gelatin capsule.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS_ _
VEPESID (etoposide) is indicated for use in the treatment of:
1.
Small cell carcinoma of the lung.
2.
Acute monocytic and myelomonocytic leukaemia.
3.
Hodgkin's disease.
4.
Non-Hodgkin's lymphoma.
4.2
DOSE AND METHOD OF ADMINISTRATION_ _
Biological activity appears to be schedule dependent with multiple
dosage over 3-5 days
showing superiority over single dose administration.
ADULT
Absorption from the oral route is variable (range 17-74% of
intravenous dose in one trial,
25-80% in another, the corresponding means being 50 and 53%).
Dosages should be titrated to achieve maximum therapeutic effect and
to minimise toxicity.
The suggested starting dose is approximately 100-200 mg/m
2
/day on days 1 to 5.
Dosage should be modified to take into account the myelosuppressive
effects of other drugs in
the combination or the effects of prior X-ray therapy or chemotherapy,
which may have
compromised bone marrow reserve.
VEPESID PI V7.0
2
Total dose should not exceed 650 mg/m
2
per course.
Capsules should be taken on an empty stomach.
PAEDIATRIC
Specific paediatric dosages have not been evaluated.
USE IN THE ELDERLY
As for adults. However see Section 4.2 DOSE AND METHOD OF
ADMINISTRATION
Impaired Liver Function and Impaired Renal Function.
IMPAIRED LIVER FUNCTION
There are indications that patients with severely impaired liver
function (as expressed by an
elevation of serum bilirubin above 85 micromoles/L and