ONDANSETRON APOTEX TABLETS ondansetron (as hydrochloride dihydrate) 8 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron hydrochloride dihydrate, Quantity: 10 mg (Equivalent: ondansetron, Qty 8 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; hypromellose; titanium dioxide; iron oxide yellow

Administration route:

Oral

Units in package:

10, 4

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ondansetron is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

Product summary:

Visual Identification: Yellow coloured, oval biconvex, film coated tablets with 'BL' debossed on one face and '8' on the other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2019-02-01

Patient Information leaflet

ONDANSETRON-APOTEX
ONDANSETRON APOTEX
_Ondansetron hydrochloride dihydrate _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ondansetron. 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 this medicine
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 WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Ondansetron is used to treat nausea
(sick feeling) and vomiting. It
belongs to a group of medicines
called antiemetics.
This medicine works by helping to
stop the nausea and vomiting which
can occur after certain treatments.
This is a special type of tablet which
dissolves in a few seconds when
placed on the tongue. It is easier to
swallow than ordinary tablets.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
for children under the age of 4 years.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
ondansetron
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
ARE TAKING APOMORPHINE, USED TO
TREAT PARKINSON'S DISEASE.
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NO

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION —
ONDANSETRON APOTEX
(ONDANSETRON HYDROCHLORIDE DIHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Ondansetron hydrochloride dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg and 8 mg Ondansetron hydrochloride
dihydrate.
EXCIPIENTS WITH KNOWN EFFECT
Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
4 MG TABLETS:
Yellow coloured, oval biconvex, film coated tablets ‘BL’ debossed
on one face and ‘4’
debossed on the other.
8 MG TABLETS:
Yellow coloured, oval biconvex, film coated tablets ‘BL’ debossed
on one face and ‘8’
debossed on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ondansetron is indicated for the prevention and treatment of nausea
and vomiting induced
by cytotoxic therapy and radiotherapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
The emetogenic potential of cancer treatment varies according to the
doses and
combinations of chemotherapy and radiotherapy regimens used. The route
of administration
and dose of ondansetron should be flexible in the range of 8 to 32 mg
a day and selected as
shown below. The lowest effective dose should be used.
Note that other dosage forms including injection, tablets, syrup,
suppositories and wafers
can be available from other brands.
2
USE IN ADULTS
EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY
For the control of chemotherapy or radiotherapy induced emesis or
nausea in adults, two
oral doses of 8 mg each at 12 HOURLY INTERVALS may be given, the first
dose being
administered 2 hours prior to chemotherapy or radiotherapy.
To protect against delayed emesis after the first 24 hours,
ondansetron should be continued
orally at a dosage of 8 mg TWICE DAILY for up to 5 days after a course
of treatment.
HIGHLY EMETOGENIC CHEMOTHERAPY
An alternative to intravenous treatment is single oral dose of up to
24 mg ondansetron taken
with oral dexamethasone 12 mg, 1 to 2 hours before commencing
chemotherapy.
Initial treatment may be followed by oral ondansetron 8 mg 12