ONDANSETRON SZ ondansetron (as hydrochloride dihydrate) 8 mg film-coated tablet 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:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

Ondansetron hydrochloride dihydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; lactose monohydrate; pregelatinised maize starch; sodium starch glycollate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400

Administration route:

Oral

Units in package:

10 tablet, 6 tablet, 4 tablet

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

Product summary:

Visual Identification: Dark yellow, oval, biconvex, film coated tablets embossed 'OND' on one side and '8' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-10-28

Patient Information leaflet

ONDANSETRON SZ
1
ONDANSETRON SZ
_Ondansetron hydrochloride dihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you use ONDANSETRON SZ
tablets.
This leaflet answers some common
questions about ONDANSETRON
SZ tablets. It does not contain all of
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 expected benefits of you taking
ONDANSETRON SZ tablets against
the risks this medicine could 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 ARE
ONDANSETRON SZ
TABLETS USED FOR?
ONDANSETRON SZ tablets contain
a medicine called ondansetron. This
belongs to a group of medicines
called serotonin receptor-3
antagonists.
ONDANSETRON SZ tablets are
used to help stop the nausea (sick
feeling) and vomiting which can
occur after medical treatments.
ONDANSETRON SZ tablets should
only be used to treat the nausea and
vomiting for which they have been
prescribed.
Your doctor may have prescribed
ONDANSETRON SZ tablets for
another reason. If you want more
information, ask your doctor.
ONDANSETRON SZ tablets are not
addictive.
BEFORE YOU TAKE
ONDANSETRON SZ
TABLETS
_DO NOT TAKE IF: _
You must not take ONDANSETRON
SZ tablets if:

YOU ARE TAKING APOMORPHINE
(USED TO TREAT PARKINSON’S
DISEASE)

YOU HAVE EVER HAD AN ALLERGIC
REACTION TO ONDANSETRON OR ANY
OF THE INGREDIENTS LISTED TOWARD
THE END OF THIS LEAFLET. (SEE
"INGREDIENTS")

YOU ARE PREGNANT, TRYING TO
BECOME PREGNANT OR BREAST
FEEDING, UNLESS YOUR DOCTOR SAYS
IT IS SAFE.

THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED.

THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING
_TELL YOUR DOCTOR IF: _
You must tell your doctor if:

YOU ARE ALLERGIC TO FOODS, DYES,
PRESERVATIVES OR ANY OTHER
MEDICINES.

YOU HAVE HAD TO STOP TAKING
ANOTHER MEDICINE FOR YOUR
NAUSEA OR VOMITING.

Y

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ONDANSETRON SZ
(ONDANSETRON HYDROCHLORIDE DIHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Ondansetron hydrochloride dihydrate
2
& 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
ONDANSETRON SZ tablet contains 4 mg or 8 mg of ondansetron (as
ondansetron hydrochloride
dihydrate).
Ondansetron hydrochloride dihydrate is a white to off white powder
with a melting point of
177°C. It is sparingly soluble in water and in alcohol, soluble in
methanol and slightly soluble in
methylene chloride. It is soluble in saline (0.9% w/v) to about 8
mg/mL. The pKa of
ondansetron hydrochloride dihydrate as determined by a solubility
procedure is 7.4. The
distribution coefficient between n-octanol and water is pH dependent
with log D = 2.2 at a pH of
10.6 and log D = 0.6 at a pH of 5.95.
EXCIPIENTS WITH KNOWN EFFECT: Contains sugars (as lactose)
Ondansetron SZ 4 mg and 8 mg tablets contain the following excipients:
Lactose monohydrate,
microcrystalline cellulose, pregelatinised maize starch, magnesium
stearate, sodium starch
glycollate, colloidal anhydrous silica, Opadry Yellow 03B52375 and
Opadry Yellow 03B52246.
Ondansetron SZ 4 mg tablets: Light yellow, oval, biconvex, film coated
tablets embossed ‘OND’
on one side and ‘4’ on other side.
Ondansetron SZ 8 mg tablets: Dark yellow, oval, biconvex, film coated
tablets embossed ‘OND’
on one side and ‘8’ on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prevention and treatment of nausea and vomiting induced by cytotoxic
therapy and
radiotherapy.
4.2
D
OSE 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.
ADULTS. EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY For the control of
chemotherapy or
radiotherapy induced emesis or