ZOFRAN ondansetron (as hydrochloride dihydrate) 8mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Aspen Pharmacare Australia Pty Ltd

Dawa fomu:

Tablet, film coated

Tungo:

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

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

15 tablets, 30 tablets, 4 tablets, 90 tablets, 10 tablets, 10 tablets foil blister pack

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Ondansetron (tablets, syrup, wafers, suppository and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy

Bidhaa muhtasari:

Visual Identification: Yellow, oval, bi-convex tablets, engraved with "GXET5" on one face and plain on the other face.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Registered

Idhini ya tarehe:

1991-04-17

Taarifa za kipeperushi

ZOFRAN
®
TABLETS
1
ZOFRAN
® TABLETS
_Ondansetron hydrochloride dihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you use Zofran Tablets.
This leaflet answers some common
questions about Zofran 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
Zofran 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 IS ZOFRAN TABLETS
USED FOR?
Zofran Tablets contain a medicine
called ondansetron. This belongs to a
group of medicines called serotonin
receptor-3 antagonists.
Zofran Tablets are used to help stop
the nausea (sick feeling) and
vomiting which can occur after
medical treatments and operations.
Zofran Tablets should only be used
to treat the nausea and vomiting for
which they have been prescribed.
Your doctor may have prescribed
Zofran Tablets for another reason. If
you want more information, ask your
doctor.
Zofran Tablets are not addictive.
BEFORE YOU TAKE
ZOFRAN TABLETS
_DO NOT TAKE IF: _
You must not take Zofran 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.
•
YOU ARE TAKING ANY OTHER
MEDICINES, INCLUDING MEDICINES
YOU BUY WITHOUT

Tabia za bidhaa

1
AUSTRALIAN PRODUCT INFORMATION
ZOFRAN (ONDANSETRON HYDROCHLORIDE DIHYDRATE) INJECTIONS, TABLETS AND
ORAL LIQUID, ZOFRAN (ONDANSETRON) SUPPOSITORIES AND
ZOFRAN ZYDIS (ONDANSETRON) WAFERS
1 NAME OF THE MEDICINE
Ondansetron hydrochloride dihydrate is the therapeutically active
ingredient in
Zofran injections, Zofran tablets and Zofran oral liquid.
Ondansetron is the therapeutically active ingredient in Zofran
suppositories and in
Zofran Zydis wafers.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Zofran 4 mg and 8 mg tablets contain 4 and 8 mg of ondansetron (as
ondansetron
hydrochloride dihydrate) and the following excipients: lactose
monohydrate,
microcrystalline cellulose, pregelatinised maize starch, magnesium
stearate,
hypromellose, titanium dioxide and iron oxide yellow.
Excipients with known effect: sugars as lactose
Zofran 24 mg tablets contain 24 mg of ondansetron (as ondansetron
hydrochloride
dihydrate) and the following excipients: lactose, microcrystalline
cellulose,
pregelatinised maize starch, magnesium stearate and Opadry Pink
YS-1-14593-A
(ARTG PI No: 3522).
Excipients with known effect: sugars as lactose
Zofran oral liquid contains 0.8 mg/mL of ondansetron (as ondansetron
hydrochloride
dihydrate) and the following excipients: citric acid, sodium citrate
dihydrate, sodium
benzoate, sorbitol solution (70 percent) (crystallising), purified
water and Strawberry
Flavouring Liquid SC887891 (ARTG PI No: 140281).
Excipients with known effect: benzoates and sorbitol (12.6g per
recommended
maximum daily dose) which may have a laxative effect or cause
diarrhoea
Zofran Zydis wafers contain 4 and 8 mg of ondansetron and the
following excipients:
gelatin, mannitol, aspartame, sodium methyl hydroxybenzoate, sodium
propyl
hydroxybenzoate and Strawberry Flavouring Liquid SC887891 (ARTG PI No:
140281).
Excipients with known effect: aspartame, hydroxybenzoates and
sulphites.
Each 2 mL Zofran injection contains 4 mg of ondansetron (as
ondansetron
hydrochloride dihydrate) and the following excipients: citric acid
monohydr