Consumer medicine information

Ondansetron ODT Viatris 8 mg Orally disintegrating tablets

Ondansetron

BRAND INFORMATION

Brand name

Ondansetron ODT Viatris

Active ingredient

Ondansetron

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ondansetron ODT Viatris 8 mg Orally disintegrating tablets.

What is in this leaflet


Please read this leaflet carefully before you start taking ONDANSETRON ODT VIATRIS orally disintegrating tablets.
This leaflet answers some common questions about ONDANSETRON ODT VIATRIS orally disintegrating 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 risks of you taking ONDANSETRON ODT VIATRIS orally disintegrating tablets against the benefits this medicine is expected to 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 ONDANSETRON ODT VIATRIS orally disintegrating tablets are used for


ONDANSETRON ODT VIATRIS orally disintegrating tablets belong to a group of medicines called antiemetics.
ONDANSETRON ODT VIATRIS orally disintegrating tablets work by helping to stop the nausea (sick feeling) and vomiting which can occur after certain treatments.
'Orally disintegrating' used in the product name, is the word used for the special type of tablet which dissolves in a few seconds when placed on the tongue. It is easier to swallow than ordinary tablets.
ONDANSETRON ODT VIATRIS orally disintegrating tablets should only be used to treat the nausea and vomiting for which they have been prescribed.
Your doctor may have prescribed ONDANSETRON ODT VIATRIS orally disintegrating tablets for another reason.
Ask your doctor if you have any questions about why ONDANSETRON ODT VIATRIS orally disintegrating tablets have been prescribed for you.
ONDANSETRON ODT VIATRIS orally disintegrating tablets are not addictive.

Before you take ONDANSETRON ODT VIATRIS orally disintegrating tablets

When you must not take them

  • Do not take ONDANSETRON ODT VIATRIS orally disintegrating tablets if you are taking apomorphine (used to treat Parkinson’s disease)
  • Do not take ONDANSETRON ODT VIATRIS orally disintegrating tablets if you have ever had an allergic reaction to ondansetron or any of the ingredients listed at the end of this leaflet.
    Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash ("hives") or fainting.
  • Do not take ONDANSETRON ODT VIATRIS orally disintegrating tablets if you are pregnant, trying to become pregnant or breastfeeding, unless your doctor says you should.
    Your doctor will discuss the risks and benefits of using ONDANSETRON ODT VIATRIS orally disintegrating tablets if you are pregnant or breastfeeding.
  • Do not take ONDANSETRON ODT VIATRIS orally disintegrating tablets after the expiry date (EXP) printed on the pack.
    If you take it after the expiry date has passed, it may not work as well.
  • Do not take ONDANSETRON ODT VIATRIS orally disintegrating tablets if the packaging is torn or shows signs of tampering.
  • If you're not sure whether you should be taking ONDANSETRON ODT VIATRIS orally disintegrating tablets, talk to your doctor.

Before you start to take them


You must tell your doctor if:
  • you are allergic to foods, dyes, preservatives or any other medicines.
  • you have, or used to have, liver problems
  • you suffer from severe constipation or have a blockage in your gut
  • you have phenylketonuria, as ONDANSETRON ODT VIATRIS orally disintegrating tablets contain aspartame.

Taking other medicines


Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when taking ONDANSETRON ODT VIATRIS orally disintegrating tablets with other medicines.
Use in children
There is limited experience in children. ONDANSETRON ODT VIATRIS orally disintegrating tablets can be taken by children over 4 years of age.

How to take ONDANSETRON ODT VIATRIS orally disintegrating tablets


The Pharmacist's label on the pack will tell you how to take ONDANSETRON ODT VIATRIS orally disintegrating tablets. If there is something you do not understand, ask your doctor or pharmacist.

How much to take


DO NOT take more ONDANSETRON ODT VIATRIS orally disintegrating tablets than your doctor or pharmacist tells you.
DO NOT take ONDANSETRON ODT VIATRIS orally disintegrating tablets MORE OFTEN than your doctor or pharmacist tells you.
If you vomit within one hour of taking your first ONDANSETRON ODT VIATRIS orally disintegrating tablet of each course prescribed for you, you should take the same dose again. If you continue to vomit, tell your doctor.

How to take them


PEEL BACK the foil top of the blister strip and GENTLY remove the ONDANSETRON ODT VIATRIS orally disintegrating tablet. (DO NOT try to push it through the foil top as the tablet is fragile and will break up inside the foil). Place the ONDANSETRON ODT VIATRIS orally disintegrating tablet on top of your tongue. It will disappear very quickly, then swallow as normal.

When to take them


Your doctor or pharmacist will be able to tell you when you should take your ONDANSETRON ODT VIATRIS orally disintegrating tablets.

How long to take them


Your doctor or pharmacist will be able to tell you how long you should take your ONDANSETRON ODT VIATRIS orally disintegrating tablets.

If you forget to take them


If you miss your dose and you do not feel sick take your next dose when you are meant to.
If you miss your dose, and you feel sick, take the missed dose as soon as possible, then go back to taking your ONDANSETRON ODT VIATRIS orally disintegrating tablet as you would normally. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

If you take too much (overdose)


Immediately telephone your doctor or Poisons Information Centre (telephone 131126) for advice, if you think you or anyone else may have taken too much ONDANSETRON ODT VIATRIS orally disintegrating tablets, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.

While you are taking ONDANSETRON ODT VIATRIS orally disintegrating tablets

Things you must do


Tell your doctor or pharmacist that you are taking ONDANSETRON ODT VIATRIS orally disintegrating tablets if you are about to be started on any new medicines.
Tell your doctor if you become pregnant or are trying to become pregnant.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Things you must not do


Do not stop taking ONDANSETRON ODT VIATRIS orally disintegrating tablets, or change the dose without first checking with your doctor.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use ONDANSETRON ODT VIATRIS orally disintegrating tablets to treat any other complaints unless your doctor says to.

Side effects


Check with your doctor as soon as possible if you have any problems while taking ONDANSETRON ODT VIATRIS orally disintegrating tablets, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Like other medicines, ONDANSETRON ODT VIATRIS orally disintegrating tablets can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.
The most commonly reported side-effects are:

  • headache
  • a sensation of warmth or flushing
  • mild stomach cramps
  • constipation or diarrhoea
  • dry mouth
  • hiccups
  • dizziness or light-headed feeling

Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist immediately if you notice any of the following:
  • chest pain or tightness of chest
  • changes in the way your heart beats eg if you notice it beating faster or slower than normal, or if it beats irregularly or if it 'throbs'
  • disturbance in heart rhythm (sometimes causing a sudden loss of consciousness)
  • low blood pressure
  • abnormal muscular body movements or shaking
  • involuntary upward movement of the eyes
  • unusual muscle tone causing distortion of the body
  • fits or convulsions
  • patients may experience “serotonin syndrome” (confusion, sweating, unsteadiness, shaking, diarrhoea) when ONDANSETRON ODT VIATRIS is taken with other serotonergic drugs. Serotonergic drugs can include certain types of antidepressants, opioid pain medicines such as tramadol and fentanyl, and lithium. Please note, this is not an exhaustive list. Please discuss with your pharmacist or doctor if you have any concerns.
  • Severe skin reaction where the top layer of the skin detaches from the lower layers.

If you think you are having an allergic reaction to ONDANSETRON ODT VIATRIS orally disintegrating tablets, TELL YOUR DOCTOR IMMEDIATELY or go to the casualty department at your nearest hospital. Symptoms usually include some or all of the following:
  • wheezing
  • swelling of the lips/mouth
  • difficulty in breathing
  • hay fever
  • lumpy rash ("hives")
  • fainting

This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.
If your nausea (feeling of sickness) or vomiting does not go away, ask your doctor what to do.
In certain illnesses and treatments where ondansetron has been used, blood vessel blockage has occurred.
However, it is important to note that blood vessel blockage has also occurred in these illnesses and treatments when ondansetron has NOT been used.
Discuss this with your doctor if you have any concerns.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side-effects. You may not experience any of them.

After taking ONDANSETRON ODT VIATRIS orally disintegrating tablets

Storage


Keep this medicine where young children cannot reach it.
A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.
Keep ONDANSETRON ODT VIATRIS orally disintegrating tablets in a cool, dry place where it stays below 30° C.
Do not store it, or any other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep your ONDANSETRON ODT VIATRIS orally disintegrating tablets in their pack until it is time to take them.
If taken out of their pack, they may not keep well.

Disposal


If your doctor tells you to stop taking ONDANSETRON ODT VIATRIS orally disintegrating tablets, or they have passed their expiry date, ask your pharmacist what to do with any tablets left over.

Product description

What ONDANSETRON ODT VIATRIS orally disintegrating tablets look like


ONDANSETRON ODT VIATRIS orally disintegrating tablets are white, round tablets, with “O” on one side and “4” or “8” on the other side. They come in a foil blister pack of 4 or 10 tablets, which is contained in a box. There is a 4 mg strength and an 8 mg strength.

Ingredients


ONDANSETRON ODT VIATRIS orally disintegrating tablets contain either 4 mg or 8 mg of the active ingredient ondansetron. They also contain cellulose, mannitol, starch, crospovidone, silica, guar gum, aspartame, magnesium stearate, sodium lauryl sulphate and strawberry flavour.

Sponsor


Dr. Reddy's Laboratories Australia Pty Ltd
Suite 3.03 Level 3
390 St Kilda Road
Melbourne VIC 3004
www.drreddys.com/australia
Phone: (03) 8394 1888

Distributor


Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
This leaflet was prepared in May 2023.
Australian registration numbers:
ONDANSETRON ODT VIATRIS 4 mg orally disintegrating tablets: AUST R 291494
ONDANSETRON ODT VIATRIS 8 mg orally disintegrating tablets: AUST R 291495.

BRAND INFORMATION

Brand name

Ondansetron ODT Viatris

Active ingredient

Ondansetron

Schedule

S4

 

Notes

Distributed by Alphapharm Pty Limited

1 Name of Medicine

Ondansetron.

2 Qualitative and Quantitative Composition

Ondansetron ODT Viatris 4 mg and 8 mg tablets contain the following excipients: Microcrystalline cellulose, mannitol, pregelatinised maize starch, crospovidone, aspartame, guar gum, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulphate, Strawberry Guarana 586997 AP0551.

3 Pharmaceutical Form

Ondansetron ODT Viatris 4 mg orally disintegrating tablets: White to off-white, round, biconvex, uncoated tablets embossed '4' on one side and 'O' on the other side.
Ondansetron ODT Viatris 8 mg orally disintegrating tablets: White to off-white, round, biconvex, uncoated tablets embossed '8' on one side and 'O' on the other side.

4 Clinical Particulars

4.9 Overdose

Symptoms. Little is known at present about overdosage with ondansetron, however, a limited number of patients have received overdoses. Manifestations that have been reported include visual disturbances, severe constipation, hypotension and a vasovagal episode with transient second degree AV block. In all instances, the events resolved completely.
Ondansetron prolongs QT interval in a dose-dependent fashion. ECG monitoring is recommended in cases of overdose.
Cases consistent with serotonin syndrome have been reported in young children following oral overdose.
Treatment. There is no specific antidote for ondansetron, therefore in cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Ondansetron did not induce mutations in Salmonella typhimurium, Escherichia coli or Chinese hamster ovary cells in the presence or absence of metabolic activation, and showed no potential for causing chromosomal damage in vitro in peripheral human lymphocytes or in vivo in a mouse micronucleus assay. No evidence for DNA damage was observed with ondansetron in a yeast mitotic gene conversion assay.
Carcinogenicity. No evidence for carcinogenic activity was found in two year studies at ondansetron doses up to 10 mg/kg/day by gavage in rats or up to 30 mg/kg/day via drinking water in mice.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Ondansetron is a white to off white powder with a melting point of approximately 230°C. It is insoluble in water. It is soluble in chloroform and acetic acid. The pKa of ondansetron is 10.4 at 30°C (Diluent: water and methanol in the ratio of 35:65).
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSONDANS.gif CAS number. 99614-02-5 (ondansetron).

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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