Consumer medicine information

Zotren ODT 4 & 8

Ondansetron

BRAND INFORMATION

Brand name

Zotren ODT

Active ingredient

Ondansetron

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Zotren ODT 4 & 8.

ZOTREN ODT 4 & 8

ZOTREN ODT 4 & 8

 Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

 1. Why am I using ZOTREN ODT?

ZOTREN ODT 4 & 8 contains the active ingredient Ondansetron. ZOTREN ODT 4 & 8 works by helping to stop the nausea (sick feeling) and vomiting which can occur after certain treatments.

For more information, see Section 1. Why am I using ZOTREN ODT? in the full CMI.

 2. What should I know before I use ZOTREN ODT?

Do not use if you have ever had an allergic reaction to ZOTREN ODT or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use ZOTREN ODT? in the full CMI.

 3. What if I am taking other medicines?

Some medicines may interfere with ZOTREN ODT and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

 4. How do I use ZOTREN ODT?
  • The Pharmacist's label on the pack will tell you how to take ZOTREN ODT. If there is something you do not understand, ask your doctor or pharmacist.
  • PEEL BACK the foil top of the blister strip and GENTLY remove the ZOTREN ODT. (DO NOT try to push it through the foil top as the tablet is fragile and will break up inside the foil). Place the ZOTREN ODT on top of your tongue. It will disappear very quickly, then swallow as normal.

More instructions can be found in Section 4. How do I use ZOTREN ODT? in the full CMI.

 5. What should I know while using ZOTREN ODT?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using ZOTREN ODT.
  • Tell your doctor if you become pregnant or are trying to become pregnant.
  • Take this medicine exactly as prescribed so that it will work properly and to prevent unwanted side effects.
Things you should not do
  • Do not stop using this medicine 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 ZOTREN ODT to treat any other complaints unless your doctor says to.
Driving or using machines
  • Be careful driving, operating machinery while you are taking ZOTREN ODT until you know how it affects you.
Looking after your medicine
  • Keep ZOTREN ODT in a cool, dry & dark place where it stays below 25°C.
  • Keep your ZOTREN ODT in their pack until it is time to take them. If taken out of their pack, they may not keep well.

For more information, see Section 5. What should I know while using ZOTREN ODT? in the full CMI.

 6. Are there any side effects?

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

ZOTREN ODT 4 & 8

Active ingredient(s): Ondansetron

 Consumer Medicine Information (CMI)

This leaflet provides important information about using ZOTREN ODT. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ZOTREN ODT.

Where to find information in this leaflet:

1. Why am I using ZOTREN ODT?
2. What should I know before I use ZOTREN ODT?
3. What if I am taking other medicines?
4. How do I use ZOTREN ODT?
5. What should I know while using ZOTREN ODT?
6. Are there any side effects?
7. Product details

 1. Why am I using ZOTREN ODT?

ZOTREN ODT contains the active ingredient ondansetron. ZOTREN ODT belongs to a group of medicines called antiemetics. ZOTREN ODT works by helping to stop the nausea (sick feeling) and vomiting which can occur after certain treatments.

ZOTREN ODT should only be used to treat the nausea and vomiting for which it has been prescribed.

Your doctor may have prescribed ZOTREN ODT for another reason. Ask your doctor if you have any questions about why ZOTREN ODT has been prescribed for you.

ZOTREN ODT is not addictive.

 2. What should I know before I use ZOTREN ODT?

Warnings

Do not use ZOTREN ODT if:

  • you are taking apomorphine (used to treat Parkinson's disease)
  • you are allergic to ondansetron, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

  • 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; or
  • you have phenylketonuria, as ZOTREN ODT contains aspartame.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not take ZOTREN ODT 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 ZOTREN ODT if you are pregnant or breastfeeding.

 3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your 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 ZOTREN ODT with other medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ZOTREN ODT.

 4. How do I use ZOTREN ODT?

How much to take

  • The Pharmacist's label on the pack will tell you how to take ZOTREN ODT. If there is something you do not understand, ask your doctor or pharmacist.
  • DO NOT take more ZOTREN ODT than your doctor or pharmacist tells you.
  • DO NOT take ZOTREN ODT more often than your doctor or pharmacist tells you.
  • If you vomit within one hour of taking your first ZOTREN ODT of each course prescribed for you, you should take the same dose again. If you continue to vomit, tell your doctor.

How to take ZOTREN ODT

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

When to use ZOTREN ODT

  • Your doctor or pharmacist will be able to tell you when you should take your ZOTREN ODT.

If you forget to use ZOTREN ODT

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 ZOTREN ODT 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 use too much ZOTREN ODT

If you think that you have used too much ZOTREN ODT, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

 5. What should I know while using ZOTREN ODT?

Things you should do

Tell your doctor or pharmacist that you are taking ZOTREN ODT 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.

Remind any doctor, dentist or pharmacist you visit that you are using ZOTREN ODT.

Things you should not do

  • Do not stop taking ZOTREN ODT, 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 ZOTREN ODT to treat any other complaints unless your doctor says to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ZOTREN ODT affects you.

Looking after your medicine

  • Keep your ZOTREN ODT in their pack until it is time to take them.
  • If taken out of their pack, they may not keep well

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

If your doctor tells you to stop taking ZOTREN ODT or it is out of date.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

 6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • Headache;
  • A sensation of warmth or flushing;
  • Mild stomach cramps;
  • Constipation or diarrhoea;
  • Dry mouth;
  • Hiccups; or
  • Dizziness or light-headed feeling.
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • Chest pain or tightness of chest;
  • Changes in the way your heart beats e.g. 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 ZOTREN ODT is taken in combination with other serotonergic drugs. Serotonergic drugs can include certain types of antidepressants and 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 ZOTREN ODT, 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"); or
  • Fainting.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious 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 ZOTREN ODT 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 ZOTREN ODT has NOT been used. Discuss this with your doctor if you have any concerns.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

 7. Product details

This medicine is only available with a doctor's prescription.

What ZOTREN ODT contains

Active ingredient
(main ingredient)		Ondansetron
Other ingredients
(inactive ingredients)
  • mannitol;
  • crospovidone;
  • lactose monohydrate;
  • microcrystalline cellulose;
  • aspartame;
  • colloidal anhydrous silica;
  • magnesium stearate; and
  • strawberry guarana
    586997 AP0551.
Potential allergensThis medicine contains lactose and aspartame.

Do not take this medicine if you are allergic to any of these ingredients.

What ZOTREN ODT looks like

ZOTREN ODT 4: White to off-white, round tablets debossed with ‘5’ on one side and ‘E’ on the other side with an embossed circular edge. (Aust R 287603).

ZOTREN ODT 8: White to off-white, round tablets debossed with ‘7’ on one side and ‘E’ on the other side with an embossed circular edge. (AUST R 287604)

Who distributes ZOTREN ODT

Arrow Pharma Pty Ltd
15-17 Chapel Street
Cremorne, Victoria 3121
Australia

This leaflet was prepared in September 2023.

Published by MIMS October 2023

BRAND INFORMATION

Brand name

Zotren ODT

Active ingredient

Ondansetron

Schedule

S4

 

1 Name of Medicine

Ondansetron.

2 Qualitative and Quantitative Composition

Zotren ODT is available as orally disintegrating tablets containing 4 mg and 8 mg ondansetron.
Excipient of known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Zotren ODT 4. White to off-white, round tablets debossed with '5' on one side and 'E' on the other side with an embossed circular edge.
Zotren ODT 8. White to off-white, round tablets debossed with '7' on one side and 'E' on the other side with an embossed circular edge.

4 Clinical Particulars

4.9 Overdose

Little is at present known about overdosage with ondansetron, however, a limited number of patients 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. There is no specific antidote for ondansetron, therefore in cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate.
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.
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

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSONDANS.gif Active ingredient: Ondansetron.
Chemical name: 3RS-1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl) methyl]-4H-carbazol-4-one.
Molecular weight: 293.4.
Molecular formula: C18H19N3O.
It is a white to off-white powder. Ondansetron is very soluble in acid solution, practically insoluble in water.
CAS number. 99614-02-5.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ZOTRENST.gif