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Ondansetron (as hydrochloride dihydrate)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Ondansetron Tabs Pfizer.

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 Ondansetron Tabs Pfizer against the benefits it 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 Tabs Pfizer is used for

Ondansetron Tabs Pfizer contains a medicine called ondansetron. This belongs to a group of medicines called serotonin receptor-3 antagonists.

Ondansetron Tabs Pfizer are used to help stop the nausea (sick feeling) and vomiting which can occur after medical treatments and operations.

Ondansetron Tabs Pfizer should only be used to treat the nausea and vomiting for which they have been prescribed.

Your doctor may have prescribed Ondansetron Tabs Pfizer for another reason. If you want more information, ask your doctor.

Ondansetron Tabs Pfizer is not addictive.

Before you take Ondansetron Tabs Pfizer

When you must not take it

Do not take Ondansetron Tabs Pfizer if you have an allergy to:

  • any medicine containing ondansetron, or
  • any of the ingredients listed at the end of this leaflet. (See ‘Ingredients’)

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 pregnant or breastfeeding, unless your doctor says it is safe.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor. Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when taking ONDANSETRON TABS PFIZER with other medicines.

How to take Ondansetron Tabs Pfizer

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how many tablets you need to take each day. This may depend on your age, your condition and whether or not you are taking any other medicines.

Do NOT take MORE TABLETS than your doctor or pharmacist tells you.

Do NOT take the tablets MORE OFTEN than your doctor or pharmacist tells you.

If you vomit within one hour taking your first Ondansetron Tabs Pfizer of each course prescribed to you, you should take the same dose again. If you continue to vomit, tell your doctor.

How to take it

Swallow the tablets whole with a full glass of water. Do not crush the tablet. If you have trouble swallowing your tablet, please tell your doctor.

How long to take it

Do not stop taking Ondansetron Tabs Pfizer, or change the dose without first checking with your doctor.

If you forget to take it

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 then missed dose as soon as possible, then go back to take your Ondansetron Tabs Pfizer 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 Australia 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Ondansetron Tabs Pfizer.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking Ondansetron Tabs Pfizer

Things you must do

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed. Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

Things you must not do

Do not give Ondansetron Tabs Pfizer to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if they have the same condition as you.

Side effects

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking Ondansetron Tabs Pfizer, even if the problem is not listed below. Like other medicines, Ondansetron Tabs Pfizer 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:

These are all mild side effects. There is no immediate reason to stop taking your tablets unless you are concerned.

Tell your doctor immediately if you notice any of the following:

  • ‘wheezy’ symptoms
  • chest pain or tightness of the 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’
  • low blood pressure
  • fits or convulsions
  • swelling of the eyelids, face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
  • skin rash, skin lumps or hives

These are all serious side effects. You may need urgent medical attention. Serious side effects are rare. 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.

Do not be alarmed by the list of side effects. You may not experience any of them.

If you nausea (feeling of sickness) or vomiting does not go away, ask your doctor what to do. In certain illnesses and treatments where Ondansetron Tabs Pfizer 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 Tabs Pfizer have NOT been used. Discuss this with your doctor if you have any concerns.

If you feel unwell or have any symptoms that you do not understand, you should tell your doctor immediately.

After taking Ondansetron Tabs Pfizer

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store Ondansetron Tabs Pfizer or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Return any unused or expired medicine to your pharmacist.

Product description

What it looks like

Ondansetron Tabs Pfizer (4 and 8 mg ondansetron as hydrochloride dihydrate) are presented in pack size of 4*, 10, 30* and 90* tablets in blister pack. Include colour, markings, any tablet scoring, colour and consistency of liquids, pack sizes, etc.

* Pack size not available in Australia

ONDANSETRON TABS PFIZER 4 mg
White to off-white, oval shaped, film coated tablets debossed with ‘E’ on one side and ’01’ on the other side.

ONDANSETRON TABS PFIZER 8 mg
Yellow coloured, oval shaped, film coated tablets debossed with ‘E’ on one side and ’02’ on the other side.

Ingredients

Active Ingredient:
Ondansetron hydrochloride dihydrate.
Each tablet contains either 4 mg or 8 mg of ondansetron (as hydrochloride dihydrate).

It also contains:

  • Lactose anhydrous
  • Cellulose microcrystalline
  • Magnesium stearate
  • Starch – pregelatinised maize
  • The 4 mg tablet also contains glycerol triacetate, titanium dioxide and hypromellose.
  • The 8 mg tablet also contains Opadry yellow 03K52033 (PI – ARTG No. 106488).

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Ondansetron Tabs Pfizer is supplied in Australia by: 
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Australia
Toll Free number: 1800 675 229

Australian registration numbers

  • 4 mg tablet: AUST R 173186
  • 8 mg tablet: AUST R 173187

Date of preparation

This leaflet was prepared in January 2012

® = Registered Trademark

Published by MIMS May 2012

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