ZILFOJIM ODT™ 4 & 8
Ondansetron 4 mg and 8 mg orally disintegrating tablets
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully before you start taking ZILFOJIM ODT.
This leaflet answers some common questions about ZILFOJIM ODT. 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 ZILFOJIM ODT 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 ZILFOJIM ODT is used for
ZILFOJIM ODT belongs to a group of medicines called antiemetics.
ZILFOJIM ODT works by helping to stop the nausea (sick feeling) and vomiting which can occur after certain treatments.
ZILFOJIM ODT should only be used to treat the nausea and vomiting for which it has been prescribed.
Your doctor may have prescribed ZILFOJIM ODT for another reason.
Ask your doctor if you have any questions about why ZILFOJIM ODT has been prescribed for you.
ZILFOJIM ODT is not addictive.
Before you take ZILFOJIM ODT
When you must not take them
- Do not take ZILFOJIM ODT if you are taking apomorphine (used to treat Parkinson's disease)
- Do not take ZILFOJIM ODT 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, hay fever, lumpy rash ("hives") or fainting.
- Do not take ZILFOJIM 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 ZILFOJIM ODT if you are pregnant or breastfeeding.
- Do not take ZILFOJIM ODT 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 ZILFOJIM ODT if the packaging is torn or shows signs of tampering.
If you're not sure whether you should be taking ZILFOJIM ODT, 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; or
- you have phenylketonuria, as ZILFOJIM ODT contains 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 ZILFOJIM ODT with other medicines.
Use in children
There is limited experience in children. ZILFOJIM ODT can be taken by children over 4 years of age.
How to take it
The Pharmacist's label on the pack will tell you how to take ZILFOJIM ODT. If there is something you do not understand, ask your doctor or pharmacist.
How much to take
DO NOT take more ZILFOJIM ODT than your doctor or pharmacist tells you.
DO NOT take ZILFOJIM ODT more often than your doctor or pharmacist tells you.
If you vomit within one hour of taking your first ZILFOJIM 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 them
PEEL BACK the foil top of the blister strip and GENTLY remove the ZILFOJIM 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 ZILFOJIM ODT 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 ZILFOJIM ODT.
How long to take them
Your doctor or pharmacist will be able to tell you how long you should take your ZILFOJIM ODT.
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 ZILFOJIM 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 take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, if you think you or anyone else may have taken too much ZILFOJIM ODT, 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 it
Things you must do
Tell your doctor or pharmacist that you are taking ZILFOJIM 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.
Things you must not do
Do not stop taking ZILFOJIM 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 ZILFOJIM ODT to treat any other complaints unless your doctor says to.
Check with your doctor as soon as possible if you have any problems while taking ZILFOJIM ODT, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Like other medicines, ZILFOJIM ODT 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:
- a sensation of warmth or flushing;
- mild stomach cramps;
- constipation or diarrhoea;
- dry mouth;
- hiccups; or
- 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 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 ZILFOJIM ODT is taken in combination with other serotonergic drugs. Serotonergic drugs can include certain types of antidepressants and opioid pain medicines; or
- 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 ZILFOJIM ODT, TELL YOUR DOCTOR IMMEDIATELY or go to the casualty department at your nearest hospital. Symptoms usually include some or all of the following:
- swelling of the lips/mouth;
- difficulty in breathing;
- hay fever;
- lumpy rash ("hives"); or
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 ZILFOJIM 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 ZILFOJIM ODT 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 it
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 ZILFOJIM ODT in a cool, dry & dark place where it stays below 25°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 ZILFOJIM ODT in their pack until it is time to take them. If taken out of their pack, they may not keep well.
If your doctor tells you to stop taking ZILFOJIM ODT, or they have passed their expiry date, ask your pharmacist what to do with any tablets left over.
What it looks like
ZILFOJIM ODT 4 & 8 (4 & 8 mg ondansetron) are presented in pack sizes* of 4, 10 & 20 tablets in blister.
ZILFOJIM ODT 4 (AUST R 196804)
White to off-white, round tablets debossed with ‘5’ on one side and ‘E’ on the other side with an embossed circular edge.
ZILFOJIM ODT 8 (AUST R 196809)
White to off-white, round tablets debossed with ‘7’ on one side and ‘E’ on the other side with an embossed circular edge.
- microcrystalline cellulose;
- colloidal anhydrous silica;
- magnesium stearate; and
- strawberry guarana 586997 AP0551.
*Some of these pack sizes are not marketed.
Sponsor/Marketing Authorisation Holder
Aurobindo Pharma Australia Pty Ltd
6 Eastern Road
Distributed by Eris Pharmaceuticals (Australia) Pty Ltd
Toll free telephone (Australia): 1800 233 588
This leaflet was prepared in September 2015
Published by MIMS December 2017