ondansetron hydrochloride dihydrate injection
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully before you have Ondaz injection.
This leaflet answers some common questions about Ondaz injection.
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 receiving this medicine against the benefits they
expect it will have for you.
If you have any concerns about receiving this medicine, ask
your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What Ondaz injection is used for
Ondaz injection contains a medicine called ondansetron. This
belongs to a group of medicines called serotonin receptor-3 antagonists.
Ondaz injection is used to help stop the nausea (sick feeling)
and vomiting which can occur after medical treatments and operations.
Ondaz injection should only be used to treat the nausea and
vomiting for which it has been prescribed.
Ask your doctor if you have any questions about why this medicine
has been prescribed for you. Your doctor may have prescribed it for another reason.
This medicine is not addictive.
Before you receive Ondaz injection
When you must not receive it
Do not have this medicine if:
- you have ever had an allergic reaction to ondansetron
or to any of the other ingredients listed at the end of this leaflet
under Product description - you are pregnant, trying to become pregnant or
breastfeeding, 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
- the injection solution is coloured, cloudy or lumpy.
Before you start to receive it
You must tell your doctor if:
- you are allergic to any other medicines, foods,
preservatives or dyes - you have had to stop taking another medicine for
your nausea or vomiting - you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket
or health food shop - you have or used to have liver problems
- you are breastfeeding, pregnant or trying to become
pregnant.
Some medicines may affect the way others work. Your doctor or
pharmacist will be able to tell you what to do when having Ondaz injection
with other medicines.
How Ondaz injection will be given
Your Ondaz injection must only be given by a doctor or nurse.
Sometimes other medicines are given at the same time.
Do NOT use the injection on your own.
The clinical safety of Ondaz in children under 2 years has not
been studied.
While you are receiving Ondaz injection
Things you must not do
Do not give your medicine to anyone else, even if their symptoms
seem similar to yours.
Do not use Ondaz injection to treat any other complaints unless
your doctor says to.
Side effects
Check with your doctor as soon as possible if you think you
are experiencing any side effects or allergic reactions due to Ondaz
injection, even if the problem is not listed below. Like other medicines, Ondaz injection 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.
Do not be alarmed by the following lists of possible side
effects. You may not experience any of them.
The most commonly reported side-effects are:
- headache
- a sensation of warmth or flushing
- mild stomach cramps
- constipation or diarrhoea
- dry mouth
- hiccups.
These are all mild side effects. There is no immediate reason
to stop having your injection 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
- blurred vision
- dizziness.
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.
If your nausea (feeling of sickness) or vomiting does not go
away, ask your doctor what to do.
In certain illnesses and treatments where Ondaz 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 Ondaz injection has 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 receiving Ondaz injection
Storage
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.
Keep your medicine in a cool dry place where the temperature
stays below 30°C and keep it away from bright sunlight.
Do not store Ondaz injection 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 Ondaz injection ampoules in their blister pack until time
to use it.
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.
Product description
What it looks like
Each ampoule contains ondansetron in 2mL or 4mL clear aqueous
solution.
Each pack of Ondaz injection 4mg/2mL will contain five ampoules.
Each pack of Ondaz injection 8mg/4mL will contain one or five
ampoules.
Ingredients
Active ingredients:
Ondaz Injection 4mg – 4mg ondansetron as ondansetron
hydrochloride dihydrate
Ondaz injection 8mg – 8mg ondansetron as ondansetron
hydrochloride dihydrate.
Your doctor will decide which strength you need.
Inactive ingredients:
- citric acid
- sodium citrate
- sodium chloride.
Supplier
Ondaz injection is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
Level 4, 100 Harris
St
Pyrmont NSW 2009
Tel: 1800 634 500
Where to go for further information
Pharmaceutical companies are not in a position
to give people an individual diagnosis or medical advice. Your doctor
or pharmacist is the best person to give you advice on the treatment
of your condition.
This leaflet was revised in January 2009.
Australian Register Numbers
4mg/2mL injection: AUST R 116420
8mg/4mL injection: AUST R 116425
Published by MIMS May 2009