Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Navoban.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from www.novartis.com.au. Those updates may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you having this medicine against the benefits they expect it will provide.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Navoban is used for
Navoban is used to prevent nausea (feeling sick) and vomiting caused by surgery and by cancer chemotherapy.
The active ingredient in Navoban is tropisetron. It works by stopping the action of a substance in the body called SEROTONIN that is thought to cause the nausea and vomiting.
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.
Navoban is only available with a doctor's prescription. It is not addictive.
There is not enough information to recommend its use in children.
Before you have Navoban
When you must not have it
Do not have Navoban if you have ever had an allergy to:
tropisetron (the active ingredient in Navoban)
any of the other ingredients listed at the end of this leaflet
similar medicines such as ondansetron and dolasetron
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 have Navoban if you are pregnant.
There is not enough information to recommend its use during pregnancy.
Do not breast-feed while you are having Navoban.
It is not known if the active ingredient in Navoban passes into breast milk and could affect your baby.
Do not have Navoban after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
In that case, return it to your pharmacist.
Before you start to have it
Tell your doctor if you have any of the following health problems / medical conditions:
high blood pressure that is not controlled
Your doctor may want to take special precautions if you have any of the above conditions.
Tell your doctor if you are lactose intolerant.
Navoban capsules contain lactose.
Tell your doctor if you have allergies to any other medicines, foods, dyes or preservatives.
Your doctor will want to know if you are prone to allergies.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Navoban may interfere with each other. These include:
some medicines for your heart
any medicine that has caused problems with your heart rhythm since this effect could be worsened
serotonergic drugs such as antidepressants
You may need to take different amounts of your medicines or to take different medicines while you are having Navoban. Your doctor and pharmacist have more information.
Tell your doctor if you are taking other serotonergic drugs. Serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) has been described following the concomitant use of tropisetron (active ingredient in NAVOBAN) and other serotonergic drugs including selective serotonin re-uptake inhibitors (SNRIs).
If you have not told your doctor about any of these things, tell him/her before you start having this medicine.
How Navoban is used
Follow all directions given to you by your doctor and pharmacist carefully.
These directions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
For nausea and vomiting caused by surgery
A single 2 mg dose is usually given by injection or through an intravenous drip shortly before surgery. If nausea and vomiting happen after surgery, a 2 mg dose of Navoban can be given at that time.
For nausea and vomiting caused by chemotherapy
A single 5 mg dose of Navoban is usually given by injection or through an intravenous drip shortly before chemotherapy is started.
This is followed by a 5 mg dose of Navoban each morning for up to 5 more days, usually taken by mouth in the form of a capsule.
Sometimes a medicine called dexamethasone is given along with Navoban to improve the control of nausea and vomiting.
How to take the capsule
Take the capsule with a full glass of water immediately after getting up in the morning. Wait at least an hour before you have breakfast.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the one that you missed.
This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you have too much (Overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have had too much Navoban. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy.
At very high doses, some people may have visual hallucinations (see things that are not there). People with high blood pressure may have their blood pressure raised even higher.
While you are having Navoban
Things you must do
Before having any surgery that requires general anaesthesia, tell the anaesthetist or the doctor in charge that you are having Navoban.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are having Navoban.
Tell any other doctor, dentist or pharmacist who treats you that you are having Navoban.
Things you must not do
Do not give this medicine to anyone else, even if their condition seems similar to yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to be alert until you know how Navoban affects you.
This medicine may cause dizziness or tiredness in some people. If you have any of these symptoms, do not drive or do anything else that could be dangerous.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are having Navoban.
All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects.
Some symptoms may be caused by your medical condition or by other treatments (e.g. surgery or chemotherapy) rather than by this medicine.
Do not be alarmed by these lists of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor immediately if you notice any of the following:
changes in your heart beat
signs of allergy such as rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing
tight feeling in the chest
The above list includes serious side effects which may require medical attention. These side effects are rare.
Tell your doctor if you notice any of the following and they worry you:
dizziness or light-headededness
loss of appetite
Tell your doctor if you notice anything else that is making you feel unwell.
Some people may have other side effects not yet known or mentioned in this leaflet. Some side effects will only be found by laboratory testing (e.g. changes in your heart rhythm on an electrocardiogram).
After having Navoban
Keep your medicine in the original container until it is time to have it.
Store it in a cool dry place.
Do not store Navoban or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Keep this medicine 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.
If your doctor tells you to stop having Navoban or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
Navoban 2 mg/2mL and 5mg/5mL solution for injection is supplied in glass ampoules containing a clear, colourless or faintly yellow-brown solution; packs of 1 or 10 ampoules.
Navoban 5 mg capsules are yellow and white capsules marked with 'NVR' and 'EA 5mg' in red; blister packs of 2, 5 or 50 capsules.
Navoban ampoules contain 2 mg or 5 mg of the active ingredient, tropisetron hydrochloride. They also contain:
water for injections
Navoban capsules contain 5 mg of the active ingredient, tropisetron hydrochloride. They also contain:
iron oxide yellow
The red printing ink is TekPrint SW-1102 Red Ink.
Navoban capsules do not contain sucrose, gluten, tartrazine or any other azo dyes.
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Telephone 1 800 671 203
(R) = Registered Trademark
This leaflet was prepared in
Australian Registration Number.
2 mg/2 mL solution for injection ampoule AUST R 58550
5 mg/5 mL solution for injection ampoule AUST R 47517
5 mg hard capsule AUST R 47518
Navoban is no longer supplied in Australia.
(nav260814c.doc based on PI nav260814i.doc)