Patient leaflet - Ondansetron Enexi 2 mg/ml solution for injection/infusion
1. What Ondansetron Enexi 2 mg/ml is and what it is used for
Ondansetron Enexi 2 mg/ml contains a medicine called ondansetron. This belongs to a group of medicines called anti-emetics.
Ondansetron Enexi 2 mg/ml is used for:
- preventing nausea and vomiting caused by chemotherapy (in adults and children) or radiotherapy for cancer (adults only)
- preventing nausea and vomiting after surgery.
Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.
2. What you need to know before you are given Ondansetron Enexi 2 mg/ml
Do not have Ondansetron Enexi 2 mg/ml if:
- you are taking apomorphine (used to treat Parkinson's disease)
you are allergic (hypersensitive) to ondansetron or any of the other ingredients in Ondansetron
Enexi 2 mg/ml (listed in Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before having Ondansetron Enexi 2 mg/ml. Warnings and precautions
Check with your doctor, nurse or pharmacist before having Ondansetron Enexi 2 mg/ml if:
- you have ever had heart problems (e.g. congestive heart failure which causes shortness of breath and swollen ankles)
- you have an uneven heart beat (arrhythmias)
- you are allergic to medicines similar to ondansetron, such as granisetron or palonosetron
- you have liver problems
- you have a blockage in your gut
- you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Ondansetron Enexi 2 mg/ml.
Other medicines and Ondansetron Enexi 2 mg/ml
Please tell your doctor, nurse or pharmacist if you are taking, or have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Ondansetron Enexi 2 mg/ml can affect the way some medicines work. Also, some other medicines can affect the way Ondansetron Enexi 2 mg/ml works. In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
- carbamazepine or phenytoin used to treat epilepsy
- rifampicin used to treat infections such as tuberculosis (TB)
- antibiotics such as erythromycin or ketoconazole
- anti-arrhythmic medicines used to treat an uneven heart beat
- beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines
- tramadol, a pain killer
- medicines that affect the heart (such as haloperidol or methadone)
- cancer medicines (especially anthracyclines and trastuzumab).
- SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, uvoxamine, citalopram, escitalopram
- SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before having Ondansetron Enexi 2 mg/ml.
Ondansetron Enexi 2 mg/ml should not be given in the same syringe or infusion (drip) as any other medication.
Tell your doctor or pharmacist immediately if you get any of these symptoms during and after the treatment with Ondansetron Enexi 2 mg/ml
if you experience sudden chest pain or chest tightness (myocardial ischemia). Pregnancy and breast-feeding
Only use during the first trimester of pregnancy after discussion with your doctor of the potential benefits and risks to you and your unborn baby of the different treatment options. This is because Ondansetron Enexi 2 mg/ml can slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or the roof of the mouth). If you are already pregnant, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before having Ondansetron Enexi 2 mg/ml. If you are a woman of childbearing potential you may be advised to use effective contraception. Do not breast-feed if you have Ondansetron Enexi 2 mg/ml. This is because small amounts pass into the mother's milk. Ask your doctor or midwife for advice. Driving and using machines
Ondansetron has no or negligible effect on the ability to drive or use machines. Ondansetron Enexi 2 mg/ml contains sodium
This medicine contains 3.60 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.18 % of the recommended maximum daily dietary intake of sodium for an adult.
3. How to use Ondansetron Enexi 2 mg/ml
Ondansetron Enexi 2 mg/ml is normally given by a nurse or doctor. The dose you have been prescribed will depend on the treatment you are having.
To prevent nausea and vomiting from chemotherapy or radiotherapy in adults On the day of chemotherapy or radiotherapy
- the usual adult dose is 8 mg given by a slow injection into your vein or muscle, just before your treatment, and another 8 mg twelve hours later. After chemotherapy, your medicine will usually be given by mouth as an 8 mg Ondansetron tablet or 10 ml (8 mg) Ondansetron syrup. On the following days
- the usual adult dose is one 8 mg tablet or 10 ml (8 mg) syrup taken twice a day
- this may be given for up to 5 days.
If your chemotherapy or radiotherapy is likely to cause severe nausea and vomiting, you may be given more than the usual dose of Ondansetron Enexi 2 mg/ml. Your doctor will decide this. To prevent nausea and vomiting from chemotherapy in children aged over 6 months and adolescents
The doctor will decide the dose depending on the child's size (body surface area) or weight. Look at the label for more information
On the day of chemotherapy
- the first dose is given by an injection in to the vein, just before your child's treatment. After chemotherapy, your child's medicine will usually be given by mouth twelve hours later, as Ondansetron syrup or a Ondansetron tablet.
On the following days
- 2.5 ml (2 mg) syrup twice a day for small children and those weighing 10 kg or less
one 4 mg tablet or 5 ml (4 mg) syrup twice a day for larger children and those weighing more than
10 kg
two 4 mg tablets or 10 ml (8 mg) syrup twice a day for teenagers (or those with a large body
surface area)
- these doses can be given for up to five days
To prevent and treat nausea and vomiting after an operation
Adult:
The usual dose for adults is 4 mg given by a slow injection into your vein or an injection into your
muscle. For prevention, this will be given just before your operation.
Children:
For children aged over 1 month and adolescents the doctor will decide the dose. The maximum
dose is 4 mg given as a slow injection into the vein. For prevention, this will be given just before the operation.
Patients with moderate or severe liver problems.
The total daily dose should not be more than 8 mg.
If you keep feeling or being sick
Ondansetron Enexi 2 mg/ml should start to work soon after having the injection. If you continue to be sick or feel sick, tell your doctor or nurse.
If you have more Ondansetron Enexi 2 mg/ml than you should
Your doctor or nurse will give you or your child Ondansetron Enexi 2 mg/ml so it is unlikely that you or your child will receive too much. If you think you or your child have been given too much or have missed a dose, tell your doctor or nurse.
4. Possible side effects
Like all medicines, Ondansetron Enexi 2 mg/ml can cause side effects, although not everybody gets them.
Some side effects could be serious
Stop taking Ondansetron Enexi 2 mg/ml and seek medical help immediately if you or your child experience any of the following:
Allergic reactions
- sudden wheezing and chest pain or chest tightness
- swelling of your eyelids, face, lips, mouth or tongue
- skin rash - red spots or lumps under your skin (hives) anywhere on your body
- collapse.
Myocardial ischemia
Signs include:
- sudden chest pain or
- chest tightness
Other side effects include:
Very common (may affect more than 1 in 10 people)
- headache.
Common (may affect up to 1 in 10 people)
- a feeling of warmth or flushing
- constipation
changes to liver function test results (if you have Ondansetron Enexi 2 mg/ml with a medicine
called cisplatin, otherwise this side effect is uncommon)
- irritation and redness at the site of injection.
Uncommon (may affect up to 1 in 100 people)
- hiccups
- low blood pressure, which can make you feel faint or dizzy
- uneven heart beat
- chest pain
- fits
- unusual body movements or shaking.
Rare (may affect up to 1 in 1,000 people)
- feeling dizzy or light headed
- blurred vision
- disturbance in heart rhythm (sometimes causing a sudden loss of consciousness) Very rare (may affect up to 1 in 10,000 people)
- poor vision or temporary loss of eyesight, which usually comes back within 20 minutes. Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Ondansetron Enexi 2 mg/ml
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the ampoule label and carton. The expiry date refers to the last day of that month.
Keep the ampoules in the outer carton, in order to protect from light.
Injection:
After first opening the medicinal product should be used immediately.
Infusion:
Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C and 2-8ºC with the solutions given in section 6.6 of the SPC.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.
The diluted solutions should be stored protected from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ondansetron Enexi 2 mg/ml contains
The active substance is ondansetron.
Each ampoule with 2 ml contains 4 mg ondansetron.
Each ampoule with 4 ml contains 8 mg ondansetron.
Each milliliter contains 2 mg ondansetron as ondansetron hydrochloride dihydrate. The other ingredients are sodium chloride, citric acid monohydrate, sodium citrate and water for injections.
What Ondansetron Enexi 2 mg/ml looks like and contents of the pack
Ondansetron Enexi 2 mg/ml is a clear and colourless solution.
Use only clear and colourless solutions.
For single use only.
It is available in colourless glass ampoules containing 2 ml or 4 ml solution for injection/ infusion. Pack sizes: 5 or 10 ampoules.
Marketing Authorisation Holder and Manufacturer
Enexi Healthcare
20-22 Wenlock Road, London, N1 7GU, United Kingdom
Manufacturer
SIA "Unifarma",
23, Vangazu Street
Riga, LV-1024
Latvia.
Liquidsun Pharma LTD
Meadow Park Industrial Estate
Bourne Road, Essendine
Stamford, PE9 4LT
United Kingdom
This leaflet was last revised in 08/2026
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The following information is only intended for healthcare professionals only: Chemotherapy and Radiotherapy induced nausea and vomiting
Adults
The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of Ondansetron should be flexible in the range of 8-32 mg a day and selected as shown below.
Emetogenic chemotherapy and radiotherapy: Ondansetron can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration. For most patients receiving emetogenic chemotherapy or radiotherapy, Ondansetron 8 mg should be administered as a slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before treatment, followed by 8 mg orally twelve hourly. To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Ondansetron should be continued for up to 5 days after a course of treatment.
Highly emetogenic chemotherapy: For patients receiving highly emetogenic chemotherapy, e.g. high dose cisplatin, Ondansetron can be given either by rectal, intravenous or intramuscular administration. Ondansetron has been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy:
- A single dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before chemotherapy.
- A dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before chemotherapy, followed by two further intravenous injections (in not less than 30 seconds) or intramuscular doses of 8 mg four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours.
A maximum initial dose of 16 mg diluted in 50-100 ml of saline or other compatible infusion fluid
(See Instructions for Use/Handling) and infused over not less than 15 minutes immediately before chemotherapy. The initial dose of Ondansetron may be followed by two additional 8 mg intravenous doses (in not less than 30 seconds) or intramuscular doses four hours apart.
- A single dose greater than 16 mg must not be given due to dose dependent increase of QT -prolongation risk (see sections 4.4, 4.8 and 5.1 of the SPC).
The selection of dose regimen should be determined by the severity of the emetogenic challenge. The efficacy of Ondansetron in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate, 20 mg administered prior to chemotherapy.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Ondansetron should be continued for up to 5 days after a course of treatment.
Paediatric Population:
CINV in children aged ≥ 6 months and adolescents
The dose for CINV can be calculated based on body surface area (BSA) or weight – see below. Ondansetron Enexi 2 mg/ml should be diluted in 5% dextrose or 0.9% sodium chloride or other compatible infusion fluid (see Instructions for Use/Handling) and infused intravenously over not less than 15 minutes. There are no data from controlled clinical trials on the use of Ondansetron in the prevention of delayed or prolonged CINV. There are no data from controlled clinical trials on the use of Ondansetron for radiotherapy-induced nausea and vomiting in children.
Dosing by BSA:
Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m2. The single intravenous dose must not exceed 8 mg. Oral dosing can commence 12 hours later and may be continued for up to 5 days (see SPC for dosing tables). The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
Dosing by bodyweight:
Weight-based dosing results in higher total daily doses compared to BSA-based dosing. Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/kg. The single intravenous dose must not exceed 8 mg. Two further intravenous doses may be given in 4-hourly intervals. Oral dosing can commence 12 hours later and may be continued for up to 5 days. The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg. (see SPC for further details).
Elderly
In patients 65 to 74 years of age, the dose schedule for adults can be followed. All intravenous doses should be diluted in 50-100 ml of saline or other compatible infusion fluid (see Instructions for Use/Handling) and infuse over 15 minutes.
In patients 75 years of age or older, the initial intravenous dose of Ondansetron should not exceed 8 mg. All intravenous doses should be diluted in 50-100 ml of saline or other compatible infusion fluid (see Instructions for Use/Handling) and infused over 15 minutes. The initial dose of 8 mg may be followed by two further intravenous doses of 8 mg, infused over 15 minutes and given no less than four hours apart (see SPC).