1. What Imatox is and what it is used for

Imatox Solution for Injection or Infusion contains a medicine called ondansetron (as hydrochloride dihydrate). This belongs to a group of medicines called anti-emetics.

Imatox is used for:

- Preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer.

- Preventing nausea and vomiting after surgery.

Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses. Imatox should start to work soon after having the injection.

You must talk to a doctor if you do not feel better or if you feel worse.

2. Before you are given Imatox
Do not have Imatox
- If you are taking apomorphine (used to treat Parkinson’s disease).
- If you are allergic (hypersensitive) to ondansetron or any of the other ingredients in Imatox.
If you are not sure, talk to your doctor, nurse or pharmacist before having Imatox.
Take special care with Imatox
Check with your doctor or pharmacist before having Imatox:
- If you have ever had heart problems.
- If you have an uneven heart beat (arrhythmias).
- If you are allergic to medicines similar to ondansetron, such as granisetron (known as ‘Kytril’).
- If you have liver problems.
- If you have a blockage in your gut.
- If 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 Imatox.
Taking other medicines
Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Imatox can affect the way some medicines work. Also some other medicines can affect the way Imatox 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, as these medicines may reduce the effect of Imatox.
- Rifampicin, used to treat infections such as tuberculosis (TB), as this medicine may reduce the effect of Imatox.
- Anti-arrhythmic medicines used to treat an uneven heart beat, as these medicines may interact with Imatox and affect the rhythm of the heart.
- Beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines, as these medicines may interact with Imatox and affect the rhythm of the heart.
- Tramadol, a pain killer, as Imatox may reduce the effect of tramadol.
- Medicines that affect the heart (such as haloperidol or methadone).
- Cancer medicines (especially anthracyclines), as these may interact with Imatox to cause heart arrhythmias.
- Medicines used to treat depression and/or anxiety:
- SSRIs (selective serotonin reuptake inhibitors) including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
- SNRIs (serotonin noradrenaline reuptake inhibitors) 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 Imatox.
Imatox should not be given in the same syringe or infusion (drip) as any other medication.
Pregnancy and breast-feeding
It is not known if Imatox is safe during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.
Do not breast-feed if you have Imatox. This is because small amounts pass into the mother’s milk. Ask your doctor or midwife for advice.
Driving and using machines
Imatox is not expected to impair the ability to drive. However, if any of the side effects affect you (e.g. dizziness, blurred vision) caution is advisable. Do not drive or operate machines if you are feeling unwell.
Important information about some of the ingredients of Imatox
Imatox Solution for Injection or Infusion contains sodium citrate and sodium chloride. This means that Imatox contains 7 mg of sodium per 4 mg dose. If you are on a low sodium diet, speak to your doctor, nurse or pharmacist before you have Imatox.

3. How Imatox is given

Imatox 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

Adults:

On the day of chemotherapy or radiotherapy

- A single dose should not be more than 16 mg.

- The usual adult dose is 8 mg given by an injection into your vein over at least 30 seconds or muscle, just before your treatment, and possibly another two 8 mg doses given by injection into your vein over at least 30 seconds or muscle four hours apart, depending on the strength of your chemotherapy or radiotherapy. 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 Imatox. Your doctor will decide this.

Elderly:

If you are over 65 years of age, your doctor will adjust your dose as required.

Children and Adolescents (aged 6 months to 17 years): To prevent nausea and vomiting from chemotherapy only

The doctor will decide the dose.

On the day of chemotherapy:

- The first dose is given by an injection into the vein (up to 8 mg), just before your child’s treatment. After chemotherapy, 12 hours after the initial injection, your child’s medicine will usually be given by mouth; -in tablet format up to 4 mg twice a day or 5 ml (4 mg) ondansetron syrup.

On the following days:

- Up to one 4 mg tablet or 5 ml (4 mg) syrup every twelve hours.

- This can be given for up to five days.

To prevent nausea and vomiting after an operation

- The usual dose for adults is 4 mg given by an injection into your vein or muscle. This will be given just before your operation.

- For children aged 2 years and over, the doctor will decide the dose. The maximum dose is 4 mg given as an injection into the vein. This will be given just before the operation.

To treat nausea and vomiting after an operation

- The usual adult dose is 4 mg given by an injection into your vein or muscle.

- For children aged 2 years and over, the doctor will decide the dose. The maximum dose is 4 mg given as an injection into the vein.

Patients with moderate or severe liver problems

The total daily dose should not be more than 8 mg. If you have blood tests to check how your liver is working this medicine may affect the results.

If you have more Imatox than you should

Your doctor or nurse will give you Imatox so it is unlikely that you will receive too much. If you think you have been given too much or have missed a dose, tell your doctor or nurse.

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions you need to look out for
Allergic reactions
These reactions are rare in people taking Imatox. If you have an allergic reaction, tell your doctor or a member of the medical staff straight away. The signs may include:
- 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.
Other side effects include:
Very common (affects more than 1 in 10 people)
- Headache.
Common (affects less than 1 in 10 people)
- A feeling of warmth or flushing.
- Constipation.
- Changes to liver function test results (if you have Imatox with a medicine called cisplatin, otherwise this side effect is uncommon).
- Irritation and redness at the site of injection.
Uncommon (affects less than 1 in 100 people)
- Hiccups.
- Low blood pressure, which can make you feel faint or dizzy.
- Uneven heart beat.
- Slow heart rate.
- Chest pain.
- Fits.
- Unusual body movements or shaking.
Rare (affects less than 1 in 1,000 people)
- Feeling dizzy or light headed during IV administration.
- Blurred vision.
- Disturbance in heart rhythm (sometimes causing a sudden loss of consciousness).
Very rare (affects less than 1 in 10,000 people)
- Poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.

5. How to store Imatox

Keep out of reach of children.

Store below 30°C.

Store in original pack to protect from light.

Dilutions of Imatox with compatible intravenous infusion fluids are stable under normal room lighting conditions or daylight for at least 24 hours, thus no protection from light is necessary while infusion takes place.

From a microbiological point of view the diluted solution for infusion should be used immediately. If not used immediately, in-use storage conditions are the responsibility of the user and would normally not be longer than 24 hours at 2-8 °C.

Do not use beyond the expiry date or if the product shows any sign of deterioration.

Imatox is a clear colorless solution, do not use if it has any other appearance, e.g. appears cloudy.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.