Ondansetron 2 mg/ml solution for injection/infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of the medicinal product is Ondansetron 2 mg/ml solution for injection/infusion but will be referred to as Ondansetron 2 mg/ml throughout the leaflet

1. What Ondansetron 2 mg/ml is and what it is used for
2. What you need to know before you use Ondansetron 2 mg/ml
3. How to use Ondansetron 2 mg/ml
4. Possible side effects
5. How to store Ondansetron 2 mg/ml
6. Contents of the pack and other information

• are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6) or to medicinal products from the same class (e.g. granisetron or dolasetron).
• are taking apomorphine (a medicine used to treat Parkinson’s disease).

If you are not sure, talk to your doctor, nurse or pharmacist.

Talk to your doctor, nurse or pharmacist before using Ondansetron 2 mg/ml if:

• you are hypersensitive to other medicines against feeling sick or being sick.
• you have a blockage in your gut or have severe constipation. Ondansetron can enhance the blockage or constipation.
• you have heart problems (e.g. congestive heart failure which causes shortness of breath and swollen ankles).
• you have an uneven heart beat (arrhythmias).
• you are having your tonsils out.
• your liver is not working as well as it should.
• 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 2 mg/ml.

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• phenytoin or carbamazepine used to treat epilepsy
• rifampicin used to treat infections such as tuberculosis (TB)
• tramadol, a pain killer
• antibiotics such as erythromycin or ketoconazole,
• anti-arrhythmic medicines used to treat an uneven heart beat,
• beta-blocker used to treat certain heart or eye problems, anxiety or prevent migraines
• medicines that affect the heart (such as haloperidol or methadone),
• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram,
• SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine,
• anthracyclines and trastuzumab (cancer medicine)

Ondansetron changes the effect of some drugs and vice versa. This includes:

• apomorphine (a medicine used to treat Parkinson’s disease): a significant drop in blood pressure and loss of consciousness has been reported with concomitant use of ondansetron and apomorphine.
• tramadol (a painkiller): ondansetron may reduce the analgesic effect of tramadol.
• phenytoin, carbamazepine (anti-epileptics) and rifampicin (an antibiotic): the blood concentrations of ondansetron are decreased.

If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before having Ondansetron 2mg/ml. Ondansetron 2 mg/ml should not be given in the same syringe or infusion (drip) as any other medication.

Only use Ondansetron 2 mg/ml 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 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 pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are a woman of childbearing potential you may be advised to use effective contraception.

Ondansetron passes into mother’s milk. Therefore mothers receiving ondansetron should NOT breast-feed.

Ondansetron has no or negligible effect on the ability to drive or use machines.

This medicine contains 3.3 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to approximately 0.17% of the recommended daily dietary intake of sodium for an adult.

Ondansetron 2 mg/ml is given as intravenous injection (into a vein) or, as intramuscular injection (into a muscle) or, after dilution, as intravenous infusion (for a longer time). It will usually be given by a doctor or a nurse. 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 8 mg tablet or syrup.

On the following days

• the usual adult dose is 8 mg tablet or 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.

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.

On the day of chemotherapy

• the first dose is given by an injection into the vein, just before your child’s treatment. After chemotherapy, your child’s medicine will usually be given by mouth twelve hours later, as syrup or tablet.

On the following days

• 2 mg syrup twice a day for small children and those weighing 10 kg or less
• 4 mg tablet or syrup twice a day for larger children and those weighing more than 10 kg
• 8 mg tablet or 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 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.

Your doctor or nurse will give you or your child Ondansetron 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.

Stop taking Ondansetron 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

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.
• irritation and redness at the site of injection.

Uncommon (may affect up to 1 in 100 people):

• unusual body movements or shaking.
• fits.
• chest pain, cardiac arrhythmias (changes in the way your heart beats) and bradycardia (slow heart rate). Chest pain and cardiac arrhythmias may be fatal in individual cases.
• low blood pressure, which can make you feel faint or dizzy.
• hiccups.
• asymptomatic increases of liver function. These reactions were particularly observed in patients under chemotherapy with cisplatin.
• hypersensitivity reactions around the injection site (e.g. rash, urticaria, itching) may occur, sometimes extending along the drug administration vein.

Rare (may affect up to 1 in 1,000 people):

• disturbance in heart rhythm (sometimes causing a sudden loss of consciousness). QTc prolongation (including Torsades de Pointes)
• feeling dizzy or light headed.
• blurred vision.

Very rare (may affect up to 1 in 10,000 people):

• depression.
• poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

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.

The active substance is ondansetron.

Each ampoule with 2 ml contains 4 mg ondansetron as ondansetron hydrochloride dihydrate.

Each ampoule with 4 ml contains 8 mg ondansetron as ondansetron hydrochloride dihydrate.

Each millilitre contains 2 mg ondansetron as ondansetron hydrochloride dihydrate.

The other ingredients are sodium chloride, sodium citrate dihydrate, citric acid monohydrate and water for injections.

Ondansetron 2 mg/ml is a clear and colourless solution in colourless glass ampoules containing 2 ml or 4 ml of solution for injection.

Pack sizes: 5 and 10 ampoules

Not all pack sizes may be marketed.

Marketing authorisation holder:

Manufacturer: