Ondansetron 2mg/ml Solution for Injection

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

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

• you are taking apomorphine (used to treat Parkinson's disease)
• you are allergic (hypersensitive) to ondansetron or to other selective 5HT3 receptor antagonists (e.g. granisetron, dolasetron) or any of the other ingredients in Ondansetron injection ( listed in section 6).

If you are not sure, talk to your doctor, nurse or pharmacist before having Ondansetron injection.

Check with your doctor, pharmacist or nurse before having Ondansetron injection 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 injection.

Please tell your doctor, pharmacist or nurse 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 injection can affect the way some medicines work. Also some other medicines can affect the way ondansetron injection works.

In particular, tell your doctor, pharmacist or nurse 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 metha-done)
• cancer medicines (especially anthracyclines and trastuzumab).
• 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

If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before having Ondansetron injection.

Ondansetron injection should not be given in the same syringe or infusion (drip) as any other medication.

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 injection 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 are might be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before having ondansetron injection. If you are a woman of childbearing potential you may be advised to use effective contraception.

Do not breast-feed if you have ondansetron injection. This is because small amounts pass into mother's milk, Ask your doctor or midwife for advice.

Ondansetron Injection has no effect on your ability to drive or use machines.

Ondansetron injection contains Sodium citrate and sodium chloride.

This product contains 3.6mg/ml of sodium. Ondansetron contains 2.52 mmol (57.6 mg) sodium per maximum daily dose of 32 mg.

To be taken into consideration by patients on a controlled sodium diet.

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 ondansetron syrup or a ondansetron tablet.

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 injection. Your doctor will decide this.

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 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 ondansetron syrup or an 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

Adult:

• The recommended 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.

The total daily dose should not be more than 8 mg.

Ondansetron injection 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 injection 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.

If you develop any of the following side effects, tell your doctor immediately:

• chest pain

The following side effects have been reported:

Allergic reactions

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.

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
• changes to liver function test results (if you have Ondansetron injection 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.

If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

The active substance in Ondansetron Injection is ondansetron (as hydrochloride dihydrate). Each ml of solution for injection contains 2 mg ondansetron (as ondansetron hydrochloride dihydrate).

Each glass ampoule of 2ml contains 4mg ondansetron (as hydrochloride dihydrate).

Each glass ampoule of 5ml (containing 4 ml of solution) contains 8mg ondansetron (as hydrochloride dihydrate).

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

Ondansetron Injection is clear, colourless solution and it comes in clear colourless glass ampoules of 2ml containing 2 ml of solution and 5 ml containing 4 ml of solution..

2 ml ampoule containing 4mg/2ml of solution.

5 ml ampoule containing 8mg/4ml of solution.

Each pack contains 25 ampoules of 2 ml or 5ml capacity glass ampoule.

Each pack contains 5 ampoules of 2 ml or 5ml capacity glass ampoule

Not all pack sizes may be marketed