Ondansetron 8 mg/5 ml Syrup

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse 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 your medicine is Ondansetron 8 mg/5 ml Syrup but it will be referred as ‘Ondansetron’ throughout this leaflet.

1. What Ondansetron is and what it is used for
2. What you need to know before you take Ondansetron
3. How to take Ondansetron
4. Possible side effects
5. How to store Ondansetron
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 any of the other ingredients of this medicine (listed in section 6).

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

Check with your doctor, nurse or pharmacist before taking Ondansetron 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 taking Ondansetron.

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 Ondansetron can affect the way some medicines work. Also some medicines can affect the way Ondansetron 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)
• 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 Ondansetron.

• if you experience sudden chest pain or chest tightness (myocardial ischemia).

Only use Ondansetron 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 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 taking Ondansetron.

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

Do not breast-feed if you are taking Ondansetron. This is because small amounts pass into the mother's milk. Ask your doctor or midwife for advice.

Sodium benzoate (E211): This medicine contains 4.8 mg sodium benzoate in each 5 ml dose which is equivalent to 0.96 mg/ml. Sodium benzoate (E211) may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

Sorbitol (E420): This medicine contains 2100 mg sorbitol in each 5 ml dose which is equivalent to 420 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Propylene glycol (E1520): This medicine contains 14.1 mg/5 ml propylene glycol in each 5 ml dose which is equivalent to 2.8 mg/ml.

Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 5 ml dose, that is to say essentially 'sodium-free'.

On the day of chemotherapy or radiotherapy:

• the usual adult dose is 8 mg (5 ml) taken one to two hours before treatment and another 8 mg (5ml) twelve hours after.

On the following days:

• the usual adult dose is 8 mg (5 ml) twice a day
• this may be given for up to 5 days.

Children aged over 6 months and adolescents:

The doctor will decide the dose depending on the child's size (body surface area) or weight.

• the usual dose for a child is up to 4 mg (2.5 ml) twice a day
• this can be given for up to 5 days.

Infants under 6 months of age:

Ondansetron is not recommended in infants under 6 months of age for the prevention of nausea and vomiting from chemotherapy.

Adults:

The usual adult dose is 16 mg (10 ml) given an hour before your operation.

Children aged over 1 month and Adolescents

It is recommended that Ondansetron is given as an injection.

Patients with moderate or severe liver problems

The total daily dose should not be more than 8 mg (5 ml). Ondansetron should start to work within one or two hours of taking a dose.

• take the same dose again
• otherwise, do not take more Ondansetron than the label says.

If you continue to feel sick, tell your doctor or nurse.

• This medicinal product must be taken orally.
• Shake well before use.
• Use the measuring syringe provided in the pack to deliver the required dose.
• Take your dose of Ondansetron as your doctor advises. It can be taken with or without food.
• Your doctor may also advise you to start or stop taking other medicines, depending on what condition you're being treated for and the way you respond to treatment.
• Always take the full dose that your doctor has prescribed. Never take only part of a dose.

Instructions for the use of syringe:

a) Open the bottle: press the cap and turn it anticlockwise (figure 1).

b) Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).

c) Turn the bottle upside down. Fill the syringe with a small amount of liquid by pulling the piston down (figure 5A) and then push the piston up in order to remove any possible air bubbles (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).

d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

e) Empty the contents of the syringe into the mouth by pushing the piston to the bottom of the syringe (figure 7). The contents of the syringe should be emptied into the side cheek of the patient's mouth to avoid a choking hazard. Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).

If you or your child take more Ondansetron than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you miss a dose and feel sick or vomit:

• take ondansetron syrup as soon as possible, then
• take your next dose at the usual time (as shown on the label)
• do not take a double dose to make up for a forgotten dose.

If you miss a dose but do not feel sick

• take the next dose as shown on the label
• do not take a double dose to make up for a forgotten dose.

Stop taking Ondansetron 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
• changes to liver function test results (if you take ondansetron with a medicine called cisplatin, otherwise this side effect is uncommon).

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
• slow heart rate
• 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.

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 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 5 ml syrup contains 8 mg ondansetron (as ondansetron hydrochloride dihydrate).

The other ingredients are citric acid monohydrate (E330), sodium citrate (E331), sodium benzoate (E211), sorbitol, liquid (non crystallising) (E420), strawberry flavour (contains propylene glycol (E1520)) and purified water.

Ondansetron is clear, colourless to pale yellow syrup with a strawberry flavour. It is supplied in type III amber colour glass bottle with HDPE, EPE wadded, tamper evident, child resistant screw on white plastic polypropylene cap.

The pack also contains a 5 ml oral syringe with 0.25 ml graduation with an adaptor.

Ondansetron is supplied in a bottle containing 50 ml syrup.