Patient leaflet - Ondansetron Steranco 4 mg /5 ml oral solution

1. What Ondansetron Steranco oral solution is and what it is used for

The name of this medicine is Ondansetron Steranco 4 mg/ 5 ml Oral Solution and is referred to as Ondansetron Steranco oral solution throughout this leaflet.

Ondansetron Steranco oral solution contains the active substance ondansetron. This belongs to a group of medicines called anti-emetics (medicines against feeling or being sick).

Ondansetron Steranco oral solution is used for:

preventing nausea (feeling sick) and vomiting (being sick) caused by chemotherapy (in adults and children) or radiotherapy for cancer (adults only)
preventing nausea and vomiting after surgery (adults only).

Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.

2. What you need to know before you take Ondansetron Steranco oral solution

Do not take Ondansetron Steranco oral solution

if you are taking apomorphine (used to treat Parkinson’s disease)
if you are allergic 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 this medicine. Warnings and precautions

Talk to your doctor, nurse or pharmacist before taking Ondansetron

if you have ever had heart problems (such as congestive heart failure which causes shortness of breath and swollen ankles)
if you have an uneven heartbeat (arrhythmias)
if you are allergic to medicines similar to ondansetron, such as granisetron or palonosetron • 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 taking Ondansetron Steranco oral solution.

Other medicines and Ondansetron

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take 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 other 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)
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 taking Ondansetron Steranco oral solution.

Pregnancy and breast-feeding

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.

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 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 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 pharmacist for advice.

Ondansetron Steranco oral solution contains:

Sorbitol: This medicine contains 1470 mg sorbitol in each 5 ml dose which is equivalent to 294 mg/ml. Sorbitol is a source of fructose. If your doctor has told 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.
Sodium benzoate: This medicine contains 10 mg benzoic acid in each 5 ml which is equivalent to
2 mg/ml.
Sodium: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Propylene glycol: This medicine contains 12.53 mg propylene glycol in each 5 ml dose. Ethanol:
This medicine contains 0.0015 mg of alcohol (ethanol) in each 5 ml which is equivalent to 0.0003 mg/ml (0.00003% w/v). The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effects.

3. How to take Ondansetron Steranco oral solution

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The dose you have been prescribed will depend on your treatment.

Do not mix this medicine with anything (not even water) before swallowing it.

To prevent nausea and vomiting from chemotherapy or radiotherapy

On the day of chemotherapy or radiotherapy

the usual adult dose is 10 ml (8 mg) taken one to two hours before treatment and another 10 ml (8 mg) twelve hours after.

On the following days

the usual adult dose is two 5 ml spoonfuls 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. Look at the label for more information.

the usual dose for a child is up to one 5 ml spoonful twice a day
this can be given for up to 5 days.

To prevent nausea and vomiting after an operation

Adults: the usual dose is four 5 ml spoonfuls before your operation.
Children aged over 1 month and adolescents: it is recommended that ondansetron is given as an injection.

Use in patients with moderate or severe liver problems

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

If you are sick (vomit) within one hour of taking a dose

take the same dose again
Otherwise, do not take more Ondansetron Steranco oral solution than the label says. If you continue to feel sick, tell your doctor or nurse.

If you take more Ondansetron Steranco oral solution than you should

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

If you forget to take Ondansetron Steranco oral solution

If you miss a dose and feel sick or vomit:

take the dose 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.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Ondansetron Steranco oral solution and see a doctor straight away 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:

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 take Ondansetron Steranco 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
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 or pharmacist. 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 Google Play Store 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 Steranco oral solution

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 bottle and carton after ‘Exp’. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions. Do not use after 60 days of first opening the bottle.

Keep the bottle upright.

Store in the original bottle in order to protect 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 Steranco oral solution contains

The active substance is ondansetron as ondansetron hydrochloride dihydrate.
Each 5 ml of oral solution contains ondansetron 4 mg.
The other ingredients are sodium benzoate (E211), sorbitol liquid (non-crystallising) (E420), citric acid anhydrous, sodium citrate, sucralose, strawberry flavour (contains propylene glycol (E1520) and ethanol) and purified water.

What Ondansetron Steranco oral solution looks like and contents of the pack

Ondansetron Steranco oral solution is a clear, colourless, strawberry flavoured solution, free from foreign particulate matter.

It is packed in an amber glass bottle fitted with a child-resistant, tamper-evident closure. Each bottle contains 50 ml of oral solution. A double-ended measuring spoon with 2.5 ml and 5 ml measuring ends is supplied with this product.

Marketing Authorisation Holder

Steranco Healthcare UK Limited

Unit 2A Olympic Way,

Sefton Business Park,

Bootle, Merseyside,

L30 1RD, United Kingdom

Manufacturer

Medley Pharma Limited