PACKAGE LEAFLET INFORMATION FORTHE USER

Ondansetron 4mg/5ml Oral Solution

(Ondansetron)

READ ALL THIS LEAFLET CAREFULLY BEFORE YOU

START TAKING THIS MEDICINE BECAUSE IT CONTAINS

IMPORTANT INFORMATION FOR YOU

•    Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist.

•    This medicine has been prescribed onlyforyou. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of these side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist (see section 4).

What is in this leaflet

1.    What Ondansetron 4mg/5ml Oral Solution is and what it is used for

2.    What you need to know before you take Ondansetron 4mg/5ml Oral Solution

3.    How to take Ondansetron 4mg/5ml Oral Solution

4.    Possible side effects

5.    How to store Ondansetron 4mg/5ml Oral Solution

6.    Contents of the pack and other information

1. What Ondansetron 4mg/5ml Oral Solution is and what it is used for

Some medical and surgical treatments can make you feel sick or be sick (nausea and vomiting). Ondansetron 4mg/5ml Oral Solution belongs to a group of medicines called anti-emetics, which can stop these effects. This medicine is used to stop nausea and vomiting after

•    chemotherapy or radiotherapy for cancer (in adults and children)

•    an operation (adults only).

Ask your doctor, nurse or pharmacist ifyou would like further explanation about these uses.

2. What you need to know before you take Ondansetron 4mg/5ml Oral Solution

Do not take Ondansetron 4mg/5ml Oral

Solution ifyou

•    know you are allergic (hypersensitive) to, or have ever had a bad reaction to ondansetron or any of the other ingredients (see section 6)

•    are taking apomorphine (used to treat Parkinson’s disease).

Take special care and check with your doctor, nurse or pharmacist before taking this medicine ifyou:

•    have ever had heart problems

•    an uneven heartbeat (arrhythmias)

•    are allergic to similar medicines, such as granisetron (also known as “Kytril”)

•    have liver problems

•    have a blockage in your gut or you suffer from severe constipation

•    have a problem 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 this medicine.

Taking other medicines Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines. This is because ondansetron can affect the way other medicines work. Also, some other medicines can affect the way ondansetron works. In particular, make sure your doctor or pharmacist knows if you or your child are taking:

•    carbamazepine or phenytoin (to treat epilepsy)

•    rifampicin (to treat serious infections such as tuberculosis (TB))

•    tramadol (to control pain)

•    medicines that affect the heart (such as haloperidol or methadone)

•    medicines to treat cancer (especially anthracyclines or trastuzumab)

•    anti-arrhythmic medicines (to treat an uneven heartbeat)

•    beta-blocker medicines (to treat certain heart or eye problems, anxiety or prevent migraines).

•    antibiotics such as erythromycin or ketoconazole

•    SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/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 using Ondansetron 4mg/5ml Oral Solution.

Pregnancy and breast-feeding

It is not known if Ondansetron is safe during pregnancy. Therefore, talk to your doctor or pharmacist before taking Ondansetron 4mg/5ml Oral Solution if you are pregnant, might become pregnant or planning to have a baby.

Do not breast feed if you are taking Ondansetron, as small amounts can pass into the breast milk. Ask your doctor or midwife for advice.

Driving and using machines

Ondansetron 4mg/5ml Oral Solution should not affect your ability to drive or to operate machinery, but if you feel faint or dizzy, do not drive or operate machinery until you feel better.

Important information about some of the ingredients of Ondansetron Oral Solution

This medicine contains a sugar called sorbitol (E420). If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking this medicine.

3. How to take Ondansetron 4mg/5ml Oral Solution

Always take Ondansetron 4mg/5ml Oral Solution exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure. The dose you have been prescribed will depend on the treatment you are having.

Do not mix your 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 8mg taken one to two hours before treatment and another 8mg twelve hours after.

On the following days

•    the usual adult dose is two 5ml spoonfuls twice a day

•    this may be given for up to 5 days

Children aged over 6 months and adolescents:

The doctorwill 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

The usual adult dose is four 5ml spoonfuls before your operation.

For children aged over 1 month and adolescents:

It is recommended that Ondansetron is given as an injection.

Patients with moderate to severe liver problems

The total daily dose should not be more than 8mg (two 5ml spoonfuls).

Ondansetron 4mg/5ml Oral Solution should start to work within 1-2 hours oftaking a dose.

Ifyou are sick (vomit) a dose backwithin 1 hour of taking a dose

•    then take the same dose again

•    otherwise do not take more doses than the label says. If you continue to be sick or feel sick, tell your doctor or nurse.

Ifyou take more than you should

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

If you forget to take

If you miss a dose and feel sick or vomit

•    take a dose as soon as possible, then

•    take the next dose at the usual time (as shown on the label).

•    do not take a double dose to make up for a forgotten dose.

Ifyou miss a dose but do notfeel sick

•    take the next dose when due (as shown on the label). If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

side effects

Like all medicines, Ondansetron 4mg/5ml Oral Solution can cause side effects, although not everybody gets them.

Allergic reactions

A few people may be allergic to Ondansetron 4mg/5ml Oral Solution, howeverthis is rare, affecting less than 1 in 1000 patients.

If you have an allergic reaction stop taking this medicine and seek medical attention immediately.

The signs may include:

•    sudden wheeziness and chest pain or chest tightness

•    difficulty breathing

•    swelling of eyelids, face, lips, mouth or tongue

•    skin rash - red spots or red spots or lumps under your skin (hives) anywhere on your body

•    feeling faint, especiallywhen standing up

•    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 take Ondansetron 4mg/5ml Oral Solution with a medicine called cisplatin, otherwise this side effect is uncommon).

Uncommon (affects less than 1 person in 100 people)

•    hiccups

•    low blood pressure, which can make you feel faint or dizzy

•    uneven heartbeat

•    chest pain

•    fits

•    unusual body movement or shaking

Rare (affects less than 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 (affects less than 1 in 10,000 people)

• poor vision or temporary loss of eyesight which usually comes backwithin 20 minutes. This is much less likely when ondansetron is given by mouth.

Reporting of side effects

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 at: www.mhra.gov. uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

•    Keep out of the sight and reach of children.

•    Do not store above 30°C.

•    Do not refrigerate. Keep the bottle upright.

•    Do not use after 28 days of first opening the bottle. Do not use after the expiry date which is stated on the label and carton after “EXP”. The expiry date

refers to the last day of the month.

Medicines should not be disposed ofvia wastewateror household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Ondansetron 4mg/5ml Oral Solution contains

• The active substance is ondansetron. Each 5 ml spoonful contains 4mg ondansetron.

The other ingredients are sodium citrate (E331), citric acid (E330), saccharin sodium, sorbitol (E420), sodium benzoate (E221), strawberryflavourand purified water.

What Ondansetron Oral Liquid 4mg/5ml looks like and contents of the pack

Ondansetron 4mg/5ml Oral Solution is a clear, sucrose-free, strawberry flavoured solution. It is supplied in a 50ml amber glass bottle, packed in a carton with a double ended (5ml and 2.5ml) measuring spoon.

Marketing Authorisation Holder

Transdermal Limited, 35 Grimwade Avenue, Croydon, CR0 5DJ, UK

Manufacturer Nupharm Laboratories Limited, 2 Newtech Square, Deeside Industrial Park, Deeside, Flintshire, CH5 2NT, UK

T-Vl

PL 14308/0015

This leaflet was last approved in July 2014.