ASANDOZ SZ00000LT000

Package leaflet: information for the user

Ondansetron 2 mg/ml Solution for Injection

Ondansetron

Read all of this leaflet carefully before you start using 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, 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 signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4. What is in this leaflet:

1.    What Ondansetron Solution for Injection is and what it is used for

2.    What you need to know before you use Ondansetron Solution for Injection

3.    How to use Ondansetron Solution for Injection

4.    Possible side effects

5.    How to store Ondansetron Solution for Injection

6.    Contents of the pack and other information

1. What Ondansetron Solution for Injection is and what it is used for

Ondansetron belongs to a group of medicines called anti-emetics, drugs against feeling sick (nausea) or being sick (vomiting). This medicine is used to stop you from feeling or being sick after surgical operation, chemotherapy, or radiotherapy.

2. What you need to know before you use Ondansetron Solution for Injection

Ondansetron Solution for Injection is not suitable for everyone.

Do not use Ondansetron Solution for Injection

•    if you are allergic to ondansetron or similar medicines to ondansetron such as granisetron or dolasetron or any of the other ingredients of this medicine (listed in section 6).

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

Ask your doctor or pharmacist if you are not sure about anything before you are given Ondansetron Solution for Injection.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Ondansetron Solution for Injection:

•    if you suffer from any blockage in your gut or if you have severe constipation.

•    if you have or have ever had heart problems, including an uneven heart beat (arrhythmia)

•    if you have liver problems.

•    if you are having your tonsils out.

•    if you have any problems with the levels of salts in your blood, such as potassium or magnesium

•    if you are pregnant or are breast-feeding (see “Pregnancy and breast-feeding” below).

Children

If your child is also being treated with other medicines which may be harmful to the liver, the doctor will monitortheir liver function closely. Other medicines and Ondansetron Solution for Injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important to mention any or all of the following, before taking this medicine:

•    phenytoin, carbamazepine, used to treat epilepsy.

•    medicines to treat depression or other mood disorders (SSRIs, SNRIs)

•    rifampicin, used to treat certain infections.

•    antibiotics such as erythromycin or ketoconazole

•    tramadol, a strong pain killer.

•    anti-arrhythmic medicines used to treat an uneven heart beat (such as amiodarone)

•    beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines (such as atenolol or timolol)

•    cancer medicines (especially anthracyclines such as doxorubicin or daunorubicin, and trastuzumab)

•    apomorphine, used in the treatment of Parkinson's disease.

Pregnancyand breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

•    Because of insufficient experience the use of ondansetron during pregnancy is not recommended.

•    Ondansetron enters the breast milk, so you should not breastfeed while you are having this medicine.

Driving and using machines

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

Ondansetron Solution for Injection contains sodium

This medicinal product contains 2.3 mmol (53.5 mg) sodium per maximum daily dose. To be taken into consideration by patients on a controlled sodium diet.

3. How to use Ondansetron Solution for Injection

This injection will usually be given to you by a doctor or nurse.

They will give you the injection into a vein. The medicine may also be given as an infusion.

Dosage

Your doctor will decide on the correct dose of ondansetron therapy for you.

The dose varies depending on your medical treatment (chemotherapy or surgery), on your liver function and on whether it is given by injection or infusion.

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 an 8 mg Ondansetron tablet or 10 ml (8 mg) Ondansetron syrup.

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. 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. 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 a Ondansetron tablet.

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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

•    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 liver problems

The largest daily dose you will be given is 8 mg (4 ml Ondansetron solution for injection), depending on the seriousness of your liver problem. Ifyou receive more of Ondansetron Solution for Injection than you should

Your doctor or nurse will give you Ondansetron injection so it is unlikely that you will receive too much. If you think you have been given too much or have missed a dose, tell your doctor or nurse.

If you forget to use Ondansetron solution for injection

If you feel that you have not received your dose of ondansetron please discuss it with your doctor or nurse.

If you stop using Ondansetron solution for injection

Your doctor will decide if you no longer need to receive ondansetron.

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

4. Possible side effects

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

Serious side effects

Tell your doctor or nurse straight away if you experience any of the following:

•    Serious allergic reaction which causes swelling of the face or throat, difficulty in breathing or dizziness, or severe itching of the skin with raised lumps.

•    Chest pain or irregular heart beat which may sometimes cause a sudden loss of consciousness.

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

Other side effects

Very common side effects (may affect more than 1 in 10 people)

•    headache

Common side effects (mayaffect up to 1 in 10 people)

•    constipation

•    feeling flushed or warm

•    local irritation around the injection side (e.g. skin rash or swelling, itching), sometimes extending along the drug administration vein

Uncommon side effects (may affect up to 1 in 100 people)

•    hiccups

•    fits (seizures)

•    problems with eye movements or spasms in the muscles or the head and neck

•    slow or uneven heart beat

•    electrocardiogram alteration

•    dizziness, low blood pressure

•    increases in liver blood test results (if you have ondansetron injection with a medicine called cisplatin this side effect is common)

Rare side effects (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)

Reporting of side effects

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

5. How to store Ondansetron Solution for Injection

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 label after EXP (abbreviation used for expiry date). The expiry date refers to the last day of that month.

Keep the ampoules in the outer carton, in order to protect from light.

Dilutions of Ondansetron Solution for Injection in compatible intravenous infusion liquids should be stored at 2-8°C and discarded after 24 hours. The diluted infusion is stable under normal room lighting conditions or daylight for at least 24 hours. Therefore, no protection from light is necessary while infusion takes place.

Do not use Ondansetron Solution for Injection if you notice signs of deterioration such as colouration of the solution or when particles are visible.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicine you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ondansetron Solution for Injection contains

The active substance is ondansetron.

Each ml solution for injection contains 2 mg ondansetron (as hydrochloride dihydrate).

The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, water for injection.

What Ondansetron Solution for Injection looks like and contents ofthe pack

Ondansetron Solution for Injection is a clear and colourless liquid that is odourless and free of particles. It is available in cartons of 1, 2, 5, 6, 10 or 5x5 glass ampoules. Not all pack sizes may be marketed.

The glass ampoules are available as ampoules containing 2 ml respectively 4 ml solution for injection.

Marketing Authorisation Holder and Manufacturer

MarketingAuthorisation Holder: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer: Lek Pharmaceuticals d.d, Verovskova 57, 1000 Ljubljana, Slovenia

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last revised in: 06/2014.

SZ00000LT000

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