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PACKAGE LEAFLET: INFORMATION FOR THE USER

ONDANSETRON 2 mg/ml SOLUTION FOR INJECTION

Ondansetron (as hydrochloride dihydrate)

The name of your medicine is Ondansetron 2 mg/ml Solution For Injection, which will be called Ondansetron injection or Ondansetron throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Ondansetron injection is and what it is used for

2.    Before you are given Ondansetron injection

3.    How you are given Ondansetron injection

4.    Possible side effects

5.    How to store Ondansetron injection

6.    Further information

1.    WHAT ONDANSETRON INJECTION IS AND WHAT IT IS USED FOR

Ondansetron injection is a clear solution containing the active ingredient ondansetron, which is an anti-emetic (prevents nausea [feeling sick] and vomiting). Ondansetron injection is used to prevent and treat nausea and vomiting caused by chemotherapy or radiotherapy and for the prevention and treatment of nausea and vomiting after surgery.

2.    BEFORE YOU ARE GIVEN ONDANSETRON INJECTION You should not be given Ondansetron injection if:

You are hypersensitive to Ondansetron or to other selective 5HT3 receptor antagonists (e.g. granisetron, dolasetron) or to any of the excipients (see list of ingredients in section 6).

Take special care with Ondansetron injection if:

-    you have signs of intestinal obstruction (blockage) - you will need to be monitored

-    you have arrhythmias or cardiac conduction disorders (heartbeat disorders) or you are being treated with antiarrhythmic agents (for irregular heartbeat)

-    you are going to have surgery to your tonsils or adenoids - you will need to be monitored.

Taking other medicines :

You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with your Ondansetron injection:

-    phenytoin, carbamazepine (treatments for epilepsy)

-    rifampicin (an antibiotic)

-    tramadol (a painkiller)

-    beta-blockers (drugs that slow heart rate)

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

It may still be all right for you to be given Ondansetron injection and your doctor will be able to decide what is suitable for you.

Pregnancy and lactation

Please tell your doctor if you are pregnant or planning to be pregnant. Ondansetron passes into breast milk, therefore nursing mothers should not breast-feed. Driving and using machines

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

Important information about some of the ingredients in Ondansetron Injection

This product contains 3.6mg/ml of sodium. If you are on a sodium-controlled diet, speak to your doctor before taking this medicine.

3.    HOW YOU ARE GIVEN ONDANSETRON INJECTION

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

Chemotherapy and radiotherapy:

Adults and the elderly

The usual dose for adults and the elderly is 8 mg as a slow intravenous (into a vein) or intramuscular (into a muscle) injection immediately before treatment, followed by 8 mg orally twelve hourly. Up to 32 mg per day may be given. Oral or rectal treatment should be continued for up to 5 days after a course of treatment. No more than 16mg should be given by injection into your vein as a single dose.

Children > 6 months and adolescents

The usual dose for children is a single intravenous dose of 5 mg/m2 (body area) immediately before chemotherapy; Two further intravenous doses may be given in 4-hourly intervals. 4 mg orally twice daily should be continued for up to 5 days after a course of treatment.

Preventing vomiting after surgery:

Adults and the elderly

The usual dose is a single dose of 4 mg given by intramuscular or slow intravenous injection with the anaesthetic.

Children > 6 months and adolescents

The usual dose for children is a dose of 0.15 mg/kg (body weight) up to a maximum of 4 mg before or after they are anaesthetized.

Treating vomiting after surgery:

Adults and the elderly

The usual dose is a single dose of 4-8 mg given by intramuscular or slow intravenous injection.

Children > 6 months and adolescents

The usual dose for children is a dose of 0.1 mg/kg (body weight) up to a maximum of 4 mg.

In all patients with a liver disorder, the maximum daily dose is 8 mg.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Ondansetron injection can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Serious side effects

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

- chest pain

The following side effects have been reported:

Common (between 1 in 100 and 1 in 10)

-    constipation

-    sensation of warmth or flushing

-    headache

-    hiccups

Uncommon (between 1 in 1000 and 1 in 100)

-    allergic reactions around the injection site such as rash (alone)

-    nettle rash

-    itching

-    interference with liver function tests

Rare (between 1 in 10,000 and 1 in 1000)

-    movement disorders

-    fits

-    dizziness

-    heartbeat disturbances

-    low blood pressure

-    slow heartbeat

-    temporary visual disturbances (e.g. blurred vision)

-    allergic reactions sometimes severe

Very rare (less than 1 in 10,000)

-    temporary blindness (most resolved within 20 minutes)

-    temporary changes in heartbeat (your doctor will be able to detect these)

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 any side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom    Ireland

Yellow Card Scheme    HPRA Pharmacovigilance

Website:www.mhra.gov.uk/yellowcard    Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971, Fax: +353 1 6762517 Website:www.hpra.ie, e-mail: medsafety@hpra.ie

5.    HOW TO STORE ONDANSETRON INJECTION

Ondansetron injection should be kept out of the sight and reach of children. Your doctor or pharmacist knows how to store Ondansetron injection.

This medicinal product does not require any special storage temperature. Keep ampoules in the outer carton, in order to protect from light.

Do not use Ondansetron Injection after the expiry date, which is stated on the packaging after “Exp”.

Only clear solutions practically free from particles should be used. Do not use if container is damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Ondansetron injection contain:

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

The other ingredients are:

-    citric acid monohydrate

-    sodium citrate

-    sodium chloride

-    water for injections

What Ondansetron injection looks like and contents of the pack

Ondansetron injection 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

Marketing Authorisation Holder:

Claris Lifesciences (UK) Limited

Crewe Hall, Golden Gate Lodge, Crewe, Cheshire, CW1 6UL

United Kingdom

Manufacturer:

Peckforton Pharmaceuticals Limited

Crewe Hall, Golden Gate Lodge, Crewe, Cheshire, CW1 6UL

United Kingdom

This medicinal product is authorized in the Member States of EEA under the following name:

Ondansetron 2mg/ml Solution for Injection - UK, Ireland

Ondansetron - Germany, Luxembourg

Ondansetrom Claris- Portugal

Ondansetron Claris - Estonia, Latvia, Lithuania, Poland

Ondansetron Claris 2 mg/ml oplossing voor injectie - Netherland

Ondansetron Claris, 2mg/ml, solution for injection - Belgium

Ondansetron Claris 4 mg/2 ml raztopina za injiciranje ali infundiranje - Slovenia

Ondansetron Claris 8 mg/4 ml raztopina za injiciranje ali infundiranje - Slovenia

NEODEX - Greece

EMISTOP - Italy

This Leaflet was last revised in 02/2015

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