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Ondansetron 2 mg/ml Solution for Injection

(ondansetron)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

-    If you have further questions, ask your doctor 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 or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

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

2.    What you need to know before you are given your Ondansetron Injection

3.    How your Ondansetron Injection is given to you

4.    Possible side effects

5.    How to store your Ondansetron Injection

6.    Contents of the pack and other information. The name of your medicine is Ondansetron 2mg/ml Solution for Injection (referred to as Ondansetron Injection throughout this leaflet).

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

Your medicine comes as a solution for injection or infusion (drip). The active ingredient is ondansetron. The other ingredients are listed in section 6. Ondansetron belongs to a group of medicines called anti-emetics or anti-sickness medicine. Ondansetron can be used to prevent or treat nausea (feeling sick) or vomiting, following an operation, cancer chemotherapy or radiation treatment.

2.    What you need to know before you are given your Ondansetron Injection

You should not be given this injection if:

-    You have ever had an allergic or unusual reaction to Ondansetron or any of the other ingredients of this medicine (listed in section 6), or to medicinal products from the same class (e.g. granisetron, dolasetron).

-    You are taking apomorphine (used to treat Parkinson's disease).

If you are not sure, talk to your doctor, nurse or pharmacist before having this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before receiving Ondansetron Injection

•    if you have or have had prolonged QT interval (seen on an ECG, electrical recording of the heart),

•    if you have or have had alterations in heart rhythm (including a slow heart beat) or other heart problems (such as heart failure or conduction disorders) or,

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

•    if you have liver problems or,

•    if you have gut problems such as a blockage or suffer from severe constipation or,

•    if you have just had or are going to have your adenoids or tonsils removed.

Special precautions should be taken if Ondansetron Injection is to be given to a child receiving medication for cancer treatment which might alter liver function.

Other medicines and Ondansetron Injection

Tell your doctor or pharmacist if you are already taking, have recently taken or might take any other medicines and especially any of the following medicines:

•    Phenytoin, Carbamazepine; to treat epilepsy,

•    Rifampicin, an antibiotic,

•    Tramadol, a strong painkiller,

•    Medicines used to treat an uneven heart beat (arrhythmias),

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The following information is intended for healthcare professionals only:

Posology and method of administration

•    Patients with moderate to severe liver problems will not be given more than 8 mg of Ondansetron in a day.

•    Ondansetron is also available as a tablet.

FOR PATIENTS HAVING CHEMOTHERAPY OR RADIATION TREATMENT Adults (including the elderly)

8 mg of Ondansetron injected immediately before treatment, followed by an 8 mg tablet 12 hours after treatment. To prevent further sickness after treatment an 8 mg tablet twice a day may be taken for up to 5 days.

FOR PATIENTS HAVING CHEMOTHERAPY THAT CAUSES SEVERE NAUSEA AND VOMITING Adults (including the elderly)

During the first day of treatment, any of the following doses may be given:

-    8 mg injected immediately before chemotherapy

-    8 mg injected immediately before chemotherapy, followed by two more 8 mg doses injected 4 hours apart or by intravenous infusion (drip) of 1 mg per hour for up to 24 hours

•    Cancer medicines (e.g. anthracyclines or trastuzumab), antibiotics (e.g. erythromycin, ketoconazole) or other medicines which might disturb your heart rhythm,

•    Beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines,

•    Medicines to treat depression such as SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors) as these may cause serotonin syndrome, a potentially life-threatening reaction. The symptoms of serotonin syndrome may include a combination of the following: nausea (feeling sick), vomiting, agitation, confusion, diarrhoea, high temperature, increased blood pressure, excessive sweating, rapid heartbeat, hallucinations, loss of coordination, overactive reflexes and coma.

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.

Driving and using machines

Ondansetron Injection should not affect your ability to drive or use machines.

Ondansetron Injection contains sodium

This medicinal product contains 3.6 mg sodium per ml of solution for injection. To be taken into consideration by patients on a controlled sodium diet.

3. How your Ondansetron Injection is given to you

Ondansetron Solution for Injection will usually be given to you by a nurse or doctor by slow injection or infusion (drip) into a vein (intravenously).

The dose you have been prescribed will depend on the treatment you are having.

To prevent nausea and vomiting from chemotherapy or radiotherapy

On the day of chemotherapy or radiotherapy

•    The usual adult dose is 8 mg given by an injection into your vein, 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 tablet.

On the following days

•    The usual adult dose is one 8 mg tablet 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.

Children aged over 6 months and adolescents The doctor will decide the dose. On the day of chemotherapy or radiotherapy

•    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 for up to 5 days.

To prevent nausea and vomiting after an operation

•    The usual dose for adults is 4 mg given by an injection into your vein. This will be given just before your operation.

•    For children aged over 1 month and adolescents, the doctor will decide the dose. The maximum dose is 4 mg given as an injection into the vein. This will be given just before the operation.

To treat nausea and vomiting after an operation

•    The usual adult dose is 4 mg given by an injection into your vein.

•    For children aged over 1 month and adolescents, the doctor will decide the dose. The maximum dose is 4 mg given as an injection into the vein.

Patients with moderate or severe liver problems

The total daily dose should not be more than 8 mg.

If you keep feeling or being sick, tell your doctor.

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Patients age 75 years or older:

-    A single dose of 8 mg given as an intravenous infusion (drip), over not less than 15 minutes, immediately before chemotherapy. A single dose greater than 8 mg must not be given.

Adult patients younger than 75 years:

-    A single dose of 16 mg given as an intravenous infusion (drip), over not less than 15 minutes, immediately before chemotherapy. A single dose greater than 16 mg must not be given.

All intravenous doses should be diluted in 50-100 ml of saline or other compatible fluid and infused over at least 15 minutes in patients age 65 years or older.

Repeat intravenous doses should be given no less than 4 hours apart.

To prevent sickness after treatment an 8 mg tablet twice a day may be taken for up to 5 days.

Children (aged 6 months and above) and adolescents

-    For chemotherapy, the usual dosage is either a single intravenous dose of 5 mg/m² body surface area or up to 3 doses of 0.15 mg/kg body weight at 4-hourly interval. The intravenous dose must not exceed 8 mg. The total daily dose must not exceed adult dose of 32 mg.

If you are concerned about how much medicine you have been given or how often you have been given it, please tell your doctor or nurse.

If you use more Ondansetron Injection than you should

There is limited experience of ondansetron overdose. In a few patients, the following symptoms were observed: visual disturbances, severe constipation, low blood pressure and unconsciousness. In all cases, the symptoms disappeared completely. Tell your doctor if any of these symptoms occur.

4.    Possible side effects

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

Stop taking Ondansetron and tell your doctor straight away if you suffer from a skin rash, breathlessness or swelling of the eyelids, face or lips. These are rare (may affect up to 1 in 1,000 people) but serious allergic effects. You may need medical attention. If you are allergic to similar medicine you are more likely to suffer these effects.

Other side effects:

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

-    Headache.

Common side effects (may affect up to 1 in 10 people)

-    Constipation. If you are constipated tell your doctor,

-    Feeling flushed or warm,

-    Redness or irritation at the injection site.

-    Changes to liver function test results (if you have ondansetron injection with a medicine called cisplatin, otherwise this side effect is uncommon).

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

-    Spasms in the muscles of the face and eyes, tremor, uncontrollable movements, fits and seizures,

-    Hiccups,

-    Chest pain, an irregular or slow heartbeat or low blood pressure.

Rare side effects (may affect up to 1 in

1.000    people)

-    Blurred vision,

-    Dizziness when ondansetron is injected quickly into the vein.

-    Disturbances in heart rhythm (sometimes causing a sudden loss of consciousness).

Very rare side effects (may affect up to 1 in

10.000    people)

-    Temporary loss of eyesight, which usually comes back within 20 minutes.

Side effects in children and adolescents were comparable to that seen in adults.

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.

5.    How to store Ondansetron Injection

•    Keep this medicine out of the sight and reach of children.

•    Do not store the injection above 30°C.

•    Store in the original package. Protect from light.

•    Do not use this medicine after the expiry date which is stated on the ampoule and carton.

6.    Contents of the pack and other information

What Ondansetron Injection contains

The active substance is: ondansetron (as ondansetron hydrochloride dihydrate).

Each ml of solution contains 2 mg of ondansetron. Each 2 ml ampoule contains 4 mg of ondansetron. Each 4 ml ampoule contains 8 mg of ondansetron. The other ingredients are: citric acid monohydrate, sodium citrate, sodium chloride and water for injections.

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-    There is no recommendation for the use of ondansetron either for the prevention of delayed or prolonged nausea and vomiting induced by chemotherapy or nausea and vomiting caused by radiotherapy.

FOR PATIENTS HAVING AN OPERATION

Adults (including the elderly)

To prevent nausea and vomiting - 4 mg injected before the operation.

To treat nausea and vomiting - 4 mg given by injection.

Children (aged 1 month and above) and adolescents

-    For prevention and treatment of post-operative nausea and vomiting after a surgery under general anaesthesia, a single dose of ondansetron at 0.1 mg/kg up to a maximum of 4 mg is administered into a vein during not less than 30 seconds.

-    There is no recommendation for the use of ondansetron in the treatment of post-operative nausea and vomiting in children under 2 years of age.

Patients with kidney problems or who cannot metabolise sparteine/debrisoquine well can take the recommended doses of ondansetron, as detailed above.

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Instructions for use/handling

•    Once opened use immediately.

•    Once diluted the solution for infusion should be stored in the original plastic container of the infusion fluid. Chemical and physical in-use stability has been demonstrated for 7 days at 5°C and 25°C when the product is diluted to a concentration of 0.32 or 0.64 mg/ml. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to the use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

•    Do not use the injection if the ampoule is damaged or the solution is cloudy or contains particles.

•    Single use only. Any unused solution should be discarded.

Overdose

There is no specific antidote to ondansetron; for that reason, if overdose is suspected, only the symptoms should be treated. Using a drug inducing vomiting (ipecacuanha) is not recommended.

ECG monitoring is recommended.