Ondansetron 2mg/Ml Solution For Injection
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER Ondansetron 2mg/mL Solution for Injection Ondansetron
Please read all of this leaflet carefully. It includes important information on how you should take this medicine correctly and safely.
• Keep this leaflet. You may need to read it again.
• The medicine is prescribed only for you, and you should 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 get serious, or you notice any side effects not listed in the leaflet, please tell your doctor, nurse or pharmacist.
The name of your medicine is Ondansetron 2mg/mL Solution for Injection
In the rest of this leaflet Ondansetron 2mg/mL Solution for Injection is called Ondansetron Injection.
In this leaflet:
1. What Ondansetron Injection is and what it is used for
2. Before you take Ondansetron Injection
3. How to take Ondansetron Injection
4. Possible side effects
5. How to store Ondansetron Injection
6. Further information
1. WHAT ONDANSETRON INJECTION IS AND WHAT IS IT USED FOR
Ondansetron is type of medicine called an anti-emetic, drugs against feeling or being sick.
Some other medicines or treatments which you have been given to treat cancer can make you feel sick (nausea) or be sick (vomiting).
Ondansetron may also be given to you to stop you feeling sick or being sick after an operation.
Ondansetron will help to reduce these effects.
2. BEFORE YOU TAKE ONDANSETRON INJECTION
The doctor or nurse giving you this medicine will ask some questions about you. They need the following information before you are given this medicine for the first time.
Do not take Ondansetron Injection
• you are taking apomorphine (used to treat Parkinson’s disease)
• If you are allergic (hypersensitive) to ondansetron or to any of the other ingredients of ondansetron injection.
Take special care with Ondansetron Injection
Check with your doctor or pharmacist before having Ondansetron injection if: you have ever had heart problems you have an uneven heart beat (arrhythmias)
you are allergic to medicines similar to ondansetron, such as granisetron (known as ‘Kytril’)
you have liver problems
you have a blockage in your gut
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 having Ondansetron injection.
Taking other medicines
Please tell your doctor about any medicines you may be taking or have recently been taking. Remember also any medicines you may be taking that do not need a prescription.
If you are taking any of the following medicines, it is very important to tell your doctor:
• If you are taking phenytoin, carbamazepine (anti-epileptics) or rifampicin (an antibiotic) as blood concentrations of Ondansetron may decrease.
• If you are taking tramadol, a painkiller, as Ondansetron may reduce the analgesic effect of tramadol.
• If you are taking Beta Blocker medicines used to treat certain heart problems.
• If you are taking any medicines used to treat an uneven heart beat (arrhythmia).
• If you are taking any cancer medicines (especially antracyclines such as Doxorubicin).
Pregnancy and breastfeeding
Because of insufficient experience the use of Ondansetron during pregnancy is not recommended. Ondansetron passes into mother’s milk. Therefore mothers receiving Ondansetron should NOT breast-feed.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ondansetron has no or negligible effect on the ability to drive or use machines.
Important information about some of the ingredients of Ondansetron Injection
This medicinal product contains 2.3mmol (53.5mg) sodium per maximum daily dose of 32mg. To be taken into consideration by patients on a controlled sodium diet.
3. HOW ONDANSETRON INJECTION IS GIVEN
Method of administration
Ondansetron Injection is given as intravenous injection (into a vein) or, after dilution, as intravenous infusion (for a longer time). It will usually be given by a doctor or a nurse.
Dosage
Your doctor will decide on the correct dose of Ondansetron therapy for you.
On the day of chemotherapy or radiotherapy
• the usual adult dose is 8 mg given by an 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.
Children aged over 6 months and adolescents
The doctor will decide the dose. Look at the label for more information
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; the usual dose is a 4 mg Ondansetron tablet or 5 ml (4 mg) Ondansetron syrup twelve hours later.
On the following days
• one 4 mg tablet or 5 ml (4 mg) syrup twice a day
• this can be given for up to five days.
To prevent nausea and vomiting after an operation
• The usual dose for adults is 4 mg given by an injection into your vein or muscle. This will be given just before your operation.
• For children aged over 1 month and adolescents over, 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 or muscle.
• 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
Ondansetron injection should start to work soon after having the injection. If you continue to be sick or feel sick, tell your doctor or nurse.
If you received more Ondansetron Injection than you should
Little is known at present about overdosage with Ondansetron. In the majority of cases, the side effects are similar to those outlined in Section 4. In a few patients, the following effects were observed after overdose: visual disturbances, severe constipation, low blood pressure and unconsciousness. In all cases, the symptoms disappeared completely.
There is no specific antidote to Ondansetron, for that reason, if overdose is suspected, only the symptoms should be treated. The use of ipecacuanha to treat overdose with ondansetron is not recommended.
Tell your doctor if any of these symptoms occur.
If you have any further questions on the use of this product, ask your doctor or pharmacist. There is a Technical Leaflet supplied to your Healthcare Professional.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ondansetron Injection can cause side effects, although not everybody gets them.
The frequency of side effects is classified into the following categories:
|
Very common |
in more than 1 in 10 patients |
|
Common |
in more than 1 in 100 patients, but less than 1 in 10 patients |
|
Uncommon |
in more than 1 in 1,000 patients, but less than 1 in 100 patients |
|
Rare |
in more than 1 in 10,000 patients, but less than 1 in 1,000 patients |
|
Very rare |
in less than 1 in 10,000 patients |
Serious side effects
Immune system disorders
Rare: Immediate allergic (hypersensitivity) reactions (reaction in which the body reacts with an exaggerated
immune response to a foreign agent), including life-threatening allergic reaction (anaphylaxis). These reactions may be: swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing. Additionally rash or itching and hives. Breathing problems may be the first sign of an allergic reaction.
Altered hypersensitivity reactions were also observed in patients, which were sensitive to medicinal products from the same class.
Cardiac disorders
Uncommon: Chest pain with or without changes on an ECG (heart trace), cardiac arrhythmias (changes in the way your
heart beats) and bradycardia (slow heart rate). Chest pain and cardiac arrhythmias may be fatal in individual cases.
Inform your doctor immediately if you experience any symptoms suggestive of an allergic reaction. Less serious side effects
Cardiac disorders
Very rare: Transitory changes in the electrocardiogram (ECG) (recording of your hearts electrical activity)
predominantly after intravenous application of ondansetron.
Nervous system disorders Very Common: Headache
Uncommon: Involuntary movement disorders, e.g. spasmodic movement of eyeballs, abnormal muscle contractions that
may cause twisting or jerking movements of the body, seizures (e.g. epileptic spasms).
Rare: Dizziness during rapid intravenous administration
Very rare: Depression
Eye disorders
Rare: Transient visual disturbances (e.g. blurred vision) during rapid intravenous administration.
Very rare: Transitory blindness, predominantly during intravenous administration. Most patients had received
chemotherapeutic agents included cisplatin. Most reported cases resolved in 20 minutes.
Vascular disorders:
Common: Sensations of flushing or warmth.
Uncommon: Hypotension (low blood pressure).
Respiratory, thorax and mediastinum disorders Uncommon: Hiccups.
Gastrointestinal disorders
Common: Ondansetron is known to increase the large bowel transit time and may cause constipation in some
patients.
It may also cause local burning sensation following the insertion of suppositories Hepato-biliary disorders
Uncommon: Asymptomatic increases of liver function. These reactions were particularly observed in patients under
chemotherapy with cisplatin.
Skin and subcutaneous tissue disorders
Uncommon: Hypersensitivity reactions around the injection site (e.g. rash, urticaria, itching) may occur, sometimes
extending along the drug administration vein.
General disorders and administration site conditions Common: Local reactions at the I.V. injection site.
Children
The side effects of Ondansetron in children and adolescents are similar to those seen in adults.
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE ONDANSETRON INJECTION
Keep out of the reach and sight of children.
Ondansetron Injection must not be given after the expiry date, which is stated on the ampoule label and carton. The expiry date refers to the last day of that month. Do not use if the product shows signs of deterioration such as discolouration.
Store below 25oC.
Keep the ampoules in the outer carton, in order to protect from light.
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 contains
The active medicine is Ondansetron (as Hydrochloride Dihydrate).
Each 1mL (millilitre) will contain 2mg (milligram) of Ondansetron.
Each 2mL ampoule (container) will contain 4mg of Ondansetron. Each 4mL ampoule will contain 8mg of Ondansetron.
The other ingredients are Citric Acid Monohydrate, Sodium Citrate Dihydrate, sodium chloride and water for injections.
What Ondansetron Injection looks like and contents of the pack
Ondansetron Injection is a clear, colourless solution for injection which can be diluted before use.
Each plastic or glass ampoule (container) will contain 2mL (millilitres) or 4mL of your medicine. These are packed in cartons of 5 ampoules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Suit.115 1065 Nicosia, Cyprus.
Manufacturer: Demo S.A., 21st km National Road Athens - Lamia, 145 68 Athens, Greece.
This medicinal product is authorised in the Member States of the EEA under the following names:
UK Ondansetron 2mg/mL Solution for Injection
Ireland Ondansetron 2mg/mL Solution for Injection
Germany Ondansetron Noridem 2mg/mL Injektionslosung
Austria Ondansetron Noridem 2mg/mL Injektions- und Infusionslosung
Greece ONDANSETRON/NORIDEM Eveai^o SiaAu^a 2mg/mL
Spain Ondansetron KERN PHARMA 2mg/mL Solucion Inyectable EFG
This leaflet was last approved in September 2012.