Ondansetron 2mg|Ml Solution For Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER Ondansetron 2mg/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 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, pharmacist or nurse . This includes any possible side effects not listed in this leaflet. See section 4.
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.
What is in this leaflet:
1. What Ondansetron Injection is and what it is used for
2. What you need to know before you take Ondansetron Injection
3. How to take Ondansetron Injection
4. Possible side effects
5. How to store Ondansetron Injection
6. Contents of the pack and other information
1. WHAT ONDANSETRON INJECTION IS AND WHAT IS IT USED FOR
Ondansetron injection contains a medicine called ondansetron. This belongs to a group of medicines called anti-emetics. Ondansetron injection is used for:
• preventing nausea and vomiting caused by chemotherapy (in adults and children) or radiotherapy for cancer (adults only)
• preventing nausea and vomiting after surgery.
Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONDANSETRON INJECTION
Do not take Ondansetron Injection if:
• you are taking apomorphine (used to treat Parkinson’s disease)
• you are allergic (hypersensitive) to ondansetron or any of the other ingredients of this medicine (listed in section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before having Ondansetron Injection.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking Ondansetron injection if:
• you have ever had heart problems (e.g. congestive heart failure which causes shortness of breath and swollen ankles)
• 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.
Other medicines and Ondansetron Injection
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
• carbamazepine or phenytoin used to treat epilepsy
• rifampicin used to treat infections such as tuberculosis (TB)
• antibiotics such as erythromycin or ketoconazole
• anti-arrhythmic medicines used to treat an uneven heart beat
• beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines
• tramadol, a pain killer
• medicines that affect the heart (such as haloperidol or methadone)
• cancer medicines (especially anthracyclines and trastuzumab).
• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or 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 having Ondansetron Injection.
Ondansetron Injection should not be given in the same syringe or infusion (drip) as any other medication.
Pregnancy and breastfeeding
It is not known if Ondansetron Injection is safe during pregnancy. 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.
Do not breast-feed if you have Ondansetron Injection. This is because small amounts pass into the mother’s milk. Ask your doctor or midwife for advice.
Ondansetron Injection contains sodium
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
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
To prevent nausea and vomiting from chemotherapy or radiotherapy in adultsOn 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 an Ondansetron tablet.
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
• two 4 mg tablets or 10 ml (8mg) syrup twice a day for teenagers (or those with a large body surface area)
• these doses can be given for up to five days.
To prevent and treat nausea and vomiting after an operation
Adult:
For
mg given
• The usual dose for adults is 4 mg given by a slow injection into your vein or an injection into your muscle. 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 as a slow injection into the vein. For prevention, this will be given just before the operation.
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 take more Ondansetron Injection than you should
Your doctor or nurse will give you or your child Ondansetron injection so it is unlikely that you or your child will receive too much. If you think you or your child have been given too much or have missed a dose, tell your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
If you have an allergic reaction, tell your doctor or a member of the medical staff straight away. The signs may include:
• sudden wheezing and chest pain or chest tightness
• swelling of your eyelids, face, lips, mouth or tongue
• skin rash - red spots or lumps under your skin (hives) anywhere on your body
• collapse.
Other side effects include:
Very common (may affect more than 1 in 10 people)
• headache.
Common (may affect up to 1 in 10 people)
• a feeling of warmth or flushing
• constipation
• changes to liver function test results (if you have Ondansetron injection with a medicine called cisplatin, otherwise this side effect is uncommon)
• irritation and redness at the site of injection.
Uncommon (may affect up to 1 in 100 people)
• hiccups
• low blood pressure, which can make you feel faint or dizzy
• uneven heart beat
• chest pain
• fits
• unusual body movements or shaking.
Rare (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)
Very rare (may affect up to 1 in 10,000 people)
• poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.
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
For UK: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
For IE: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www. hpra.ie, E-mail: medsafety@hpra.ie.
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 use this medicine after the expiry date which is stated on the ampoule label and carton after EXP. The expiry date refers to the last day of that month. Do not use this medicine if you notice signs of deterioration such as discolouration.
Store below 25oC.
Keep the ampoules in the outer carton, in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ondansetron Injection contains
The active substance 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 Ireland Germany Austria Greece Spain |
Ondansetron 2mg/mL Solution for Injection Ondansetron 2mg/mL Solution for Injection Ondansetron Noridem 2mg/mL Injektionslosung Ondansetron Noridem 2mg/mL Injektions- und Infusionslosung ONDANSETRON/NORIDEM Eveaipo SiaAupa 2mg/mL Ondansetron KERN PHARMA 2mg/mL Solucion Inyectable EFG |
This leaflet was last revised in February 2016.
If this leaflet is difficult to see or read please contact the following address for help:
Athlone Laboratories, Ballymurray, Co. Roscommon, Ireland.
Tel +353-9066-61109. Email medical@athlone-laboratories.com