Teva Ondansetron 4 Mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
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, please 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. See Section 4
WHAT IS IN THIS LEAFLET:
1. What Ondansetron is and what it is used for.
2. What you need to know before you take Ondansetron.
3. How to take Ondansetron.
4. Possible side effects.
5. How to store Ondansetron.
6. Contents of the pack and other information.
1. WHAT ONDANSETRON IS AND WHAT IT IS USED FOR
Ondansetron belongs to a group of drugs called anti-emetics, which prevent nausea and vomiting (feeling sick or being sick)
Ondansetron is used:
• to treat nausea (feeling sick) and vomiting (being sick) caused by receiving chemotherapy or radiotherapy.
• to prevent and treat nausea and vomiting following surgical operations.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONDANSETRON
Do NOT take Ondansetron if you:
• are allergic (hypersensitive) to ondansetron or any of the other ingredients of this medicine (listed in section 6).
• have ever suffered an allergic reaction to other similar medicines e.g. granisetron, tropisetron or dolasetron.
• use apomorphine (used to treat Parkinson’s disease)
Warnings and precautions
Talk to your doctor or pharmacist before taking Ondansetron if you:
• have liver problems.
• have a blockage in your gut or if you suffer from severe constipation.
• have had surgery on your gut
• have had surgery on your adenoids or tonsils
• have had heart problems, including an uneven heart beat (arrhytmias)
• have problems with the levels of salts in your blood, such as potassium, sodium and magnesium
Other medicines and Ondansetron
Tell your doctor if you are taking any of the following medicines:
• Phenytoin (used in the treatment of epilepsy).
• Carbamazepine (used in the treatment of epilepsy).
• Rifampicin (used in the treatment of tuberculosis).
• Tramadol (used to relieve moderate to moderately severe pain).
• Medicines that affect the heart (such as haloperidol or methadone)
• Medicines used to treat an uneven heart beat (anti-arrhytmics)
• Beta-blocking medicines (used to treat heart problems, eye problems, anxiety or for prevention of migraines)
• Cancer medicines (especially anthracyclines)
• Medicines used to treat infections (erythromycin, ketoconazole)
If you have a blood test to check how your liver is working while you are taking
Ondansetron, please make sure the doctor knows you are taking this medicine, as it may
affect the results of these tests.
Pregnancy and Breast-feeding:
• Ondansetron is not recommended if you are pregnant, planning to become pregnant or breast-feeding. Ask your doctor for advice before taking this medicine.
• Do not breast-feed if you are taking Ondansetron. This is because small amounts pass into mother’s milk. Ask your doctor for advice.
Driving and using machines
• Ondansetron is not expected to affect your ability to drive or operate machinery.
Ondansetron contains lactose
• Patients who are intolerant to lactose should note that Ondansetron tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE ONDANSETRON
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The tablets should be swallowed whole preferably with a drink of water. The recommended dose is:
To treat nausea and vomiting caused by receiving chemotherapy or radiotherapy:
• Adults (including the elderly):
8 mg taken 1 to 2 hours before chemotherapy or radiotherapy, followed by 8 mg 12 hours later. 24 hours after chemotherapy or radiotherapy, 8 mg twice a day may be taken for up to 5 days.
• Use in children (aged over 6 months) and adolescents
Ondansetron may be given initially by a single injection into the vein over 15 minutes before chemotherapy, followed by tablets which may be given two to three times a day for up to 5 days following chemotherapy. The dose of tablets will depend on your body size and will be calculated by your doctor.
To prevent nausea and vomiting after an operation:
• Adults (including the elderly):
A dose of 16 mg can be taken one hour before the anaesthesia.
Alternatively, a dose of 8 mg can be taken one hour before the anaesthesia, followed by two further 8 mg doses as eight hourly intervals.
• Use in children (aged over 1 month) and adolescents
It is recommended that an intravenous injection containing Ondansetron should be given.
Patients with Liver Problems:
The total daily dose should not exceed 8 mg.
Ondansetron should start to work within one to two hours of taking the dose. If you vomit the dose back within one hour, take another dose. Otherwise, continue to take your tablets as on the label, but do not take more than your doctor has recommended. If you continue to feel sick then you should tell the doctor.
If you take more Ondansetron than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
An overdose can cause temporary problem with your sight, severe constipation, feeling dizzy or faint.
Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Ondansetron
If you forget to take a tablet and feel sick or vomit, take one as soon as you remember and then carry on as before. If you forget to take a tablet and do not feel sick, then wait until the next dose as on the label. Take the remaining doses at the correct time.
If you stop taking Ondansetron
Do not stop taking you medicine without talking to your doctor first even if you feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
• an allergic reaction causing (swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing, skin rash).
• 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 take Ondansetron tablets with a medicine called cisplatin, otherwise this side effect is uncommon).
Uncommon (may affect up to 1 in 100 people)
• hiccups
• low blood pressure, which can make you feel faint or dizzy
• uneven heart beat or 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
• disturbances in heart rhythm (sometimes causing a sudden loss of consciusness).
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 or pharmacist. 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
Keep Ondansetron out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) which is stated on the blister and carton. The expiry date (EXP) refers to the last day of that month. 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 protect the environment.
This medicinal product does not require any special storage conditions.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ondansetron tablets contain:
• The active ingredient is Ondansetron. Each film-coated tablet contains 4 mg & 8 mg of Ondansetron (as ondansetron hydrochloride dihydrate).
• The other ingredients are:
o tablet core: lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, pregelatinised starch, magnesium stearate,
o coating: hypromellose, titanium dioxide (E171), macrogol (400 & 6000) and yellow iron oxide (E172).
What Ondansetron tablets look like and contents of the pack:
• Ondansetron 4 mg tablets are yellow, oblong film-coated tablets engraved “4” on one side and plain on the other.
• Ondansetron 8 mg tablets are yellow, oblong film-coated tablets engraved “8” on one side and scoreline on the other.
• Ondansetron 4 mg tablets are available in pack sizes of 2, 4, 5, 6, 10, 15, 30, 100 & 500 film-coated tablets
• Ondansetron 8 mg tablets are available in pack sizes of 2, 4, 5, 6, 9, 10, 15, 18, 50, 100 & 500 film-coated tablets.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Teva Pharma BV Computerweg 10 3542 Dr Utrecht The Netherlands Manufacturer:
Teva UK Limited,
Brampton Road,
Hampden Park,
Eastbourne,
East Sussex, BN22 9AG,
United Kingdom
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Pharmachemie B.V., | ||
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Swensweg 5 |
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Postbus 522 | ||
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2003 RN Haarlem, | ||
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The Netherlands | ||
Teva Pharmaceutical Works Co. Ltd Pallagi Street 13 4042 Debrecen Hungary
Teva UK Limited 18 Bruntcliffe Way
Morley, Leeds,
West Yorkshire LS27 0JG United Kingdom
Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Teva Ondansetron 4mg & 8mg Film-Coated Tablets AT: Ondansetron Teva® 4mg & 8mg Filmtabletten CZ: Ondansetron-Teva 4mg &
DE: Ondansetron-GRY® 4mg & 8mg Filmtabletten
DK: Ondansetron Teva 4mg & 8mg Fimovertukne tabletter
ES: Ondansetron TEVA 4mg & 8mg comprimidose recubiertos con pelicula EFG
IE: Ondansetron 4mg and 8mg Film-Coated Tablets
LT: Ondansetron-Teva 4mg & 8mg Tabletes
NL: Ondansetron 4mg & 8mg Compimido revestido
SE: Ondansetron Teva 4mg & 8mg Filmdragerad tablet
SK: Ondansetron-Teva 4mg & 8mg
This leaflet was last revised in: January 2014