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ONDANSETRON 4 MG FILM-COATED TABLETS

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE / ONDANSETRON HYDROCHLORIDE DIHYDRATE / ONDANSETRON HYDROCHLORIDE DIHYDRATE

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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 PACKAGE LEAFLET: INFORMATION FOR THE USER tramadol, a pain killer medicines that affect the heart (such as Read all of this leaflet carefully before you start haloperidol or methadone) taking this medicine. cancer medicines (especially anthracyclines and Keep this leaflet. You may need to read it again. trastuzumab). If you have any further questions, ask your If you are not sure if any of the above applies to doctor or pharmacist. you, talk to your doctor, nurse or pharmacist before This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even having Ondansetron tablets. if their symptoms are the same as yours. If you have a blood test to check how your liver is If any of the side effects get serious, or if you working while you are taking Ondansetron, please notice any side effects not listed in this leaflet, make sure the doctor knows you are taking this please tell your doctor or pharmacist. medicine, as it may affect the results of these tests. Pregnancy and breast-feeding IN THIS LEAFLET: Ondansetron is not recommended if you are 1. What Ondansetron is and what it is used for pregnant, planning to become pregnant or 2. Before you take Ondansetron breast-feeding. Ask your doctor for advice before 3. How to take Ondansetron taking this medicine. 4. Possible side effects Driving and using machines 5. How to store Ondansetron Ondansetron is not expected to affect your ability 6. Further information to drive or operate machinery. WHAT ONDANSETRON IS AND WHAT IT IS Important information about some of the USED FOR ingredients of Ondansetron Patients who are intolerant to lactose should Ondansetron belongs to a group of drugs called note that Ondansetron tablets contain a small anti-emetics, which prevent nausea and vomiting amount of lactose. If your doctor has told you (feeling sick or being sick), caused by that you have an intolerance to some sugars, chemotherapy or radiotherapy. contact your doctor before taking this medicine. Ondansetron is used: to treat nausea (feeling sick) and vomiting HOW TO TAKE ONDANSETRON (being sick) caused by receiving chemotherapy or radiotherapy for cancer (in adults and Always take Ondansetron exactly as your doctor children) has told you. You should check with your doctor or to prevent and treat nausea and vomiting pharmacist if you are not sure. following surgical operations (adults only). The tablets should be swallowed whole preferably with a drink of water. The usual dose is: BEFORE YOU TAKE ONDANSETRON To treat nausea and vomiting caused by receiving chemotherapy or radiotherapy: Do NOT take Ondansetron if you: Adults (including the elderly): are allergic (hypersensitive) to ondansetron or 8 mg taken 1 to 2 hours before chemotherapy or any of the other ingredients of this medicine. radiotherapy, followed by 8 mg 12 hours later. Take special care with Ondansetron 24 hours after chemotherapy or radiotherapy, Talk to your doctor before you start to take this 8 mg twice a day may be taken for up to 5 days. medicine if you have: ever suffered an allergic reaction to other similar Children aged over 6 months and adolescents The doctor will decide the dose. Look at the label medicines e.g. granisetron or tropisetron for more information. ever had heart problems the usual dose for a child is up to 4 mg twice a an uneven heart beat (arrhythmias) day liver problems this can be given for up to 5 days. a blockage in your gut problems with the levels of salts in your blood, To prevent nausea and vomiting after an operation: such as potassium, sodium and magnesium. Adults (including the elderly): If you are not sure if any of the above apply to you, A dose of 16 mg can be taken one hour before talk to your doctor, nurse or pharmacist before the anaesthetic. taking Ondansetron Tablets. Alternatively, a dose of 8 mg can be taken one hour before the anaesthetic, followed by two Taking other medicines further 8 mg doses at eight hourly intervals. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, Children aged over 1 month and adolescents: including medicines obtained without a prescription. It is recommended that Ondansetron be given as In particular, tell your doctor, nurse or pharmacist if an injection. you are taking any of the following medicines: Patients with Liver Problems: carbamazepine or phenytoin used to treat epilepsy The total daily dose should not exceed 8 mg. rifampicin used to treat infections such as tuberculosis (TB)

ONDANSETRON 4 mg AND 8 mg FILM-COATED TABLETS

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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 your 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 swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause temporary problems with your sight, severe constipation or 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 your medicine without talking to your doctor first even if you feel better. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Rare (affects less than 1 in 1000 people) dizziness temporary visual disturbance e.g. blurred vision. Very rare (affects less than 1 in 10,000 people) poor vision or temporary loss of eyesight which usually comes back within 20 minutes. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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HOW TO STORE ONDANSETRON

Keep out of the reach and sight of children. Do not use Ondansetron after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. 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.

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FURTHER INFORMATION

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POSSIBLE SIDE EFFECTS

Like all medicines, Ondansetron 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 (signs of which may include swelling of the lips, face or neck leading to severe difficulty in breathing, sudden wheezing and chest pain or tightness, skin rash or hives). These are very serious but rare side effects. You may need urgent medical attention or hospitalisation. Other side effects include: Very common (affects more than 1 in 10 people) Headache. Common (affects less than 1 in 10 people) flushing or a feeling of warmth constipation changes to liver test results (if you take Ondansetron Tablets with a medicine called cisplatin, otherwise this side effect is uncommon). Uncommon (affects less than 1 in 100 people) hiccups low blood pressure causing a light-headed feeling chest pain uneven heart beat slow pulse rate fits abnormal muscle stiffness, body movements or shaking abnormal eye movement, upward rolling of the eyes.

What Ondansetron tablets contain: The active ingredient is ondansetron hydrochloride dihydrate. The other ingredients are lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, pre-gelatinised starch, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol and yellow iron oxide (E172). What Ondansetron tablets look like and contents of the pack: Ondansetron 4 mg tablets are yellow, oblong film-coated engraved 4 on one side and plain on the other. Ondansetron 8 mg tablets are yellow, oblong film-coated engraved 8 on one side and plain on the other. Ondansetron 4 mg tablets are available in pack sizes of 2, 4, 5, 6, 10, 15, 30, 100 & 500 tablets. Ondansetron 8 mg tablets are available in pack sizes of 2, 4, 5, 6, 9, 10, 15, 18, 50, 100, 500 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG. This leaflet was last revised: September 2010 PL00289/0540-41

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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