ONDANSETRON 4MG FILM COATED TABLETS
Active substance: ONDANSETRON HYDROCHLORIDE DIHYDRATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER Ondansetron 4 mg Film-coated tablets Ondansetron 8 mg Film-coated tablets Ondansetron hydrochloride dehydrate Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, nurse or pharmacist. This medicine has been prescribed for you. Do 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. In this leaflet: 1. What Ondansetron tablets are and what they are used for 2. Before you take Ondansetron tablets 3. How to take Ondansetron tablets 4. Possible Side effects 5. How to store Ondansetron tablets 6. Further information.
1. WHAT ONDANSETRON TABLETS ARE AND WHAT THEY ARE USED FOR Ondansetron belongs to a group of medicines known as anti-emetics or anti-sickness medicines. Ondansetron tablets are used for: preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer (in adults and children) preventing nausea and vomiting after surgery (adults only). Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.
2. BEFORE YOU TAKE ONDANSETRON TABLETS Do not take Ondansetron tablets if: - you are allergic (hypersensitive) to ondansetron or any of the other ingredients in Ondansetron tablets (listed in Section 6). If you are not sure, talk to your doctor, nurse or pharmacist before taking Ondansetron tablets. Take special care with Ondansetron tablets Check with your doctor or pharmacist before taking Ondansetron tablets if: you have ever had heart problems you have an uneven heart beat (arrhythmias) you are allergic to medicines similar to ondanseteron, such as granisteron you have liver problems you have a blockage in your gut you have problem with the level of salts in your blood, such as potassium, sodium or magnesium If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Ondansetron tablets.
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Taking other medicines Please tell your doctor, nurse or pharmacist if you are already taking or recently have taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Ondansetron tablets can affect the way some medicines work. Also some other medicines can affect the Ondansetron tablets. In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines: carbamazepine or phenytoin used to treat epilepsyrifampicin used to treat infections such as tuberculosis (TB) anti-arrhythmic medicines use 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) If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Ondansetron tablets. Pregnancy and breast-feeding It is not known if Ondansetron tablets is safe during pregnancy. Talk to your doctor before taking Ondansetron tablets if you are pregnant or might become pregnant. Do not breast-feed if you are taking Ondansetron tablets. This is because small amounts pass into the mothers milk. Ask your doctor or midwife for advice. Driving and using machines Ondansetron Tablets should not affect your ability to drive or use machines. Important information about some of the ingredients of Ondansetron tablets Ondansetron tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE ONDANSETRON TABLETS Always take Ondansetron tablets exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure. The dose you have been prescribed will depend on the treatment you are having. Swallow the tablets with a glass of water Patients with liver problems should not take more than 8 mg of Ondansetron each day Ondansetron is also available as an injection.
To prevent nausea and vomiting from chemotherapy and radiotherapy On the day of chemotherapy and radiotherapy the usual adult dose is 8 mg taken one or two hours before treatment and and another 8 mg twelve hours after. On the following days the usual adult dose is 8 mg twice a day this may be given for up to 5 days. Children aged over 6 months and adolescents The doctor will decide the dose. Look at the label for more information.
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the usual dose for a child is up to 4 mg twice a day this can be given for up to 5 days.
To prevent nausea and vomiting after an operation The usual adult dose is 16 mg before your operation or 8 mg before an operation, then 8 mg after the operation, then 8 mg after further 8 hours. Children aged over 1 month and adolescents It is recommended that Ondansetron is given as an injection. Patients with moderate or severe liver problems The total daily dose should not be more than 8 mg. Ondansetron tablets should start to work within one or two hours of taking a dose. If you are sick (vomit) within one hour of taking a dose take the same dose again otherwise do not take more Ondansetron tablets than the label says. If you continue to feel sick, tell your doctor or nurse. If you take more Ondansetron tablets than you should If you take more Ondansetron tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. If you forget to take Ondansetron tablets If you miss a dose and feel sick or vomit: take Ondansetron tablets as soon as possible, then take your next tablet at the usual time (as shown on the label) do not take a double dose to make up for a forgotten dose. If you miss a dose but do not feel sick take the next dose as shown on the label. do not take a double dose to make up for a forgotten dose. Patients with kidney problemsPatients with kidney problems or who cannot metabolise sparteine/debrisoquine well can take the recommended doses of ondansetron, as detailed above.
4. POSSIBLE SIDE EFFECTS Like all medicines, Ondansetron tablets can cause side effects, although not everybody gets them. Allergic reactions If you have an allergic reaction, stop taking it and see a doctor 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 (affecting more than 1 in 10 people) headache
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Common (affecting less than 1 in 10 people) a feeling of warmth or flushing constipation changes to liver function test result (if you take Ondansetron tablets with a medicine called cisplatin, otherwise this side effect is uncommon). Uncommon (affecting less than 1 in 100 people) hiccups low blood pressure, which can make you feel faint or dizzy uneven heart beat chest pain with or without ECG changes fits unusual body movements or shaking Rare (affecting less than 1 in 1,000 people) feeling dizzy or light headed transient blurred vision. Very rare side effects (affecting fewer 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
5. HOW TO STORE ONDANSETRON TABLETS Keep out of the reach and sight of children Do not store tablets above 30C Do not take this medicine after the expiry date shown on the pack. 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 Tablets contain Each tablet contains either 4 mg or 8 mg of the active ingredient ondansetron (as the hydrochloride dihydrate). The other ingredientcs are lactose monohydrate, microcrystalline cellulose (E460), pregelatinised maize starch, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), propylene glycol (E1520), hydroxypropyl cellulose (E463), sorbitan monooleate (E494), sorbic acid (E200), vanillin and quinoline yellow (E104). What Ondansetron Tablets look like and contents of the pack The Ondansetron Tablets are round, pale yellow film-coated tablets. The 4 mg strength tablets are marked 41 on one side and the 8 mg strength are marked 42 on one side. Ondansetron tablets are available in blister packs of 3, 6, 10, 14, 15, 20, 30, 40, 50, 60, 90, 100, 200, 300, 500 tablets. * (*Only marketed pack sizes will feature in the printed leaflet)
Product Licence Holder and manufacturer:
Generics [UK] Ltd, Station Close, Potters Bar, Herts, EN6 1TL.
Date leaflet prepared: 09/2011
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1. WHAT ONDANSETRON TABLETS ARE AND WHAT THEY ARE USED FOR Ondansetron belongs to a group of medicines known as anti-emetics or anti-sickness medicines. Ondansetron tablets are used for: preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer (in adults and children) preventing nausea and vomiting after surgery (adults only). Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.
2. BEFORE YOU TAKE ONDANSETRON TABLETS Do not take Ondansetron tablets if: - you are allergic (hypersensitive) to ondansetron or any of the other ingredients in Ondansetron tablets (listed in Section 6). If you are not sure, talk to your doctor, nurse or pharmacist before taking Ondansetron tablets. Take special care with Ondansetron tablets Check with your doctor or pharmacist before taking Ondansetron tablets if: you have ever had heart problems you have an uneven heart beat (arrhythmias) you are allergic to medicines similar to ondanseteron, such as granisteron you have liver problems you have a blockage in your gut you have problem with the level of salts in your blood, such as potassium, sodium or magnesium If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Ondansetron tablets.
1
Taking other medicines Please tell your doctor, nurse or pharmacist if you are already taking or recently have taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Ondansetron tablets can affect the way some medicines work. Also some other medicines can affect the Ondansetron tablets. In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines: carbamazepine or phenytoin used to treat epilepsyrifampicin used to treat infections such as tuberculosis (TB) anti-arrhythmic medicines use 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) If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Ondansetron tablets. Pregnancy and breast-feeding It is not known if Ondansetron tablets is safe during pregnancy. Talk to your doctor before taking Ondansetron tablets if you are pregnant or might become pregnant. Do not breast-feed if you are taking Ondansetron tablets. This is because small amounts pass into the mothers milk. Ask your doctor or midwife for advice. Driving and using machines Ondansetron Tablets should not affect your ability to drive or use machines. Important information about some of the ingredients of Ondansetron tablets Ondansetron tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE ONDANSETRON TABLETS Always take Ondansetron tablets exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure. The dose you have been prescribed will depend on the treatment you are having. Swallow the tablets with a glass of water Patients with liver problems should not take more than 8 mg of Ondansetron each day Ondansetron is also available as an injection.
To prevent nausea and vomiting from chemotherapy and radiotherapy On the day of chemotherapy and radiotherapy the usual adult dose is 8 mg taken one or two hours before treatment and and another 8 mg twelve hours after. On the following days the usual adult dose is 8 mg twice a day this may be given for up to 5 days. Children aged over 6 months and adolescents The doctor will decide the dose. Look at the label for more information.
2
-
the usual dose for a child is up to 4 mg twice a day this can be given for up to 5 days.
To prevent nausea and vomiting after an operation The usual adult dose is 16 mg before your operation or 8 mg before an operation, then 8 mg after the operation, then 8 mg after further 8 hours. Children aged over 1 month and adolescents It is recommended that Ondansetron is given as an injection. Patients with moderate or severe liver problems The total daily dose should not be more than 8 mg. Ondansetron tablets should start to work within one or two hours of taking a dose. If you are sick (vomit) within one hour of taking a dose take the same dose again otherwise do not take more Ondansetron tablets than the label says. If you continue to feel sick, tell your doctor or nurse. If you take more Ondansetron tablets than you should If you take more Ondansetron tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. If you forget to take Ondansetron tablets If you miss a dose and feel sick or vomit: take Ondansetron tablets as soon as possible, then take your next tablet at the usual time (as shown on the label) do not take a double dose to make up for a forgotten dose. If you miss a dose but do not feel sick take the next dose as shown on the label. do not take a double dose to make up for a forgotten dose. Patients with kidney problemsPatients with kidney problems or who cannot metabolise sparteine/debrisoquine well can take the recommended doses of ondansetron, as detailed above.
4. POSSIBLE SIDE EFFECTS Like all medicines, Ondansetron tablets can cause side effects, although not everybody gets them. Allergic reactions If you have an allergic reaction, stop taking it and see a doctor 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 (affecting more than 1 in 10 people) headache
3
Common (affecting less than 1 in 10 people) a feeling of warmth or flushing constipation changes to liver function test result (if you take Ondansetron tablets with a medicine called cisplatin, otherwise this side effect is uncommon). Uncommon (affecting less than 1 in 100 people) hiccups low blood pressure, which can make you feel faint or dizzy uneven heart beat chest pain with or without ECG changes fits unusual body movements or shaking Rare (affecting less than 1 in 1,000 people) feeling dizzy or light headed transient blurred vision. Very rare side effects (affecting fewer 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
5. HOW TO STORE ONDANSETRON TABLETS Keep out of the reach and sight of children Do not store tablets above 30C Do not take this medicine after the expiry date shown on the pack. 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 Tablets contain Each tablet contains either 4 mg or 8 mg of the active ingredient ondansetron (as the hydrochloride dihydrate). The other ingredientcs are lactose monohydrate, microcrystalline cellulose (E460), pregelatinised maize starch, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), propylene glycol (E1520), hydroxypropyl cellulose (E463), sorbitan monooleate (E494), sorbic acid (E200), vanillin and quinoline yellow (E104). What Ondansetron Tablets look like and contents of the pack The Ondansetron Tablets are round, pale yellow film-coated tablets. The 4 mg strength tablets are marked 41 on one side and the 8 mg strength are marked 42 on one side. Ondansetron tablets are available in blister packs of 3, 6, 10, 14, 15, 20, 30, 40, 50, 60, 90, 100, 200, 300, 500 tablets. * (*Only marketed pack sizes will feature in the printed leaflet)
Product Licence Holder and manufacturer:
Generics [UK] Ltd, Station Close, Potters Bar, Herts, EN6 1TL.
Date leaflet prepared: 09/2011
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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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
