ONDEMET 8MG TABLETS
Active substance: ONDANSETRON HYDROCHLORIDE DIHYDRATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER Ondemet 4mg and 8mg Tablets (Ondansetron) 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 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 side effects trouble you, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Ondansetron is and what it is used for 2. Before you take Ondansetron 3. How to take Ondansetron 4. Possible side effects 5. How to store Ondansetron 6. Further information 1. WHAT ONDANSETRON IS AND WHAT IT IS USED FOR Ondansetron belongs to a group of drugs called anti-emetics. Ondansetron inhibits the effect of the neuro-transmitter serotonin in the brain. Serotonin causes nausea and vomiting. Ondansetron is used to prevent or treat nausea and vomiting induced by chemotherapy or radiotherapy. In addition it may be used to prevent or treat post-operative nausea and vomiting. Your doctor may have prescribed Ondansetron for another use. Always follow your doctor's advice. 2. 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) if you have previously experienced allergy (hypersensitivity) to other drugs belonging to the group of serotonin antagonists used to prevent and treat nausea and vomiting (e.g. granisetron, dolasetron). If this is the case, it is possible that you are also allergic to Ondansetron if you are pregnant or breastfeeding. Take special care with Ondansetron Tell your doctor: if you have a blockage of your intestines or constipation, as you will need to be closely monitored by your doctor if you are going to have or recently had your tonsils removed, as treatment with Ondansetron may hide symptoms of internal bleeding if you have heart problems (with arrhythmias or conduction disorders) and are being treated with other medicines such as anaesthetics, anti-arrhythmic or beta-blockers at the same time. if it is for a child under the age of 6 months if you have liver problems. Always tell the laboratory if you are having blood or urine tests, that you are being treated with Ondansetron. Taking other medicines Ondansetron may have an effect on other drugs or other drugs may have an effect on Ondansetron. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, natural supplements or vitamins or minerals. You must tell your doctor that you are taking Ondansetron, if he/she starts treating you with any of the following medicines: Phenytoin or carbamazepine, used to treat epilepsy Rifampicin, an antibiotic used to treat infections Tramadol, a pain relieving medicine Cancer medicines (especially anthracyclines and trastuzumab). Contact your doctor. It may be necessary to adjust the dose. Taking Ondansetron with food and drink You may take Ondansetron with food and drinks. The tablets should be taken with a glass of water. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy: It is not known if ondansetron is safe during pregnancy. Talk to your doctor before taking Ondansetron tablets if you are pregnant or might become pregnant. Breast-feeding: Do not take Ondansetron if you are breast-feeding, because it is excreted into the milk. Driving and using machines Ondansetron may cause problems with your vision. If affected do not drive or operate machinery. Important information about some of the ingredients of Ondansetron Ondansetron contains Lactose monohydrate. Contact your doctor before taking this medicine if your doctor has told you that you do not tolerate certain types of sugar. 3. HOW TO TAKE ONDANSETRON Always take Ondansetron exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Treatment and prevention of nausea and vomiting in connection with chemotherapy or radiotherapy Adults: The usual dose is 8 mg 1-2 hours before chemotherapy or radiotherapy, followed by 8 mg every 12 hours for up to 5 days. Your doctor may decide to give the first dose as an injection. Children (aged over 6 months) and adolescents under the age of 18 years: The doctor will decide the dose. Look at the label for more information. The usual dose for a child is up to 4mg twice a day. This can be given for up to 5 days.
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Treatment and prevention of post-operative nausea and vomiting Adults, prevention and treatment: The usual dose is 16 mg one hour before anaesthesia or alternatively, 8 mg taken one hour before anaesthesia followed by an additional 8 mg after 8 and 16 hours. Your doctor may choose to give you the medicine as injections. Children aged over 1 month and adolescents under the age of 18 years: It is recommended that ondansetron is given as an injection. Insufficient function of the liver: The daily dose should not exceed 8 mg if you have moderately to severely reduced function of the liver. The tablets should be taken with a glass of water. Always follow your doctor's advice. There are differences in individual patients needs. Do not change or stop your treatment without first talking to your doctor. If you take more Ondansetron than you should Contact your doctor, hospital casualty department or the pharmacy if you have taken more Ondansetron than recommended in this package leaflet or than prescribed by your doctor and you feel uncomfortable. The symptoms of overdose are disturbances of vision, severe constipation, low blood pressure and disturbances in heart beat rhythm. If you forget to take Ondansetron Do not take a double dose to make up for a forgotten dose. 4. POSSIBLE SIDE EFFECTS Like all medicines, Ondansetron can cause side effects, although not everybody gets them. Serious, rare side effects (occur in between 1 and 10 of 10,000 patients treated): Tell your doctor or go to the nearest hospital casualty department immediately if you experience any of the following signs of a serious allergic reaction: Swollen tongue or throat Difficulty breathing Hives (also known as nettle rash or urticaria). Very common side effects (occur in more than 1 in 10 patients treated): Headache. Common side effects (occur in between 1 and 10 of 100 patients treated): A sensation of reddening and warmth Constipation. . Uncommon side effects (occur in between1 and 10 of 1,000 patients treated): Hiccups Low blood pressure (you may feel dizzy or faint when you stand up), irregular heart beats, chest pain and slow pulse Involuntary movements Changes in liver function Seizures (fits).
Rare side effects (occur in between 1 and 10 of 10,000 patients treated): Temporary blurred vision. Very rare side effects (occur in less than 1 of 10, 000 patients treated): Temporary blindness (usually following ondansetron injection). Abnormally rapid heart rhythm (Torsades de pointes). If any of these side effects occur, immediately seek medical attention. Tell your doctor or pharmacist if you notice any other side effects not listed in this package leaflet. This will ensure that side effects are recorded by the National Drug regulatory authority, and help to improve knowledge on side effects. Tell your doctor or pharmacist if you experience side effects that persist, bother or concern you in any way. 5. HOW TO STORE ONDANSETRON Keep out of the reach and sight of children Store in the original package Do not use Ondansetron after the expiry date which is stated on the blister and on the carton 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 contains The active substance is ondansetron 4 mg or 8 mg as ondansetron hydrochloride dihydrate. The other ingredients are Cellulose, microcrystalline; Lactose monohydrate; Starch, pregelatinised (maize); Magnesium stearate; Hypromellose; Hydroxypropylcellulose; Propylene glycol; Sorbitane oleate; Sorbic acid; Vanillin; Titanium dioxide (EI7l) and Quinoline yellow (E I04). What Ondansetron looks like and contents of the pack Ondemet 4 mg are yellow round, biconvex film-coated tablets with a diameter of 7.2 mm and marked 41 on one side. Ondemet 8 mg are yellow round, biconvex film-coated tablets with a diameter of 9.2 mm and marked 42 on one side. 4 mg blister: 6, 10, 30, 50 and 100 film-coated tablets. 8 mg blister: 6, 10, 15, 30, 50 and 100 film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Alliance Pharmaceuticals Ltd, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK Manufacturer Pharmathen S.A., 6. Dervenakion str., 15351 Pallini. Attikis, Greece This leaflet was last revised in January 2012 Ondemet is a registered trademark in the United Kingdom of Alliance Pharmaceuticals Limited. Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited. Alliance Pharmaceuticals Limited 2012
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Treatment and prevention of post-operative nausea and vomiting Adults, prevention and treatment: The usual dose is 16 mg one hour before anaesthesia or alternatively, 8 mg taken one hour before anaesthesia followed by an additional 8 mg after 8 and 16 hours. Your doctor may choose to give you the medicine as injections. Children aged over 1 month and adolescents under the age of 18 years: It is recommended that ondansetron is given as an injection. Insufficient function of the liver: The daily dose should not exceed 8 mg if you have moderately to severely reduced function of the liver. The tablets should be taken with a glass of water. Always follow your doctor's advice. There are differences in individual patients needs. Do not change or stop your treatment without first talking to your doctor. If you take more Ondansetron than you should Contact your doctor, hospital casualty department or the pharmacy if you have taken more Ondansetron than recommended in this package leaflet or than prescribed by your doctor and you feel uncomfortable. The symptoms of overdose are disturbances of vision, severe constipation, low blood pressure and disturbances in heart beat rhythm. If you forget to take Ondansetron Do not take a double dose to make up for a forgotten dose. 4. POSSIBLE SIDE EFFECTS Like all medicines, Ondansetron can cause side effects, although not everybody gets them. Serious, rare side effects (occur in between 1 and 10 of 10,000 patients treated): Tell your doctor or go to the nearest hospital casualty department immediately if you experience any of the following signs of a serious allergic reaction: Swollen tongue or throat Difficulty breathing Hives (also known as nettle rash or urticaria). Very common side effects (occur in more than 1 in 10 patients treated): Headache. Common side effects (occur in between 1 and 10 of 100 patients treated): A sensation of reddening and warmth Constipation. . Uncommon side effects (occur in between1 and 10 of 1,000 patients treated): Hiccups Low blood pressure (you may feel dizzy or faint when you stand up), irregular heart beats, chest pain and slow pulse Involuntary movements Changes in liver function Seizures (fits).
Rare side effects (occur in between 1 and 10 of 10,000 patients treated): Temporary blurred vision. Very rare side effects (occur in less than 1 of 10, 000 patients treated): Temporary blindness (usually following ondansetron injection). Abnormally rapid heart rhythm (Torsades de pointes). If any of these side effects occur, immediately seek medical attention. Tell your doctor or pharmacist if you notice any other side effects not listed in this package leaflet. This will ensure that side effects are recorded by the National Drug regulatory authority, and help to improve knowledge on side effects. Tell your doctor or pharmacist if you experience side effects that persist, bother or concern you in any way. 5. HOW TO STORE ONDANSETRON Keep out of the reach and sight of children Store in the original package Do not use Ondansetron after the expiry date which is stated on the blister and on the carton 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 contains The active substance is ondansetron 4 mg or 8 mg as ondansetron hydrochloride dihydrate. The other ingredients are Cellulose, microcrystalline; Lactose monohydrate; Starch, pregelatinised (maize); Magnesium stearate; Hypromellose; Hydroxypropylcellulose; Propylene glycol; Sorbitane oleate; Sorbic acid; Vanillin; Titanium dioxide (EI7l) and Quinoline yellow (E I04). What Ondansetron looks like and contents of the pack Ondemet 4 mg are yellow round, biconvex film-coated tablets with a diameter of 7.2 mm and marked 41 on one side. Ondemet 8 mg are yellow round, biconvex film-coated tablets with a diameter of 9.2 mm and marked 42 on one side. 4 mg blister: 6, 10, 30, 50 and 100 film-coated tablets. 8 mg blister: 6, 10, 15, 30, 50 and 100 film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Alliance Pharmaceuticals Ltd, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK Manufacturer Pharmathen S.A., 6. Dervenakion str., 15351 Pallini. Attikis, Greece This leaflet was last revised in January 2012 Ondemet is a registered trademark in the United Kingdom of Alliance Pharmaceuticals Limited. Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited. Alliance Pharmaceuticals Limited 2012
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.
