PACKAGE LEAFLET: INFORMATION FOR THE USER Ondansetron BMM Pharma 4 mg film-coated tablets Ondansetron BMM Pharma 8 mg film-coated tablets 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 or 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 symptoms are the same as yours. - If you get side effects,talk to your doctor or pharmacist or nurse This includes any possible side effects not listed in this leaflet. What is in this leaflet: 1. What Ondansetron BMM Pharma is and what it is used for 2. Before you take Ondansetron BMM Pharma 3. How to take Ondansetron BMM Pharma 4. Possible side effects 5. How to store Ondansetron BMM Pharma 6. Contents of the pack and other information 1. WHAT ONDANSETRON BMM PHARMA IS AND WHAT IT IS USED FOR Ondansetron BMM Pharma belongs to a group of drugs called anti emetics. Ondansetron BMM Pharma inhibits the effect of the neuro- transmitter serotonin in the brain. Serotonin causes nausea and vomiting. Ondansetron BMM Pharma 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. Ondansetron BMM Pharma is used to prevent or treat chemotherapy-induced nausea and vomiting in children aged 6 months and prevent and treat post-operative nausea and vomiting in children aged 1 month Your doctor may have prescribed other use. Always follow your doctor s prescription. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONDANSETRON BMM PHARMA Do not take Ondansetron BMM Pharma - if you are allergic (hypersensitive) to Ondansetron or any of the other ingredients of Ondansetron BMM Pharma. - If you are taking apomorphine (used to treat Parkinson s disease) Warnings & precausions - if you are hypersensitive to other drugs belonging to the group of selective serotonin (5-HT 3 )-receptor antagonists (eg. granisetron, dolasetron). It is, in such case, possible that you are also allergic to ondansetron. - if you have stricture of intestines or constipation, because you will need special surveillance by your doctor. - if you are going to have or recently have had your tonsils removed, because treatment with Ondansetron BMM Pharma may hide symptoms of internal bleeding. 1
- if you are heart patient (with arrythmias or conduction disorders) and are being treated with other medication such as anesthetics, anti-arrythmics or beta-blockers at the same time, because or the limited experience hereby. - if you have liver impairment. - if a child receive ondansetron with hepatotoxic chemotherapeutical agents they should be monitored closely for impaired hepatic function. - Tell your doctor if any of the above warnings apply to you. Always inform the laboratory during tests of blood and urine that you are being treated with Ondansetron BMM Pharma. Other medicines and Ondansetron BMM Pharma Ondansetron BMM Pharma may have an effect on other drugs or other drugs may have an effect on Ondansetron BMM Pharma. 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 BMM Pharma, if he/she starts treating you with the following medicine: Drugs for epilepsy (phenytoin, carbamazepin), which may reduce the effect of Ondansetron BMM Pharma. Antibiotics (rifampicin), which may reduce the effect of Ondansetron BMM Pharma. Pain relieving medicine (tramadol), which effect may be reduced by Ondansetron BMM Pharma. Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride (used to treat Parkinson s disease), concomitant use with apomorphine is contraindicated. Contact your doctor. It may be necessary to adjust the dose. Taking Ondansetron BMM Pharma with food and drink You may take Ondansetron BMM Pharma with food and drinks. The tablets should be taken with a glass of water. Pregnancy and breast-feeding Pregnancy: There is only limited experience with the use of ondansetron during pregnancy. Ondansetron in pregnancy is not recommended. Breast-feeding: You should not breast-feed your infant whilst taking Ondansetron BMM Pharma. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Ondansetron BMM Pharma does not affect the ability to use any tools or machines or the ability to drive safely in traffic. Important information about some of the ingredients of Ondansetron BMM Pharma Ondansetron BMM Pharma 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 BMM PHARMA
Always take Ondansetron BMM Pharma 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: 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. Elderly: The same dose as for adults. Use in children and adolescents: Chemotherapy-induced nausea and vomiting in children aged 6 months and adolescents Children (age 2 years and up) and adolescents under the age of 18 years: The dose is individual and depends on the size/surface of the child. Ondansetron are given immediately before chemotherapy as an injection and an oral dosage can be started twelve hours after chemotherapy and be continued for up to 5 days. The total daily dose must not exceed adult dose of 32 mg. Treatment and prevention of post-operative nausea and vomiting. Adults, prevention and treatment: 16 mg one hour prior to anesthesia or alternatively, 8 mg administered one hour prior to anesthesia followed by an additional 8 mg after 8 and 16 hours. Your doctor may choose to give you the medicine as injections. Elderly, prevention and treatment: There is limited experience with the use of ondansetron to elderly patients. Ondansetron is however tolerated well by patients above 65 years in chemotherapy (please refer to sections above). Use in children and adolescents: Post-operative nausea and vomiting in children aged 1 month and adolescents: Oral Formulation: Since it s not investigated weather orally administered ondansetron can be used for prevention or treatment of nausea and vomiting after surgery your doctor may choose to give you the medicine as injections. Insufficient function of the liver: The daily dose should not exceed 8 mg if you have moderately to severely decreased function of the liver. The tablets should be taken with a glass of water. Always follow your doctor s prescription. There are differences in what the individual patients need. Changes in or discontinuation of treatment should only occur in consultation with your doctor. If you take more Ondansetron BMM Pharma than you should Contact your doctor, the emergency room or the pharmacy if you have taken more Ondansetron BMM Pharma 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 BMM Pharma Do not take a double dose to make up for a forgotten dose. 4. POSSIBLE SIDE EFFECTS Like all medicines, Ondansetron BMM Pharma can cause side effects, although not everybody gets them. Very common side effects (occur in more than 1 of 10 treated):
Headache. Common side effects (occur in between 1 and 10 of 100 treated): A sensation of reddening and warmth. Constipation. Uncommon side effects (occur in between 1 and 10 of 1.000 treated): Seizures. Hiccups. Low blood pressure, irregular heart beats, chest pain and slow pulse. Involuntary movements. Involuntary eye movements. Sometimes changes in liver function have been observed. Rare side effects (occur in between 1 and 10 of 10.000 treated): Nettle rash (urticaria).dizziness, transient blurred vision predominantly during intravenous administration. Anaphylactic shock collapse, including swollen tongue and throat and trouble with breathing. Serious heart rhythm disturbances with rapid, irregular pulse. If any of these symptoms occur, immediately seek medical attention. Very rare side effects (occur in less than 1 of 10.000 treated): Transient blindness predominantly during intravenous administration. Most of these blindness cases were resolved within 20 minutes. Inform your doctor or pharmacist if you notice any side effects other than those listed in this package leaflet, in order to assure that side effects be recorded by your National Drug regulatory authority, and to improve knowledge on side effects. Inform your doctor or pharmacist if you experience side effects that persist, bother or concern you in any way. 5. HOW TO STORE ONDANSETRON BMM PHARMA Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions. Do not use Ondansetron BMM Pharma after the expiry date which is stated 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. CONTENT OF THE PACK AND OTHER INFORMATION What Ondansetron BMM Pharma contains The active substance is ondansetron. Each tablet contains 4 mg or 8 mg Ondansetron. The other ingredients are tablet core: Microcrystalline cellulose, lactose monohydrate, magnesium stearate, maize starch, film coating: Hypromellose, macrogol and colourings (titanium dioxide E171). What Ondansetron BMM Pharma looks like and contents of the pack 4 mg tablets: White, round, biconvex, film-coated tablet, marked with 4 on one side and blank on the other. 8 mg tablets: White, round, biconvex, film-coated tablet, marked with 8 on one side and blank with a central break-line on the other. 4 mg blister: 5, 10, 15, 30, 50, 60 and 100 film-coated tablets. 8 mg blister: 5, 10, 15, 30, 50, 60 and 100 film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder BMM Pharma AB
Blasieholmsgatan 2 SE-111 48 Stockholm Sweden Manufacturer Basic Pharma Manufacturing B.V. Burgemeester Lemmensstraat 352 6163 JT Geleen The Netherlands This medicinal product is authorised in the Member States of the EEA under the following names: Denmark/Estonia: Ondansetron BMM Pharma Finland: Ondansetron BMM Pharma 4 mg tabletti, kalvopäällysteinen Ondansetron BMM Pharma 8 mg tabletti, kalvopäällysteinen Latvia: Ondansetron BMM Pharma 4 mg apvalkotās tabletes Ondansetron BMM Pharma 8 mg apvalkotās tabletes Lithuania: Ondansetron BMM Pharma 4 mg plėvele dengtos tabletės Ondansetron BMM Pharma 8 mg plėvele dengtos tabletės Norway: Ondansetron BMM Pharma 4 mg tabletter, filmdrasjerte Ondansetron BMM Pharma 8 mg tabletter, filmdrasjerte Sweden: Ondansetron BMM Pharma 4 mg filmdragerade tabletter Ondansetron BMM Pharma 8 mg filmdragerade tabletter This leaflet was last approved in