Contains:
Each ampoule contain Ondansetron 4mg
Package:
2ml ampoule *10/ box
Package:
Product Description
| What is in this leaflet1. What Ondansetron is and what it is used for2. What you need to know before you are given Ondansetron3. How Ondansetron is given4. Possible side effects5. How to store Ondansetron6. Contents of the pack and other information1. What Ondansetron is and what it is used forOndansetron contains a medicine called ondansetron. This belongs to a group of medicines called antiemetics that relieve nausea and vomiting.AdultsOndansetron is used for the management of nausea and vomiting caused by chemotherapy and radiotherapy, and for the prevention and treatment of nausea and vomiting after surgery.Children and adolescentsOndansetron is used for the management of nausea and vomiting caused by chemotherapy in children over 6 months of age and adolescents.Ondansetron is used for the prevention and treatment of nausea and vomiting after surgery in children over 1month of age and adolescents.What you need to know before you are given Ondansetron ‒ you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6);‒ you are using apomorphine (to treat Parkinson’s disease).You will not be given Ondansetron if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine.Warnings and precautionsTalk to your doctor or nurse before you are given Ondansetron if:‒ you have symptoms of an allergic reaction such as itching, difficulty breathing or swelling of the face, lips, throat or tongue;‒ you have ever been allergic to other medicines for nausea and vomiting (e.g. granisetron or palonosetron); ‒ you have heart problems; there may bea temporary change in electrocardiogram (ECG);‒ you use medicines for treating heart rhythm disorders (antiarrhythmics) or medicines that lower blood pressure and the heart rate at rest (beta blockers); ‒ you are constipated or have a bowel disease that can lead to constipation; ‒ you have liver problems or take any medicines that may be harmful to the liver (hepatotoxic chemotherapy drugs). In these cases, your liver function will be monitored closely, especially in children and adolescents; ‒ if you have undergone a blood test to check your liver values (ondansetron can affect the results); ‒ you have problems with the levels of salts in your blood, such as potassium and magnesium; ‒ if you are going to have tonsil surgery. In this case, you need to be carefully monitored. If you are not sure if any of the above apply to you, talk to your doctor or nurse before having this medicine. Other medicines and Ondansetron Tell your doctor or nurse, if you are using, have recently used or might use any other medicines. In particular, tell your doctor or nurse if you are using any of the following medicines: • apomorphine (see ‘You should not be given Ondansetron’); • carbamazepine or phenytoin (used to treat epilepsy); • rifampicin (used to treat infections such as tuberculosis); • tramadol (pain killer); • medicines used to treat depression and/or anxiety: ‒ SSRIs (selective serotonin reuptake inhibitors) including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram; ‒ SNRIs (serotonin noradrenaline reuptake inhibitors) including venlafaxine, duloxetine. When given together with medicines for certain heart conditions, changes in your ECG picture mayoccur. Simultaneous use of medicinal products that damage the heart (e.g. anthracyclines (such as doxorubicin, daunorubicin) or trastuzumab), antibiotics (such as erythromycin), antifungals (such as ketoconazole), antiarrhythmics (such as amiodarone) and beta blockers (such as atenolol or timolol)) may increase the risk of heart rhythm disorders. Pregnancy, breast-feeding and fertility If you are pregnant or breast- feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Pregnancy You should not use Ondansetron during the first trimester of pregnancy. This is because Ondansetron can slightlyincrease the risk ofa baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or the roof of the mouth). If you are already pregnant, think you are might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using Ondansetron. Women of childbearing potential If you are a woman of childbearing potential you may be advised to use effective contraception. Breast feeding Breast-feeding should be discontinued prior to treatment with ondansetron. Fertility Ondansetron has no effect on fertility. Driving and using machines Ondansetron has no or negligible influence on the ability to drive and use machines. Ondansetron contains sodium This medicine contains 3.52 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.18% of the recommended maximum daily dietary intake of sodium for an adult. 3. How Ondansetron is given Ondansetron will be given by a doctor or nurse as a slow injection or slow infusion into a vein or as an injection into a muscle. Ondansetron is also available in dosage forms suitable for rectal and/or oral administration, and thus allows the dosage to be individually adjusted. However, Ondansetron is intended to be administered into a vein or muscle only. The dose you have been prescribed will depend on the treatment you are having. Adults To prevent nausea and vomiting from chemotherapy or radiotherapy • On the day of chemotherapy or radiotherapy Ondansetron will be administered immediately before chemotherapy or radiation therapy. The usual adult dose is 8 mg, given by a slow injection into a vein or muscle, or by slow infusion into a vein. • On the following days After initial treatment, your doctor may prescribe you ondansetron to be taken by mouth or administered rectally. Please follow the instructions on respective package leaflet, as necessary. Always take ondansetron exactly as your doctor has told you. If necessary, the dose can be increased up to32 mg per day. To prevent and treat nausea and vomiting after an operation The usual adult dose is 4 mg given by a slow injection into a vein or muscle. Paediatric population To prevent nausea and vomiting from chemotherapy in children from 6 months and adolescentsIn children, this medicine is given slowly intoa vein (intravenously) immediately before chemotherapy (recommended dose: 5 mg/m2 or 0.15 mg/kg). The intravenous dose must not exceed 8 mg. Oral dosing can commence 12 hours later. This treatment can be continued for up to5 days after chemotherapy. The oral dose is calculated based on bodyweight or body surface area. The total daily dose must not exceed the adult dose of 32 mg. To prevent and treat nausea and vomiting after an operation in children from 1 month and adolescents In children, the dose is calculated based on bodyweight or body surface area. The total daily dose must not exceed the adult dose of 32 mg. The dose is given as a slow intravenous injection before, during or after induction of anaesthesia. Elderly (over 65 years) Ondansetron is well tolerated in patients over 65 years of age. Chemotherapy and radiotherapy induced nausea and vomiting In patients 65 years of age or older, all intravenous doses should be diluted and infused over15 minutes. If repeated dosing is necessary, these should be given at least 4 hours apart. In patients 65 to 74 years of age, the initial dose of 8 mg or 16 mg. In patients over 75 years of age, the initial dose should not exceed 8 mg. For the prevention and treatment of nausea and vomiting after surgery There is limited experience in the elderly. Patients with liver impairment In patients with moderate or severe liver problems, the total daily dose should not exceed 8 mg. Patients with kidney impairment No dose adjustment or frequency of dosing, or route of administration are required. If you are given more Ondansetron than you should Your doctor or nurse will give you or your child Ondansetron injection so it is unlikely that you or your child will receive too much. If you think you or your child have been given too much or have missed a dose, tell your doctor or nurse. The following symptoms may occur: visual disturbances,severe constipation, low blood pressure and a slow heartbeat. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects in children and adolescents are similar to those in adults. Severe allergic reactions. These rarely occur in people using ondansetron. The complaints include: • Raised and itchy skin rash (hives) • Swelling, sometimes of your face or mouth (angioedema) with difficulty breathing • Brief loss of consciousness Contact a doctor immediately if you experience any of these symptoms. Stop using this medicine. Very common side effects (may affect more than 1 in 10 patients) • Headache Common side effects (may affect up to 1 in10 patients) • A feeling of warmth or flushing • Constipation • Flush • Irritation at the site of injection (after injection into a vein) Uncommon side effects (may affect up to 1 in100 patients) • Seizures • Involuntary muscle movements or twitching • Irregular or slow heartbeat • Chest pain • Low blood pressure • Hiccups • An increase in liver enzymes Rare side effects (may affect up to 1 in1,000 patients) • Heart rhythm disturbances (which sometimes causes a sudden loss of consciousness) • Dizziness • Transient blurred vision or visual disturbances Very rare side effects (may affect up to 1 in 10,000 patients) • A widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis) • Transient loss of eyesight Not known (cannot be estimated from the available data) • Dry mouth • Myocardial ischemia (signs include: sudden chest pain or chest tightness) 5.How to store Ondansetron Store at controlled room temperature (77°F or 25°C) and protect from light during storage. 6.Contents of the pack and other information Is available in packs containing 2 ml ampoule *10 in box |
