NIOPAM 340 SOLUTION FOR INJECTION
Active substance: IOPAMIDOL
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Niopam 340 solution for injection
(Iopamidol)
The name of your medicine is Niopam 340 solution for injection, which will be called Niopam throughout this leaflet. 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 of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Niopam is and what it is used for 2. Before you are given Niopam 3. How you are given Niopam 4. Possible side effects 5. How to store Niopam 6. Further information
1. WHAT NIOPAM IS AND WHAT IT IS USED FOR
Niopam is a special dye (or contrast agent) which blocks X-rays because it contains iodine. Niopam works by helping your doctor to see the internal body structures on an X-ray picture. Your doctor has prescribed Niopam to help view the blood vessels, kidney, bladder or joints using X-rays. This medicine is for diagnostic use only.
2. BEFORE YOU ARE GIVEN NIOPAM
You should not be given Niopam if you: Are allergic (hypersensitive) to Niopam, or other contrast media that contain iodine Are allergic to any other ingredients of Niopam (see list of ingredients in Section 6) Take special care with Niopam and tell your doctor if you have any of the following conditions: A history of allergy or asthma Blood clots, circulation problems, inflammations of the veins An infection Diabetes Sickle cell disease (your body produces abnormally shaped red blood cells, which leads to aneamia) Heart problems High blood pressure in the lungs Kidney or liver problems Over-active thyroid gland (this is particularly important in newborn babies) Myasthenia gravis (a disease causing weak muscles) Brain tumour or other brain diseases A history of epilepsy Alcoholism Phaeochromocytoma (a tumor of the adrenal gland) Homocystinuria (an inherited condition affecting the muscles, nervous system and heart) Multiple sclerosis (MS) - a nervous system disease Myelomatosis (a disease of the bone marrow) Poor general health High blood pressure Particular care should be taken in children under 1 year of age and in the elderly. These groups might be susceptible to adverse side effects. Tell your doctor if you have had thyroid function tests performed in the past. Tell your doctor if you have been given recently a cholecystographic agent, a special dye to help check for problems of the gallbladder and the biliary tract, as side effects risks may be increased. Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. Especially tell your doctor if you are taking the following medicines, as they may react with Niopam: painkillers neuroleptics (treatments for mental illness) antiemetics (treatments that prevent vomiting) metformin (a treatment for diabetes) antihistamines (treatments for allergies) sedatives anti-epileptics (treatment for epileptic fits) vasopressors such as papaverine (used to treat impotence) Beta blockers ( drugs to be used to treat heart or blood pressure) Interleukin-2 (treatment for cancer) Niopam may affect the results of laboratory tests such as thyroid function test, bilirubin, proteins or other substances. Always tell your doctor or laboratory staff that you have been given Niopam. It may still be all right for you to be given Niopam and your doctor will be able to decide what is suitable for you. Using with food and drink If you have a disorder of your body water or body salts balance this will be corrected before the examination this will be corrected before the examination. Do not reduce the amount you normally drink before the investigation , especially if you have any of the following: Severe kidney problems Severe liver problems Severe cardiac problems Multiple myeloma (disease of the bone marrow) Diabetes Blood disease Abnormal production of urine (large or small amounts) Poor general health If the examination is for your baby or young child do not reduce the fluid intake. Pregnancy and breast-feeding If you are pregnant or breast-feeding, you should only be given Niopam if your doctor believes it is clearly necessary. Tell your doctor if you are or believe you might be pregnant. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines You should not drive or operate machinery for one hour after the last injection because of possible side effects. 3. HOW YOU ARE GIVEN NIOPAM Niopam will be given to you by a doctor or a nurse in hospital or clinic. It will be injected into an artery or a vein or into the heart or in a joint.
Dosage The actual dose depends on which part of the body is being X-rayed and is usually in the range 5-250 ml. Your doctor may decide to vary this dose or to repeat the dose if required. The dose for children depends also on the age and the body size. If you have any further questions on the use of this product, ask your doctor or pharmacist. If you are given more Niopam than you should: You should know that the hospital area or clinic where Niopam is given to you is well equipped to treat any effects of overdose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Niopam can cause side effects, although not everybody gets them. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). These are signs of an allergic reaction which can be serious and might require medical treatment. The following side effects have been reported following injection of Niopam Common: (more than 1 out of 100 persons and less than 1 out of 10 persons) headache feeling sick (nausea) feeling hot Uncommon: (more than 1 out 1,000 persons and less than 1 out of 100 persons) dizziness, problems with sense of taste changes in heart rhythm low and high blood pressure flushing vomiting diarrhoea abdominal pain dry mouth itching, skin rash, urge to itch, redness of the skin increased sweating back pain kidney failure chest pain, injection site pain fever feeling cold abnormal laboratory test results for creatinine (this can be detected by a test carried out by a doctor) Rare: (more than 1 out 10,000 persons and less than 1 out of 1,000 persons) confusion sensation of tingling, pricking or numbness slow heart beat water in the lungs asthma difficulty in breathing muscle cramps Not known: (cannot be estimated) reduced blood platelet count (this can be detected by a test carried out by a doctor) allergic reaction coma mini-stroke fainting, low level of consciousness, loss of consciousness temporary loss of vision,vision difficulties, inflamed eyes, excessive sensitivity to light heart attack, heart failure, the cessation of normal circulation of the blood due to failure of the heart to contract effectively, increased heart rate failure of the blood circulation stopped breathing, respiratory failure, acute respiratory distress syndrome (a severe lung disease), abnormal breathing, suspension of breathing, shortness of breath swelling of the throat, swelling of the face, swollen salivary glands increased salivation severe disease of the skin pain in the bones, muscles, ligaments, tendons and/or nerves pain, feeling of general discomfort or uneasiness abnormal electrocardiogram (this can be detected by a test carried out by a doctor) If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. If you think you notice any side effects after receiving an injection of Niopam, immediately tell the medical staff. If you have any other questions not answered in this leaflet please ask the medical staff
5. HOW TO STORE NIOPAM
You will not be required to store the medicine yourself. Your doctor or hospital pharmacist will know how to store Niopam. Niopam should be kept out of the reach and sight of children, stored below 30 C and protected from light. Niopam should not be used after the expiry date stated on the label. Niopam should be given to you immediately once drawn up into the syringe. Medicine should not be disposed of in waste-water or with household garbage. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Niopam contains One ml of Niopam 340 contains 694 mg of the active substance iopamidol, equivalent to 340 mg iodine. The other ingredients are trometamol, hydrochloric acid, edetate calcium disodium and water. What Niopam looks like and contents of the pack Niopam is supplied in glass ampoules and bottles containing: 50, 70, 100 and 200 ml. Not all packs sizes may be marketed. Marketing Authorisation Holder Bracco U.K. Ltd, Bracco House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire HP10 OHH, United Kingdom Manufacturers Bracco spa, Via E. Folli 50, 20134 Milano, Italy and Patheon Italia S.p.A.,Via Morolense 87, 03013 Ferentino (FR), Italy This leaflet was last revised in May 2012
CI00VC - 255630
Niopam 340 solution for injection
(Iopamidol)
The name of your medicine is Niopam 340 solution for injection, which will be called Niopam throughout this leaflet. 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 of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Niopam is and what it is used for 2. Before you are given Niopam 3. How you are given Niopam 4. Possible side effects 5. How to store Niopam 6. Further information
1. WHAT NIOPAM IS AND WHAT IT IS USED FOR
Niopam is a special dye (or contrast agent) which blocks X-rays because it contains iodine. Niopam works by helping your doctor to see the internal body structures on an X-ray picture. Your doctor has prescribed Niopam to help view the blood vessels, kidney, bladder or joints using X-rays. This medicine is for diagnostic use only.
2. BEFORE YOU ARE GIVEN NIOPAM
You should not be given Niopam if you: Are allergic (hypersensitive) to Niopam, or other contrast media that contain iodine Are allergic to any other ingredients of Niopam (see list of ingredients in Section 6) Take special care with Niopam and tell your doctor if you have any of the following conditions: A history of allergy or asthma Blood clots, circulation problems, inflammations of the veins An infection Diabetes Sickle cell disease (your body produces abnormally shaped red blood cells, which leads to aneamia) Heart problems High blood pressure in the lungs Kidney or liver problems Over-active thyroid gland (this is particularly important in newborn babies) Myasthenia gravis (a disease causing weak muscles) Brain tumour or other brain diseases A history of epilepsy Alcoholism Phaeochromocytoma (a tumor of the adrenal gland) Homocystinuria (an inherited condition affecting the muscles, nervous system and heart) Multiple sclerosis (MS) - a nervous system disease Myelomatosis (a disease of the bone marrow) Poor general health High blood pressure Particular care should be taken in children under 1 year of age and in the elderly. These groups might be susceptible to adverse side effects. Tell your doctor if you have had thyroid function tests performed in the past. Tell your doctor if you have been given recently a cholecystographic agent, a special dye to help check for problems of the gallbladder and the biliary tract, as side effects risks may be increased. Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. Especially tell your doctor if you are taking the following medicines, as they may react with Niopam: painkillers neuroleptics (treatments for mental illness) antiemetics (treatments that prevent vomiting) metformin (a treatment for diabetes) antihistamines (treatments for allergies) sedatives anti-epileptics (treatment for epileptic fits) vasopressors such as papaverine (used to treat impotence) Beta blockers ( drugs to be used to treat heart or blood pressure) Interleukin-2 (treatment for cancer) Niopam may affect the results of laboratory tests such as thyroid function test, bilirubin, proteins or other substances. Always tell your doctor or laboratory staff that you have been given Niopam. It may still be all right for you to be given Niopam and your doctor will be able to decide what is suitable for you. Using with food and drink If you have a disorder of your body water or body salts balance this will be corrected before the examination this will be corrected before the examination. Do not reduce the amount you normally drink before the investigation , especially if you have any of the following: Severe kidney problems Severe liver problems Severe cardiac problems Multiple myeloma (disease of the bone marrow) Diabetes Blood disease Abnormal production of urine (large or small amounts) Poor general health If the examination is for your baby or young child do not reduce the fluid intake. Pregnancy and breast-feeding If you are pregnant or breast-feeding, you should only be given Niopam if your doctor believes it is clearly necessary. Tell your doctor if you are or believe you might be pregnant. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines You should not drive or operate machinery for one hour after the last injection because of possible side effects. 3. HOW YOU ARE GIVEN NIOPAM Niopam will be given to you by a doctor or a nurse in hospital or clinic. It will be injected into an artery or a vein or into the heart or in a joint.
Dosage The actual dose depends on which part of the body is being X-rayed and is usually in the range 5-250 ml. Your doctor may decide to vary this dose or to repeat the dose if required. The dose for children depends also on the age and the body size. If you have any further questions on the use of this product, ask your doctor or pharmacist. If you are given more Niopam than you should: You should know that the hospital area or clinic where Niopam is given to you is well equipped to treat any effects of overdose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Niopam can cause side effects, although not everybody gets them. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). These are signs of an allergic reaction which can be serious and might require medical treatment. The following side effects have been reported following injection of Niopam Common: (more than 1 out of 100 persons and less than 1 out of 10 persons) headache feeling sick (nausea) feeling hot Uncommon: (more than 1 out 1,000 persons and less than 1 out of 100 persons) dizziness, problems with sense of taste changes in heart rhythm low and high blood pressure flushing vomiting diarrhoea abdominal pain dry mouth itching, skin rash, urge to itch, redness of the skin increased sweating back pain kidney failure chest pain, injection site pain fever feeling cold abnormal laboratory test results for creatinine (this can be detected by a test carried out by a doctor) Rare: (more than 1 out 10,000 persons and less than 1 out of 1,000 persons) confusion sensation of tingling, pricking or numbness slow heart beat water in the lungs asthma difficulty in breathing muscle cramps Not known: (cannot be estimated) reduced blood platelet count (this can be detected by a test carried out by a doctor) allergic reaction coma mini-stroke fainting, low level of consciousness, loss of consciousness temporary loss of vision,vision difficulties, inflamed eyes, excessive sensitivity to light heart attack, heart failure, the cessation of normal circulation of the blood due to failure of the heart to contract effectively, increased heart rate failure of the blood circulation stopped breathing, respiratory failure, acute respiratory distress syndrome (a severe lung disease), abnormal breathing, suspension of breathing, shortness of breath swelling of the throat, swelling of the face, swollen salivary glands increased salivation severe disease of the skin pain in the bones, muscles, ligaments, tendons and/or nerves pain, feeling of general discomfort or uneasiness abnormal electrocardiogram (this can be detected by a test carried out by a doctor) If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. If you think you notice any side effects after receiving an injection of Niopam, immediately tell the medical staff. If you have any other questions not answered in this leaflet please ask the medical staff
5. HOW TO STORE NIOPAM
You will not be required to store the medicine yourself. Your doctor or hospital pharmacist will know how to store Niopam. Niopam should be kept out of the reach and sight of children, stored below 30 C and protected from light. Niopam should not be used after the expiry date stated on the label. Niopam should be given to you immediately once drawn up into the syringe. Medicine should not be disposed of in waste-water or with household garbage. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Niopam contains One ml of Niopam 340 contains 694 mg of the active substance iopamidol, equivalent to 340 mg iodine. The other ingredients are trometamol, hydrochloric acid, edetate calcium disodium and water. What Niopam looks like and contents of the pack Niopam is supplied in glass ampoules and bottles containing: 50, 70, 100 and 200 ml. Not all packs sizes may be marketed. Marketing Authorisation Holder Bracco U.K. Ltd, Bracco House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire HP10 OHH, United Kingdom Manufacturers Bracco spa, Via E. Folli 50, 20134 Milano, Italy and Patheon Italia S.p.A.,Via Morolense 87, 03013 Ferentino (FR), Italy This leaflet was last revised in May 2012
CI00VC - 255630
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.
