PACKAGE LEAFLET Package leaflet: Information for the patient <Product name> 300 mg Iodine/ml solution for injection Iohexol Read all of this leaflet carefully before you start using 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What <Product name> 300 mg Iodine/ml solution is and what it is used for 2. What you need to know before you use <Product name> 300 mg Iodine/ml solution 3. How to use <Product name> 300 mg Iodine/ml solution 4. Possible side effects 5. How to store <Product name> 300 mg Iodine/ml solution 6. Contents of the pack and other information 1. What <Product name> 300 mg Iodine/ml solution is and what it is used for This medicine is for diagnostic use only. It is used only to help identify an illness. <Product name> 300 mg Iodine/ml solution is a “contrast medium”. It contains Iohexol as drug substance for application in adults, neonates, infants, children and adolescents. It is given before an X-ray to make the picture that your doctor takes clearer. Once injected, it can help your doctor tell apart normal or abnormal appearance and shape of some organs in your body. It can be used for - X-rays of your heart and blood vessels - X-rays of your kidneys and urinary system (urography) - Contrast enhancement when using comupted tomography (CT contrast enhancement) - Introduction of contrast agent into the vertebral canal (cervical myelography and computed tomography of the basal cisterns after subarachnoid instillation) - X-rays of your joints (arthrography) - X-rays of ovarian tubes (hysterosalpingography) - X-rays of salivary glands (sialography) - Investigation of your gastrointestinal tract. The doctor will explain which part of your body will be scanned. 2. What you need to know before you use <Product name> 300 mg Iodine/ml solution Do not use <Product name> 300 mg Iodine/ml solution - If you suffer from hyperfunction of thyroid gland - if you are allergic to Iohexol or any of the other ingredients of this medicine (listed in section 6) - if you had serious reactions to Iohexol in previous use 1 - <Product name> 300 mg Iodine/ml and <Product name> 350 mg Iodine/ml are not suitable for imaging procedure in children up to 14 years, where the contrast agent is injected into the vertebral canal. Warnings and precautions Talk to your doctor before having <Product name> 300 mg Iodine/ml solution. During or shortly after the imaging procedure you may experience a short-term brain disorder called encephalopathy. Tell your doctor straight away if you notice any of the signs and symptoms related to this condition described in Section 4. Check with your doctor before having <Product name> 300 mg Iodine/ml solution: - If you have ever had an allergic reaction after a medicine similar to <Product name> 300 mg Iodine/ml solution, called a “contrast medium”. - If you have any thyroid problems. - If you have ever had any allergies. - If you have asthma. - If you have diabetes. - If you have any brain disease, brain tumours or spinal cord tumour. - If you have severe cardiac disease (involving heart or blood vessels) including irregular heartbeats (arrhythmias). - If you have kidney problems or both liver and kidney probems. - If you have an illness called “myastenia gravis” (a condition causing severe muscle weakness). - If you have bad general condition, dehydration. - If you have a “phaeochromocytoma” (constant or attacks of high blood pressure due to a rare tumour of your adrenal gland). - If you have any problems with your blood - If you have ever been dependent on alcohol or drugs. - If you have epilepsy. - If you are having a thyroid function test in the next weeks. - If you have pulmonary hypertension (high blood pressure in the arteries to your lungs). - If you have dysproteinaemia or paraproteinaemias (the presence of excessive amount of an abnormal protein in your blood). - If you are having blood or urine samples taken on the same day. - If you are suffering from a disease caused by an overreaction of the immune system against the body’s own tissues (autoimmune disease). - If you have homocystinuria (a condition with increased excretion of the amino acid homocysteine in urine). - If your are homozygous for sickle cell disease. If you are not sure if any of the above apply to you, talk to your doctor before having <Product name> 300 mg Iodine/ml solution. Make sure to drink plenty of fluid before and after receiving <Product name> 300 mg Iodine/ml solution. This applies especially to patients with multiple myeloma (white blood cells disease), diabetes, kidney problems and elderly patients. Children and adolescents Make sure to drink plenty of fluid before and after receiving <Product name> 300 mg Iodine/ml solution. This applies especially to infants and small children. Drugs that can damage the kidneys should not be taken at the same time as <Product name> 300 mg Iodine/ml solution. Thyroid function should be checked in neonates during the first week of life, if the mother has received <Product name> 300 mg Iodine/ml solution during pregnancy. <Product name> 300 mg Iodine/ml solution may be removed from an infant’s body more slowly than an adult. 2 Young infants (less than 1 year of age) and especially newly born are suceptible to changes in certain laboratory tests (in balance in salts and minerals) and circulatory changes in blood circulation (blood flow to the heart). Other medicines and <Product name> 300 mg Iodine/ml solution Tell your doctor if you are taking, have recently taken or might take any other medicines. This is because some medicines can affect the way <Product name> 300 mg Iodine/ml solution works. Tell your doctor if you are taking or have recently taken one of the following medicines: - Anticonvulsant medicines - Diabetic medicines like Metformin - Other contrast agent - Interleukin-2 - Interferons - Beta-blocker - Other medicines to treat high blood pressure Beta-blockers may increase your risk of experiencing breathing difficulties and may interfere with the treatment of severe allergic reactions, which is a risk of <product name> 300 mg Iodine/ml solution. Interactions may occur with drugs that can lower seizure threshold. It is therefore recommended to discontinue the use of the drugs 48 hours before and 24 hours after the examination: - Phenothiazine derivatives - Antihistamines - Medicines against depression, like tricyclic antidrepressants or monoamine oxidase inhibitors, - Analeptics - Antipsychotics - Neuroleptic-acting anti-emetics. Pregnancy and breast-feeding 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. Basically any woman of childbearing potential who has missed a period should be assumed to be pregnant. Pregnancy The safety of <Product name> 300 mg Iodine/ml for use in human pregnancy has not been established. Experimental animal studies do not indicate harmful effects with respect to the unborn child, the course of gestation and development of the child around or after birth. X-ray procedures carried out on pregnant women also involve radiation dose to the unborn child. Therefore, the benefits of an X-ray examination, with or without contrast media, should be carefully weighed against the possible risk. Apart from avoidance of exposition of the unborn child to radiation, the sensitivity of the thyroid gland of the unborn child to iodine should be taken into account. Thyroid function should be checked in all newborns during the first week of life following administration of iodinated contrast agents to the mother during pregnancy. Repeat testing of thyroid function is recommended at 2 to 6 weeks of age, particularly in low birth weight newborn or premature newborn. Breast-feeding Breast-feeding may be continued normally after an examination of the mother with <Product name> 300 mg Iodine/ml solution. Iohexol is poorly excreted in human breast milk and minimal amounts are absorbed by the intestine of the suckling child. Your doctor will only use this product if it is considered that the benefit outweighs the risk. 3 Driving and using machines It is not advisable to drive or use tools or machines after your last injection of <Product name> 300 mg Iodine/ml solution for: - 24 hours, if it has been given into your spine, or - One hour in all other cases. This is because you may feel dizzy or have other signs of a reaction afterwards. <Product name> 300 mg Iodine/ml solution contains sodium. This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially “sodium free”. 3. How to use <Product name> 300 mg Iodine/ml solution <Product name> 300 mg Iodine/ml solution will always be given to you by a speciall trained and qualified person. - <Product name> 300 mg Iodine/ml solution will always be used in a hospital or clinic. - They will tell you anything you need to know for its safe use. Your doctor will decide the dose that is best for you. You should not eat two hours before examination. The usual dose is: - One single injection or you may be asked to swallow it. - A total dose of 1.5 g iodine per kg body weight should not be exceeded per examination day. After you have been given <Product name> 300 mg Iodine/ml solution You will be asked: - To drink plenty of fluid afterwards (to help flush the medicine from your body), and - To stay in or around the area where you had your scan or X-ray for around 15 minutes, and - To stay in the clinic or hospital for one hour.