Jopamiron Solution

JOPAMIRON contains the active substance iopamidol. JOPAMIRON is a contrast medium which is injected for use in diagnostic purposes during a radiological examination. JOPAMIRON works by helping your health care provider to see the internal body structures on an X-ray picture. Different radiographic (X-ray) procedures can be performed and depending on the procedure, certain areas in your body or any undergoing pathological processes can be seen more clearly.

JOPAMIRON should not be administered to you:

• If you are hypersensitive (allergic) to iopamidol, iodine or any of the other ingredients of JOPAMIRON (listed in section 6).
• If you are being treated with medicines such as corticosteroids (a type of anti-inflammatory medicine) by intrathecal administration (an injection into the space surrounding spinal cord) and the radiological examination requires the administration of JOPAMIRON in the intrathecal space (see section 2 “Other medicines and JOPAMIRON”).
• If you have to repeat, in a short time, the radiological examination with JOPAMIRON in the intrathecal space (space surrounding spinal cord), since the repeated administration of JOPAMIRON could cause undesirable effects due to excessive dosage.
• If you have cerebral fits, e.g. fits or seizures (a sudden, uncontrolled electrical disturbance in the brain).
• If you are suffering from a condition known as hyperthyroidism (overactivity of the thyroid gland).
• If you have Waldenström’s macroglobulinemia (a rare type of cancer that begins in the white blood cells).
• If you have multiple myeloma (a cancer that forms in a type of white blood cell called a plasma cell).
• If you have severe kidney disease.
• If you are pregnant (see section 2 “Pregnancy and breastfeeding”).

Warnings and precautions

JOPAMIRON is for diagnostic use only. JOPAMIRON is only administered in hospitals or clinics. Tell your doctor or health care provider before you are given the injection:

• If you have any known hypersensitivities or if you have ever developed a previous allergic reaction after using contrast medicines.
• If you are a known epileptic or have a history of epilepsy (having fits/seizures). It is important that your epilepsy be properly managed, or in some cases, your doctor can even increase your anticonvulsant therapy before the examination.
• If you have a history of bronchial asthma (a lung disease causing difficulty in breathing), especially if you have been taking beta-blocking medicines (e.g. propranolol or carvedilol).
• If you have congestive heart failure (a condition in which the heart cannot pump enough blood to meet the body's requirement). You should be carefully observed for several hours following the procedure.
• If you have any underlying conditions or disease affecting the functioning of your liver or kidneys.
• If you have kidney problems or if you are being treated with certain diabetes medicines (e.g. metformin) or medicines that are toxic to the kidneys (see section 2 “Other medicines”), you are at higher risk for developing more kidney problems.
• If you have thyroid problems or develop symptoms of a thyroid storm [e.g. a rapid heartbeat, an increased temperature, diarrhoea and feeling sick, yellowing of the eyes and skin (jaundice), severe agitation, being confused, loss of consciousness].
• If you have previously been treated for Grave’s disease [an immune system disorder that results in the overproduction of thyroid hormones (hyperthyroidism)], it is also possible that symptoms of an overactive thyroid can reoccur.
• If you have sickle cell disease (your body produces abnormally shaped red blood cells, which leads to anaemia), it is important that you are properly hydrated with fluids and a high concentration of electrolytes.

You will not be expected to give yourself JOPAMIRON. It will be given to you by a person who is qualified to do so. JOPAMIRON will be injected into a vein, into an artery, into the intrathecal space, e.g. the space surrounding the spinal cord or into a body cavity. Your dosage will depend on the technique used and the desired type of examination. Your doctor will tell you how long your treatment with JOPAMIRON will last. If you have the impression that the effect of JOPAMIRON is too strong or too weak, tell your doctor or pharmacist.

If you receive more JOPAMIRON than you should

Since a health care provider will administer this medicine, he/she will control the dosage. However, in the event of overdosage, your doctor will manage the overdosage.

JOPAMIRON can have side effects. Not all side effects reported for JOPAMIRON are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving JOPAMIRON, please consult your health care provider for advice. If any of the following happens, stop receiving JOPAMIRON and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to JOPAMIRON. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Chest pain or changes in your blood pressure, such as bradycardia (slow heart rate) or tachycardia (rapid or irregular heart rate).
• Kidney failure.
• Cardiac dysrhythmias (irregular heartbeat) or fibrillations (irregular heart rhythm).
• Bronchospasm (where your airways go into spasm making it difficult to breathe, which may cause wheezing or coughing).
• Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• A red, scaly, widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis).
• Myocardial ischaemia or infarction (when the blood flow through the major arteries that supply blood to your heart slows or stops).
• Kounis syndrome (heart attack caused by an allergic reaction).
• Circulatory collapse (a life-threatening condition in which your heart suddenly can't pump enough blood to meet your body's needs) or shock.
• Respiratory arrest, respiratory failure, acute respiratory distress syndrome, respiratory distress (inability of your lungs or breathing system to function).
• Severe bacterial infection or inflammation of the meninges.
• Hemiplegia (muscle weakness, partial paralysis or inability to move one side of the body).
• Brain disorder (encephalopathy) with symptoms including headache, difficulties with vision, loss of vision, confusion, seizures, loss of coordination, loss of movement in one side of the body, problems with speech and loss of consciousness.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache.
• Feeling hot.
• Nausea.

Less frequent side effects:

• Dizziness.
• Confusion.
• Differences in your taste sensations.
• Tingling or prickling, “pins-and-needles”.
• Changes in your blood pressure.
• Flushing or redness of the skin.
• Increased sweating.
• Muscle spasms.
• Back pain, neck pain or pain in your limbs such as arms or legs.
• Sensation of heaviness.
• Asthma.
• Changes in bodily temperature where you have fever, or if you experience feeling differently, either feeling cold.
• Pain at site of injection.
• Chest pain.
• Vomiting.

Unknown side effects:

• Infection or inflammation of the inner eyelid (e.g. pink eye).
• Sight disturbances, vision loss.
• Sensitivity for light exposure.
• Fits or seizures.
• Disorientation or restlessness.
• Feeling agitated.
• Dyspnoea (sensation of uncomfortable breathing).
• Feeling ill.
• Chills (rigors or trembling).
• Increased amount of saliva in the mouth or drooling.
• Muscle pain or weakness.
• Lowered level of consciousness.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of JOPAMIRON.

Store all medicines out of reach of children. Store at or below 30 °C. Protect from light, heat and secondary X-rays. JOPAMIRON should be used immediately following reconstitution and must not be stored.