Imeron Injection

IMERON is an injectable contrast medium which contains iodine. Under certain circumstances, your doctor will want to investigate a certain area of your body with an x-ray scan. IMERON injection acts like a dye to show the relevant area of your body more clearly on the x-ray film. This medicine is for diagnostic use only.

IMERON should not be administered to you:

• If you are hypersensitive (allergic) to iomeprol or any of the other ingredients of IMERON (listed in section 6).
• If you suffer from a disease called Waldenström's paraproteinaemia (an increase in the cells which produce antibodies).
• If you have cancer called multiple myeloma (cancer of plasma cells in bone marrow).
• If your liver and kidney functions are severely impaired.
• If you are pregnant or suspect you are pregnant.
• IMERON 200: If you have inflammation of the pelvic cavity (symptoms include stomach pain and tenderness, fever and irregular menstrual periods).
• IMERON 200/250/300 should not be administered to you together with corticosteroid medicine.

Warnings and precautions:

IMERON is only administered in hospitals or clinics. Tell your doctor or health care provider before being given the injection:

• If you have any known hypersensitivities or if you have ever developed a previous allergic reaction after using contrast media, especially iodine-containing contrast media.
• If you have asthma.
• If you are elderly.
• An overactive thyroid gland (hyperthyroidism) or a swollen neck due to an enlarged thyroid gland (goitre).
• If you have kidney problems or if you are being treated with metformin for your condition namely diabetes mellitus (high blood sugar) (see section 2 “Other medicines”), you are at higher risk for developing more kidney problems.
• Heart or blood circulation problems, because in the rare event that you have an allergic reaction, it is more likely to be serious or fatal.
• If you suffer from epilepsy, have a history of seizures, or any other condition affecting the brain.
• If you are taking medicines to treat pain, depression, nausea or vomiting. Your doctor may ask you to stop the medication for a short period.

You will not be expected to give yourself IMERON. It will be given to you by a person who is qualified to do so. IMERON will be injected into a vein, into an artery, or into a body cavity. Your doctor will decide how much IMERON is needed for your particular investigation. He/she will explain how everything works and what position you should lie in on the x-ray table. The dose of IMERON varies depending on the investigation, your weight and your age. You will be asked to stay in the hospital for 1 hour after your examination. If you develop any symptoms during this time, you should tell your doctor immediately.

If you receive more IMERON than you should: Your doctor or other health care provider will administer IMERON and will control the dosage. In the event of overdosage, your doctor will manage the overdosage.

IMERON can have side effects. Not all side effects reported for IMERON are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving IMERON, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop receiving IMERON 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 IMERON. 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:

• Flushing, feeling hot, increased sweating.
• Dizziness and feeling faint, unconsciousness, coma and fit (convulsion).
• Inability to move some parts or all of your body.
• Difficulty breathing, feeling of suffocation.
• Itchy or watery eyes, tickling in the throat or nose, hoarseness, coughing or sneezing.
• Pain or tightness in the chest.
• Changes to your heartbeat (such as beating slower or faster than normal or skipping beats).
• Heart attack (chest pain, pain radiating into your arm, sweating, difficulty breathing, tightness in your chest, heartburn).
• Kidneys not working properly, production of small amounts of urine, or protein in your urine.
• Unexplained bleeding, nosebleeds, bruising or pinpoint bleeds on your skin.
• Blindness.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Side effects with a common frequency:
• Headache.
• Pale skin.
• Nausea (feeling sick).
• A sensation of pain and warmth at the injection site.
• Side effects with an uncommon frequency:
• Agitation (state of anxiety or nervous excitement).
• Dizziness.
• Feeling weak.
• Changes to and blood pressure.
• Stuffy nose, difficult breathing.
• Vomiting (being sick).
• Redness of skin.
• Sweating.
• Back pain.
• Bleeding at the injection site.
• Side effects with a rare frequency:
• Shakiness and confusion.
• Problems with your eyesight and speech.
• Blue lips; blue or pale skin.
• Widening of blood vessels; decreased blood flow to parts of the brain.
• Muscle spasm; weakness or loss of strength.
• Side effects occurring with an unknown frequency:
• Haemolytic anaemia (abnormal breakdown of red blood cells, which may cause fatigue, rapid heart rate and shortness of breath).
• Anxiety.
• Abdominal pain and diarrhoea.
• Loss of memories (amnesia).
• Taste disturbances.
• Sleeplessness.
• Eye discomfort in bright light, increased tearing, inflammation of your eyes (redness, itching or pain).
• Asthma, high pitched sound while breathing.
• Runny nose.
• sneezing or throat discomfort.
• Changes in your voice.
• Pancreatitis (inflammation of your pancreas causing pain of your stomach area radiating to your back, nausea, vomiting, increased heartbeat, fever).
• Difficulty swallowing, increased saliva, enlarged salivary glands.
• Joint pain or muscle weakness.
• Chills, fever.
• Tiredness.
• Increased thirst.
• Changes in blood test results.

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 or pharmacist. You can also report side effects to SAHPRA via the “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 IMERON.

• Store at or below 25 ºC.
• Protect from light and X-rays.
• KEEP ALL MEDICINES OUT OF REACH OF CHILDREN
• Do not use the medicine after the expiry date printed on the carton and bottle.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).