PATIENT INFORMATION LEAFLET

Iomeron300 mg Iodo/ml injectable solution

Iomeprol

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

1. What isIomeron300 mg Iodo/ml injectable solutionand what it is used for

2. What you need to know before you start usingIomeron300 mg Iodo/ml injectable solution

3. How to useIomeron300 mg Iodo/ml injectable solution

4. Possible side effects

5. Storage ofIomeron300 mg Iodo/ml injectable solution

6. Contents of the pack and additional information

This medication is solely for diagnostic use.

Iomeron belongs to the group of medications known as low osmolar, water-soluble, and nephrotropic X-ray contrast media.

Iomeron is used to improve visualization of different body areas through certain radiological techniques. It is used in adults for intravenous urography, computed tomography (CT) of the head and body, cavernosography, conventional angiography, angiocardiography, selective conventional coronary arteriography, peripheral phlebography, digital subtraction phlebography, digital subtraction arteriography, CPER, arthrography, hysterosalpingography, fistulography, discography, galactography, dacryocystography, sialography, retrograde cholangiography, retrograde ureterography, retrograde pieloureterography, and myelography.In children aged 0 to 18 years for intravenous urography, computed tomography (CT) of the head and body, conventional angiography, angiocardiography, digital subtraction phlebography, and digital subtraction arteriography.

No use Iomeron 300 mg Iodo/ml solución inyectable

Genital tract examinations are contraindicated in case of suspected pregnancy or confirmed pregnancy and in case of acute inflammation.

The immediate repetition of Iomeron administration in case of a failure in the technique is contraindicated in myelography.

Warnings and Precautions

It is recommended to perform fluoroscopy to minimize extravasation during injection.

You may experience a short-term cerebral disorder, called encephalopathy, during or shortly after the imaging procedure. Inform your doctor immediately if you notice any symptoms related to this condition, described in section 4.

Thyroid disorders have been observed after administration of Iomeron in both children and adults. Newborns may also be exposed through the mother during pregnancy. Your doctor may need to perform thyroid function tests before and/or after administration of Iomeron.

Severe skin reactions, including Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (TEN), acute generalized pustular psoriasis (AGPP), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been associated with the use of Iomeron. Seek medical attention immediately if you observe any symptoms related to these severe skin reactions described in section 4.

Consult your doctor before starting to use Iomeron 300 mg Iodo/ml injectable solution.

Children

Children under one year of age, especially newborns, are particularly susceptible to electrolyte imbalances and hemodynamic alterations.

Other Medications and Iomeron 300 mg Iodo/ml injectable solution

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Do not interrupt treatment with anticonvulsant medications and ensure their administration in optimal doses.

In patients treated with immunomodulatory medications, such as Interleukin-2, allergic reactions to contrast media are more frequent and may manifest as delayed reactions.

This medication should not be mixed with others.

Interference with laboratory tests:

Iodinated contrast media may interfere with thyroid function studies, as the thyroid's ability to capture radioisotopes will be reduced for periods of two weeks or more.

High concentrations of contrast media in plasma and urine may alter the results of laboratory tests for bilirubin, proteins, and inorganic substances (e.g. iron, copper, calcium, phosphate).

Use of Iomeron 300 mg Iodo/ml injectable solution with food and beverages

If there are no specific instructions from your doctor, you can follow a normal diet on the day of the examination. Confirm adequate fluid intake. However, you should abstain from eating for two hours before the examination.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Pregnancy

Inform your doctor if you are pregnant or think you may be.

Like other non-ionic contrast media, there are no controlled studies in pregnant women that confirm the safety of the product in humans. Since, whenever possible, exposure to radiation during pregnancy should be avoided, the risk-benefit ratio of any X-ray examination, with or without contrast medium, should be carefully evaluated.

If you are pregnant and have received Iomeron during pregnancy, it is recommended to analyze the thyroid function of your newborn.

Lactation

Iodinated contrast media are poorly excreted in breast milk, and it is remote that the infant may be harmed.

Driving and operating machinery

No effects on the ability to drive and operate machinery are known.

This medication will always be administered by qualified and properly trained personnel, in hospitals or clinics that have the necessary personnel and equipment.

The dose you will receive will vary depending on the type of examination, age, body weight, cardiac output, and overall condition you present, as well as the technique used.

If you use more Iomeron 300 mg Iodo/ml injectable solution than you should

Overdosing may cause severe adverse reactions, mainly through effects on the cardiovascular and pulmonary systems.

The treatment of an overdose is aimed at maintaining all vital functions and preventing the rapid onset of symptomatic therapy. Iomeron can be eliminated from the body through dialysis.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have doubts about the use of this product, consult with your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Generally, side effects range from mild to moderate and are of a transient nature. However, severe and potentially fatal reactions have been reported, sometimes with fatal outcome. In most cases, reactions occur within minutes of administration, although they may appear later.

Inform your doctor immediately if you experience any of the following symptoms: sudden hissing breathing, breathing difficulty, eyelid, face, or lip inflammation, skin rash or itching affecting the entire body.

The following side effects have been reported:

Intravascular administration

Frequent(may affect up to 1 in 10 people):

• feeling of heat

Infrequent(may affect up to 1 in 100 people):

• headache
• dizziness
• increased blood pressure
• breathing difficulty
• nausea, vomiting
• flushing, urticaria, itching
• chest pain, heat, and pain at the injection site

Rare(may affect up to 1 in 1,000 people):

• syncope
• abnormal heart rhythm
• decreased blood pressure
• skin rash
• back pain
• asthenia, rigidity, fever
• increased creatinine in the blood

Unknown frequency(cannot be estimated from available data):

• Consult a doctor as soon as possible if you experience a severe skin reaction, such as:

• blistering, peeling of the skin, mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).
• generalized rash, elevated body temperature, and increased lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)

• anxiety, hyperkinetic syndrome (increased motor activity), confusion
• allergic reactions
• hyperthyroidism
• loss of appetite (anorexia)
• alteration of taste, difficulty speaking, brain function disorder, cerebral edema (fluid in the brain), transient problems with blood supply to the brain with few or no sequelae (transient ischemic attacks), memory loss, drowsiness, altered sensitivity (tingling, itching) apoplexy, loss of consciousness, tremors, coma, convulsions, alteration of the sense of smell
• cerebral disorder (encephalopathy) with symptoms including headache, vision difficulties, vision loss, confusion, convulsions, loss of coordination, loss of movement in a part of the body, speech difficulties, and loss of consciousness.
• temporary blindness, vision deterioration, conjunctivitis, increased tear production, photopsia (light vision)
• myocardial infarction, cardiac arrest, chest tightness, cardiac arrhythmias, angina pectoris, heart failure, coronary artery thrombosis (after catheter insertion), irregular heartbeat, cardiac conduction disorders, rapid and weak pulse
• flushing, shock (severe drop in blood pressure), pallor, fatigue, cold and moist skin, reduced consciousness) caused by sudden and severe dilation of blood vessels, blue discoloration of the skin and mucous membranes, clots, vasospasm, and, as a result, ischemia
• circulatory failure (circulatory collapse)
• coronary artery obstruction (after catheter insertion)
• respiratory arrest, cough, acute respiratory distress syndrome (ARDS), wheezing, asthma attacks, accumulation of fluid in the throat, fluid in the lungs, nasal mucosa inflammation characterized by nasal obstruction, sneezing, and discharge (rhinitis), hoarseness (dysphonia), insufficient oxygen supply to tissues (hypoxia), throat and larynx pain, sudden constriction of airways (bronchospasm)
• intestinal incontinence, diarrhea, abdominal pain, excessive salivation, difficulty swallowing, pancreatitis inflammation along with severe abdominal pain radiating to the back with nausea and vomiting
• severe allergic reactions, characterized by symptoms such as increased sweat production, dizziness, itching, pulsating headache, throat constriction, mouth and throat mucosa inflammation, which makes breathing difficult
• eczema, skin rash, increased sweat production, sudden accumulation of fluid in the skin and mucous membranes (e.g., throat or tongue), possibly with difficulty breathing and/or skin rash (angioedema), appearance of circular blisters on the skin (whose center is usually paler) (erythema multiforme)
• joint pain, muscle rigidity
• acute renal failure, urinary incontinence, urine abnormalities, decreased urine production
• general feeling of illness (malaise), chills, localized feeling of cold, thirst, reaction at the injection site, hematoma at the injection site
• blood disorders (thrombocytopenia) accompanied by hematomas and propensity to bleed
• hemolytic anemia (abnormal decrease in red blood cells, which may cause fatigue, rapid heart rate, and breathing difficulty)

It may cause transient hypothyroidism in children under 3 years old.

In some cases, alterations are detected during medical examinations (blood tests, cardiac and liver function tests).

Intrathecal administration

Very frequent(affects more than 1 in 10 people):

• headache

Frequent(affects more than 1 in 100 people and less than 1 in 10 people):

• dizziness
• increased blood pressure
• nausea, vomiting
• back pain, limb pain
• reaction at the injection site

Infrequent(affects more than 1 in 1,000 people and less than 1 in 100 people):

• loss of consciousness
• altered sensitivity
• drowsiness
• decreased blood pressure
• flushing
• muscle rigidity
• neck pain
• feeling of heat
• chest pain
• fever

Unknown frequency(cannot be estimated from available data):

• allergic reactions
• epilepsy
• skin rash
• general malaise
• cerebral disorder (encephalopathy) with symptoms including headache, vision difficulties, vision loss, confusion, convulsions, loss of coordination, loss of movement in a part of the body, speech difficulties, and loss of consciousness

Intra-cavity administration

• allergic reactions
• alteration of blood tests (after pancreas examination)
• like with other iodinated contrast media, it may cause pelvic pain and general discomfort after a uterine, fallopian tube, and ovary examination.

Consult your doctor if you experience severe symptoms or allergic reactions (hypersensitivity), or if symptoms persist for long periods of time.

The safety profile of iomeprol is similar in adults and children for all administration routes.for all administration routes.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use http://www.notificaRam.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store the vial in the outer packaging to protect it from light.

Although the X-ray sensitivity of iomeprol is low, it is recommended to store the product out of the reach of ionizing radiation.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.In case of doubt,ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Iomeron 300 mg Iodo/ml injectable solution

• The active ingredient is iomeprol. 1 ml of injectable solution contains 612.4 mg of iomeprol, equivalent to 300 mg of iodine.
• The other components are trometamol, hydrochloric acid to adjust the pH, and water for injection.

Aspect of the product and contents of the package

Iomeron is packaged in glass vials closed with halobutilo stoppers and an aluminum capsule.

Vials of 50 ml, 75 ml, 100 ml, and 500 ml. The 50 ml, 75 ml, and 100 ml vials are single-dose; the 500 ml vial is multidose.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bracco Imaging s.p.a .

Via E. Folli 50

20134 (Milan – Italy)

Responsible for manufacturing

Patheon Italia s.p.a.

2nd Trav. SX Via Morolense, 5

03013 Ferentino (Italy)

BIPSO GmbH

Robert-Gerwig-Strasse 4

78224 Singen (Germany)

Bracco Imaging S.p.A.

Bioindustry Park - Via Ribes, 5

10010 Colleretto Giacosa (TO) (Italy)

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Tel: 913756230

Last review date of this leaflet: September 2023 September 2023

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Iomeron 300 mg Iodo/ml is an injectable solution for intravenous, intraarterial, intracavernosal, intracolangiopancreatic, intraarticular, intrauterine, intradiscal, intramammary, intraglandular, intravesical, and intrathecal administration.

Whenever possible, intravascular administration of contrast media should be done with the patient lying down. Maintain the patient under observation for at least 30 minutes after administration.

Before use, the solution must be visually inspected. Only solutions without visible signs of deterioration or particles will be used.

Instructions for administration if single-dose vials are used :

Do not extract multiple doses from a vial. The rubber stopper should never be perforated more than once. It is recommended to use an appropriate extraction cannula to pierce the stopper and extract the contrast medium. This should not be extracted in the syringe until immediately before use. The residual amount of solution not used for an examination should be discarded.

Instructions for administration if multidose vials are used :

Only multidose vials should be used connected to autoinjectors/pumps.

Autoinjectors/pumps should not be used in small children.

A single perforation should be made.

The connection route from the autoinjector/pump to the patient should be changed after each patient.

The excess contrast medium solution remaining in the vial, as well as the connection tubes and all replaceable parts of the injection system, should be discarded within 8 hours.

It is essential to strictly follow the additional instructions provided by the manufacturer of the autoinjector/pump.

The disposal of unused medication and all materials that have come into contact with it should be carried out in accordance with local regulations.

Precautions

• Regarding the patient:

Hydration - Correct any severe electrolyte imbalance. Ensure adequate hydration before the examination, especially in patients with severe renal dysfunction, multiple myeloma, anemia, diabetes mellitus, polyuria, oliguria, hyperuricemia, as well as in neonates, children, and elderly patients.

Dietary suggestions - If there are no specific instructions from the doctor, a normal diet can be followed. Confirm adequate fluid intake. However, the patient should abstain from eating for 2 hours before the examination.

Hypersensitivity - In patients with a predisposition to allergies, with known hypersensitivity to iodinated contrast media, and with a history of asthma, premedication with antihistamines and/or corticosteroids may be considered to prevent possible anaphylactoid reactions.

Severe cutaneous adverse reactions - Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), generalized acute exanthematous pustulosis (GEP), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be fatal or potentially fatal, have been reported in patients who received iodinated contrast media intravascularly. At the time of administration, patients should be warned of the signs and symptoms, and closely monitored for the appearance of cutaneous reactions. If signs and symptoms suggest the development of these reactions, administration of Iomeron should be immediately suspended. If a patient has developed a severe reaction such as SJS, TEN, GEP, or DRESS with the use of Iomeron, Iomeron should not be administered to that patient at any time.

Anxiety - States of excitement, anxiety, and pain can be a cause of secondary effects or can intensify reactions related to the contrast medium. In these cases, a sedative may be administered.

Concomitant treatments - Consider interrupting treatment with medications that reduce the convulsive threshold for at least 24 hours after the procedure, in the case of intrathecal administration, and in patients with disorders of the blood-brain barrier (see "Neurological symptoms").

• Regarding the procedure:

Coagulation, catheterism - A property of non-ionic contrast media is their minimal interference with physiological functions. As a consequence, non-ionic contrast media have, in vitro, a lower anticoagulant activity than ionic contrast media. Medical and paramedical personnel performing vascular catheterism should be informed of this and pay particular attention to angiographic technique. Non-ionic contrast media should not come into contact with blood in the syringe, and catheters should be frequently cleaned to minimize the risk of thromboembolic complications related to the procedure.

Patient observation - Whenever possible, intravascular administration of contrast media should be done with the patient lying down. Maintain the patient under observation for at least 30 minutes after administration.

Reaction test - A reaction test is practically useless, as the appearance of severe or fatal reactions due to contrast media cannot be predicted with this test.

Risk of inflammation and extravasation - It is recommended to exercise caution during the injection of contrast media to avoid extravasation.

Warnings

• Common to all administration routes

Considering the possible severe secondary effects, the use of organic iodine contrast media should be limited to specific needs for contrastographic explorations.

This need should be considered according to the patient's clinical conditions, especially in relation to cardiovascular, urinary, and hepatobiliary pathologies.

Contrast media for angiographic explorations should be used in hospitals or clinics with competent personnel and necessary equipment for emergency care in case of complications. In centers where common diagnostic examinations requiring the use of iodinated contrast media are performed, the radiology services where these examinations are performed should have therapeutic measures and resuscitation equipment confirmed by experience (Ambu balloon, oxygen, antihistamines, vasoconstrictors, etc.).

Use in:

Pediatric population - Children under the age of 1 year, especially neonates, are particularly susceptible to electrolyte imbalances and hemodynamic alterations. Attention should be paid to the doses to be used, the procedure technique, and the patient's condition. Possible hypothyroidism or transient thyroid suppression may be observed after exposure to iodinated contrast media. Particular attention should be paid to pediatric patients under 3 years old, as an episode of low thyroid activity during the first years of life may be detrimental to motor, auditory, and cognitive development and may require temporary substitution treatment with T4. The incidence of hypothyroidism in patients under 3 years old exposed to iodinated contrast media has been reported to be between 1.3% and 15%, depending on the age of the subjects and the dose of the iodinated contrast medium, with a higher frequency in neonates and premature infants. Thyroid function should be evaluated in all pediatric patients under 3 years old after exposure to iodinated contrast media. If hypothyroidism is detected, the need for treatment should be considered, and thyroid function should be monitored until it normalizes.

Elderly patients - Elderly patients should be considered