IOPAMIRO 370 mg/ml INJECTABLE SOLUTION

2. What you need to know before you use Iopamiro

Do not use Iopamiro

• if you are allergic to the active substance or to any of the other ingredients of this medicinal product (listed in section 6).
• if you have clinical hyperthyroidism (your thyroid gland produces too much thyroid hormone).
• if you have a history of severe immediate or delayed skin reaction to iopamidol injection.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Iopamiro. Be especially careful if:

• You have experienced any reaction during previous injection of an iodinated contrast agent.
• You have a history of asthma.
• You have renal insufficiency, diabetes mellitus, or multiple myeloma.
• You have heart failure, coronary insufficiency, or other heart disease.
• You have any cardiovascular disease.
• You suffer from homocystinuria (a hereditary disease in which the body is unable to fully metabolize the amino acid methionine).
• You have liver failure.
• You suffer from any nervous system disease, such as epilepsy, stroke, pheochromocytoma (excessive production of hormones causing severe hypertension), myasthenia gravis (an autoimmune disease affecting muscles), or other autoimmune diseases.
• You have a history of thyroid dysfunction.
• You are in a state of excitement, anxiety, and intense pain, as this may increase the risk of adverse reactions or their intensity.
• You suffer from any bone marrow disease (multiple myeloma or Waldenström's macroglobulinemia).
• You have a recent history of intracranial hemorrhage or epilepsy.
• You have cerebral edema or a brain tumor.
• You have significantly deteriorated health.
• You have developed a severe skin rash, desquamation, blisters, and/or ulcers in the mouth after taking Iopamiro or other iodinated contrast agents.

Be especially careful with Iopamiro:

Severe skin reactions, including Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), have been reported with the use of Iopamiro.

Seek medical attention immediately if you experience any of the symptoms related to these severe skin reactions described in section 4.

You may experience a short-term brain 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.

You must inform your radiologist if you are an alcoholic or drug addict.

Special care should be taken when administering to children under one year of age and to elderly patients. These groups may be susceptible to adverse reactions.

Inform your doctor if you have had thyroid function tests previously.

Thyroid disorders have been observed after iopamidol administration. Special attention should be paid to newborns, including those whose mother received iopamidol during pregnancy, and to premature infants. Doctors may check the child's thyroid function.

Consult your doctor, even if any of the above circumstances have occurred to you at any time.

Inform your doctor if you are going to undergo a thyroid function test or receive radioactive iodine treatment soon.

High concentrations of contrast agents in serum and urine may interfere with the analysis of bilirubin, proteins, and inorganic substances (iron, copper, calcium, and phosphates). It is recommended that these determinations not be performed in the first 24 hours after the examination.

Using Iopamiro with other medicines

Inform your doctor or pharmacist that you are using, have recently used, or may need to use any other medicines.

Certain medicines may interact with Iopamiro, and it may be necessary to change the dose or discontinue treatment with one of the medicines. It is especially important to inform your doctor if you are using any of the following medicines:

• Biguanides (metformin) (medicines used to treat some forms of diabetes mellitus)
• Neuroleptics (medicines commonly used to treat psychosis)
• Analgesics (medicines that relieve or eliminate pain)
• Anti-emetics (medicines that prevent vomiting or nausea)
• Antihistamines (medicines for the treatment of allergic rhinitis or dermatitis)
• Phenothiazine sedatives (medicines that calm or induce sleep)
• Beta-blockers (drugs used to treat hypertension)
• Interleukin-2 (a medicine that regulates the immune response)
• Oral cholecystographic contrast agents (for diagnostic use)
• Diuretics (medicines that increase urine elimination)
• Radioactive medicines (for diagnostic and therapeutic use)

Consult your doctor if you have any doubts.

Using Iopamiro with food and drink

Any alteration of the hydroelectrolytic balance should be corrected before the administration of the contrast agent.

Before the test, do not reduce the amount of water you normally drink, especially if you are in any of the following situations:

• Severe renal insufficiency
• Severe liver insufficiency
• Severe heart failure
• Multiple myeloma (bone marrow disease)
• Diabetes mellitus
• Blood disease
• Increased or decreased urine production
• Deterioration of health
• Elderly patients

Fluid intake should not be reduced in infants or young children.

You can maintain a normal diet until two hours before the examination. During the 2 hours prior to the study, you should abstain from eating.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicinal product.

Pregnancy

X-ray examinations in pregnant women should only be performed if the doctor considers it absolutely necessary or when the benefit to the mother outweighs the risk to the fetus.

Breastfeeding

Iodinated contrast agents are excreted in breast milk in very small amounts. However, as a precautionary measure, breastfeeding should be suspended for at least 24 hours after the administration of the contrast agent.

Driving and using machines

No effects on the ability to drive and use machines have been reported.

Iopamiro contains sodium

This medicinal product contains less than 1 mmol (23 mg) of sodium per dose, and is therefore considered essentially "sodium-free".

3. How to use Iopamiro

Follow the instructions for administration of this medicinal product exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

Iopamiro will be administered to you by a doctor or nurse in a hospital or diagnostic clinic.

Iopamiro must be administered into a vein or artery, into the spinal column, or into a joint.

You should be well-hydrated before receiving Iopamiro.

After the administration of the contrast agent, you should remain under observation for at least 30 minutes, as most adverse reactions occur during this time. However, delayed reactions may occur.

The dose depends on the part of the body to be examined and usually ranges from 5 to 250 ml.

Your doctor may decide to vary this dose or repeat it if necessary.

The dose used in children also depends on age and body weight.

If you use more Iopamiro than you should

You should know that the hospital or clinic area where Iopamiro is administered is equipped to treat any reaction caused by an overdose.

In case of overdose, allergic reactions, respiratory symptoms, cardiovascular disorders, convulsions, or tetanic crises (muscle stiffness) may occur.

Treatment of overdose should be aimed at ensuring support of vital functions and rapid establishment of symptomatic therapy.

If necessary, hemodialysis can be used to remove Iopamiro from your body.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicinal product and the amount ingested.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Iopamiro can cause side effects, although not everybody gets them.

The side effects that you may experience after administration of a contrast agent are usually mild to moderate and short-lived.

However, as with other contrast agents, severe reactions may occur, which can be life-threatening and require rapid and effective treatment.

If you notice any of the following symptoms, inform your radiologist or X-ray personnel immediately, as these may be signs of an allergic reaction or shock. The examination should be interrupted and you may need treatment. The symptoms are:

• Swelling of the face and throat (angioedema).
• Tearful or itchy eyes (conjunctivitis), cough, itching, rhinorrhea or nasal congestion, sneezing, urticaria.
• Severe drop in blood pressure, increased heart rate (tachycardia).
• Difficulty breathing, nausea, feeling of suffocation (allergic reactions).
• Agitation, blue lips, blue or pale face, cold sweats, loss of consciousness.
• Headache, dizziness.
• The drop in blood pressure may also be associated with a decrease in heart rate (bradycardia), from which an increase in heart rate (tachycardia) usually develops.

These reactions can occur delayed and independently of the administered dose and method of administration.

Seek medical attention immediately if you notice any of the following symptoms:

• Reddish patches, without swelling, circular or target-shaped on the trunk, often with central blisters, skin peeling, ulcers in the 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 generalized scaly red rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

The frequency of these side effects is not known.

In addition, the following side effects have been reported after injection with Iopamiro:

Intra-arterial and intravenous use (administration into blood vessels):

Common(may affect up to 1 in 10 people)

• allergic and/or anaphylactoid reactions
• headache, taste disturbances
• tearful or itchy eyes (conjunctivitis)
• dyspnea (difficulty breathing)
• nausea, vomiting
• edema, flushing, urticaria, rash, itching, and redness of the skin
• feeling of heat

Uncommon(may affect up to 1 in 100 people)

• dizziness
• cardiac arrhythmias (heart rhythm disturbances)
• high or low blood pressure
• diarrhea, abdominal pain, dry mouth
• increased sweating
• back pain
• acute renal failure
• chest pain, pain at the injection site, fever, feeling of cold
• abnormal laboratory test results for creatinine (this can be detected in a test performed by a doctor)

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

• confusion
• paresthesia (tingling, numbness, or prickling sensation)
• decreased heart rate
• fluid accumulation in the lungs, asthma, bronchospasm
• muscle spasms
• swelling at the injection site

Frequency not known(cannot be estimated from the available data)

• decreased platelet count in blood (detected by a test performed by a doctor)
• anaphylaxis
• coma
• transient ischemic attack (reduced blood flow to the brain)
• fainting, decreased level of consciousness or loss of consciousness, convulsions
• transient blindness, visual disturbances, photophobia (excessive sensitivity to light)
• heart attack, heart failure, cardio-respiratory arrest, increased heart rate
• circulatory collapse (failure of blood circulation)
• respiratory arrest, respiratory failure, acute respiratory distress syndrome (severe lung disease), apnea (interruption of breathing), laryngeal inflammation
• increased salivation, enlargement of the salivary glands
• facial edema (swelling of the face)
• musculoskeletal pain, muscle weakness
• chills, pain, general malaise
• electrocardiogram abnormalities (this can be detected in a test performed by a doctor)
• inability to move one side of the body
• heart attack caused by an allergic reaction
• brain disorder (encephalopathy) with symptoms including headache, vision difficulties, loss of vision, confusion, convulsions, loss of coordination, loss of movement in a part of the body, speech problems, and loss of consciousness
• severe skin disease (see top of section)
• skin necrosis due to leakage of the product outside the vessel
• muscle pain with abnormal sensations (compartment syndrome)
• pain in bones, muscles, ligaments, tendons, and/or nerves
• redness, heat, and pain at the injection site

Children

Thyroid disorders have been reported in premature newborns.

The following adverse reactions have been reported after administration of Iopamiro in body cavities:

• increased amylase in blood (pancreas examination)
• allergic reactions, mainly manifesting as skin reactions
• pancreatitis, with symptoms of severe abdominal pain in the upper abdomen, radiating to the back, as well as nausea and vomiting
• the reactions reported after X-ray examinations of the joints (arthrography) and fistulas (fistulography) are mostly irritations that occur in addition to tissue inflammation.

Reporting of side effects

If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use http://www.notificaRam.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Iopamiro

Keep this medicinal product out of the sight and reach of children.

This medicinal product does not require any special storage temperature. Do not freeze.

Store in the original packaging to protect from light.

Do not use this medicinal product after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content and Additional Information

Iopamiro Composition

The active ingredient is iopamidol. 1 ml of injectable solution contains 755 mg of iopamidol (equivalent to 370 mg of iodine).

The other components are: trometamol, calcium and sodium edetate, hydrochloric acid (pH adjustment) and water for injectable preparations. See section 2 "Iopamiro contains sodium".

Product Appearance and Packaging Content

Iopamiro is a clear and colorless sterile aqueous injectable solution.

Iopamiro is presented in colorless glass vials of 30, 50, 100 and 500 ml.

A 30 ml vial contains 22.65 g of iopamidol (equivalent to 11.1 g of iodine)

A 50 ml vial contains 37.75 g of iopamidol (equivalent to 18.5 g of iodine)

A 100 ml vial contains 75.5 g of iopamidol (equivalent to 37 g of iodine)

A 500 ml vial contains 377.5 g of iopamidol (equivalent to 185 g of iodine)

The 30, 50 and 100 ml vials are single-dose. The 500 ml vial is multi-dose.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Bracco Imaging, S.p.A.

Via Egidio Folli, 50

20134 Milan (Italy)

Manufacturer:

Patheon Italia S.p.A.

Via Morolense, 87

03013 Ferentino (Italy)

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Date of Last Revision of this Leaflet:October 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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This information is intended exclusively for healthcare professionals:

The complete technical data sheet of Iopamiro 370 mg/ml injectable solution is provided as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this medicinal product.

Please consult the technical data sheet (the technical data sheet should be included in the box).