PATIENT INFORMATION LEAFLET

IOPAMIRO 300 mg/ml injectable solution

Iopamidol

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

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

1.What Iopamiro is and what it is used for

2.What you need to know before using Iopamiro

3.How to use Iopamiro

4.Possible side effects

5Storage of Iopamiro

6.Contents of the pack and additional information

This medication is solely for diagnostic use.

Iopamiro belongs to a group of medications known as iodinated X-ray contrast media.

Iopamiro is authorized as a radiological contrast medium for the following indications:

• myelography (visualization of the bone marrow),
• arteriography (visualization of arteries),
• angiocardiography (visualization of the heart's blood vessels),
• phlebography (visualization of veins),
• digital subtraction angiography (visualization of blood vessels),
• computed tomography (CT) (obtaining images of slices or sections of a specific body region),
• intravenous urography (visualization of the urinary tract)and
• arthrography (visualization of joints).

No use Iopamiro

• If you are allergic to the active ingredient or any of the other components of this medication (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 reactions to the injection of iopamidol.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Iopamiro. Be especially careful if:

• You have experienced any reaction during a previous injection of an iodinated contrast medium.
• You have 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 have homocystinuria (a hereditary disease in which the body is unable to completely metabolize the amino acid methionine).
• You have liver insufficiency.
• You have any nervous system disease, such as epilepsy, a stroke, phaeochromocytoma (excessive production of hormones causing severe hypertension), myasthenia gravis (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 the intensity of the same.
• You have any bone marrow disease (multiple myeloma or Waldenström's paraproteinemia).
• You have had recent history of intracranial hemorrhage or epilepsy.
• You have cerebral edema or a brain tumor.
• You have a significant deterioration in your health status.
• You have developed intense skin rash or skin peeling, blisters, and/or mouth ulcers after taking Iopamiro or other iodinated contrast agents.

Be especially careful with Iopamiro:

Severe skin reactions, including Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (Lyell's syndrome or NET), and acute generalized pustular psoriasis (PEGA), have been associated with the use of Iopamiro.

Seek medical attention immediately if you experience any symptoms related to those 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 should inform your radiologist if you are an alcoholic or drug-dependent.

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

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

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

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

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

Elevated concentrations of contrast media in serum and urine may interfere with bilirubin, protein, and inorganic substance (iron, copper, calcium, and phosphate) analysis. It is recommended that these determinations not be performed in the first 24 hours after the examination.

Use of Iopamiro with other medications

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

Anticonvulsant therapy should be maintained before and after myelographic procedures in patients with a known seizure disorder.

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

• Biguanides (metformin) (medications used in the treatment of certain forms of diabetes mellitus)
• Neuroleptics (medications commonly used for the treatment of psychosis)
• Analgesics (medications that calm or eliminate pain)
• Antiemetics (medications that prevent vomiting or nausea)
• Antihistamines (medications for the treatment of allergic rhinitis or dermatitis)
• Sedatives of the phenothiazine group (tranquilizers)
• Beta-blockers (medications used in the treatment of hypertension)
• Interleukin-2 (medication that regulates the immune response)
• Oral cholecystographic contrast media (for diagnostic use)
• Diuretics (medications that increase urine elimination)
• Radiopharmaceuticals (for diagnostic and therapeutic use)

Consult your doctor if you have any doubts.

Use of Iopamiro with food and beverages

Correct any imbalance of electrolytes and fluids before administering the contrast medium.

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 status
• Elderly patients

Do not reduce the intake of liquids in infants or young children.

You may maintain a normal diet until two hours before the examination. During the two hours preceding the study, you should abstain from eating.

Pregnancy and lactation

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

Pregnancy

Imaging tests with X-rays 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.

Lactation

Iodinated contrast media are excreted in breast milk in very small amounts. However, as a precaution, it is recommended to suspend breastfeeding for at least 24 hours after administration of the contrast medium.

Driving and operating machinery

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

Iopamiro contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per dose, making it essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

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

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

Make sure you are well-hydrated before receiving Iopamiro.

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

The dose depends on the part of the body to be analyzed and usually varies between 5 and 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 will be administered is equipped to treat any reaction caused by an overdose.

In case of overdose, allergic reactions, respiratory symptoms, cardiovascular disorders, seizures, and tetanic crises (muscular rigidity) may appear.

The treatment of an overdose should be directed at ensuring vital function support and rapid establishment of symptomatic therapy.

If necessary, hemodialysis may be used to eliminate Iopamiro from your body.

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

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

Like all medications, Iopamiro may cause side effects, although not everyone will experience them.

The side effects that may occur after administration of a contrast medium are usually mild to moderate and usually do not last long.

However, as with other contrast media, in some cases, severe reactions may occur, which can even put a person's life at risk, requiring rapid and effective treatment.

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

• Swelling of the face and throat (angioedema).
• Itchy or watery eyes (conjunctivitis), cough, hives, runny nose, congestion, sneezing, or 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 related to 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 the method of administration.

Go to the doctor immediately if you notice any of the following symptoms:

• Reddish spots, without volume, circular or in the shape of a bull's eye on the trunk, often with central blisters, skin peeling, mouth sores, throat, nose, genital, and eye sores. These severe skin eruptions can be preceded by fever and symptoms such as the flu (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 beginning of treatment (acute generalized pustular psoriasis).

The frequency of occurrence of these side effects is unknown.

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

Intraarterial and intravenous use (administration in blood vessels):

Frequent(may affect up to 1 in 10 people)

• Allergic reactions and/or anaphylactoid reactions
• Headache, taste alterations
• Itchy or watery eyes (conjunctivitis)
• Dyspnea (difficulty breathing)
• Nausea, vomiting
• Edema, redness, urticaria, itching, and skin flushing
• Sensation of heat

Rare(may affect up to 1 in 100 people)

• Dizziness
• Cardiac arrhythmias (alterations in heart rhythm)
• High or low blood pressure
• Diarrhea, abdominal pain, dry mouth
• Increased sweating
• Back pain
• Acute renal failure
• Pain in the chest, pain at the injection site, fever, feeling of cold
• Abnormal results in laboratory tests for creatinine detection (this can be detected by a test performed by a doctor)

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

• Confusion
• Paresthesia (sensation of tingling, pinching, or numbness)
• Decreased heart rate
• Pulmonary edema, asthma, bronchial constriction
• Muscle spasms
• Swelling at the injection site

Frequency unknown(cannot be estimated from available data)

• Decreased platelet count in blood (detected by a test performed by a doctor)
• Anaphylaxis
• Coma
• Transient ischemic attack (decreased blood flow to the brain)
• Loss of consciousness, convulsions
• Transient blindness, visual disturbances, photophobia (excessive sensitivity to light)
• Cardiac arrest, heart failure, cardiorespiratory arrest, increased heart rate
• Circulatory collapse (failure of blood circulation)
• Respiratory arrest, respiratory failure, acute respiratory distress syndrome (severe lung disease), apnea (breathing interruption), laryngeal inflammation
• Increased salivation, salivary gland enlargement
• Facial edema (inflammation of the face)
• Musculoskeletal pain, muscle weakness
• Chills, pain, general discomfort
• Electrocardiogram alterations (this can be detected by a test performed by a doctor)
• Inability to move one side of the body
• Cardiac arrest caused by an allergic reaction
• Cerebral disorder (encephalopathy) with symptoms including headache, vision difficulties, vision loss, confusion, convulsions, loss of coordination, loss of movement in one part of the body, speech problems, and loss of consciousness
• Severe skin disease (see upper part of the section)
• Skin necrosis due to product leakage 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.

Intrathecal use (administration in the spinal column):

Very frequent(may affect more than 1 in 10 people)

• Headache, disorientation
• Nausea, vomiting

Frequent(may affect up to 1 in 10 people)

• Meningeal irritation causing photophobia (excessive sensitivity to light) and meningitis
• Redness
• Back pain, neck pain, pain in the limbs, feeling of heaviness
• Pain at the injection site, sensation of tingling and numbness at the injection site

Rare(may affect up to 1 in 100 people)

• Hives

Frequency unknown(cannot be estimated from available data)

• Meningitis
• Allergic reactions, which can be severe and potentially fatal (anaphylaxis)
• Confusion, disorientation, agitation, nervousness
• Coma, paralysis, convulsions
• Loss of consciousness, dizziness
• Paresthesia (sensation of tingling, pinching, or numbness), hypoesthesia (decreased sensitivity)
• Transient blindness
• Cardiac arrhythmias (alterations in heart rhythm)
• High blood pressure
• Respiratory arrest, dyspnea
• Fever, general discomfort, chills
• Cerebral disorder (encephalopathy) with symptoms including headache, vision difficulties, vision loss, confusion, convulsions, loss of coordination, loss of movement in one part of the body, speech problems, and loss of consciousness

The following adverse reactions have been observed after administering Iopamiro in body cavities:

• Increased amylase in blood (pancreas examination)
• Allergic reactions, mainly manifesting as skin reactions
• Pancreatitis, with symptoms of intense abdominal pain in the upper abdomen, directed towards the back, as well as nausea and vomiting
• The reactions reported after X-ray examinations of joints (arthrography) and fistulas (fistulography) are mostly irritations that occur in addition to inflammation of the tissues.

In some of these patients, electrocardiogram alterations have been observed.

Reporting of adverse effects

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

Keepthis medicationout of the sight and reach of children.

This medication does not require any special storage temperature. Do not freeze.

Store in the original packaging to protect it from light.

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 trash. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Iopamiro Composition

The active ingredient is iopamidol. 1 ml of injectable solution contains 612 mg of iopamidol (equivalent to 300 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 Contents

Iopamiro is an aqueous, sterile, clear, and colorless injectable solution.

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

A 30 ml bottle contains18.36gof iopamidol (equivalent to9 gof iodine)

A 50 ml bottle contains30.6 gof iopamidol (equivalent to 15 g of iodine)

A 100 ml bottle contains61.2 gof iopamidol (equivalent to30 gof iodine)

A 500 ml bottle contains306 gof iopamidol (equivalent to150 gof iodine)

The 30, 50, and 100 ml bottles are single-dose. The 500 ml bottle is a multidose.

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 more information about this medication, please contact the local representative of the marketing authorization holder:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Last Review Date of this Leaflet:October 2022

For detailed and updated information about this medication, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

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This information is intended solely for medical professionals or healthcare professionals:

The complete technical dossier of Iopamiro 300 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 medication.

Please, consult the technical dossier(the technical dossier must be included in the box).