Iopamiro 370 mg/ml solution for injection

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

IOPAMIRO 370 mg/ml injectable solution

Iopamidol

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

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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
5. How to store Iopamiro
6. Contents of the pack and other information

1. What Iopamiro is and what it is used for

This medicine is for diagnostic use only.

Iopamiro belongs to a group of medicines called iodinated X-ray contrast media.

Iopamiro is approved as a radiological contrast agent for the following indications:

• arteriography (visualization of arteries),
• angiocardiography (visualization of blood vessels of the heart),
• ventriculography (visualization of the heart ventricles),
• phlebography (visualization of veins),
• digital subtraction angiography (visualization of blood vessels),
• computed tomography (CT) (obtaining cross-sectional images of a specific body region),
• intravenous urography (visualization of the urinary tract)

2. What you need to know before using Iopamiro

Do not use Iopamiro

• if you are allergic to the active substance or any of the other components of this medicine (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 previous injection with iopamidol.

Warnings and precautions

Talk to your doctor or pharmacist before using Iopamiro. Be especially careful if:

• You have experienced any reaction during a previous injection of an iodinated contrast medium.
• You have had asthma.
• You have renal impairment, 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 condition in which the body is unable to fully metabolize the amino acid methionine).
• You have hepatic impairment.
• You have any neurological disorder, such as epilepsy, stroke, pheochromocytoma (excessive hormone production causing severe hypertension), myasthenia gravis (an autoimmune disease affecting muscles), or other autoimmune diseases.
• You have had thyroid dysfunction.
• You are in a state of excitement, anxiety, or intense pain, as this may increase the risk or severity of adverse reactions.
• You have a bone marrow disorder (such as multiple myeloma or Waldenström's macroglobulinemia).
• You have recently had intracranial hemorrhage or epilepsy.
• You have cerebral edema or a brain tumor.
• You are in a significantly deteriorated general health condition.
• You have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Iopamiro or other iodinated contrast agents.

Special care with Iopamiro:

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

Seek immediate medical attention if you experience any 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-dependent.

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

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

Thyroid disorders have been observed following administration of iopamidol. Particular attention should be paid to newborns, including those whose mothers received iopamidol during pregnancy, and to premature infants. Doctors may check the infant's thyroid gland function.

Consult your doctor, even if any of the above circumstances occurred only once in the past.

Inform your doctor if you are scheduled to undergo thyroid function testing or will receive treatment with radioactive iodine.

High concentrations of contrast media 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 tests not be performed within the first 24 hours after the examination.

Use of Iopamiro with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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

Consult your doctor if you have any doubts.

Use of Iopamiro with food and drink

Any disturbance in fluid and electrolyte balance should be corrected before contrast medium administration.

Before the test, do not reduce your normal fluid intake, especially if you are in any of the following conditions:

• Severe renal impairment
• Severe hepatic impairment
• Severe heart failure
• Multiple myeloma (a bone marrow disorder)
• Diabetes mellitus
• Blood disorders
• Increased or decreased urine output
• Deteriorated general health
• Elderly patients

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

You may maintain a normal diet up to two hours before the examination. During the two hours prior to the study, you should refrain 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 medicine.

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

Driving and using machines

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

Iopamiro contains sodium

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

3. How to use Iopamiro

Follow exactly the instructions for administration of this medicine as given by your doctor. If in 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 into a vein or artery, into the spinal column, or into a joint.

You must ensure you are well hydrated before receiving Iopamiro.

After administration of the contrast medium, you must 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 normally ranges between 5 and 250 ml.

Your doctor may decide to adjust 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 area of the hospital or clinic where Iopamiro will be administered is equipped to treat any reactions caused by an overdose.

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

Treatment of overdose should focus on ensuring vital function support and prompt initiation of symptomatic therapy.

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

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

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

4. Possible adverse effects

Like all medicines, Iopamiro may cause adverse effects, although not everyone experiences them.

The adverse effects that may occur after administration of a contrast medium are usually mild to moderate in severity and typically short-lived.

However, as with other contrast media, in some cases serious reactions may occur, which can even be life-threatening and require prompt and effective treatment.

If you experience any of the following symptoms, inform your radiologist or X-ray staff immediately, as these may be signs of an allergic reaction or shock. The examination should be stopped and you may require treatment. Symptoms include:

• Swelling of the face and throat (angioedema).
• Watery or itchy eyes (conjunctivitis), cough, itching, runny nose or nasal congestion, sneezing, hives.
• Severe drop in blood pressure, increased heart rate (tachycardia).
• Difficulty breathing, nausea, sensation of suffocation (allergic reactions).
• Agitation, blue lips, blue or pale face, cold sweats, loss of consciousness.
• Headache, dizziness.
• Drop in blood pressure may also be associated with a decreased heart rate (bradycardia), which often progresses to an increased heart rate (tachycardia).

These reactions may occur delayed and independently of the administered dose and route of administration.

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

• Red, flat, circular or target-shaped rashes on the trunk, often with central blisters, skin peeling, sores in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• A widespread red scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The frequency of occurrence of these adverse effects is unknown.

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

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

Frequent (may affect up to 1 in 10 people)

• Allergic and/or anaphylactoid reactions
• Headache, taste disturbances
• Watery or itchy eyes (conjunctivitis)
• Dyspnea (difficulty breathing)
• Nausea, vomiting
• Edema, flushing, urticaria, rash, itching, and skin redness
• Sensation of warmth

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 kidney failure
• Chest pain, injection site pain, fever, feeling cold
• Abnormal laboratory test results for creatinine (this may be detected in a test performed by a doctor)

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

• Confusion
• Paresthesia (tingling, prickling, or numbness sensations)
• Decreased heart rate
• Fluid accumulation in the lungs, asthma, bronchospasm
• Muscle spasms
• Swelling at the injection site

Frequency not known (cannot be estimated from available data)

• Decreased platelet count in blood (detected by a blood 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, seizures
• Transient blindness, visual disturbances, photophobia (excessive sensitivity to light)
• Heart attack, heart failure, cardiorespiratory arrest, increased heart rate
• Circulatory collapse (failure of blood circulation)
• Respiratory arrest, respiratory failure, acute respiratory distress syndrome (a serious lung condition), 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 (can be detected by 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, vision loss, confusion, seizures, loss of coordination, paralysis on one side of the body, speech problems, and loss of consciousness
• Serious skin disease (see top of this 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, warmth, and pain at the injection site

Children

Thyroid disorders have been reported in premature newborns.

The following adverse reactions have been observed after administration of Iopamiro into body cavities:

• Increased blood amylase levels (a pancreatic test)
• Allergic reactions, mainly presenting as skin reactions
• Inflammation of the pancreas, with symptoms of severe abdominal pain in the upper abdomen radiating to the back, as well as nausea and vomiting (pancreatitis)
• Reactions reported following X-ray examinations of joints (arthrography) and fistulas (fistulography) are mostly additional irritations occurring alongside tissue inflammation.

Reporting of adverse effects

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

5. Storage of Iopamiro

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

This medicine does not require special storage temperature conditions. Do not freeze.

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Iopamiro

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

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

Appearance of the product and contents of the pack

Iopamiro is a sterile, clear, colourless, aqueous injectable solution.

Iopamiro is available in colourless 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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Bracco Imaging, S.p.A.

Via Egidio Folli, 50

20134 Milan (Italy)

Manufacturer:

Patheon Italia S.p.A.

2º Trav. SX Via Morolense, 5

03013 Ferentino (Italy)

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

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid, Spain

Date of the most recent review of this summary: October 2022

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

This information is intended for healthcare professionals only:

The full Summary of Product Characteristics (SmPC) for Iopamiro 370 mg/ml injectable solution is supplied as a separate document within the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this medicinal product.

Please refer to the Summary of Product Characteristics (the SmPC must be included in the carton).