PATIENT INFORMATION LEAFLET

OMNIPAQUE240 mg Iodine/ml solutioninjectable

OMNIPAQUE 300 mg Iodine/ml solutioninjectable

OMNIPAQUE350 mg Iodine/ml solutioninjectable

Iohexol

This medication is solely for diagnostic use. It is only used to help identify a disease in children and adults.

OMNIPAQUE is a "contrast medium". It is administered before an X-ray examination to make the image taken by the doctor clearer.

• Once injected, it may help the doctor to detect, locate, and differentiate the normal or abnormal appearance and shape of some organs in your body.
• It can be used for X-ray examinations of the urinary system, the spine, or blood vessels, including those of the heart.
• Some people are given this medication before or during an exploration of their head or body using "computed tomography" (also called CT scan). This type of exploration uses X-rays.
• It may also be used in some mammography explorations.
• It can also be used to examine the salivary glands, gastrointestinal tract, or to visualize the cavities of the body, such as the joints, uterus, Fallopian tubes, bile ducts, pancreas, and to determine how your kidneys function (glomerular filtration rate).

Your doctor will explain which part of your body will be explored.

No use OMNIPAQUE

• If you suffer from severe thyroid problems.
• If you are allergic (hypersensitive) to iohexol or to any of the other components of OMNIPAQUE (listed in section 6).

Warnings and precautions

Consult your doctor before OMNIPAQUE is administered to you.

• If you have or have had any allergic reaction to a similar medication to OMNIPAQUE, known as a "contrast medium".
• If you have any thyroid problems.
• If you have had any allergies.
• If you have asthma.
• If you have diabetes.
• If you have any brain disease (including migraine) or tumors.
• If you have or have had a severe heart disease (affecting the heart or blood vessels) including high blood pressure, blood clots, stroke, and irregular heartbeats (arrhythmias) If you have pulmonary hypertension (high blood pressure in the arteries leading to the lungs).
• If you have paraproteinemia (excessive presence of abnormal proteins in the blood)
• If you have kidney or liver and kidney problems.
• If you have a disease called "myasthenia gravis" (a disease characterized by severe muscle weakness).
• If you have "pheochromocytoma" (a rare tumor of the adrenal gland that can cause high blood pressure).
• If you have "homocystinuria" (a condition with increased excretion of the amino acid cysteine in the urine).
• If you have any blood or bone marrow disorders.
• If you have an immune system disease.
• If you have had or have a dependence on drugs or alcohol.
• If you have epilepsy.

• If you are scheduled for a thyroid function test in the coming weeks.

• If you are having a urine or blood sample taken on the same day.

During or shortly after the diagnostic imaging procedure, you may experience a temporary brain disorder called encephalopathy. Inform your doctor immediately if you notice any of the signs and symptoms related to this condition described in section 4.

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

Mammography with contrast exposes you to higher levels of ionizing radiation than traditional mammography, although they remain within the limits defined by international guidelines on mammography. The radiation dose depends on the thickness of the breast and the type of mammography device used.

If you are unsure whether you have any of the above conditions, consult your doctor before using OMNIPAQUE.

Make sure to drink plenty of liquids before and after receiving Omnipaque. This applies especially to patients with multiple myeloma (a disease of the white blood cells), diabetes, kidney problems, patients in poor general health, children, and the elderly.

Medications that can damage the kidneys should not be taken at the same time as Omnipaque. Thyroid function should be monitored in newborns during the first week of life if the mother received Omnipaque during pregnancy.

Omnipaque may be eliminated from the body of a baby more slowly than an adult.

Young children (under 1 year of age) and especially newborns are susceptible to changes in certain laboratory tests (imbalance of salts and minerals) and in blood circulation (blood flow in vessels, or from the heart).

Use of OMNIPAQUE with other medications

Inform your doctor:

• if you are diabetic and taking any medication containing metformin, as a precaution, its administration should be interrupted 48 hours before the examination and resumed when your doctor instructs you, or
• if you have recently taken other medications, including those purchased without a prescription, or if you are taking beta-blockers (medications used to treat high blood pressure), vasoactive substances, ACE inhibitors, or angiotensin antagonists (medications used to treat high blood pressure) or have recently been treated with interleukin-2 or interferon (medications used primarily to treat oncological diseases), antidepressants (medications used to treat mental disorders such as depression).

The reason is that some medications may affect how Omnipaque works.

Beta-blockers may increase the risk of experiencing breathing difficulties and may interfere with the treatment of severe allergic reactions, which poses a risk with Omnipaque.

Pregnancy and lactation

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

The product should not be used during pregnancy unless the benefit outweighs the risk for both the mother and the baby. If the mother received Omnipaque during pregnancy, it is recommended to monitor the thyroid function of the infants (see Warnings and precautions).Whenever possible, exposure to radiation during pregnancy should be avoided.

The lactation can continue normally when Omnipaque is administered to the mother.

Driving and operating machinery

Do not drive or operate tools or machines after the administration of OMNIPAQUE for the first 24 hours following the spinal column examination.

The reason is that you may feel dizzy or experience other symptoms of a delayed reaction.

Other special precautions

Contrast media can also interfere with the results of blood or urine samples taken on the same day or after the X-ray examination. Inform your doctor that you have received OMNIPAQUE if you have any blood or urine samples taken during these days.

OMNIPAQUE contains sodium

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

Omnipaque will always be administered by qualified and properly trained personnel.

• Omnipaque will always be used in a hospital or clinic.
• They will inform you of everything you need to know for safe use.

Your doctor will decide on the best dose for you.

After administration of Omnipaque
You will be asked:

• to drink plenty of liquid before and after (to help eliminate the medication from your body), and
• to remain near the location where the examination or X-rays were performed for about 30 minutes.

If you experience any adverse effects during this time, inform your doctor immediately (see section 4 "Possible adverse effects").

The above recommendation appliesto all patientswho have received OMNIPAQUE. If you have not understood something from the above, ask your doctor.

Omnipaquecan be administered in many different ways, a description of
how it is usually administered can be found below:

Injection into an artery or a vein
Omnipaqueis injected into a vein in the arm or leg or administered through a thin plastic tube (catheter), usually in an artery in the arm or groin.

Injection into the spinal column
Omnipaque is injected into the space surrounding the spinal cord to visualize the spinal canal. If you have been administeredOmnipaquein the spinal column, you will be asked to follow the recommendations indicated below:

• to rest for an hour with your head and body upright, or for six hours if you remain in bed, and
• to walk carefully and try not to bend over for six hours, and
• not to be completely alone for the first 24 hours after receivingOmnipaque, if you are an outpatient and have ever had seizures.

The above recommendation only applies if you have been injected withOmnipaquein the spinal column. If you have not understood something from the above, ask your doctor.

Use in body cavities or in joints

For the examination of intra-articular, intracolangiopancreatic, intraperitoneal, oral, and intrauterine cavities.
How and where Omnipaque will be administeredwill vary from one to another.

Use by oral route
For the examination of the esophagus, stomach, or intestine,Omnipaqueis usually administered orally. For these examinationsOmnipaquecan be diluted with water.

Use in children

You must ensure, especially in babies and young children, adequate hydration before and after the administration of contrast media.

If you use more OMNIPAQUE than you should

If you use more OMNIPAQUE than you should, inform your doctor.

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

Allergic reactions
If you experience an allergic reaction when Omnipaque is being administered in a hospital or clinic, inform your doctor immediately. The symptoms may be:

• difficulty breathing or chest tightness or pain, noisy breathing
• skin rash, hives, itchy patches, blisters on skin and mouth, red or itchy eyes, runny nose, sneezing, or other allergy symptoms
• swelling of the face
• feeling of dizziness or fainting (caused by low blood pressure)

The side effects described above may occur several hours or days after the administration of Omnipaque. If any of these side effects occur after leaving the hospital or clinic, go directly to the emergency department of your nearest hospital.

After administration of Omnipaque, a temporary decrease in urine formation due to decreased renal function is common. This may cause kidney damage.
Other side effects you may experience are as follows, which will depend on how or for what Omnipaque was administered to you. Consult your doctor if you are unsure how Omnipaque was administered to you.

General
(applies to all uses of Omnipaque)
Frequent(may affect up to 1 in 10 patients)

• feeling of heat

Uncommon(may affect up to 1 in 100 patients)

• nausea
• increased sweating / abnormal, feeling of cold, dizziness / fainting
• headache

Rare(may affect up to 1 in 1000 patients)

• allergic reactions (hypersensitivity) (which may be fatal)
• low heart rate
• vomiting, fever, abdominal pain

Very rare(may affect up to 1 in 10,000 patients)

• temporary change in taste
• high or low blood pressure, chills
• diarrhea
• allergic reaction, including severe reactions that may cause shock and collapse, see the section “Allergic reactions” described above for the rest of the symptoms.
• fainting (syncope)

Frequency unknown(cannot be estimated from available data)

• swelling and sensitivity (pain) of salivary glands

After injection into an artery or vein
Frequent(may affect up to 1 in 10 patients)

• short-term changes in respiratory rate, respiratory problems

Uncommon(may affect up to 1 in 100 patients)

• pain and discomfort
• acute kidney injury

Rare(may affect up to 1 in 1000 patients)

• diarrhea
• irregular heartbeats, including slow or fast heart rate
• cough, interrupted breathing, fever, general discomfort
• dizziness, feeling of weakness, muscle weakness
• intolerance to bright light
• abnormal feeling of fatigue
• skin rash and itching, redness of the skin
• reduced vision (including double vision and blurred vision)

Very rare(may affect up to 1 in 10,000 patients)

• seizures (attacks), altered consciousness, stroke, alteration of senses (such as touch), tremors, stupor (“somnolent state”)
• flushing
• difficulty breathing
• heart attack
• chest pain

Frequency unknown(cannot be estimated from available data)

• severe skin reactions, including severe skin rash, blisters, and skin peeling
• feeling of confusion, disorientation, agitation, restless or anxious
• hyperactive thyroid gland (excess thyroid hormone in the blood causing a variety of symptoms, such as rapid heart rate, sweating, anxiety), transient hypothyroidism (thyroid function anomaly that later returns to normal)
• difficulty moving for a time

• speech disorders including aphasia (inability to speak), dysarthria (difficulty pronouncing words)
• temporary blindness (hours or days), temporary hearing loss
• heart problems, including heart failure, coronary artery spasms, and cyanosis (blue or purple skin due to lack of oxygen)
• chest tightness or breathing problems, including lung inflammation, respiratory spasms
• pancreatitis (inflammation of the pancreas) worsening, causing stomach pain that worsens with eating
• vein pain and inflammation, blood clots (thrombosis)
• joint pain, injection site reaction, back pain
• asthma attack
• iodism (excessive iodine in the body) causing inflammation and sensitivity (pain) of salivary glands
• psoriasis outbreak
• memory loss (amnesia)
• short-term brain disorders (contrast encephalopathy) that may cause headache, vision difficulties, vision loss, seizures, confusion, disorientation, drowsiness, loss of consciousness, coma, loss of coordination, loss of movement in one side of the body, speech problems, memory loss, and brain inflammation
• thrombocytopenia (a condition in which the platelet count is low and the blood does not clot as well as it normally does)
• increased creatinine levels in the blood

After injection into the spine
Very frequent(may affect more than 1 in 10 patients)

• headache (may be severe and prolonged)

Frequent(may affect up to 1 in 10 patients)

• nausea, vomiting

Uncommon(may affect up to 1 in 100 patients)

• inflammation of the membranes surrounding the brain and spinal cord

Rare(may affect up to 1 in 1000 patients)

• seizures (attacks), dizziness
• arm or leg pain, neck pain, back pain

Frequency unknown(cannot be estimated from available data)

• agitation
• anxiety
• feeling of disorientation
• intolerance to bright light, neck stiffness
• difficulty moving for a time, feeling of confusion
• alteration of senses (such as touch), temporary blindness (hours or days), temporary hearing loss
• seizures (lasting more than five minutes)
• tingling sensation, muscle contractions (spasms), injection site reaction
• short-term brain disorders (contrast encephalopathy) that may cause headache, vision difficulties, vision loss, seizures, confusion, disorientation, drowsiness, loss of consciousness, coma, loss of coordination, loss of movement in one side of the body, speech problems, memory loss, and brain inflammation.
• speech disorders, including aphasia (inability to speak), dysarthria (difficulty pronouncing words)

After being administered in body cavities
(such as the uterus and fallopian tubes, gallbladder, and pancreas or hernia)
Very frequent(may affect more than 1 in 10 patients)

• abdominal pain throughout the area

Frequent(may affect up to 1 in 10 patients)

• inflammation of the pancreas gland (pancreatitis)
• abnormal amount of a substance produced by the pancreas gland detected by laboratory investigation

Frequency unknown(cannot be estimated from available data)

• pain

After injection into joints
Very frequent(may affect more than 1 in 10 patients)

• pain at the injection site

Frequency unknown(cannot be estimated from available data)

• joint inflammation

After being administered orally
Very frequent(may affect more than 1 in 10 patients)

• diarrhea

Frequent(may affect up to 1 in 10 patients)

• nausea, vomiting

Uncommon(may affect up to 1 in 100 patients)

• abdominal pain throughout the area

Use in children

Transient hypothyroidism has been described in premature babies, newborns, and other children after administration of iodinated contrast media. Premature babies are particularly sensitive to the effect of iodine.

Transient alteration of thyroid function (hypothyroidism) has been described in a premature baby with breastfeeding. The mother was repeatedly exposed to Omnipaque.

Ensure adequate hydration before and after administration of contrast media, especially in babies and young children.

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side 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 at a temperature equal to or below 30°C. Store in the outer packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging.

Composition of OMNIPAQUE

The active ingredient is iohexol

The other components are:

Trometamol, calcium and sodium edetate, hydrochloric acid (pH adjustment) and water for injection preparations.

Appearance of the product and contents of the container

OMNIPAQUE is an injectable solution that is presented ready for use in the form of a clear, colorless or slightly yellowish aqueous solution.

It is available in three concentrations:

OMNIPAQUE 240 mg Iodo/ml contains 518 mg of Iohexol per ml (equivalent to 240 mg of iodine per ml)

OMNIPAQUE 300 mg Iodo/ml contains 647 mg of Iohexol per ml (equivalent to 300 mg of iodine per ml)

OMNIPAQUE 350 mg Iodo/ml contains 755 mg of Iohexol per ml (equivalent to 350 mg of iodine per ml)

Presentations:

OMNIPAQUE 240 mg Iodo/ml:

1 and 10 vials of 50 and 200 ml

1 and 6 vials of 500 ml

OMNIPAQUE 300 mg Iodo/ml:

1 and 10 vials of 50, 100 and 200 ml

1 and 6 vials of 500 ml

OMNIPAQUE 350 mg Iodo/ml:

1 and 10 vials of 50, 100 and 200 ml

1 and 6 vials of 500 ml

Only some sizes of containers may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

GE Healthcare Bio-Sciences, S.A.U.

Gobelas Street, 35-37, La Florida

28023 Madrid

Manufacturers:

GE Healthcare Ireland Limited

IDA Business Park

Carrigtohill

Co. Cork, Ireland

GE Healthcare AS,

Nycoveien 1

NO-0485 Oslo, Norway

Last review date of thisleaflet: February 2024

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