Omnipaque 350 mg iodine/ml solution for injection

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

OMNIPAQUE 240 mg Iodine/ml injectable solution

OMNIPAQUE 300 mg Iodine/ml injectable solution

OMNIPAQUE 350 mg Iodine/ml injectable solution

Iohexol

Read the entire 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. If you experience any adverse effects, consult your doctor, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What OMNIPAQUE is and what it is used for
2. What you need to know before using OMNIPAQUE
3. How to use OMNIPAQUE
4. Possible side effects
5. Storage of OMNIPAQUE
6. Contents of the pack and other information

1. What OMNIPAQUE is and what it is used for

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

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

• Once injected, it can help the doctor detect, locate, and distinguish the normal or abnormal appearance and shape of certain organs in your body.
• It can be used for X-ray examinations of the urinary system, the spinal column, or blood vessels, including the vessels of the heart.
• Some patients may receive this medicine before or during a scan of the head or body using "computed tomography" (also called CT). This type of scan uses X-rays.
• It may also be used in certain mammography examinations.
• It can also be used to examine the salivary glands, gastrointestinal tract, or to visualize body cavities such as the joints, uterus, fallopian tubes, biliary ducts and pancreas, and to assess kidney function (glomerular filtration rate).

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

2. What you need to know before using OMNIPAQUE

Do not use OMNIPAQUE

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

Warnings and precautions

Talk to your doctor before you are given OMNIPAQUE

• If you have ever had an allergic reaction to a medicine similar to OMNIPAQUE, called a “contrast medium”.

• If you have or have had any thyroid problems.

• If you have ever had 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 serious heart disease (affecting the heart or blood vessels), including high blood pressure, blood clots, stroke, and irregular heartbeat (arrhythmias), or if you have pulmonary hypertension (high blood pressure in the arteries leading to the lungs).

• If you have paraproteinemia (presence in the blood of an excessive amount of an abnormal protein).

• If you have kidney problems or combined liver and kidney problems.

• If you have a disease called “myasthenia gravis” (a condition characterized by severe muscle weakness).

• If you have “pheochromocytoma” (a rare tumor of the adrenal gland that may 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 drug or alcohol dependence.

• If you have epilepsy.

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

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

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

Thyroid disorders may occur after 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 administration of Omnipaque.

Contrast mammography exposes you to higher levels of ionizing radiation than conventional mammography, although still within the limits defined by international mammography guidelines. The radiation dose depends on breast thickness and the type of mammographic device used.

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

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

Medicines that may 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 a baby’s body more slowly than from an adult’s.

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

Use of OMNIPAQUE with other medicines

Tell your doctor:

• if you are diabetic and are taking any medicine containing metformin, as a precaution, this should be stopped 48 hours before the examination and restarted only when your doctor advises, or
• if you have recently taken other medicines, including those obtained without a prescription, or if you are taking beta-blockers (medicines used to treat high blood pressure), vasoactive substances, ACE enzyme inhibitors, or angiotensin antagonists (medicines used to treat high blood pressure), or if you have recently been treated with interleukin-2 or interferon (medicines mainly used to treat cancer), or antidepressants (medicines used to treat mental disorders such as depression).

This is because some medicines 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 breastfeeding

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

This product should not be used during pregnancy unless the benefit outweighs the risk for both mother and baby. If the mother received Omnipaque during pregnancy, monitoring of thyroid function in infants is recommended (see Warnings and precautions). Radiation exposure should be avoided during pregnancy whenever possible.

Breastfeeding can be continued normally when OMNIPAQUE is administered to the mother.

Driving and use of machines

Do not drive or operate tools or machinery after receiving OMNIPACE, especially during the first 24 hours following spinal examination.

This is because you may feel dizzy or experience other symptoms of a delayed reaction.

Other special precautions

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

OMNIPAQUE 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 OMNIPAQUE

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

• OMNIPAQUE will always be used in a hospital or clinic.
• You will be informed of everything you need to know for its safe use.

Your doctor will decide the dose that is best for you.

After administration of Omnipaque You will be advised:

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

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

The above recommendation applies to all patients who have received OMNIPAQUE. If you do not understand any of the above, please ask your doctor.

Omnipaque can be administered in many different ways. A description of the usual methods of administration is provided below:

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

Injection into the spinal canal Omnipaque is injected into the space surrounding the spinal cord to visualize the spinal canal. If you have received Omnipaque via spinal injection, you will be advised to follow the recommendations below:

• rest for one hour with your head and body in an upright position, or for six hours if you remain in bed, and
• walk carefully and avoid bending over for six hours, and
• not be left completely alone during the first 24 hours after receiving Omnipaque, if you are an outpatient and have ever had seizures.

The above recommendation applies only if Omnipaque has been injected into your spinal canal. If you do not understand any of the above, please ask your doctor.

Use in body cavities or joints
For examination of intra-articular, intrabiliary, intrapancreatic, intraperitoneal, oral, and intrauterine cavities. How and where Omnipaque is administered will vary depending on the cavity.

Oral use
For examination of the esophagus, stomach, or intestines, Omnipaque is usually administered orally. For these examinations, Omnipaque may be diluted with water.

Use in children
Ensure adequate hydration, especially in infants and young children, before and after administration of contrast agents.

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

4. Possible adverse effects

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

Allergic reactions If you experience an allergic reaction while Omnipaque is being administered to you in a hospital or clinic, inform your doctor immediately. Symptoms may include:

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

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

After administration of Omnipaque, a short-term decrease in urine production due to reduced kidney function is common. This may lead to kidney damage. Other side effects you may experience depend on how or for what purpose 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)
Common (may affect up to 1 in 10 patients)

• sensation of warmth

Uncommon (may affect up to 1 in 100 patients)

• nausea

• increased or abnormal sweating, feeling cold, dizziness/fainting

• headache

Rare (may affect up to 1 in 1,000 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 sensation
• high or low blood pressure, chills
• diarrhea
• allergic reaction, including those that may be severe and cause shock and collapse; see the section “Allergic reactions” above for further symptoms
• Fainting (syncope)

Frequency not known (cannot be estimated from available data)

• swelling and tenderness (pain) of the salivary glands

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

• short-term changes in respiratory rate, breathing problems

Uncommon (may affect up to 1 in 100 patients)

• pain and discomfort
• acute kidney injury

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

• Diarrhea
• Irregular heartbeat, including slow or fast heart rate
• Cough, breathing interruption, fever, general malaise
• dizziness, feeling weak, muscle weakness
• intolerance to bright light
• abnormal sensation of fatigue
• skin rash and itching, skin redness
• reduced vision (including double vision and blurred vision)

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

• seizures (fits), altered consciousness, stroke, sensory disturbances (such as touch), tremor, stupor (“drowsy state”)
• flushing
• difficulty breathing
• myocardial infarction
• chest pain

Frequency not known (cannot be estimated from available data)

• severe skin reactions, including severe rash, blisters, and peeling of the skin
• feeling confused, disoriented, agitated, restless, or anxious
• overactive thyroid gland (excess thyroid hormone in the blood causing various symptoms such as rapid heartbeat, sweating, anxiety), transient hypothyroidism (a temporary thyroid dysfunction that later returns to normal)
• difficulty moving for a period of time
• speech disorders including aphasia (inability to speak), dysarthria (difficulty pronouncing words)
• temporary blindness (lasting hours or a few days), short-term hearing loss
• heart problems, including heart failure, spasms of the heart arteries, and cyanosis (blue to purple skin color due to lack of oxygen)
• tightness in the chest or breathing problems, including lung inflammation, spasms of the airways
• worsening of inflammation of the pancreas (an organ behind the stomach), causing stomach pain that worsens with eating
• pain and inflammation of a vein, blood clots (thrombosis)
• joint pain, reaction at injection site, back pain
• asthma attack
• iodism (excessive amounts of iodine in the body) causing swelling and tenderness (pain) of the salivary glands
• flare-up of psoriasis
• memory loss (amnesia)
• short-term brain disorders (contrast-induced encephalopathy) which may cause headache, vision difficulties, loss of vision, seizures, confusion, disorientation, drowsiness, loss of consciousness, coma, loss of coordination, loss of movement on one side of the body, speech problems, memory loss, and brain inflammation
• thrombocytopenia (a condition in which platelet count is low, causing blood to not clot as well as normal)
• Increased level of creatinine in blood

After injection into the spinal canal
Very common (may affect more than 1 in 10 patients)

• headache (may be severe and prolonged)

Common (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 1,000 patients)

• seizures (fits), dizziness
• pain in arms or legs, neck pain, back pain

Frequency not known (cannot be estimated from available data)

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

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

• pain in the entire abdominal area

Common (may affect up to 1 in 10 patients)

• inflammation of the pancreas (pancreatitis)
• abnormal level of a substance produced by the pancreas detected by laboratory testing

Frequency not known (cannot be estimated from available data)

• pain

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

• pain at injection site

Frequency not known (cannot be estimated from available data)

• joint inflammation

After oral administration
Very common (may affect more than 1 in 10 patients)

• diarrhea

Common (may affect up to 1 in 10 patients)

• nausea, vomiting

Uncommon (may affect up to 1 in 100 patients)

• pain in the entire abdominal area

Use in children

Transient hypothyroidism has been reported in premature infants, neonates, and other children following administration of iodinated contrast media. Premature infants are particularly sensitive to the effects of iodine.

Short-term thyroid dysfunction (transient hypothyroidism) has been reported in a premature infant who was breastfed. The mother had been repeatedly exposed to Omnipaque.

Adequate hydration must be ensured, especially in infants and young children, before and after administration of contrast agents.

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of OMNIPAQUE

Keep this medicine out of sight and reach of children.

Store at a temperature not exceeding 30°C. Keep in the outer packaging to protect from light.

Do not use this medicine after the expiry date stated on the container.

6. Contents of the pack and other information

Composition of OMNIPAQUE

The active substance is iohexol.

The other components are:

Trometamol, calcium disodium edetate, hydrochloric acid (for pH adjustment), and water for injections.

Appearance of the medicinal product and contents of the container

Omnipaque is an injectable solution presented ready for use as a sterile, clear, aqueous solution, colourless or slightly yellow.

It is available in three concentrations:

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

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

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

Presentations:

OMNIPAQUE 240 mg Iodine/ml:

1 and 10 vials of 50 and 200 ml

1 and 6 vials of 500 ml

OMNIPAQUE 300 mg Iodine/ml:

1 and 10 vials of 50, 100 and 200 ml

1 and 6 vials of 500 ml

OMNIPAQUE 350 mg Iodine/ml:

1 and 10 vials of 50, 100 and 200 ml

1 and 6 vials of 500 ml

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

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

Calle Gobelas, 35-37, La Florida

28023 Madrid, Spain

Manufacturers:

GE Healthcare Ireland Limited

IDA Business Park

Carrigtohill

Co. Cork, Ireland

GE Healthcare AS

Nycoveien 1

0485 Oslo, Norway

Date of the most recent revision of the package leaflet: March 2026

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