Label: information for the user

VISIPAQUE 270 mg /ml, injectable solution

VISIPAQUE 320 mg/ml, injectable solution

Iodixanol

This medication is solely for diagnostic use.

It is only used to help identify a disease.

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

• Once injected, it can 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 can also be used to examine the esophagus, stomach, and intestines, or to visualize the cavities of the body, such as joints, the uterus, and fallopian tubes.Your doctor will explain which part of your body will be explored.

No use VISIPAQUE:

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

Warnings and precautions

Consult with your doctor before VISIPAQUE is administered to you:

• If you have or have had any allergic reaction with any medication similar to VISIPAQUE, known as "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 epilepsy, clots, cerebral hemorrhage, or tumors.
• If you have a severe heart disease or pulmonary hypertension.
• 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" (episodes of high blood pressure due to a rare adrenal gland tumor).
• If you have "homocystinuria" (a disease characterized by an increase in the excretion of the amino acid cysteine in the urine)
• If you have any blood or bone marrow disorder.
• If you have had or have dependence on drugs or alcohol.
• If you are scheduled to have a thyroid function test in the coming weeks.
• If you are to have blood or urine samples taken on the same day.

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

Thyroid disorders may be observed after the administration of Visipaque 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 Visipaque.

If you are unsure if you are affected by any of the above, speak with your doctor before using VISIPAQUE.

Interaction of VISIPAQUE with other medications

Inform your doctor if you are taking, have taken, or may need to take any other medication.

In diabetic patients taking any medication containing metformin.

In patients taking immunosuppressive medications, for example, transplant medications (interleukin-2).

In patients taking medications to lower blood pressure (beta-blockers)

Pregnancy and lactation

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

The product should not be used during pregnancy unless the benefit outweighs the risk and is considered essential by your doctor.

If Visipaque was administered to the mother during pregnancy, it is recommended to monitor the thyroid function of the babies.

Lactation may continue normally after administration of VISIPAQUE to the mother.

Driving and use of machines:

Do not drive or use tools or machines after the administration of VISIPAQUE for:

• 24 hours after the spine exploration or
• one hour in all other cases.

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

VISIPAQUE contains sodium chloride and calcium and sodium edetate.

VISIPAQUE 270 mg/ml: Patients with low-sodium diets should note that this medication contains 0.76 mg (0.03 mmol) of sodium per ml.

VISIPAQUE 320 mg/ml: Patients with low-sodium diets should note that this medication contains 0.45 mg (0.02 mmol) of sodium per ml.

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

• VISIPAQUE will always be used in a hospital or clinic.

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

Your doctor will decide the best dose for you.
The recommended dose is:

• A single injection or they will ask you to take it.

After the administration of VISIPAQUEyou will be asked

• to drink a lot of liquid afterwards (to help eliminate the medication from your body), and
• to remain near the location where you underwent the examination or X-rays 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 VISIPAQUE. If you have not understood something from the above, ask your doctor.

VISIPAQUEcan be administered in many different ways, a description of the ways in which it is generally administered can be found below:

Injection into an artery or a vein

VISIPAQUEis 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

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

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

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

Use in body cavities or in joints
Body cavities such as joints, the uterus, and fallopian tubes. How and where VISIPAQUE will be administered will vary from one to another.

Use by oral route
For the examination of the esophagus, stomach, or small intestine,VISIPAQUEis usually administered orally. In children, it is also administered rectally.

Like all medications, VISIPAQUE may cause side effects, although not everyone experiences them.

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

• noisy breathing, difficulty breathing, or chest tightness or pain
• skin rash, hives, itchy patches, blisters on the skin and in the mouth, and 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 VISIPAQUE administration. If any of these side effects occur after leaving the hospital or clinic, go directly to the emergency department of your nearest hospital.

Other side effects you may experience are as follows, which will depend on how or for what VISIPAQUE was administered to you. Consult your doctor if you are unsure how VISIPAQUE was administered to you.

After an injection into an artery or vein
Rare(affects less than 1 in 100 patients)

• allergic reaction also known as hypersensitivity reaction, see "Allergic reactions" described above for the rest of the symptoms
• headache, nausea, vomiting
• flushing, skin rash, and itching
• feeling of heat, chest pain
• kidney damage

Rare(affects less than 1 in 1,000 patients)

• dizziness, arrhythmias, low blood pressure, myocardial infarction
• cough, discomfort, chills, fever, skin redness or mucous membrane inflammation, or injection site reactions
• pain
• alterations in taste, smell, and numbness

Very rare(affects less than 1 in 10,000 patients)

• agitation, anxiety, tremor, loss of tactile sense
• stroke
• auditory disturbances
• fainting
• excessive sweating
• high blood pressure, cardiac disorders, palpitations
• difficulty breathing
• fatigue, discomfort
• abdominal pain or discomfort
• cardiac arrest
• back pain
• muscle spasms
• decreased blood flow (ischemia)
• temporary blindness
• vision disturbances

Frequency unknown

• allergic reaction, severe anaphylactic shock leading to shock and collapse, see "Allergic reactions" described above for the rest of the symptoms

• dizziness, fainting, difficulty moving for a time, muscle cramps
• blood clots (thrombosis), pain and swelling of a vein, shock

• severe respiratory difficulty (due to fluid in the lungs) respiratory arrest
• pulmonary edema
• joint pain, swelling, and pain of the salivary glands
• severe and generalized skin reactions, including mucous membrane and other organ involvement
• transient cerebral disturbances (encephalopathy) including hallucinations
• dizziness, memory loss, difficulty speaking,visual disturbances, loss of vision, seizures, loss of coordination, loss of movement in one side of the body, speech problems, and loss of consciousness
• coma
• anaphylactic shock
• coronary artery spasm
• pancreatic problems (acute inflammation or worsening of inflammation)
• seizures
• iodism (excess iodine) transient hyper or hypothyroidism
• decreased heart activity in pumping blood
• decreased platelets (thrombocytopenia)
• non-localized swelling

After an injection into the spinal column (intrathecal)
Rare(affects less than 1 in 100 patients)

• headache (may be severe and last for hours)
• vomiting

Frequency unknown(cannot be estimated from available data)

• hypersensitivity, including anaphylactic/anaphylactoid reactions
• dizziness
• nausea, tremor
• pain (at the injection site)

• allergic reaction, see "Allergic reactions" described above for the rest of the symptoms
• transient cerebral disturbances (encephalopathy) including hallucinations, dizziness, memory loss, difficulty speaking,visual disturbances, loss of vision, seizures, loss of coordination, loss of movement in one side of the body, speech problems, and loss of consciousness
• muscle spasms

After being administered into body cavities(such as the uterus and fallopian tubes)
Very common(affects more than 1 in 10 patients)

• vaginal bleeding

Common(affects less than 1 in 10 patients)

• headache, dizziness (nausea), high temperature

Rare(affects less than 1 in 100 patients)

•vomiting

Frequency unknown(cannot be estimated from available data)

• tremor
• injection site reactions
• abdominal pain (after hysterosalpingography)
• allergic reaction, see "Allergic reactions" described above for the rest of the symptoms

After injection into the joints
Common(affects less than 1 in 10 patients)

• pain at the injection site

Frequency unknown(cannot be estimated from available data)

• allergic reaction, see "Allergic reactions" described above for the rest of the symptoms
• tremor

After being administered orally
Common(affects less than 1 in 10 patients)

• diarrhea, nausea (urge to vomit)
• abdominal pain

Rare(affects less than 1 in 100 patients)

• vomiting

Frequency unknown(cannot be estimated from available data)

• allergic reaction, see "Allergic reactions" described above for the rest of the symptoms, tremor

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 prospectus. 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 medication.

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

Store below 30°C. Store in the outer packaging to protect it from light.

Expiration Date

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.

Composition of VISIPAQUE

The active ingredient is Iodixanol:

One milliliter of solution contains 550 mg of Iodixanol (equivalent to 270 mg of iodine)

One milliliter of solution contains 652 mg of Iodixanol (equivalent to 320 mg of iodine)

The other components are:

trometamol, sodium chloride, calcium chloride, calcium and sodium edetate, hydrochloric acid (pH adjustment) and water for injection. (See section 2 VISIPAQUE contains sodium chloride and calcium and sodium edetate).

Appearance of the product and contents of the container

VISIPAQUE is presented ready for use in the form of a clear, colorless or slightly yellowish aqueous solution.

It is available in two concentrations:

Presentations:

VISIPAQUE 270 mg /ml–1 and 10 vials of 50, 75, 100, 200, and 1 and 6 vials of 500 ml.

VISIPAQUE 320 mg /ml–1 and 10 vials of 50, 100, 200, and 1 and 6 vials of 500 ml.

The 50 ml, 75 ml, 100 ml and 200 ml vials are single-dose.

The 500 ml vials are multidose.

Only some sizes of containers may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

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

Calle Gobelas, 35-37, La Florida

28023, Madrid

Manufacturer responsible:

GE Healthcare Ireland Limited

IDABusinessPark

Carrigtohill

Co. Cork, Ireland

or

GE Healthcare AS.

Nycoveien, 1

NO-0485 Oslo

Norway

Last review date of thisleaflet: April 2022

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