Visipaque 320 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VISIPAQUE 270 mg/ml, injection solution

VISIPAQUE 320 mg/ml, injection solution

Iodixanol

Package leaflet:

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

1. What VISIPAQUE is and what it is used for

This medicine is for diagnostic use only.

It is used solely to help identify a disease.

VISIPAQUE 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 detect, locate, and distinguish the normal or abnormal appearance and shape of certain organs in your body.
• It can be used in X-ray examinations of the urinary system, the spine, or blood vessels, including the vessels of the heart.
• Some other people are given this medicine before or during a scan of their head or body using "computed tomography" (also called CT). This type of scan uses X-rays.

It may also be used to examine the esophagus, stomach, and intestine, or to visualize body cavities such as the joints, uterus, and fallopian tubes. Your doctor will explain which part of your body will be examined.

2. What you need to know before using VISIPAQUE

Do not use VISIPAQUE:

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

Warnings and precautions

Talk to your doctor before you are given Visipaque:

• If you have ever had an allergic reaction to a medicine similar to VISIPAQUE, called a "contrast medium".

• If you have or have had any thyroid problems.

• If you have ever had any allergies.

• If you have asthma.

• If you have diabetes.

• If you have any brain disorders, including epilepsy, blood clots, stroke, or brain tumors.

• If you have severe heart disease or pulmonary hypertension.

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

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

• If you have "pheochromocytoma" (episodes of high blood pressure due to a rare tumor of the adrenal gland).

• If you have "homocystinuria" (a disorder characterized by increased excretion of the amino acid cysteine in the urine).

• If you have any blood or bone marrow disorders.

• If you have had or currently have drug or alcohol dependence.

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

• If blood or urine samples will be taken from you on the same day.

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

Thyroid disorders may occur after 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 administration of Visipaque.

If you are unsure whether any of the above apply to you, speak with your doctor before using VISIPAQUE.

Interaction of VISIPAQUE with other medicines

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

In diabetic patients taking medications containing metformin.

In patients taking medicines that suppress the immune system, for example transplant medications (interleukin-2).

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

Pregnancy and breastfeeding

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

This product should not be used during pregnancy unless the benefit outweighs the risk and its use is considered essential by the doctor.

If Visipaque was administered to the mother during pregnancy, thyroid function monitoring of the baby is recommended.

Breastfeeding can be continued normally after administration of VISIPAQUE to the mother.

Driving and use of machines:

Do not drive or operate tools or machinery after administration of VISIPAQUE for:

• 24 hours following spinal examination, or
• one hour in all other cases.

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

VISIPAQUE contains sodium chloride and calcium disodium edetate.

VISIPAQUE 270 mg/ml: patients on sodium-restricted diets should be aware that this medicinal product contains 0.76 mg (0.03 mmol) of sodium per ml.

VISIPAQUE 320 mg/ml: patients on sodium-restricted diets should be aware that this medicinal product contains 0.45 mg (0.02 mmol) of sodium per ml.

3. How to use VISIPAQUE

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 medicine as given by your doctor. If in doubt, consult your doctor again.

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

• A single injection or you will be asked to swallow it.

After receiving VISIPAQUE, you will be asked to:

• drink plenty of fluids afterwards (to help eliminate the medicine from your body), and
• remain near the place where your 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 VISIPAQUE. If you do not understand any of the above, ask your doctor.

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

Injection into an artery or vein

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

Injection into the spinal canal

VISIPAQUE is injected into the space surrounding the spinal cord to visualize the spinal canal. If you have received VISIPAQUE in the spine, you will be asked to follow the recommendations below:

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

The above recommendation applies only if you have received VISIPAQUE injected into the spinal canal. If you do not understand any of the above, ask your doctor.

Use in body cavities or joints
Body cavities such as joints, the uterus, and the fallopian tubes. How and where VISIPAQUE will be administered will vary depending on the cavity.

Oral use
For examination of the esophagus, stomach, or small intestine, VISIPAQUE is usually administered orally. In children, it may also be administered rectally.

4. Possible adverse effects

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

Allergic reactions If you experience an allergic reaction while receiving VISIPAQUE in a hospital or clinic, inform your doctor immediately. Symptoms may include:

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

Other side effects you may experience are listed below, depending on how or for what purpose VISIPAQUE was administered to you. Consult your doctor if you are unsure how VISIPAQUE was administered.

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

• allergic reaction also known as hypersensitivity reaction; see "Allergic reactions" above for additional symptoms
• headache, nausea, vomiting
• flushing, skin rashes, and itching
• sensation of warmth, chest pain
• kidney damage

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

• dizziness, arrhythmias, low blood pressure, myocardial infarction
• cough, malaise, chills, fever, redness of the skin or mucous membranes, injection site reactions
• pain
• disturbances in taste, smell, and tingling sensations

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

• agitation, anxiety, tremor, loss of sense of touch
• stroke
• hearing disturbances
• fainting
• excessive sweating
• high blood pressure, cardiac disorders, palpitations
• difficulty breathing
• fatigue, malaise
• pain or discomfort in the stomach area (abdominal pain)
• cardiac arrest
• back pain
• muscle spasms
• reduced blood flow (ischemia)
• temporary blindness
• visual disturbances

Frequency not known

• allergic reaction, severe allergic shock leading to shock and collapse; see "Allergic reactions" above for additional symptoms

• feeling confused, fainting, difficulty moving temporarily, cramps

• blood clots (thrombosis), pain and swelling of a vein, shock

• severe breathing 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 involvement of mucous membranes and other organs

• transient brain disturbances (encephalopathy) including hallucinations

• feeling confused, memory loss, difficulty speaking, visual difficulties, loss of vision, seizures, loss of coordination, loss of movement on one side of the body, speech problems, and loss of consciousness

• coma

• anaphylactic shock

• coronary artery spasm

• pancreas problems (acute inflammation or worsening of inflammation)

• seizures

• iodism (excess iodine), hyper- or hypothyroidism (transient)

• decreased heart activity in pumping blood

• decrease in platelets (thrombocytopenia)

• generalized swelling

After injection into the spinal canal (intrathecal)
Uncommon (affects less than 1 in 100 patients)

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

Frequency not known (cannot be estimated from available data)

• hypersensitivity, including anaphylactic/anaphylactoid reactions
• dizziness
• nausea, tremor
• pain (at injection site)
• allergic reaction; see "Allergic reactions" above for additional symptoms
• transient brain disturbances (encephalopathy) including hallucinations, confusion, memory loss, difficulty speaking, visual difficulties, loss of vision, seizures, loss of coordination, loss of movement on one side of the body, speech problems, and loss of consciousness
• muscle spasms

After administration into body cavities (such as 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

Uncommon (affects less than 1 in 100 patients)

• vomiting

Frequency not known (cannot be estimated from available data)

• tremor
• injection site reactions
• abdominal pain (after hysterosalpingography)
• allergic reaction; see "Allergic reactions" above for additional symptoms

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

• pain at injection site

Frequency not known (cannot be estimated from available data)

• allergic reaction; see "Allergic reactions" above for additional symptoms
• tremor

After oral administration
Common (affects less than 1 in 10 patients)

• diarrhea, nausea (feeling like vomiting)
• stomach area pain

Uncommon (affects less than 1 in 100 patients)

• vomiting

Frequency not known (cannot be estimated from available data)

• allergic reaction; see "Allergic reactions" above for additional symptoms, tremor

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 VISIPAQUE

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

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

Expiry date

Do not use this medicine after the expiry date shown on the packaging after EXP.

The expiry date is the last day of the month indicated.

6. Contents of the pack and other information

Composition of VISIPAQUE

The active substance is Iodixanol:

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

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

The other components are:

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

Nature of the medicinal product and contents of the container

VISIPAQUE is presented ready for use as a clear, colourless or slightly yellow 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 multi-dose.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

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

Calle Gobelas, 35-37, La Florida

28023, Madrid, Spain

Manufacturer:

GE Healthcare Ireland Limited

IDABusinessPark

Carrigtohill

Co. Cork, Ireland

or

GE Healthcare AS.

Nycoveien, 1

0485 Oslo, Norway

Date of the most recent review of thisleaflet: April 2026**

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.es