VISIPAQUE 320 mg/ml INJECTABLE SOLUTION

2. What you need to know before you use VISIPAQUE

Do not use VISIPAQUE:

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

Warnings and precautions

Consult your doctor before Visipaque is administered to you:

• If you have had an allergic reaction to a medicinal product similar to VISIPAQUE, called 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 epilepsy, blood clots, stroke, or brain tumors.
• If you have 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 tumor of the adrenal gland).
• 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 disorders.
• If you have had or have a history of drug or alcohol dependence.
• If you are going to have a thyroid function test in the coming weeks.
• If you are going to have blood or urine samples taken on the same day.

During or shortly after the diagnostic imaging procedure, you may experience a short-term 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 Visipaque administration 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 Visipaque administration.

If you are not sure if any of the above applies to you, talk to your doctor before using VISIPAQUE.

Interaction of VISIPAQUE with other medicinal products

Tell your doctor if you are taking, have recently taken, or might take any other medicinal products.

In diabetic patients who are taking a medicinal product containing metformin.

In patients who are taking medicinal products that inhibit the immune system, for example, transplant medicinal products (interleukin-2).

In patients who are taking medicinal products to lower blood pressure (beta-blockers)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicinal product.

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

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

Breast-feeding can continue normally after VISIPAQUE administration to the mother.

Driving and using machines:

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

• the next 24 hours after spinal examination or
• one hour in all other cases.

The reason is that you may feel dizzy or have other symptoms of a late reaction.

VISIPAQUE contains sodium chloride and calcium and sodium edetate.

VISIPAQUE 270 mg/ml: patients on low-sodium 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 low-sodium 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 of this medicinal product given by your doctor. In case of 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 VISIPAQUE administration, you will be asked

• to drink plenty of liquid afterwards (to help eliminate the medicinal product from your body), and
• to stay near the place where you had the examination or X-ray for about 30 minutes.

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

The above recommendation applies to all patientswho have received VISIPAQUE. If you have not understood something from the above, ask your doctor.

VISIPAQUE can be administered in many different ways, a description of the ways it is generally administered can be found 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 in an artery in the arm or groin.

Injection into the spine

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

• rest for one hour with your head and body upright, or for six hours if you stay in bed, and
• walk carefully and try not to bend during six hours, and
• not be completely alone during the first 24 hours after receiving VISIPAQUE, if you are an outpatient and have ever had fainting spells.

The above recommendation only applies if you have been injected with VISIPAQUE in the spine. If you have not understood something from the above, ask your doctor.

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

Oral useFor the examination of the esophagus, stomach, or small intestine, VISIPAQUE is normally administered orally. In children, it is also administered rectally.

4. Possible side effects

Like all medicinal products, VISIPAQUE can cause side effects, although not everybody gets them.

Allergic reactionsIf you experience an allergic reaction when VISIPAQUE is being administered to you in a hospital or clinic, inform the doctor immediately. The symptoms can be:

• noisy breathing, difficulty breathing, or tightness or pain in the chest
• skin rash, hives, itching spots, blisters on the skin and in the mouth, or other symptoms of allergy
• swelling of the face
• feeling of dizziness or fainting (caused by low blood pressure)

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

Other side effects you may experience are the following, which will depend on how or why VISIPAQUE was administered to you. Consult your doctor if you are not sure how VISIPAQUE was administered to you.

After injection into an artery or veinUncommon(affects less than 1 in 100 people)

• 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 people)

• feeling of dizziness, arrhythmias, low blood pressure, heart attack
• cough, discomfort, chills, fever, redness of the skin or mucous membranes, reactions at the injection site
• pain
• alterations of taste, smell, and sensation of tingling

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

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

Frequency not known

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

• feeling of confusion, fainting, difficulty moving for a while, cramps
• blood clots (thrombosis), pain and swelling of a vein, shock

• severe breathing difficulties (due to fluid in the lungs) respiratory arrest
• Pulmonary edema
• pain in the joints, swelling, and pain of the salivary glands
• severe and generalized skin reactions including mucosal and other organ involvement
• transient cerebral disorders (encephalopathy) including hallucinations
• feeling of confusion, memory loss, difficulty speaking, visual difficulties, loss of vision, convulsions, 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 or worsening inflammation)
• convulsions
• iodism (excess iodine) transient hyper or hypothyroidism
• decreased heart activity to pump blood
• decrease in platelets (thrombocytopenia)
• non-localized swelling

After injection into the spine (intrathecal)Uncommon(affects less than 1 in 100 people)

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

Frequency not known(cannot be estimated from the available data)

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

• allergic reaction, see "Allergic reactions" described above for the rest of the symptoms
• transient cerebral disorders (encephalopathy) including hallucinations, feeling of confusion, memory loss, difficulty speaking, visual difficulties, loss of vision, convulsions, loss of coordination, loss of movement on one side of the body, speech problems, and loss of consciousness
• muscle spasm

After administration into body cavities(such as uterus and fallopian tubes)Very common(affects more than 1 in 10 people)

• vaginal bleeding

Common(affects less than 1 in 10 people)

• headache, feeling of dizziness (nausea), high temperature.

Uncommon(affects less than 1 in 100 people)

• vomiting

Frequency not known(cannot be estimated from the available data)

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

After injection into the jointsCommon(affects less than 1 in 10 people)

• pain at the injection site

Frequency not known(cannot be estimated from the available data)

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

After oral administrationCommon(affects less than 1 in 10 people)

• diarrhea, nausea (feeling of vomiting)
• pain in the stomach area

Uncommon(affects less than 1 in 100 people)

• vomiting

Frequency not known(cannot be estimated from the available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of VISIPAQUE

Keep this medicinal product 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 medicinal product after the expiry date which is stated on the packaging after EXP.

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

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 ingredients are:

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

Appearance of the product and pack contents

VISIPAQUE is presented ready for use as a clear, colorless or slightly yellowish aqueous solution.

It is available in two concentrations:

Presentation:

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 for single use

The 500 ml vials are for multiple use.

Not all 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

Manufacturer:

GE Healthcare Ireland Limited

IDABusinessPark

Carrigtohill

Co. Cork, Ireland

or

GE Healthcare AS.

Nycoveien, 1

NO-0485 Oslo

Norway

Date of last revision of thisleaflet: April 2022

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