PATIENT INFORMATION LEAFLET

Optiray Ultraject 350 mg/ml injectable solution

Ioversol

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet.

Optiray Ultraject 350 is used in adults for different types of X-ray procedures, which include:

• vascular imaging, arteries, and veins
• kidneys
• CT scans

Optiray Ultraject 350 is a contrast medium containing iodine. Iodine does not allow X-rays to pass through, enabling the visualization of blood vessels and other organs

Do not take Optiray Ultraject 350

• if you are allergic to contrast media that contain iodine or to any of the other components of this medication (listed in section 6).
• if you have clinical hyperthyroidism

Warnings and precautions

Consult your doctor before using Optiray Ultraject 350 if you have

• asthma or have had previous allergic reactions such as nausea, vomiting, low blood pressure, skin symptoms
• heart failure, high blood pressure, circulatory problems, or if you have had a stroke, and if you are very elderly
• diabetes
• kidney or liver disease
• brain problems
• bone marrow problems, such as some types of blood cancer known as multiple myeloma, Waldenström macroglobulinemia
• some abnormalities of red blood cells, known as sickle cell anemia
• adrenal gland tumor, which affects blood pressure, known as pheochromocytoma
• an increase in the level of the amino acid homocysteine, due to abnormal metabolism
• a recent study of the gallbladder with contrast medium

• planned study of the thyroid gland using a substance that contains iodine. This can be postponed since Optiray Ultraject 350 may affect the results for up to 16 days.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (Lyell syndrome or NET), and acute exanthematous pustulosis (PEAG), which can be life-threatening, have been reported with the use of Optiray.

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

Children under 18 years

Optiray Ultraject 350 is not recommended in this age group

In case of exposure (direct exposure or newborns whose mothers received iodinated contrast medium during pregnancy), the thyroid function should be evaluated at birth and in all pediatric patients under 3 years within a month of exposure.

Use of Optiray Ultraject 350 with other medications

Inform your doctor or radiologist if you are using or have used recently or may use other medications.

The following medications may interact, influence, or be influenced by Optiray Ultraject 350:

• metformin: medication to treat diabetes

Your doctor will measure your kidney function before and after using Optiray Ultraject 350. Depending on the level of your kidney function, your doctor may consider interrupting the use of metformin between 48 hours before and during the test. Do not resume until at least 48 hours later and only if your kidney function has returned to normal

• interleukin: medication to treat some tumors
• some medications to increase blood pressure due to narrowing of the vessels and to prevent any risk of nervous system disorders. Optiray should never be used while using these medications
• general anesthetics

High-frequency adverse effects have been reported

• diuretics:medications that increase urine production and decrease blood pressure.

In the case of dehydration caused by the use of diuretics, the use of iodinated contrast media may increase the risk of acute renal failure.

Use of Optiray Ultraject 350 with food and beverages:

Limit food intake before the test. Please consult your doctor if you have any doubts. If you have kidney disease, do not limit fluid intake as it may reduce kidney function.

Pregnancy and breastfeeding

• Pregnancy

Consult your doctor if you are pregnant or think you may be pregnant. Your doctor will administer Optiray Ultraject during pregnancy only if it is absolutely necessary, as it may harm the fetus.

• Breastfeeding

Stop breastfeeding for a day after the injection, as there is not enough information about its safety. Consult your doctor or radiologist.

Driving and operating machinery:

It is not recommended to drive or operate machineryfor at least one hour afterthe injection. Additionally, symptoms such as dizziness, drowsiness, fatigue, and visual disturbances have been reported. If this affects you, do not perform any activity that requires concentration and adequate reaction time.

Warnings related to excipients

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free”.

The useofOptiray Ultraject 350should only be carried out under the direction ofa specialist doctor inradiology, who will decide the dose.

Optiray isinjected into a blood vesseland is distributed throughout the body through the bloodstream. It must be warmed to body temperature before use and then injected one or more times during the radiology procedure.

The dose depends on the specific procedure and other factors such as health and age.

The lowest possible dose will be used to obtain adequate radiology images.

If you use more Optiray Ultraject 350 than you should:

Overdose can be potentially hazardous and affect breathing, the heart, and the circulatory system. Inform your doctor or radiology specialist immediately if you notice any of these symptoms after receiving Optiray.

If you have any further questions about the use of this medication, consult your doctor or radiology specialist.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone915620420.

Like all medications, Optiray 240may have adverse effects, although not everyone will experience them. Adverse reactions associated with Optiray are generally independent of the administered dose. In most cases, they are moderate, although in rare instances, they can be severe or life-threatening.

Inform your doctor immediatelyif you develop any of the followingsevere adverse effects:

• cardiac or respiratory arrest
• spasms in the coronary arteries or blood clots
• stroke, blue lips, fainting
• memory loss
• speech disorders
• sudden movements
• transient blindness
• acute renal failure
• skin eruption, redness, or blisters, which may become life-threatening skin reactions, including extensive skin peeling (toxic epidermal necrolysis) or a drug reaction that causes rash, fever, internal organ inflammation, hematological abnormalities, and systemic disease (DRESS)
• signs of allergic reactions such as:
• • anaphylactic shock
  • airway constriction
  • inflammation of the vocal cords, throat, or tongue
  • respiratory difficulties
  • coughing, sneezing
  • redness and/or inflammation of the face and eyes
  • itching, rash, and hives

Adverse effects may occur with the following frequencies:

Very common,(occurring in more than 1 in 10 patients)

• feeling of heat

Common,(occurring in up to 1 in 10 patients)

• pain
• nausea

Uncommon,(occurring in up to 1 in 100 patients)

• hives
• skin redness, itching
• dizziness
• headache
• alteration of taste
• abnormal sensation, such as pins and needles
• vomiting
• sneezing
• high blood pressure

Rare,(occurring in up to 1 in 1,000 people)

• syncope
• dizziness
• blurred vision
• rapid pulse
• low blood pressure
• rubefaction
• laryngeal spasms
• inflammation and constriction of the airways, including laryngeal constriction, wheezing
• respiratory difficulties
• inflammation of the nasal interior causing sneezing and nasal congestion
• coughing, throat irritation
• dry mouth
• eruption
• urgent need to urinate
• inflammation of the face, including the eyes
• chills
• involuntary tremors
• feeling of cold

Very rare,(occurring in fewer than 1 in 10,000 patients)

• severe allergic reactions
• confusion, anxiety, restlessness
• loss of consciousness, numbness
• paralysis

• drowsiness
• stupor

• speech disorders
• language disorders
• reduced tactile sensation or sensitivity
• allergic inflammation of the eye causing red, watery, and itchy eyes
• ringing or buzzing in the ear
• irregular heartbeat, slow pulse
• chest pain
• changes in heart activity measured using an ECG
• disease affecting blood flow through the brain
• venous inflammation, dilation of blood vessels
• fluid accumulation in the lungs
• sores in the throat
• low oxygen levels in the blood
• abdominal pain
• inflammation of the salivary glands and tongue
• difficulty swallowing, increased salivation
• severe inflammation of the deep layers of the skin, often painful, mainly on the face
• increased sweating
• muscle spasms
• acute renal failure or abnormal renal function
• urinary incontinence, blood in urine, reduced urination
• inflammation caused by excess fluid
• reactions at the injection site, including pain, redness, bleeding, or cell degeneration
• feeling of discomfort or abnormality, fatigue, slowness

Frequency not known(cannot be estimated from available data)

• severe allergic reaction
• temporary low thyroid activity
• seizures
• short-term cerebral alterations (encephalopathy), which may cause confusion, hallucinations, visual disturbances, blindness, convulsions, loss of coordination, loss of movement in one side of the body, speech problems, and loss of consciousness
• movement disorders
• memory loss
• transient blindness
• cardiac arrest, irregular heartbeat that is life-threatening
• extra beats
• contractions of the coronary artery, pounding the heart
• blue discoloration of the skin due to low oxygen levels in the blood
• shock
• blood clots or spasms of blood vessels
• pallor
• respiratory arrest, asthma, airway constriction
• reduction in the ability to produce sounds with the vocal organs
• diarrhea
• severe reaction affecting the skin, blood, and internal organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS, or drug hypersensitivity syndrome)
• red, scaly, and widespread eruption with bumps under the skin and blisters, accompanied by fever at the start of treatment (acute generalized pustular exanthema)
• red, papular, or macular granules
• reaction that may be life-threatening, with flu-like symptoms and painful/vesicular eruption affecting the skin, mouth, eyes, and genitals (Steven-Johnson syndrome/toxic epidermal necrolysis)
• painful urination, with difficulty or absence of urination
• temporary low thyroid activity in newborns
• fever

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use this medication after the expiration date listed on the label. The expiration date refers to the last day of the month indicated.

Store the container within the outer cardboard box to protect it from light. Protect from X-rays. Do not store at a temperature above30°C. Do not freeze. This product may also be stored at 37°C for one month, in a contrast medium warmer using a circulating warm air current.

Do not useOptiray Ultraject 350in case of significant color alterations.

The disposal of unused medication and all materials that have been in contact with it, will be carried out in accordance with local regulations.

Composition of Optiray 240

• The active ingredient isIoversol
• The other components are: trometamol, trometamol hydrochloride, calcium and sodium edetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injection

Appearance of the product and contents of the packaging

This product is supplied in colourless, neutral type I glass bottles (Ph. Eur.) sealed with bromobutyl rubber stoppers (Ph. Eur.) free from latex and with anodized aluminium caps in single-dose vials of 50 or 100 ml.

It is also available in pre-filled syringes of 50 ml for manual use, and pre-filled syringes for use with autoinjector/pump of 75, 100 and 125 ml.

Packaging sizes:

1 and 10 vials of 50 ml

1, 10 and 12 vials of 100 ml

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Guerbet

BP 57400

95943 Roissy CdG Cedex, France

Manufacturer responsible:

Guerbet BP 57400

95943 Roissy CdG Cedex France,

located at Jean Chaptal 16-24, 93600 Aulnay sous Bois, France

For any information about this medication, please contact the Local Representative of the Marketing Authorization Holder:

Guerbet Pharmaceutical Laboratories, S.A.

Pº de la Castellana, 91, 3rd floor

28046 Madrid

+ (34) 91 504 50 00

Last review date of this leaflet: November 2023

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