Label: information for the user

Fluoresceína Oculos 100 mg/ml injectable solution

Sodium fluorescein

Read this label carefully before starting to use the medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• This medication has been prescribed only to you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this label. See section 4.

1. What is Fluoresceína Oculos and for what it is used

2. What you need to know before starting to use Fluoresceína Oculos

3. How to use Fluoresceína Oculos

4. Possible adverse effects

5. Storage of Fluoresceína Oculos

6. Contents of the package and additional information

This medication is for diagnostic use only.

Fluoresceína Oculos belongs to a group of medications called “Diagnostic agents: dyes”.

Fluoresceína Oculos is an injectable solution that is administered only through a vein (intravenous route).

Fluoresceína Oculos is a dye used in adults (18 years and older) as a contrast medium to visualize blood vessels in the back of the eye and the iris, using a technique called fluorescence angiography.

Before Fluoresceína Oculos is administered to you, your doctor may collect your complete medical history, including information about the medications you are taking.

If you have had fluoresceína or another diagnostic test medication in the past and have experienced a severe hypersensitivity reaction, your doctor will decide whether you can use fluoresceína again.

Do not use Fluoresceína Oculos

• If you are allergic (hypersensitive) to fluoresceína or any of the other components of this medication (listed in section 6).
• This medication should not be injected into the arteries (arterial route) or the spinal column (intrathecal route).

Warnings and precautions

Your doctor or another healthcare professional will administer this medication to you through an injection into one of your veins. Fluoresceína Oculos is only for intravenous injection and should NOT be injected into the arteries (arterial route) or the spinal column (intrathecal route).

Reactions to this injection may occur during treatment with Fluoresceína Oculos. Before the injection, you may be given medications to help reduce the possibility of infusion-related reactions (see "Medications administered during treatment with Fluoresceína Oculos" in section 3).

Inform your doctor or nurse immediately if you experience any signs of infusion-related reactions. These signs are listed at the beginning of section 4.

Consult your doctor before starting to use Fluoresceína Oculos.

• If you have a history of cardiovascular disease, diabetes, or lung disease.
• If you have or have had asthma (a disease that affects the lungs) or any type of allergy, you should tell your doctor as Fluoresceína Oculos may cause severe reactions in these cases.
• If you have had a previous angiography (a medical test to see the blood vessels) and as a result experienced a severe reaction, or have had severe allergic reactions in the past, you should tell your doctor. In these cases, your doctor will decide on the importance of performing this test versus the risk of having a severe allergic reaction.
• If you are taking medications called beta-blockers, including eye drops, severe allergic reactions (anaphylactic reactions) that put your life at risk may occur, although rarely, when used with Fluoresceína Oculos.

If any of the above applies to you, inform your doctor before starting to take Fluoresceína Oculos.

Other medications and Fluoresceína Oculos

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

If you are being treated with medications called beta-blockers, including eye drops, inform your doctor as using them together with Fluoresceína Oculos may cause, although rarely, severe allergic reactions (anaphylactic reactions) with a risk to life.

Avoid simultaneous intravenous use of sodium fluorescein with other solutions or mixing with other solutions or agents, as interactions cannot be ruled out.

Interference with diagnostic tests

If you are to undergo any diagnostic test (blood or urine analysis), inform your doctor about the treatment with Fluoresceína Oculos, as this medication has the property of producing fluorescence (produces a green fluorescent color) and may alter the results for 3 to 4 days after administration.

Children and adolescents

No specific studies have been conducted in children. Therefore, this medication should not be used in children and adolescents under 18 years old.

Geriatric population

Fluoresceína Oculos may be used in patients 65 years or older.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Pregnancy

No data, or limited data, are available on the use of sodium fluorescein in pregnant women. Use of Fluoresceína Oculos during pregnancy should be avoided unless absolutely necessary.

Lactation

If you are breastfeeding, consult your doctor before taking this medication.

Fluoresceína is excreted in breast milk. After taking this medication, do not breastfeed for 7 days. During this period, express and discard breast milk.

Driving and operating machinery

No adverse effects on the ability to drive or operate machinery have been reported with Fluoresceína Oculos. However, for the test for which Fluoresceína Oculos is used, in many cases, medications that cause pupil dilation (enlargement) are used, causing temporary visual problems that may prevent driving vehicles and operating machinery.

Fluoresceína Oculos contains sodium

This medication contains 65.5 mg of sodium (the main component of table salt) per ampoule. This is equivalent to 3.3% of the maximum daily recommended intake in the diet for an adult.

Adults

A dose of 1 single vial of 5 ml is administered only through a vein (intravenous route) preferably in the antecubital vein, located in the arm, after taking precautions to prevent Fluoresceína Oculos from leaking out of the vein and into surrounding tissues (extravasation).

Fluoresceína Oculos is a medication used for diagnostic testing, which should be performed in the presence of qualified personnel, preferably under the supervision of a doctor, who will instruct you at all times on the steps to follow.

This medication should not be administered via intrathecal (injected into the lower back) or intra-arterial (injected directly into an artery) routes.

Children and adolescents

This medication should not be used in children and adolescents under 18 years of age, as its safety and efficacy have not been established in this age group. See section 2.

Older adults (65 years and older)

No changes are necessary in the dose administered to this group of patients.

Medications administered during Fluoresceína Oculos treatment

Before the injection, your doctor or nurse may give you medications to help reduce the risk of reactions related to infusion. These include antihistamines and corticosteroids (a medication that suppresses inflammation).

If you use more Fluoresceína Oculos than you should

In case of overdose or accidental ingestion, consult your doctor or nurse immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, Fluoresceína Oculos may cause side effects, although not everyone will experience them.

Some side effects may be serious and may require medical attention.

• Severe allergic reactions, including anaphylactic shock (rare, may affect up to 1 in 100 people)/anaphylactoid (very rare, may affect up to 1 in 1,000 people) with life-threatening risk, have been reported in patients who received Fluoresceína Oculos. These reactions require urgent medical attention. Inform your doctor or nurse immediately if you experience any of the following symptoms after administration of Fluoresceína Oculos: chest pain (rare, may affect up to 1 in 1,000 people) or a feeling of oppression in the chest (frequency not known, cannot be estimated from available data), wheezing (rare, may affect up to 1 in 1,000 people), difficulty breathing (rare, may affect up to 1 in 1,000 people), skin rash and urticaria (rare, may affect up to 1 in 1,000 people), swelling of the face, lips, or tongue, dizziness (rare, may affect up to 1 in 1,000 people).

• Reactions at the injection site, such as vein inflammation: symptoms may include thrombosis at the infusion site (frequency not known, cannot be estimated from available data), swelling (rare, may affect up to 1 in 1,000 people), pain (frequency not known, cannot be estimated from available data), redness at the injection site that may cause tissue damage. If the product penetrates the tissue surrounding the injection site (extravasation) (rare, may affect up to 1 in 100 people), a painful inflammatory reaction may occur that may even cause tissue death. Inform your doctor immediately if you experience any of the above symptoms.

If necessary, the patient will be asked to remain under medical supervision for at least 30 minutes after the test.

Other side effects:

Rare: may affect up to 1 in 100 people

Allergic reactions, loss of consciousness, low blood pressure, vomiting, nausea, skin rash, skin redness, urticaria, itching, discomfort.

Very rare: may affect up to 1 in 1,000 people

Coma, convulsions, headache, dizziness, numbness, changes in taste, tremors in a part of the body, cardiac arrest, heart attack, cardiovascular system collapse, decreased heart rate, increased heart rate, shock, pallor, hot flashes, laryngeal edema, asthma, dyspnea, cough, throat irritation, sneezing, difficulty breathing including constriction of the airways, abdominal pain, dermatitis, excessive sweating, skin discoloration (yellowish color), urine discoloration (yellowish color), edema, asthenia, feeling of heat, chills.

Very rare: may affect up to 1 in 10,000 people

Low platelet count, partial or total loss of sensation in a part of the body, respiratory arrest, pulmonary edema, excessive salivation, cold sweat.

Unknown: cannot be estimated from available data

Stroke, aphasia, venous thrombosis, hypertension, respiratory disorder, throat constriction, hiccups.

If any of the above symptoms worsen,inform your doctor or nurse immediately.

Reporting of adverse effects

Ifyou experienceany type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after “Expiration Date”. The expiration date is the last day of the month indicated.

Do not store above 25 °C.

Store the vials in the outer packaging.

Medications should not be disposed of through drains or in the trash. This will help protect the environment.

Composition of Fluoresceína Oculos

• The active ingredient is sodium fluorescein. Each ampoule (5 ml) contains 500 mg of sodium fluorescein.
• The other components are sodium hydroxide and water for injection preparations.

Appearance of the product and contents of the package

Fluoresceína Oculos is presented in the form of an injectable solution in colorless glass ampoules of 5 ml. Each package contains 1 or 10 ampoules.

Only some package sizes may be commercially available.

Holder of the marketing authorization

SERB SA

Avenue Louise, 480

1050 Brussels

Belgium

Responsiblefor manufacturing

SERB

40, Avenue George V

75008 Paris France

Local representative

LABORATORIOS RUBIO, S.A.

Industria 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Last review date of this leaflet: November 2023.

The 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.gob.es/.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

This information is intended solely for doctors or healthcare professionals:

This medicine should not be administered intrathecally or intra-arterially. Fluoresceína Oculos should be administered in the antecubital vein after taking precautions to avoid extravasation.

Before administration, carefully inspect the contents of the ampoule to ensure that there is no discoloration of the product or precipitation of particles from the solution.

After opening an ampoule, use it immediately.

Do not mix or dilute in the syringe with other medications or solutions. To avoid physical incompatibilities, Fluoresceína Oculos should not be administered simultaneously with injectable solutions of acidic medications (particularly antihistamines such as promethazine) or citric acid through the same intravenous route, as they may precipitate the fluorescein. Additionally, the intravenous cannulas should be washed before and after the injection of the drugs.

Before initiating the injection of fluorescein, take precautions to avoid extravasation and ensure that the needle is correctly inserted into the vein (preferably the antecubital vein). The high pH of the fluorescein solution may cause severe local tissue damage. Secondary complications due to extravasation may cause severe pain, thrombophlebitis, and an inflammatory reaction of the tissue that may produce tissue necrosis.

In the event of extravasation, the injection should be stopped immediately and the necessary measures should be taken to alleviate the pain and treat the damaged tissue.

During administration, a first aid cart with the necessary equipment for resuscitation should always be available, including medications used for the treatment of hypersensitivity reactions, such as epinephrine, intravenous fluids for volume replacement, and corticosteroids.

In patients identified as being at risk of hypersensitivity reactions, but in whom it is essential to perform an angiography by fluorescence, the procedure should be carried out in the presence of a specialist in resuscitation.

The patient should be closely monitored for at least 30 minutes after the angiography by fluorescence.

Fluoresceína Oculos contains 65.5 mg of sodium (the main component of table salt) per ampoule. This is equivalent to 3.3% of the maximum daily recommended amount in the diet for an adult.

Dispose of any unused contents.

Consult section 3 of this leaflet and the Technical Data Sheet before administering Fluoresceína Oculos to a patient.