FLUORESCEIN OCULOS 10% INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Fluorescein Oculos 100 mg/ml Solution for Injection

Sodium Fluorescein

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

This medicinal product is for diagnostic use only.

Fluorescein Oculos belongs to a group of medicines called "Diagnostic Agents: Dyes".

Fluorescein Oculos is a solution for injection that is administered only through a vein (intravenously).

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

2. What you need to know before you use Fluorescein Oculos

Before you are given Fluorescein Oculos, your doctor may collect your complete medical history, including information about the medicines you are taking.

In case you have been given fluorescein or another medicine used for diagnostic tests and have had a severe hypersensitivity reaction, your doctor will decide whether you can use fluorescein again.

Do not use Fluorescein Oculos

• If you are allergic (hypersensitive) to fluorescein or any of the other ingredients of this medicinal product (listed in section 6).
• This medicinal product must not be injected into the arteries (arterial route) or into the spinal cord (intrathecal route).

Warnings and Precautions

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

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

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

Consult your doctor before starting treatment with Fluorescein Oculos.

• If you have a history of cardiovascular disease, diabetes, or lung disease.
• If you suffer from or have suffered from a disease called bronchial asthma (a disease that affects the lungs) or any type of allergy, you should tell your doctor, as Fluorescein Oculos can cause severe reactions in these cases.
• If you have previously undergone an angiography (medical test to visualize blood vessels) and as a result have had a severe reaction, or have had severe allergic reactions before, 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 medicines called beta-blockers, including beta-blockers in the form of eye drops, severe allergic reactions (anaphylactic reactions) can occur, although rarely, which can be life-threatening when used with Fluorescein Oculos.

If any of the above applies to you, inform your doctor before starting treatment with Fluorescein Oculos.

Other medicines and Fluorescein Oculos

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

If you are being treated with medicines called beta-blockers, including beta-blockers in the form of eye drops, tell your doctor, as they can cause severe allergic reactions (anaphylactic reactions) when used with Fluorescein Oculos, although this is rare.

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 going to have any diagnostic tests (blood or urine tests), tell your doctor about treatment with Fluorescein Oculos, as this medicinal product has the property of producing fluorescence (producing a green fluorescent color) and can alter the results for 3 or 4 days after administration.

Children and adolescents

No specific studies have been conducted in children. Therefore, this medicinal product must not be used in children and adolescents under 18 years of age.

Elderly population

Fluorescein Oculos can be used in patients 65 years of age and older.

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 medicine.

Pregnancy

There are limited data on the use of sodium fluorescein in pregnant women. The use of Fluorescein Oculos should be avoided during pregnancy unless it is absolutely necessary.

Breast-feeding

If you are breast-feeding, consult your doctor before taking this medicinal product.

Fluorescein is excreted in breast milk. After taking this medicinal product, you should not breast-feed for 7 days. During this period, you should express and discard your breast milk.

Driving and using machines

Fluorescein Oculos is not known to affect the ability to drive or use machines. However, for the performance of the test for which Fluorescein Oculos is used, it is often necessary to use medicines that cause pupil dilation (enlargement), which can then cause transient visual problems that prevent driving and using machines.

Fluorescein Oculos contains sodium

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

3. How to use Fluorescein Oculos

Adults

A dose of 1 single ampoule of 5 ml is administered only through a vein (intravenously), preferably in the antecubital vein, which is located in the arm, after taking precautions to avoid leakage of Fluorescein Oculos outside the vein and into surrounding tissues (extravasation).

Fluorescein Oculos is a medicinal product used to perform a diagnostic test, which must be carried out in the presence of qualified personnel, preferably under the supervision of a doctor, who will indicate the instructions to follow at all times.

This medicinal product must not be administered by the intrathecal route (injected into the lower back) or by the intra-arterial route (injected directly into an artery).

Children and adolescents

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

Elderly patients (65 years and older)

No dose adjustment is necessary for this group of patients.

Medicines administered during treatment with Fluorescein Oculos

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

If you use more Fluorescein Oculos than you should

In case of overdose or accidental ingestion, consult your doctor or nurse immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicinal product and the amount ingested.

If you have any further questions on the use of this medicinal product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Fluorescein Oculos can cause side effects, although not everybody gets them.

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

• Severe allergic reactions, including anaphylactic shock (uncommon, may affect up to 1 in 100 people)/anaphylactoid reaction (rare, may affect up to 1 in 1,000 people) with a risk to life, have been reported in patients who received Fluorescein Oculos. These reactions require urgent medical attention. Tell your doctor or nurse immediately if you experience any of the following symptoms after administration of Fluorescein Oculos: pain (rare, may affect up to 1 in 1,000 people) or feeling of oppression in the chest (frequency not known, cannot be estimated from the 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, fainting (rare, may affect up to 1 in 1,000 people).
• Reactions at the injection site, such as inflammation of the veins: symptoms may include thrombosis at the infusion site (frequency not known, cannot be estimated from the available data), swelling (rare, may affect up to 1 in 1,000 people), pain (frequency not known, cannot be estimated from the available data), redness at the injection site that can cause tissue damage. If the product penetrates into the tissue surrounding the injection site (extravasation) (uncommon, may affect up to 1 in 100 people), a painful inflammatory reaction may occur, which can even cause tissue death. Tell 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:

Uncommon: may affect up to 1 in 100 people

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

Rare: may affect up to 1 in 1,000 people

Coma, convulsions, headache, dizziness, tingling, changes in taste, tremors in one part of the body, cardiac arrest, heart attack, collapse of the cardiovascular system, 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, discoloration (yellowish color) of the skin, discoloration (yellowish color) of the urine, 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 sensitivity in one part of the body, respiratory arrest, pulmonary edema, excessive salivation, cold sweat.

Not known: cannot be estimated from the available data

Stroke, aphasia, venous thrombosis, arterial hypertension, respiratory disorder, throat compression, gagging.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es/. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Fluorescein Oculos

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date which is stated on the carton after "Expiry Date". The expiry date is the last day of the month stated.

Do not store above 25°C.

Store the ampoules in the outer packaging.

Medicines should not be disposed of via wastewater or household waste. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluorescein Oculos

• The active substance is sodium fluorescein. Each ampoule (5 ml) contains 500 mg of sodium fluorescein.
• The other ingredients are sodium hydroxide and water for injections.

Appearance and packaging of the product

Fluorescein Oculos is presented as a solution for injection in colorless glass ampoules of 5 ml. Each pack contains 1 or 10 ampoules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

SERB SA

Avenue Louise, 480

1050 Brussels

Belgium

Manufacturer

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

Date of last revision of this leaflet: November 2023.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.

Information for Healthcare Professionals

This information is intended only for doctors or healthcare professionals:

This medicinal product must not be administered by the intrathecal or intra-arterial route. Fluorescein Oculos must 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 medicines or solutions. To avoid physical incompatibilities, Fluorescein Oculos must not be administered simultaneously with injectable solutions of medicines with an acidic pH (in particular antihistamines such as promethazine) or with citric acid through the same intravenous route, as they may precipitate fluorescein. Additionally, intravenous cannulas should be flushed before and after injection of the medicinal product.

Before starting the injection of fluorescein, precautions should be taken to avoid extravasation and to ensure that the needle is correctly inserted into the vein (preferably the antecubital vein). The high pH of the fluorescein solution can cause severe local tissue damage. Complications secondary to extravasation can cause severe pain, thrombophlebitis, and an inflammatory reaction of the tissue that can produce tissue necrosis.

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

During administration, an emergency cart with adequate resuscitation equipment, including medicines used to treat hypersensitivity reactions, such as epinephrine, intravenous fluids for volume replacement, and corticosteroids, should always be available.

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

The patient should be kept under close observation for at least 30 minutes after the fluorescence angiography.

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

Discard any unused contents.

Consult section 3 of this Package Leaflet and the Summary of Product Characteristics before administering Fluorescein Oculos to a patient.