Fluorescein sodium Monico

Package leaflet: Information for the user

FLUORESCEIN SODIUM MONICO 1 g/5 ml (20%) injectable solution

Sodium fluorescein
Please read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What FLUORESCEIN SODIUM MONICO is and what it is used for
2. What you need to know before being given FLUORESCEIN SODIUM MONICO
3. How FLUORESCEIN SODIUM MONICO is given
4. Possible side effects
5. How to store FLUORESCEIN SODIUM MONICO
6. Contents of the pack and other information

1. What FLUORESCEINA SODICA MONICO is and what it is used for

FLUORESCEINA SODICA MONICO is a staining solution that makes the blood vessels of the back of the eye visible during an eye examination (this procedure is known as fluorescein angiography or angioscopy of the ocular fundus or iris vessels).
This medicinal product is for diagnostic use only. It is not used for the treatment of diseases.

2. What you need to know before being administered FLUORESCEINA SODICA MONICO

FLUORESCEINA SODICA MONICO must not be administered

• if you are allergic to injectable fluorescein administered intrathecally (into the spinal canal) or intra-arterially;
• if you are in the first trimester of pregnancy;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or nurse before being administered FLUORESCEINA SODICA MONICO.
Inform your doctor before this medicine is administered to you:

• if you are elderly and suffer from heart disease or diabetes mellitus;
• if you have previously suffered from heart or lung problems. Pay special attention and inform your doctor, especially before this medicine is administered, in the following cases:
• if you are taking medicines called beta-blockers (atenolol, sotalol, propranolol, metoprolol, bisoprolol), which are used to treat hypertension and various heart conditions, as well as in eye drops for the treatment of glaucoma (an eye disease). In this case, there could be a severe drop in blood pressure if you were to have an allergic reaction to fluorescein;
• if you have previously experienced allergic reactions to fluorescein; in this case, it is advisable to use an alternative medicine;
• leakage of the solution from the vein at the injection site may cause skin damage (desquamation), severe arm pain, and inflammation of the veins (superficial phlebitis).

If an X-ray procedure is scheduled within 36 hours after injection (the maximum duration of fluorescein persistence in the body), inform the doctor that you have received this medicine, as test results may be altered.

• if you are allergic to any food, drug, or pollens;
• if you suffer from eczema (skin rash);
• if you have asthma (a respiratory disease);
• if you suffer from dyspnea (difficulty breathing);
• if you have allergic rhinitis (nasal congestion caused by allergies).

Other medicines and FLUORESCEINA SODICA MONICO
Inform your doctor or nurse if you are currently using, have recently used, or might use any other medicine.
If you are being treated with probenecid, a medicine used for gout.
If you are taking beta-blockers (atenolol, sotalol, propranolol, metoprolol, bisoprololo), which are used to treat hypertension and various heart conditions, as well as in eye drops for the treatment of glaucoma (an eye disease).
Fluorescein may interfere with certain urine and blood tests for 3 to 4 days after administration.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or nurse before using this medicine.
Fluorescein crosses the placenta.
FLUORESCEINA SODICA MONICO must not be administered during the first trimester of pregnancy.
If you are pregnant, this medicine should only be administered if specifically indicated by your doctor and after careful evaluation of potential risks.
After administration of FLUORESCEINA SODICA MONICO, avoid breastfeeding for 4 days, as fluorescein passes into breast milk. During this period, you must express breast milk and discard it.

Driving and using machines
During the examination, you may be administered eye drops together with FLUORESCEINA SODICA MONICO to dilate the pupil of the eye. This may temporarily affect your vision and thus your ability to drive vehicles or operate machinery. It is recommended not to drive or operate machinery until your vision has returned to normal.

3. How to administer FLUORESCEIN SODIUM MONICO

This medicine will be administered to you by a doctor or another healthcare professional.
The doctor may decide to adjust the dosage depending on your general condition, whether you have kidney problems, and whether you are on dialysis.
The recommended dose depends on body weight:
administer 10 mg/kg body weight up to a maximum of 15 mg/kg body weight.
Use of FLUORESCEIN SODIUM MONICO in children
The recommended dose for children is 8 mg/kg body weight.
If you receive more FLUORESCEIN SODIUM MONICO than you should
Cases of overdose have not been reported.
If you are concerned that you may have received an excessive dose of the medicine, inform your doctor or nurse immediately.
If you have any doubts about the use of this medicine, consult your doctor or nurse. 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Very common (may affect more than 1 in 10 people)
Nausea.
Common (may affect up to 1 in 10 people)
Vomiting, fainting (syncope), itching, extravasation.
Uncommon (may affect up to 1 in 100 people)
Hypersensitivity, headache, dizziness, paresthesia (sensation of pins and needles), cough, choking, abdominal pain, urticaria, dysphasia (difficulty speaking), pain, feeling of warmth, allergic reactions, thrombophlebitis (vein inflammation with blood clots).
Rare (may affect up to 1 in 1,000 people)
Anaphylactic reaction (severe allergic reaction), cardiac arrest, hypotension (low blood pressure), shock, bronchospasm (difficulty breathing).
Very rare (may affect up to 1 in 10,000 people)
Severe allergic reaction that may lead to death (anaphylactic shock), convulsions, chest pain (angina pectoris), reduced heart rate (bradycardia), increased heart rate (tachycardia), increased blood pressure (hypertension), constriction of blood vessels (vasospasm), vasodilation, pallor, hot flushes, respiratory arrest, lung problems (pulmonary edema), swelling of the larynx (laryngeal edema), shortness of breath (dyspnea), nasal swelling, sneezing.
Not known (frequency cannot be estimated from available data)
Vascular insufficiency (vertebrobasilar insufficiency), reduced taste (dysgeusia), loss of consciousness, tremor, reduced sensitivity (hypoesthesia), vomiting urges, skin rash, cold sweating, skin inflammation (eczema), skin redness (erythema), increased sweating (hyperhidrosis), swelling due to fluid retention in tissues (edema), malaise, generalized weakness (asthenia), myocardial infarction.
Other side effects that may occur are listed below:

• yellowish discoloration of the skin, which usually disappears within 6–12 hours;
• bright yellow discoloration of the urine, which may take between 24 and 36 hours to return to normal;

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FLUORESCEINA SODICA MONICO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Once opened, the solution must be used immediately.
Medical and nursing staff are aware of the appropriate storage conditions for this medicine:

• store at a temperature not exceeding 25°C;
• do not refrigerate or freeze;
• protect from light;
• do not use the medicine if the packaging is torn or damaged;
• the solution should be inspected for the presence of any impurities or abnormal discoloration before administration. The solution should only be used if it is clear and free from particles.
  Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FLUORESCEINA SODICA MONICO contains

• The active substance is sodium fluorescein. One 5 ml vial contains 1.0 g of sodium fluorescein.
• The other component is water for injections.

Description of the appearance of FLUORESCEINA SODICA MONICO and contents of the pack
FLUORESCEINA SODICA MONICO is a clear, red-orange solution for injection.
FLUORESCEINA SODICA MONICO is available in packs of 10 vials of 5 ml each.
Marketing Authorization Holder and Manufacturer
MONICO SPA, Via Ponte di Pietra 7 - VENEZIA/MESTRE.

The following information is intended exclusively for healthcare professionals:

Inject 10 mg/kg body weight (up to a maximum of 15 mg/kg body weight) of FLUORESCEIN SODIUM MONICO 1 g/5 ml injectable solution rapidly into the antecubital vein, taking appropriate precautions to prevent extravasation. In cases involving highly sensitive imaging systems, such as when using a scanning laser ophthalmoscope, the dosage should be reduced to 1 ml of FLUORESCEIN SODIUM MONICO 1 g/5 ml injectable solution.
Special populations
Paediatric population:
The recommended dose is 8 mg/kg body weight.
Renal impairment:
Available safety data in patients with renal insufficiency are limited. Fluorescein is eliminated via the kidneys; therefore, caution is recommended during administration.
Patients on dialysis: reduce the dose by half.
Avoid concomitant intravenous injection of other solutions or mixing FLUORESCEIN SODIUM MONICO 1 g/5 ml injectable solution with other solutions, as interactions cannot be excluded.
Method of administration
FLUORESCEIN SODIUM MONICO 1 g/5 ml injectable solution must be used only by qualified physicians with technical expertise in performing and interpreting fluorescein angiography. The product must be administered exclusively by intravenous route. To prevent physical incompatibility reactions, intravenous cannulas should be flushed with sodium chloride solution (0.9%) before and after administration of medicinal products. The injection should be administered rapidly (usually approximately 1 ml every 2 seconds) into the antecubital vein; as a precaution to avoid extravasation, use a 23-gauge butterfly needle for injection. Typically, fluorescence becomes visible in the retina and choroidal vessels within 7–14 seconds.
Precautions to be taken before handling the medicinal product
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. To avoid physical incompatibilities, the product must not be administered simultaneously with other injectable solutions with acidic pH (especially antihistamines) via the same intravenous line.