Consumer Information for: FLUORESCITE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

FLUORESCITE is a diagnostic aid used by your doctor as part of certain eye exams.

What it does

FLUORESCITE contains fluorescein sodium, which acts by lighting up your eye (fluorescence) to allow your doctor to see the blood moving through the small blood vessels at the back of your eye(s).

When it should not be used

FLUORESCITE should not be used if you are allergic to fluorescein sodium or any other of the ingredients in FLUORESCITE (see What the important nonmedicinal ingredients are).

FLUORESCITE is injected into a vein and must not be injected into an artery or intrathecally (i.e. into any space surrounded by a sheath or membrane, such as the spine or brain).

What the medicinal ingredient is

Fluorescein sodium (fluorescein 100 mg/mL)

What the non-medicinal ingredients are

Hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water

What dosage form it comes in

FLUORESCITE comes as a solution for intravenous injection in a 5 mL bottle.

Warnings and precautions

Serious Warnings and Precautions

Your doctor must weigh the benefit of using FLUORESCITE as a diagnostic agent with the risk of a serious allergic reaction (see Side Effects and What to Do About Them).

BEFORE FLUORESCITE is used, tell to your doctor if you:

  • Have ever had any side effects (other than nausea or vomiting) after FLUORESCITE was used.
  • Have a history of allergies, including those to foods or other drugs.
  • Have asthma.
  • Have or have had heart disease.
  • Have diabetes.
  • Are taking many different drugs at the same type.
  • Are pregnant or planning to become pregnant.

These are all important factors your doctor needs to know about when deciding whether to use FLUORESCITE.

Low Salt Diet

Before FLUORESCITE is used, tell your doctor if you are on a low salt diet. FLUORESCITE can contain a lot of salt.

Breastfeeding

Tell your doctor if you are or planning to breastfeed. Stop breastfeeding for at least 1 week after FLUORESCITE is used. Breast milk should be pumped and discarded.

Driving and Using Machines

If you experience blurry vision after FLUORESCITE is used, wait until your vision is back to normal before driving or using machines.

Interactions with this medication

Tell your doctor about all the medicines you are taking, recently took or are planning to take.

Drugs that may interact with FLUORESCITE include:

  • Beta-blocking agents (e.g. propranolol, atenolol, sotalol).
  • Antiarrhythmics (for irregular heartbeat, e.g. quinidine, digoxin).
  • Probenecid (gout medicine).

If you are scheduled for any laboratory tests, tell your doctor that you were given FLUORESCITE as it may affect your test results.

Proper use of this medication

Usual Dose

Your doctor will decide how much to give to you or your child and will administer FLUORESCITE by injection into a vein.

Overdose

Your doctor should carefully decide how much FLUORESCITE to give you to avoid an overdose.

If you feel you have been given too much FLUORESCITE, contact your attending healthcare practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Side effects and what to do about them

Like all medicines, FLUORESCITE may cause side effects, but not everyone gets them.

Side effects that can occur at the injection site may include: general pain and soreness or accidental leakage of FLUORESCITE into surrounding areas, which may cause intense pain, local reaction and other effects, such as a dull aching pain in the injected arm. If this occurs, contact your healthcare professional immediately for medical attention.

Your skin may also become yellowish in colour and your urine may become bright. These effects should go away on their own after a few days.

Other side effects include: stomach pain/discomfort, nausea, vomiting, feeling hot or cold, dizziness, bad taste in the mouth, fainting, a tingling or numb sensation, headache, tremors, cough, shortness of breath, sneezing, throat irritation, rash or itchy skin, excess sweating and low or high blood pressure.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Tell your doctor if you experience any of the following side effects:

  • Allergic reaction (includes itching, hives, difficulty breathing, swelling in the throat, chest tightness and itching or tingling around the lips or tongue).
  • Severe shock or fits (convulsions).
  • Swelling in the vein.
  • Irregular heartbeat or cardiac arrest (i.e. heart stops beating).

Your doctor will watch you closely for any signs of these serious side effects, for at least 30 minutes after treatment, and give you immediate medical treatment if you need it.

This is not a complete list of side effects.

How to store

The healthcare professional will store FLUORESCITE between 2°C to 30°C.

Reporting side effects

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at http://www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, Ontario
      K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at http://www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

You may also report any suspected side effects to Alcon Canada Inc. directly at: 1-800-613-2245.

More information

This document plus the full product information, prepared for health professionals can be found at: www.alcon.ca or by contacting the sponsor, Alcon Canada Inc., at: 1-800-613-2245

This leaflet was prepared by Alcon Canada Inc.

Last revised: December 29, 2020

©2018, 2020 Alcon Inc.

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