Patient Medication Information: uses, side effects, how to take - Alcaine

ABOUT THIS MEDICATION

What the medication is used for:

ALCAINE is a local anesthetic used by your doctor during certain types of eye procedures and before eye surgery.

What it does:

ALCAINE temporarily numbs or blocks the sensation in your eye(s).

When it should not be used:

ALCAINE should not be given to you if you are allergic to proparacaine hydrochloride or any of the other ingredients in ALCAINE.
ALCAINE should only be put into your eye(s) by a healthcare professional and should not be given to you to use.

What the medicinal ingredient is:

Proparacaine hydrochloride

What the nonmedicinal ingredients are:

Preservative: benzalkonium chloride

Others: glycerin, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.

What dosage forms it comes in:

ALCAINE is available as an eye drop solution.

WARNINGS AND PRECAUTIONS

BEFORE you are given ALCAINE tell your doctor if you:

Have allergies.
Have heart disease.
Have an overactive thyroid (hyperthyroidism).
Are pregnant.
Are breastfeeding.
Have received ALCAINE or similar products before and how often.

After you are given ALCAINE:

Repeated use or abuse of this product may lead to permanent corneal disorders/eye damage, including loss of vision.
Avoid touching and rubbing your eyes.
Protect your eyes from irritating chemicals.
Due to the effect of the anesthetic, your eyes will be numb and care should be taken to avoid accidental injuries to your eyes. Do not touch or rub the eye and take precautions to protect it from everyday contaminants
- Wear contact lenses only after sensation returns to your eye(s).
- Do not drive or use machines until your vision has cleared and is not blurry.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor about all the medicines you are taking, recently took or are planning to take, including those without a prescription.

PROPER USE OF THIS MEDICATION

ALCAINE should only be put into your eye(s) by a healthcare professional and should not be given to you to use.

Usual dose:

Your doctor will decide the dose you need based on the type of eye procedure or surgery you are having.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Known side effects in the eye include:

Irritated, burning or stinging eyes
Eye pain
Eye swelling
Eye redness
Blurred vision
Sensitivity to light
Increased tearing and/or winking
Dilated pupils
Eye inflammation including the coloured part of the eye
Scratch in the eye surface with or without softening
Clouding of the eye surface
Shedding of dead eye surface cells
Dizziness
Swelling of the outermost layer of the eye (corneal oedema)

Permanent corneal disorders/eye damage, including loss of vision, can occur with long term use or abuse of ALCAINE.

Known side effects in the rest of the body include: drying or splitting of the skin on your fingertips from repeated contact with ALCAINE and fainting.

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 (signs include shortness of breath, swelling of the face, lips or tongue, rash or hives).
Nervousness, shaking (tremors) or seizures (convulsions).
Loss of consciousness.
Difficulty breathing.

This is not a complete list of side effects. Tell your doctor or pharmacist if you experience any unexpected side effects.

HOW TO STORE IT

ALCAINE is stored in the refrigerator between 2^oC and 8^oC.

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:

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Report online at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
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 1908C
  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 https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html.

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.

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: 1-800-613-8883.

DIN	00035076
Schedule(s)	ETHICAL
Active ingredient(s)	Proparacaine hydrochloride 0.5 %
Dosage form(s)	Drops
Route(s) of administration	Ophthalmic
Drug class (WHO ATC)	S Sensory organ drugs S01 Ophthalmologicals S01H Local anesthetics, ophthalmologic S01HA Local anesthetics S01HA04 Proxymetacaine
Company	ALCON CANADA INC
Current status	Marketed
Current status date	August 21, 2019

Alcaine: Uses, Side Effects and Dosage