Alcaine

Package Leaflet: Information for the Patient

Alcaine, 5 mg/ml, Eye Drops, Solution

Proxymetacaine Hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Alcaine and what is it used for
• 2. Important information before using Alcaine
• 3. How to use Alcaine
• 4. Possible side effects
• 5. How to store Alcaine
• 6. Contents of the pack and other information

1. What is Alcaine and what is it used for

Alcaine contains the active substance proxymetacaine hydrochloride, which acts as a local anesthetic.
Alcaine is used for surface anesthesia before ophthalmic procedures that require rapid and short-term anesthesia, such as: preparation for cataract surgery, removal of corneal sutures, tonometric measurement of intraocular pressure, gonioscopic examination, removal of foreign bodies, scraping of the conjunctiva for diagnostic purposes, and other procedures where surface anesthesia is necessary.

2. Important information before using Alcaine

When not to use Alcaine

• without medical supervision,
• for a long time, as this may cause damage to the cornea, vision loss, and prolonged healing time,
• while wearing contact lenses, as Alcaine contains benzalkonium chloride.

Warnings and precautions

Before starting treatment with Alcaine, discuss it with your doctor or pharmacist.

• Alcaine is intended for local administration to the eye only by a doctor. It must not be injected.
• The medicine should only be used for eye drops (eyes).
• Repeated use or abuse of this medicine may lead to infections and corneal damage.
• Due to the anesthetic effect, the eyes will lose sensation, so caution should be exercised to avoid accidental eye injury. Do not touch or rub the eye and take precautions to protect it from everyday contaminants (such as dust, dirt, etc.).
• Repeated use of this medicine may lead to a shortened anesthetic effect.
• Proxymetacaine hydrochloride may cause contact allergic dermatitis. Avoid contact between Alcaine and the skin.
• If you are using other medicines, also read the section "Alcaine and other medicines".
• Caution should be exercised when using the medicine in patients:
• with epilepsy, heart disease, hyperthyroidism, or respiratory disorders,
• with myasthenia, as they are particularly sensitive to the effects of local anesthetics,
• with low acetylcholinesterase enzyme activity in blood serum and patients treated with cholinesterase inhibitors, as there is an increased risk of systemic side effects after local use of ester-type local anesthetics. Patients should avoid touching or rubbing the eye until the local anesthetic effect has worn off.

If hypersensitivity or irritation symptoms occur or worsen, consult a doctor immediately.

Alcaine and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Using Alcaine during pregnancy and breastfeeding is not recommended.

Driving and using machines

After using Alcaine, temporary blurred vision may occur. Do not drive or operate machinery until this symptom has resolved.

Alcaine contains benzalkonium chloride

The medicine contains 0.0035 mg of benzalkonium chloride in each drop, which corresponds to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before instillation and wait at least 15 minutes before reinserting. Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or eye pain occur after using the medicine, consult a doctor.

3. How to use Alcaine

Alcaine is intended for use by a doctor only.
Recommended dose
When preparing a patient for a simple examination, e.g., tonometric examination or other short-term procedures, usually one to two drops are instilled directly before the procedure.
Before minor surgical procedures, such as removal of a foreign body or sutures, instill one to two drops every five to ten minutes, one to three times.
To achieve long-term anesthesia, for example, during cataract surgery, instill one to two drops of the medicine into the eye (eyes) every five to ten minutes, three to five times.
Remember that the local anesthetic effect occurs within 30 seconds and may last up to 15 minutes.
Method of administration
Alcaine should only be instilled into the eye (eyes).
Remove the cap. If the protective collar is loose after removing the cap, discard it before using the medicine.
To prevent infection of the dropper tip or solution, be careful not to touch the dropper tip to the eyelids or surrounding tissues. Keep the bottle tightly closed when not in use.
The absorption of the medicine into the general circulation can be reduced by using the following methods after instillation:

• close the eyelids for 2 minutes;
• press the nasolacrimal duct with your finger for 2 minutes.

Do not use the solution if it is cloudy or has changed color.
Note: Since there is no blinking reflex after using the medicine, it is recommended to apply an eye patch after the procedure.
If you are using other eye drops or ointments at the same time,wait at least 5 minutes between administrations of the different medicines. Apply eye ointments last.

Using a higher dose of Alcaine than recommended

In case of using a higher dose than recommended, flush the eye with lukewarm water.
In case of overdose or accidental ingestion, contact a doctor, pharmacist, or poison control center immediately, as severe reactions from the nervous or respiratory system may occur.

Missing a dose of Alcaine

Do not double the dose to make up for a missed dose.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alcaine can cause side effects, although not everybody gets them.
The following side effects have been observed with the use of Alcaine, but their frequency cannot be estimated from the available data:

• Eye-related effects: corneal damage, clouding of the eye surface, swelling of the eye surface, inflammation of the eye surface, blurred vision, photophobia, pupil dilation, eye pain, eye irritation, eye swelling, discomfort in the eye, redness of the eye, increased tear production.
• General side effects: hypersensitivity (allergy), fainting, dizziness. Transient symptoms, such as a feeling of stinging, burning, or redness of the conjunctiva, may occur. In rare cases, an allergic reaction of the cornea (characterized by acute, diffuse inflammation of the corneal epithelium with the formation of fibers and (or) separation of large areas of necrosis, diffuse edema of the underlying tissue, inflammation of the posterior limiting layer, and inflammation of the iris) may occur. In very rare cases, after local application to the eye, systemic toxic effects may occur, characterized by central nervous system stimulation, followed by its depression.

Additionally, uncontrolled use or abuse of Alcaine may lead to permanent corneal disorders and (or) eye damage.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alcaine

Keep the medicine out of the sight and reach of children.
Protect from light.
Store in a refrigerator (2°C – 8°C).
Shelf life after first opening the bottle: 4 weeks.
After each use, close the bottle tightly.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
Do not use this medicine if you notice clouding or a change in color.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Alcaine contains

• The active substance is proxymetacaine hydrochloride. 1 ml of solution contains 5 mg of proxymetacaine hydrochloride.
• The other ingredients (excipients) are: glycerol, hydrochloric acid and/or sodium hydroxide, benzalkonium chloride, purified water.

What Alcaine looks like and contents of the pack

Alcaine is available as a sterile, isotonic aqueous solution.
The LDPE bottle with a dropper contains 15 ml of solution.

Marketing authorization holder

Alcon Polska Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel.: (+48) 22 820 34 50

Importer, responsible for batch release

Alcon Laboratories Belgium
Lichterveld 3
2870 Puurs-Sint-Amands
Belgium

Date of last revision of the leaflet: