Alcaine

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Alcaine, 5 mg/ml (0.5%), eye drops, solution
Proxymetacaini hydrochloridum
Read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Alcaine is and what it is 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 Alcaine is and what it is used for

Alcaine contains the active substance proxymetacaine hydrochloride, which acts as a local anesthetic.
Alcaine is used for topical anesthesia prior to ophthalmic procedures requiring rapid and short-duration anesthesia, such as: preparation for removal of a cataractous lens, removal of corneal sutures, tonometric measurement of intraocular pressure, gonioscopic examination, removal of foreign bodies, collection of conjunctival scrapings for diagnostic purposes, and other procedures where surface anesthesia is required.

2. Important information before using Alcaine

When not to use Alcaine

• if the patient is allergic to proxymetacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• without medical supervision,
• for prolonged periods, as this may cause corneal damage, loss of vision, and delayed healing,
• while wearing contact lenses, because Alcaine contains benzalkonium chloride.

Warnings and precautions
Before starting to use Alcaine, discuss this with your doctor or pharmacist.

• Alcaine is intended for local ocular administration only and must be administered solely by a physician. It must not be injected.
• The medicine should be used only for instillation into the eye(s).
• Repeated use or overuse of this medicine may lead to infections and corneal damage.
• Due to its anaesthetic effect, the eyes will lose sensation; therefore, care must be taken 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 result in reduced duration of anaesthesia.
• Proxymetacaine hydrochloride may cause allergic contact dermatitis. Avoid contact of Alcaine with the skin.
• If you are using other medicines, please also refer to the section Alcaine and other medicines.
• Exercise caution when using this medicine in patients:
• with epilepsy, heart disease, hyperthyroidism, or respiratory disorders,
• with myasthenia gravis, as they are particularly sensitive to the effects of local anaesthetics,
• with low plasma cholinesterase activity, and in patients treated with cholinesterase inhibitors, due to an increased risk of systemic adverse effects following local administration of ester-type local anaesthetics. Patients should avoid touching or rubbing the eye until the local anaesthetic effect has worn off.

If symptoms of hypersensitivity or irritation occur or worsen,
consult a doctor immediately.
Alcaine and other medicines
Inform your doctor or pharmacist about all medicines currently or recently used,
as well as any medicines you plan to take.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant,
she should consult a doctor before using this medicine.
Use of Alcaine during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
Blurred vision may occur temporarily after using Alcaine. Do not drive
or operate machinery until this symptom has resolved.
Alcaine contains benzalkonium chloride
Alcaine contains 0.0035 mg of benzalkonium chloride per drop, equivalent to 0.1 mg/mL.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Contact lenses must be removed before instillation and at least 15 minutes should elapse before reinsertion. Benzalkonium chloride may also cause eye irritation, particularly in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations occur in the eye, such as stinging or pain after using the medicine, contact a doctor.

3. How to use Alcaine

Alcaine is intended for administration only by a physician.
Recommended dose
When preparing a patient for a simple procedure, e.g. tonometry or other short-term procedures, one to two drops are usually instilled directly before the procedure.
For minor surgical procedures, such as removal of a foreign body or sutures, one to two drops should be administered one to three times, at five- to ten-minute intervals.
To achieve prolonged local anaesthesia, for example during cataract extraction surgery, one to two drops of Alcaine should be instilled into the eye(s) three to five times, at five- to ten-minute intervals.
Please note that local anaesthetic effect occurs within 30 seconds and may last up to 15 minutes.
Method of administration
Alcaine must be administered only into the eye(s).
Unscrew the cap. If, after removing the cap, the safety collar is loose, it should be discarded before using the medicine.
To prevent contamination of the dropper tip or the solution, care must be taken not to touch the dropper tip to the eyelids or surrounding tissues. The bottle should be kept tightly closed when not in use.
Systemic absorption of the drug can be reduced by applying the following measures after instillation of eye drops:

• closing the eyelids for 2 minutes;
• pressing with a finger on the nasolacrimal duct for 2 minutes.

Do not use the solution if it is cloudy or has changed colour.
Note: Since blinking reflex may be transiently absent after administration of the drug, eye protection is recommended following the procedure.
If the patient is using other eye drops or ointments simultaneously, a minimum interval of 5 minutes should be maintained between administration of each medicinal product. Eye ointments should be administered last.
Use of a higher than recommended dose of Alcaine
If a higher than recommended dose has been administered, the eye should be rinsed with lukewarm water.
In case of overdose or accidental ingestion, immediate contact should be made with a physician, pharmacist or poison control centre, as serious neurological or respiratory reactions may occur.
Missed dose of Alcaine
Do not double the dose to make up for a missed administration.
If there are any further questions regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed with the use of Alcaine, for which the frequency cannot be determined from available data:

• Eye-related reactions: corneal damage, corneal surface clouding, ocular surface swelling, ocular surface inflammation, blurred vision, photophobia, pupil dilation, eye pain, eye irritation, eye swelling, sensation of ocular discomfort, eye redness, increased tear production.
• General adverse reactions: hypersensitivity (allergy), fainting, dizziness. Transient symptoms such as prickling, burning, or conjunctival redness may occur. In rare cases, an early-type allergic reaction of the cornea may occur (characterized by acute, diffuse epithelial keratitis with fibrin formation and/or separation of large areas of epithelial necrosis, diffuse stromal edema, posterior lamellar keratitis, and iritis).

In very rare cases, after topical ocular administration, systemic toxic effects may occur, manifesting as initial central nervous system stimulation followed by depression of its functions.
Additionally, uncontrolled use or abuse of Alcaine may lead to permanent corneal disturbances and/or eye damage.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicine and helps provide safer use.

5. How to store Alcaine

Keep this medicine out of sight and reach of children.
Store in a refrigerator, at a temperature between 2°C and 8°C.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the specified month.
Do not use the solution if it is cloudy or has changed colour.
Keep the bottle tightly closed after each use.
The shelf life after first opening the bottle is 4 weeks.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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
The medicine is available as a sterile, isotonic aqueous solution.
White, opaque bottle (DROP-TAINER) made of low-density polyethylene (LDPE), with a white cap and a dropper made of low-density polyethylene, containing 15 ml of solution.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Greece, country of export:
Alcon Laboratories Hellas – Monoprósopi A.E.B.E.
Agiou Thoma 27
151 24 Maroussi, Greece
Manufacturer:
Alcon Laboratories Belgium
Lichterveld 3
2870 Puurs-Sint-Amands
Belgium
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Greece, country of export: 43182/10/12-05-2011
Parallel Import Authorisation Number: 49/24