Alcaine

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the 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-term 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 when surface anesthesia is required.

2. Important information before using Alcaine

When not to use Alcaine

• if the patient is allergic to hydrochloride of proparacaine 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 by a healthcare professional. It must not be injected.
• The medicine should be used only for instillation into the eye (eyes).
• Repeated use or abuse of this medicine may lead to infections and corneal damage.
• Due to its anaesthetic effect, the eyes will lose sensation; therefore, caution should 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 anaesthetic effect.
• Hydrochloride of proparacaine may cause allergic contact dermatitis. Contact of Alcaine with the skin should be avoided.
• If other medicines are being used, please also refer to the section Alcaine with other medicines.
• Caution is advised when using Alcaine in patients:
• with epilepsy, heart disease, hyperthyroidism, or respiratory disorders,
• with myasthenia gravis, as these patients are particularly sensitive to the effects of local anaesthetics,
• with low plasma cholinesterase enzyme activity, and in patients treated with cholinesterase inhibitors, due to increased risk of systemic adverse reactions 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 with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
The use of Alcaine during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
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 per drop, equivalent to 0.1 mg/mL.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Contact lenses must be removed before instillation and at least 15 minutes should elapse before reinserting them. Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (transparent front layer of the eye). If abnormal sensations, stinging, or eye pain occur after using the medicine, contact your doctor.

3. How to use Alcaine

Alcaine is intended for administration by a physician only.
Recommended dose
When preparing a patient for a simple examination, e.g. tonometry or other short procedures, one to two drops are usually instilled immediately 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.
For prolonged anaesthesia, for example during cataract lens removal, 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 begins within 30 seconds and may last up to 15 minutes.
Method of administration
Alcaine must be instilled only into the eye(s).
Unscrew the cap. If, after removing the cap, the safety collar is loose, discard it before using the medicine.
To prevent contamination of the dropper tip or the solution, take care 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 minimized by applying the following measures after instillation of eye drops:

• closing the eyelids for 2 minutes;
• pressing the finger against the nasolacrimal duct for 2 minutes.

Do not use the solution if it is cloudy or has changed colour.
Note: Since the 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 eye ointments simultaneously, at least a 5-minute interval should be maintained between administration of successive products. Eye ointments should be administered last.
Use of a higher than recommended dose of Alcaine
If a higher than recommended dose is administered, the eye should be rinsed with lukewarm water.
In case of overdose or accidental ingestion, seek immediate medical advice from a physician, pharmacist, or poison control centre, as severe nervous or respiratory system reactions may occur.
Missed dose of Alcaine
Do not double the dose to make up for a missed dose.
If you have any further questions concerning use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

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

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

In very rare cases, systemic toxic effects may occur after topical ocular administration, manifesting initially as 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 a 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, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Alcaine

Keep this medicine out of sight and reach of children.
Protect from light.
Store in a refrigerator, at a temperature between 2°C and 8°C.
The 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.
The expiry date refers to the last day of the stated month.
Do not use the solution if it is cloudy or has changed colour.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package 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 dropper and white polypropylene cap, containing 15 ml of solution.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Bulgaria, country of export:
Alcon Farmaceutika d.o.o.
Avenija Dubrovnik 16
10160 Zagreb, Croatia
Manufacturer:
S.A. ALCON-COUVREUR N.V.
Rijksweg 14
2870 Puurs
Belgium
Alcon Laboratories Belgium
Lichterveld 3
2870 Puurs-Sint-Amands
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 authorization number in Bulgaria, country of export: 20000223
Parallel import authorization number: 153/23