Alcaine

Patient Information Leaflet

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, 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 the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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
anaesthetic.
Alcaine is used for topical anaesthesia prior to ophthalmic procedures requiring rapid and short-term anaesthesia, such as: preparation for removal of 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 anaesthesia is required.

2. Important information before using Alcaine

When not to use Alcaine

• if the patient is allergic to hydrochloride of proxymetacaine 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 it 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 solely for instillation into the eye(s).

• Repeated use or abuse of this medicine may lead to infections and corneal damage.

• Due to its anesthetic effect, the eyes will lose sensation; therefore, caution 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 shorter duration of anesthetic effect.

• Proxymetacaine hydrochloride may cause contact allergic dermatitis. Contact between Alcaine and the skin should be avoided.

• If other medicines are being used, refer also to the section Alcaine with other medicines.

• Caution is required when using Alcaine in patients:

• with epilepsy, heart disease, hyperthyroidism, or respiratory disorders,

• with myasthenia gravis, as they are particularly sensitive to the effects of local anesthetics,

• with low plasma cholinesterase activity and in patients treated with cholinesterase inhibitors, because there is an increased risk of systemic adverse reactions following local administration of ester-type local anesthetics. Patients should avoid touching or rubbing the eye until the local anesthetic effect has worn off.

If symptoms of hypersensitivity or irritation occur or worsen, consult a doctor immediately.
Alcaine with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might 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
Blurred vision may occur temporarily after using Alcaine. 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 color. 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 (the transparent layer at the front of the eye). If abnormal sensations, stinging, or pain in the eye occur after using the medicine, contact a doctor.

3. How to use Alcaine

Alcaine is intended for administration only by a healthcare professional.
Recommended dose
When preparing a patient for a simple procedure, such as 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 every five to ten minutes – once up to three times.
To achieve prolonged local anesthesia, for example during cataract extraction surgery, one to two drops of Alcaine should be instilled into the eye(s) every five to ten minutes, three to five times.
It should be noted that local anesthetic 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 the safety collar is loose after removing the cap, discard it before using the medicine.
To prevent contamination of the dropper tip or solution, exercise caution and do not let the dropper tip touch 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:

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

Do not use the solution if it is cloudy or has changed color.
Note: Since the blinking reflex may be transiently absent after administration of the drug, eye protection (e.g. eye patch) is recommended after completion of the procedure.
If the patient is using other eye drops or ointments simultaneously, at least a 5-minute interval should be maintained between administration of each product. Eye ointments should be used 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, contact a physician, pharmacist, or poison control center immediately, as serious 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 about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences 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, eye surface swelling, eye surface inflammation, blurred vision, photophobia, pupil dilation, eye pain, eye irritation, eye swelling, sensation of ocular discomfort, eye redness, increased lacrimation.
• General adverse reactions: hypersensitivity (allergic reaction), fainting, dizziness. Transient symptoms such as stinging, burning, or conjunctival redness may occur. In rare cases, an early-type allergic reaction of the cornea may occur (characterized by acute, diffuse keratoepitheliitis with fibrin formation and/or large areas of epithelial necrosis, diffuse stromal edema, posterior lamellar keratitis, and iritis).

In very rare cases, after local 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 persistent corneal disorders and/or eye damage.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 helps to provide more information on the safety of this medicine.

5. How to store Alcaine

Keep this medicine out of 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. The expiry date refers to the last day of the specified month.
Do not use this medicine if cloudiness or change in colour is observed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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. A white, opaque bottle made of low-density polyethylene (LDPE), with a dropper and a white polypropylene cap (DROP-TAINER) contains 15 ml of solution.

For more detailed information, please contact the responsible party or parallel importer:
Responsible entity in Bulgaria, country of export:
Alcon Farmaceutika d.o.o.
Avenija Dubrovnik 16, 10160 Zagreb
Croatia
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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorisation number in Bulgaria, country of export: 20000223
Parallel import authorisation number: 44/23