Alcaine

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
ALCAINE, 5 mg/ml (0.5%), eye drops, solution
Proxymetacaini hydrochloridum
Please read all of this leaflet carefully before using this 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. It may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those 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-acting 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 topical anaesthesia 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 misuse of this medicine may lead to infections and corneal damage.

• Due to its anaesthetic 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 reduced duration of anaesthetic effect.

• Proparacaine hydrochloride may cause allergic contact dermatitis. Contact of Alcaine with the skin should be avoided.

• If using other medicines, also refer to the section Alcaine and other medicines.

• Exercise caution when using the 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, because there is 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 taken, as well as any medicines planned for use.
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 a 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 colour. Contact lenses must be removed before instillation and at least 15 minutes should be waited 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 eye pain occur after using the medicine, contact a doctor.

3. How to use Alcaine

Alcaine is intended for administration only by a physician.
Recommended dose
For preparing a patient for a simple examination, e.g. tonometry or other short procedures, usually one to two drops are instilled immediately before the procedure.
Prior to minor surgical procedures, such as removal of a foreign body or sutures, one to two drops should be administered once to three times, every five to ten minutes.
For prolonged anaesthesia, for example during cataract lens removal, one to two drops of Alcaine should be instilled into the eye(s) every five to ten minutes, three to five times.
Please note that local anaesthetic effect appears 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 protective collar is loose, it should be discarded before using the medicine.
To prevent contamination of the dropper tip or 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 reduced by applying the following measures after instillation of eye drops:

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

Do not use the solution if it is cloudy or has changed colour.
Note: Since blinking reflex is 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, at least a 5-minute interval should be maintained between administration of each medication. Eye ointments should be used last.
Use of a higher than recommended dose of Alcaine
If a higher than recommended dose is used, Alcaine should be flushed out of the eye with lukewarm water.
In case of overdose or accidental ingestion, seek immediate medical advice from a physician, pharmacist, or poison control centre, 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 regarding 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, 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. Transient symptoms such as stinging, burning, or conjunctival redness may occur. In rare cases, an early-type allergic reaction involving the cornea may occur (characterized by acute, diffuse epithelial keratitis with formation of filaments and/or 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 central nervous system stimulation followed by depression of its function.
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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 helps to provide more information on the safety of the medicine.

5. How to store Alcaine

Keep this medicine out of the 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 month indicated.
Do not use this medicine if cloudiness or a change in colour is observed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This helps protect the environment.
After each use, close the bottle tightly.
Shelf life after first opening the bottle: 4 weeks.

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 components (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 (DROPTAINER) made of low-density polyethylene (LDPE), with a white cap and a dropper made of low-density polyethylene, contains 15 ml of solution.

For further information, contact the responsible party or parallel importer:
Marketing Authorisation Holder in Greece, country of export:
Alcon Laboratories Hellas - Monoprosopi A.E.B.E.
27 Agiou Thoma, 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:
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
Marketing Authorisation number in Greece, country of export: 43182/10/12-05-2011
Parallel Import licence number: 187/23