Artelac

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Artelac

3.2 mg/ml, eye drops, solution
Hypromellose

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• The leaflet should be kept so that it can be re-read if necessary.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Artelac and what is it used for

Artelac is an eye drop solution. The active substance of the medicine is hypromellose.

Indications

Artelac is used for the symptomatic treatment of dry eye syndrome. Dry eye syndrome may occur when there is a deficiency in tear secretion or when the eyelids cannot be fully or partially closed.
The medicine may also be used to moisten hard contact lenses.
If there is no improvement or the patient feels worse, they should contact their doctor.
One in five patients treated by an ophthalmologist has symptoms of dry eye syndrome. There are many causes of this condition, such as decreased tear production in older age, working in an air-conditioned room, working on a computer, hormonal changes during menopause, etc. Environmental pollution and climate can also play a role in the development of dry eye syndrome.

Understanding the term "dry eye"

Daily, we blink our eyelids about 14,000 times. During each blink, a very thin layer of tears is spread over the surface of the eyeball, maintaining smoothness, cleanliness, and moisture, and protecting against environmental pollutants. If the amount or composition of the tear fluid is disturbed, the phenomenon of drying of the cornea and conjunctiva occurs, causing symptoms such as burning, feeling of dry eye, feeling of sand in the eye, feeling of pressure, and sensitivity to light.
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2. Important information before using Artelac

When not to use Artelac

• if the patient is allergic to hypromellose or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Artelac, you should discuss it with your doctor or pharmacist:

• Artelac is intended for use in the eyes only.
• If symptoms of eye irritation, eye pain, redness of the eyes, vision problems occur or worsen, you should stop using the medicine and consult an eye doctor.
• If the symptoms of dry eye syndrome persist or worsen, the use of the medicine should be consulted with a doctor.
• Contact lenses should be removed before administering the medicine and not put back on until at least 15 minutes have passed.

Artelac and other medicines

You should 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.
Interactions with other medicines are not known at present.
If Artelac is used with other eye medicines, a 15-minute interval should be maintained between the administration of the medicines. Artelac should always be administered last, after 15 minutes from the administration of another medicine, to ensure sufficient time of action and thus the moisturizing effect of Artelac.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before using this medicine.
Artelac should not be used during pregnancy and breastfeeding, unless your doctor decides otherwise.

Driving and using machines

Artelac may temporarily blur vision after administration. You should not drive or operate machinery until your vision is clear.
Artelac contains cetrimide as a preservative.It may cause eye irritation (burning, redness, feeling of a foreign body) and damage to the corneal epithelium, especially when used for a long time.
Therefore, for long-term or continuous treatment of dry eye syndrome, preservative-free medicines are recommended.

Artelac contains sodium dihydrogen phosphate dihydrate and sodium hydrogen phosphate dodecahydrate

(1 ml of solution contains 1.84 mg of phosphates).
In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposition during treatment.

3. How to use Artelac

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This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Recommended dose
Treatment of dry eye syndrome requires individual dosing.
Depending on the severity and intensity of the symptoms, usually one drop is instilled into the conjunctival sac 3 to 5 times a day, or more often if needed.
You should consult an eye doctor if you need long-term or continuous treatment with Artelac.
The medicine can also be used to moisten hard contact lenses.

Administration instructions:

Warning!

To avoid contamination of the eye drops, do not touch the dropper tip with your fingers or touch it to the surface of the eye or any other surface. Using contaminated drops can lead to serious eye damage, including vision loss.

• 1. Wash your hands thoroughly.
• 2. Remove the protective cap.
• 3. Hold the bottle vertically over the eye, holding it between your thumb and index finger.
• 4. Tilt your head back.
• 5. With the index finger of your other hand, gently pull down the lower eyelid to create a "pocket" between the eye and the eyelid, where the medicine will be instilled.

into the created "pocket".

• 6. Bring the dropper tip close to the eye without touching the eye, eyelid, or surrounding areas.
• 7. Gently squeeze the bottle to release a single drop of medicine.
• 8. Looking up, instill 1 drop of medicine into the created "pocket". If the drop does not get into the eye, repeat the action.
• 9. Try to keep the eye open and move it to distribute the drop evenly.
• 10. If drops are to be administered to both eyes, the above steps should be repeated for the second eye.
• 11. Immediately after use, carefully close the bottle.

Having someone else help or using a mirror can make it easier to administer the medicine.
If you feel that the effect of Artelac is too strong or too weak, you should consult your doctor or pharmacist.

Using a higher dose of Artelac than recommended

If a higher dose of the medicine is used than recommended, it may cause vision disturbances, which will pass quickly.

Missing a dose of Artelac

If a dose is missed, the next dose should be taken at the usual time, according to the recommended dosing schedule. A double dose should not be taken to make up for a missed dose.
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If you have any further questions about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Artelac can cause side effects, although not everybody gets them.
The frequency of possible side effects is defined as follows:
Very common

• occur in more than 1 in 10 patients Common
• occur in 1 to 10 in 100 patients Uncommon
• occur in 1 to 10 in 1,000 patients Rare
• occur in 1 to 10 in 10,000 patients Very rare
• occur in less than 1 in 10,000 patients Not known
• cannot be estimated from the available data

The following side effects may occur:
Frequency not known:

• Conjunctival congestion
• Eye irritation
• Eye pain
• Eye itching
• Eye burning
• Eye redness
• Feeling of a foreign body in the eye
• Excessive tearing
• Eye lid sticking together
• Visual disturbances
• Hypersensitivity
• Itching
• Rash
• Corneal clouding due to calcium deposition (see section 2 for more information)

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Artelac

The medicine should be stored out of the sight and reach of children.
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Do not store above 30°C.
Shelf life after first opening the bottle – 6 weeks.
Any unused contents of the packaging should be discarded 6 weeks after the first opening of the bottle.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Artelac contains

• The active substance of the medicine is hypromellose. 1 ml of solution contains 3.2 mg of hypromellose.
• The other ingredients are: cetrimide, disodium edetate, sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dodecahydrate, sorbitol, water for injections.

What Artelac looks like and contents of the packaging

Artelac is an eye drop solution.
Packaging available:
Bottle containing 10 ml of eye drops.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Dr. Gerhard Mann
Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin, Germany

Manufacturer:

Dr. Gerhard Mann
Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin, Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German authorization number: 50145.00.00

Parallel import authorization number: 45/13 Date of leaflet approval: 13.01.2023

[Information about the trademark]
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