Artelac

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Artelac
3.2 mg/ml, eye drops, solution
(Hypromellose)
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If symptoms do not improve or worsen, consult a doctor.

Table of contents:

1. What Artelac is and what it is 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 pack and other information

1. What Artelac is and what it is used for

Artelac is an eye drop formulation. The active substance in Artelac is hypromellose.
Indications
Artelac is used for symptomatic treatment of dry eye syndrome. Dry eye syndrome may occur due to impaired tear secretion or when the eyelids cannot be fully or partially closed.
The product may also be used to moisten rigid contact lenses.
If there is no improvement or if the patient feels worse, medical advice should be sought.
One in five patients treated by an ophthalmologist suffers from symptoms of dry eye syndrome. There are many causes of this condition, such as reduced tear production associated with aging, working in air-conditioned rooms, computer work, hormonal changes during menopause, etc. Environmental pollution and climatic factors may also contribute to the development of dry eye syndrome.
Understanding the term "dry eye"
During the day, we blink our eyelids approximately 14,000 times. With 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 contaminants. If the quantity or composition of the tear fluid is disturbed, drying of the cornea and conjunctiva occurs, leading to symptoms such as burning, dry eye sensation, feeling of grit or sand in the eye, pressure sensation, and light sensitivity.

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, discuss this with your doctor or pharmacist:

• Artelac is intended for ophthalmic use only.
• If irritation, eye pain, redness of the eye or vision problems occur or worsen, stop using the medicine and contact your ophthalmologist.
• If symptoms of dry eye syndrome persist or worsen, consult your doctor.
• Contact lenses must be removed before applying the medicine and should not be reinserted earlier than about 15 minutes after administration.
  Artelac and other medicines Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.

No interactions with other medicines are currently known.
If Artelac is used together with other locally applied ophthalmic medicines,
a 15-minute interval should be maintained between the administration of the medicines. Artelac should
always be administered last, 15 minutes after the other medicine, to ensure sufficient duration of action and thus optimal moisturizing effect of Artelac.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant,
she should consult her doctor or pharmacist before using this medicine.
Artelac should not be used during pregnancy and breastfeeding unless otherwise decided by a doctor.
Driving and operating machinery
Artelac may temporarily blur vision shortly after instillation. Do not drive or operate machinery as long as vision remains blurred.
Artelac contains cetrimide as a preservative. It may cause eye irritation (burning sensation, redness, foreign body sensation) and corneal epithelial damage, especially with prolonged use.
Therefore, for long-term or continuous treatment of dry eye syndrome, preservative-free formulations are recommended.
Artelac contains sodium dihydrogen phosphate dihydrate and disodium hydrogen phosphate dodecahydrate
(1 ml of solution contains 1.84 mg of phosphates).
In patients with severe corneal damage, phosphates may very rarely lead to corneal calcification and opacities during treatment.

3. How to use Artelac

This medicine should always be used exactly as described in this patient leaflet or as advised by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Treatment of dry eye syndrome requires individual dosing.
Depending on the severity and intensity of symptoms, one drop is usually instilled into the conjunctival sac 3 to 5 times daily, or more frequently, depending on need.
Consult an ophthalmologist if long-term or continuous treatment with Artelac is required.
The medicine may also be used to moisten rigid contact lenses.
Instructions for administration:

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

1. Wash hands thoroughly.
2. Unscrew the protective cap.
3. Hold the bottle upright above the eye, using your thumb and index finger.
4. Tilt your head backward.
5. With the index finger of the other hand, gently pull down the lower eyelid to create a "pocket" between the eyeball and the eyelid, into which the medicine will be instilled.
6. Bring the dropper tip close to the eye without touching the eye, eyelid, surrounding area, or any other surface.
7. Gently squeeze the bottle to release a single drop of the medicine.
8. Look upward and instill 1 drop of the medicine into the formed "pocket." If the drop misses the eye, repeat the procedure.
9. Try to keep the eye open and move it around so that the drop spreads evenly.
10. If drops are to be administered to both eyes, repeat the above steps for the second eye.
11. Immediately after use, close the bottle carefully.

Assistance from another person or the use of a mirror may facilitate administration.
If you feel that the effect of Artelac is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Artelac
If a higher than recommended dose is accidentally used, it may cause visual disturbances, which resolve quickly.
Missed dose of Artelac
If you miss a dose, apply the next dose at the usual time, according to the recommended dosing schedule. Do not use a double dose to make up for the missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The frequency of possible adverse reactions is defined as follows:
Very common – occurs in more than 1 in 10 people.
Common – occurs in 1 to 10 in 100 people.
Uncommon – occurs in 1 to 10 in 1,000 people.
Rare – occurs in 1 to 10 in 10,000 people.
Very rare – occurs in fewer than 1 in 10,000 people.
Frequency not known – cannot be estimated from the available data.

The following adverse reactions may occur:
Frequency not known:

• Conjunctival hyperaemia;
• Eye irritation;
• Eye pain;
• Itching of the eye;
• Burning sensation in the eye;
• Eye redness;
• Foreign body sensation;
• Excessive tearing;
• Eyelid sticking;
• Visual disturbances;
• Hypersensitivity;
• Itching;
• Rash;
• Corneal opacities due to calcium deposits (see section 2 for additional information).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 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 further information on the safety of the medicine to be collected.

5. How to store Artelac

Keep out of the sight and reach of children.
Do not store at temperatures above 30°C.
The shelf-life after first opening the bottle is 6 weeks.
The unused contents of the container should be discarded 6 weeks after first opening the bottle.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Artelac contains

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

What Artelac looks like and contents of the pack
The medicine is in the form of eye drops, solution.
Available pack sizes:
Bottle containing 10 ml of eye drops.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Marketing authorisation number in Germany, the country of export: 50145.00.00
Parallel import authorisation number: 247/13