Artelac

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Artelac
3.2 mg/ml, eye drops, solution
Hypromellosum
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If your symptoms do not improve or worsen, contact your 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 the symptomatic treatment of dry eye syndrome. Dry eye syndrome may occur due to reduced tear production or when the eyelids cannot be fully or partially closed.
Artelac may also be used to moisten rigid (hard) contact lenses.
If symptoms do not improve or if you feel worse, contact your 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 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 eye, 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, foreign body sensation (feeling of sand in the eye), pressure sensation, and light sensitivity.
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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 using Artelac, discuss with your doctor or pharmacist:

• Artelac is intended for ocular use only.
• If eye irritation, eye pain, redness of the eye or vision problems occur or worsen, discontinue use and contact your ophthalmologist.
• If symptoms of dry eye syndrome persist or worsen, use of this medicine should be discussed with your doctor.
• Contact lenses must be removed before administration of the medicine and should not be reinserted earlier than approximately 15 minutes after application.

Artelac with other medicines
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines you plan to use.
Interactions with other medicines are currently unknown.
If Artelac is used together with other locally applied ophthalmic medicines, a 15-minute interval should be maintained between applications. Artelac should always be administered last, 15 minutes after the other medicine, to ensure sufficient duration of action and thus the moisturizing effect of Artelac.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Artelac should not be used during pregnancy or 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, redness, foreign body sensation) and corneal epithelial damage, especially when the medicine is used long-term.
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 cause corneal opacities due to calcium accumulation 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 a physician 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 as needed.
Consult an ophthalmologist if long-term or continuous treatment with Artelac is required.
This 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 over the eye, using the thumb and index finger.
4. Tilt the 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 into the created "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 tightly.

Administration may be facilitated by assistance from another person or by using a mirror.
If you feel that the effect of Artelac is too strong or too weak, consult your doctor or pharmacist.

Overdose of Artelac
If an excessive dose is accidentally used, it may cause visual disturbances, which usually resolve quickly.

Missed dose of Artelac
If a dose is missed, apply the next dose at the usual time according to the recommended dosing schedule. Do not use a double dose to make up for a missed dose.

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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 medicine can cause adverse reactions, although not everyone experiences them.
The frequency of possible adverse reactions is defined as follows:
Very common – occurs in more than 1 in 10 patients
Common – occurs in 1 to 10 in 100 patients
Uncommon – occurs in 1 to 10 in 1,000 patients
Rare – occurs in 1 to 10 in 10,000 patients
Very rare – occurs in fewer than 1 in 10,000 patients
Frequency not known – cannot be estimated from available data

The following adverse reactions may occur:
Frequency not known:

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

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

5. How to store Artelac

Keep this medicine out of the sight and reach of children.
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Do not store above 30°C.
Period of usability after first opening the bottle – 6 weeks.
The unused contents of the container should be discarded 6 weeks after first opening 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will 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.
• Other components are: cetylpyridinium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dodecahydrate, sorbitol, water for injections.

What Artelac looks like and contents of the pack
The medicinal product is available as eye drops solution.
Available pack sizes:
Bottle containing 10 ml of eye drops.
For further 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
German marketing authorisation number (country of export): 50145.00.00
Parallel import authorisation number: 45/13
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