Artelac

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Artelac

3.2 mg/ml, eye drops, solution

Hypromellose

Read the leaflet carefully 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.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If you do not feel better or if you feel worse, you should contact your 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 pack and other information

1. What is Artelac and what is it used for

Artelac is an eye drop solution. The active substance 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 production or when the eyelids cannot be fully or partially closed.

The medicine may also be used to moisten hard contact lenses.

If you do not feel better or if you feel worse, you should 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 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"

During the day, we blink our eyelids about 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 pollutants. If the amount or composition of the tear fluid is disturbed, the cornea and conjunctiva dry out, causing symptoms such as burning, feeling of dryness, feeling of sand in the eye, feeling of pressure, and sensitivity to light.

2. Important information before using Artelac

When not to use Artelac

Warnings and precautions

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

• Artelac is for use in the eyes only.
• If you experience eye irritation, eye pain, redness of the eyes, vision problems, you should stop using the medicine and contact your ophthalmologist.
• If the symptoms of dry eye syndrome persist or worsen, you should consult your doctor.
• You should remove contact lenses before administering the medicine and not put them back in for at least 15 minutes.

Artelac and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Interactions with other medicines are not known.

If Artelac is used with other eye medicines, you should wait 15 minutes between applications. Artelac should always be administered last, after 15 minutes from the application of another medicine, to ensure sufficient time for 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, 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 cause temporary blurred vision after application. 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 with long-term use.

Therefore, for long-term or continuous treatment of dry eye syndrome, preservative-free medicines are recommended.

Artelac contains sodium dihydrogen phosphate dihydrate and disodium 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 rarely cause corneal clouding due to calcium deposition during treatment.

3. How to use Artelac

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, ask your doctor or pharmacist.

Recommended dose

Treatment of dry eye syndrome requires individual dosing.

Depending on the severity and frequency of symptoms, usually one drop is instilled into the conjunctival sac 3 to 5 times a day, or more often if needed.

You should consult your ophthalmologist if you need long-term or continuous treatment with Artelac.

The medicine can also be used to moisten hard contact lenses.

Instructions for administration:

Warning!

To avoid contamination of the eye drops, do not touch the dropper tip with your fingers or touch it to 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, with 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.

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, repeat the above steps for the other eye.
• 11. Immediately after use, tightly close the bottle.

Having someone else help you 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 more than the recommended dose of Artelac

If you accidentally use more than the recommended dose, it may cause blurred vision, which will clear up quickly.

Missing a dose of Artelac

If you miss a dose, take the next dose at the usual time, as directed. Do not take a double dose to make up for the missed dose.

If you have any further questions about using this medicine, ask 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: 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 less than 1 in 10,000 patients
• Frequency not known: cannot be estimated from available data

The following side effects may occur:

Frequency not known:

• Conjunctival hyperemia
• Eye irritation
• Eye pain
• Itching of the eye
• Burning sensation in the eye
• Redness of the eye
• Feeling of a foreign body in the eye
• Excessive tearing
• Stickiness of the eyelids
• 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Artelac

Keep the medicine out of the sight and reach of children.

Store in a temperature below 30°C.

Shelf life after first opening the bottle: 6 weeks.

Discard any unused contents of the pack after 6 weeks from 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 month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sorbitol, water for injections.

What Artelac looks like and contents of the pack

Artelac is an eye drop solution.

Available packs:

Bottle containing 10 ml of eye drops.

For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, country of export:

BAUSCH + LOMB IRELAND LIMITED, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

Manufacturer:

Dr. Gerhard Mann Chem-Pharm Fabrik GmbH, Brunsbütteler Damm 165/173, D-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

Netherlands, country of export, authorization number: RVG 32371

Parallel import authorization number:136/23

Date of leaflet approval: 13.07.2023

[Information about the trademark]

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