ARTELAC EDO eye drops

Artelac EDO 3.20 mg/ml eye drops, solution. Active ingredient: Hypromellose. Indications: For the symptomatic treatment of drying symptoms of the cornea and conjunctiva (dry eye) caused by impaired tear secretion and tear function resulting from local or systemic diseases, as well as insufficient or incomplete eyelid closure, which can manifest, for example, as burning eyes, a foreign body sensation, and photophobia in windy, hot weather, or fatigue. For the lubrication and rewetting of soft and hard contact lenses. Warnings: Contains phosphates.

For risks and side effects, read the package insert and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Artelac EDO 3.20 mg/ml eye drops, solution, for the symptomatic treatment of drying symptoms of the cornea and conjunctiva, as well as for the lubrication and rewetting of soft and hard contact lenses.
Active ingredient: hypromellose.

Read the entire package leaflet carefully before you start using this medicine because it contains important information. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may want to read it again later.
• Ask your pharmacist if you need further information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse, consult your doctor.

What is in this leaflet:

1. WHAT IS ARTELAC EDO AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING ARTELAC EDO?
3. HOW SHOULD ARTELAC EDO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ARTELAC EDO BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS ARTELAC EDO AND WHAT IS IT USED FOR?

Artelac EDO is a synthetic tear solution and contact lens wetting agent.

Artelac EDO is used:

• For the symptomatic treatment of drying out of the cornea and conjunctiva (dry eye) caused by impaired tear secretion and tear function, as a result of local or systemic diseases, as well as insufficient or incomplete eyelid closure, which can manifest itself, for example, in burning eyes, a foreign body sensation, and photophobia in wind, heat, and fatigue.
• for wetting and rewetting soft and hard contact lenses.

Because it is unpreserved, Artelac EDO is particularly suitable for users who cannot tolerate preserved artificial tear substitutes.

2. WHAT SHOULD YOU CONSIDER BEFORE USING ARTELAC EDO?

Artelac EDO must not be used
- if you are allergic to hypromellose or any of the other ingredients of this medicine listed in section 6.1.

Warnings and precautions:
Please talk to your doctor or pharmacist before using Artelac EDO.

Using Artelac EDO with other medicines:
Tell your doctor or pharmacist if you are taking or using any other medicines, have recently taken or used any other medicines, or intend to take or use any other medicines. No specific interactions with other medicines are known.

Note:
If you are also using other medicines in your eyes, there should be an interval of approximately 15 minutes between applications of the different preparations. Artelac EDO should always be used last to ensure that the duration of the medication remains in the eye and thus the effect is not shortened.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

No specific studies have been conducted with Artelac EDO in pregnant patients. However, as a general rule, Artelac EDO should only be used during pregnancy or breastfeeding after careful risk-benefit assessment by the doctor.

Driving and using machines:
As with all eye drops, temporary blurred vision or other visual impairments may affect your ability to drive or operate machinery. If blurred vision occurs immediately after instillation, you must not drive or operate machinery until this impairment has subsided.

Artelac EDO contains phosphates:
This medicine contains 0.068 mg phosphate per drop, equivalent to 1.84 mg/ml.

If you suffer from severe damage to the cornea (the transparent layer at the front of the eye), phosphates may, in very rare cases, cause opacities (cloudy patches) of the cornea due to calcium deposits during treatment.

3. HOW SHOULD ARTELAC EDO BE USED?

Always use this medicine exactly as described in this package leaflet or as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are unsure.

The recommended dose is 1 drop in the conjunctival sac 3 to 5 times daily, or more often as needed.

Treatment of dry eye requires individual dosing.

The same applies to rewetting soft and hard contact lenses.

The contents of one single-dose ophtioles are sufficient for simultaneous use in both eyes.

Method of administration:
For ocular use.

Correct handling of single-dose ophtioles (EDO):

• Carefully separate a dropper container from the strip.
• Turn (do not pull) off the cap of the dropper container.
• Tilt your head back slightly and pull the lower eyelid down a little.
• Hold the drip container with the opening facing down.
• Then gently squeeze the dropper container without touching the eye or the surrounding skin until a drop falls into the lower eyelid. This will prevent possible injury to the eye or contamination of the medication remaining in the dropper container.
• Close your eye and move it slightly to the right and left and blink to distribute the drop evenly over the surface of the eye.

Duration of use:
Use in the condition of dry eye is for long-term or continuous therapy.

Note:
An ophthalmologist should always be consulted for long-term or continuous use for the treatment of dry eye. Rewetting of soft and hard contact lenses with Artelac EDO can be carried out without any restriction on the duration of use.

If you use more Artelac EDO than you should:
No overdose reactions are known and no action is necessary.

If you forget to use Artelac EDO:
Do not use a double dose to make up for a forgotten dose. Continue treatment at the next scheduled time with the same dosage and at the same time interval/rhythm as described or as prescribed by your doctor. If necessary, you can also use Artelac EDO between two scheduled times.

If you stop using Artelac EDO:
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very rare (may affect up to 1 in 10,000 people):
Occurrence of local intolerances (burning, reddening, itching of the eyes, blurred vision).

In very rare cases, patients with severe corneal damage developed clouding of the cornea due to calcium deposits during treatment with phosphate-containing eye drops.

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD YOU STORE ARTELAC EDO?

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

Do not use this medicine after the expiry date stated on the container and carton after ###use by/use by###. The expiry date refers to the last day of that month.

Information on shelf life after opening:
Artelac EDO does not contain a preservative. Opened single-dose ophtioles must therefore not be stored. Any remaining amount in the ophtiole after use must be discarded.

Storage conditions:
Do not store above 25°C.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment. Further information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Artelac EDO contains:
The active ingredient is:
Hypromellose. 1 ml of solution contains 3.20 mg hypromellose.

The other ingredients are:
Sodium monohydrogen phosphate dodecahydrate (Ph. Eur.)%%% Sodium dihydrogen phosphate dihydrate%%% Sorbitol (Ph. Eur.)%%% Water for injections.

What Artelac EDO looks like and contents of the pack:
Artelac EDO is a clear, colorless solution.

Artelac EDO is available in transparent, colorless LDPE packs containing 10, 20, 30, 60, 90, and 120 single-dose ophthalmic syringes, each containing 0.6 ml of solution, and as a sample pack containing 10 single-dose ophthalmic syringes, each containing 0.6 ml of solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Dr. Gerhard Mann
chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
13581 Berlin, Germany
Email: kontakt@bausch.com

This package leaflet was last revised in September 2024.

information in the package leaflet
as of May 2025.

Active ingredient: Hypromellose. Indications: For the symptomatic treatment of drying symptoms of the cornea and conjunctiva (dry eye) caused by impaired tear secretion and tear function resulting from local or systemic diseases, as well as insufficient or incomplete eyelid closure, which can manifest, for example, as burning eyes, foreign body sensation, and photophobia in windy, hot weather, or fatigue. For the lubrication and rewetting of soft and hard contact lenses. Warnings: Contains phosphates.