ARTELAC EDO

ARTELAC EDO eye drops

Important notes (mandatory information)

Artelac EDO eye drops Active ingredient: Hypromellose. Areas of application: for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva (dry eye) due to tear secretion and tear function disorders, as a result of local or systemic diseases as well as in the case of 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 and for wetting and rewetting soft and hard contact lenses.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Artelac EDO eye drops
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 package leaflet or exactly as directed by your doctor or pharmacist.
o Keep the package leaflet. You may want to read it again later.
o Ask your pharmacist if you need more information or advice.
o If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
o If you do not feel better or if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS ARTELAC EDO AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING ARTELAC EDO?
3. HOW TO USE ARTELAC EDO?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ARTELAC EDO?
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 fluid and a contact lens wetting agent.

Artelac EDO is used

o for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva (dry eye) due to tear secretion and tear function disorders, as a result of local or systemic diseases as well as in the case of 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.
o for wetting and rewetting soft and hard contact lenses.

Artelac EDO is - since it is unpreserved - particularly suitable for users who do not 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.

Warnings and precautions

Please talk to your doctor or pharmacist before using Artelac EDO.

Use of Artelac EDO together with other medicines

Tell your doctor or pharmacist if you are taking or using, have recently taken or used, or plan to take or use any other medicines. No specific interactions with other agents are known.

Note

If you are also using other medicines on your eye, there should be a time interval of about 15 minutes between the applications of the various preparations. Artelac EDO should always be used last so that the residence time and thus the effect is not shortened.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. No specific studies have been conducted on pregnant patients with Artelac EDO. However, Artelac EDO should only be used during pregnancy or breast-feeding after careful consideration of the benefits and risks by the doctor.

Driving and using machines

Since this medicine, even when used as intended, briefly affects vision and thus the ability to react by forming streaks, you should not participate in road traffic, work without a secure hold or operate machines during this time.

3. HOW TO USE ARTELAC EDO?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Dosage

The clinical picture of dry eye requires individual dosing. Unless otherwise prescribed, 1 drop should be instilled into the conjunctival sac 3 to 5 times a day or more often as required. The same applies to the rewetting of soft and hard contact lenses.

Type of use

For use on the eye.

Correct handling of single-dose ophtioles (=

EDO)

o Separate a single-dose ophtiole from the bar and hold it by the label side.
o Twist off the cap of the single-dose ophtiole.
o Tilt your head back and pull down the lower eyelid of the eye with the index finger of one hand. Hold the single-dose ophtiole vertically above the eye (without touching the eye) and gently press the finger on the single-dose ophtiole to instill a drop into the pulled-down conjunctival sac. Close the eye slowly and move it back and forth so that the drop can spread well.
o The contents of a single-dose ophtiole are sufficient for simultaneous use on both eyes.

Duration of use

The application for the clinical picture of dry eye is as long-term or permanent therapy. Notes: In the case of long-term or permanent use for the therapy of dry eye, an ophthalmologist should always be consulted. The rewetting of soft and hard contact lenses with Artelac EDO can be carried out without restriction of the duration of use.

If you have used more Artelac EDO than you should

No overdose reactions are known and no measures are required.

If you forget to use Artelac EDO

Do not use twice the amount if you have forgotten the previous application. Continue the therapy 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 have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. In very rare cases (may affect up to 1 in 10,000 people), local intolerances (burning eyes, redness, itching, blurred vision) may occur. In very rare cases (may affect up to 1 in 10,000 people), patients with pronounced corneal damage developed corneal opacities due to calcium deposits during treatment with phosphate-containing eye drops.

Reporting of side effects

If you get any side effects, talk to 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. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE ARTELAC EDO?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after "use by/expiry date". The expiry date refers to the last day of the month indicated.

Storage condition

Do not store above +25°C!

Note on shelf life after opening

Artelac EDO contains no preservative. Opened single-dose ophtioles should therefore not be stored. The remaining amount left in the ophtiole after use must be discarded.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Artelac EDO contains

The active ingredient is hypromellose. 1 ml 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

Clear colourless eye drops. Sample packs with 10 single-dose ophtioles each with 0.6 ml eye drops; packs with 10, 20, 30, 60, 90 and 120 single-dose ophtioles (bundle pack 2 x 60 single-dose ophtioles) each with 0.6 ml eye drops. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165 - 173
13581 Berlin
E-mail: kontakt@bausch.com

This leaflet was last revised in July 2017.

Source: Information from the package leaflet
Status: 12/2020
Active ingredient: Hypromellose. Areas of application: for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva (dry eye) due to tear secretion and tear function disorders, as a result of local or systemic diseases as well as in the case of 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 and for wetting and rewetting soft and hard contact lenses.