ARTIFIC 3.20 mg/ml EYE DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the User

Artific 3.20 mg/ml eye drops, solution in single-dose container

Hypromellose

Read the package leaflet carefully before starting to use this medicine because it contains important information for you.

It contains information that is important for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

Keep this package leaflet, as you may need to read it again.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Artific is and what it is used for
2. What you need to know before using Artific
3. How to use Artific
4. Possible side effects
5. Storage of Artific
6. Contents of the pack and further information

1. What Artific is and what it is used for

Artific is a medicine that belongs to the group of artificial tears.

Artific is indicated for the symptomatic relief of irritation and dryness of the eyes.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before using Artific

Do not use Artific

If you are allergic to hypromellose or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Artific.

If irritation, pain, redness, or changes in vision occur, or if you think your condition is worsening, stop using this medicine and consult your doctor or pharmacist.

Using Artific with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

No interactions with other medicines have been described to date in intraocular application.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is no experience regarding the safety of this product during pregnancy or breastfeeding.

Driving and using machines

No effects on the ability to drive or use machines have been described with the use of Artific.

Artific contains sodium phosphate dodecahydrate and sodium dihydrogen phosphate dihydrate

This medicine contains 0.068 mg of phosphates in each drop, which is equivalent to 1.84 mg/ml.

If you have severe damage to the transparent layer of the front of the eye (cornea), treatment with phosphates may, in very rare cases, cause blurred vision due to calcium accumulation.

3. How to use Artific

Follow the administration instructions of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Artific should only be used via the ocular route, as eye drops.

The recommended dose is one drop in the eye 3 to 5 times a day, or more frequently if necessary. The treatment of dry eye syndrome requires an individualized dosing regimen.

This medicine does not contain preservatives; therefore, wearers of soft contact lensesdo not need to remove them before administering this medicine.

1. Separate a single-dose container from the blister pack.
2. Turn the cap and open the container.
3. Instill the eye drops into the eye by placing the container perpendicular to it.

Do not store after opening. Discard the remaining contents of the single-dose container after each application.

If you use more Artific than you should

If you have used more Artific than you should, consult your doctor or pharmacist immediately.

No adverse effects due to ocular overdose are known, and no overdose effects are expected with ocular administration.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Artific

Do not use a double dose to make up for forgotten doses.

If you stop using Artific

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

You may experience the following side effects:

Uncommon (between 1 and 10 in every 1000 patients): burning sensation, blurred vision, and sticky eyelids.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es.

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

5. Storage of Artific

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

Do not use this medicine after the expiry date stated on the container after CAD. The expiry date is the last day of the month indicated.

Discard after use. Do not reuse.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Artific

• The active ingredient is hypromellose (methocel F4M). 1 ml of solution contains 3.20 mg of hypromellose.
• The other ingredients are: sodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, sorbitol (E420), and water for injection.

Appearance and packaging of the product

Artific is a clear, transparent, and particle-free solution.

It is presented in boxes of 30 single-dose containers of 0.5 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch & Lomb S.A.

Avda. Valdeparra, 4

28108 – Alcobendas, Madrid

Spain

Manufacturer

Dr. Gerhard Mann Brunsbütteler Damm 165/173

13581 Berlin

Germany

Date of the last revision of this package leaflet: November 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/