ARTIFIC 3.20 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Artific 3.20 mg/ml Eye Drops Solution

Hypromellose

Read the package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication 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.
• 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 your condition 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. Package Contents and Additional Information

1. What Artific is and what it is used for

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

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

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

2. What you need to know before using Artific

Do not useArtific

If you are allergic to hypromellose or any of the other components of this medication (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 medication and consult your doctor or pharmacist.

Soft contact lens wearers should remove their lenses before administering this medication and wait at least 15 minutes before putting them back on.

Using Artific with Other Medications

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

No interactions with other medications 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 medication.

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

Driving and Using Machines

No effects on driving ability or machine operation have been described with the use of Artific.

Artific contains sodium dihydrogen phosphate dihydrate and disodium phosphate dodecahydrate

This medication contains 0.051 mg of phosphates per drop, which is equivalent to 1.84 mg/ml.

If you have severe damage to the transparent layer on 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 for this medication 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.

Do not use after 6 weeks from the first opening of the bottle.

If you use moreArtificthan you should

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

No adverse effects are known due to ocular overdosing, 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 medication and the amount ingested.

If you forget to useArtific

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

If you stop usingArtific

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

You may experience the following side effects:

Uncommon (between 1 and 10 out of 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 Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Artific

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Discard 6 weeks after the first opening of the bottle.

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofArtific

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

Appearance of the Product and Package Contents

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

It is presented in a 10 ml plastic dropper bottle.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bausch & Lomb S.A.

Avda., Valdelaparra, 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 medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/