Patient Information Leaflet: Information for the Patient

Artific 3,20 mg/ml eye drops in solution

Hypromellose

Read this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist, or nurse.

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

1. What is Artific and what it is used for

2. What you need to know before starting to use Artific

3. How to use Artific

4. Possible side effects

5. Storage of Artific

6. Contents of the pack and additional information

Artificis a medication that belongs to the group of artificial tears.

Artificis indicated for the symptomatic relief of eye irritation and dryness.

Consult a doctor if symptoms worsen or do not improve after 7 days.

Do not useArtific

If you are allergic to hypromellose or any of the other ingredients 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 consider your condition to worsen, stop using this medication and consult with your doctor or pharmacist.

Wearers of soft contact lenses should remove them before administering this medication and wait at least 15 minutes before reinserting them.

Use of Artific with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

In intraocular application, no interactions with other medications have been described to date.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

No experience is available regarding the safety of this product during pregnancy or breastfeeding.

Driving and operating machinery

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

Artific contains sodium dodecahydrate hydrogen phosphate and dihydrogen sodium phosphate dihydrate

This medication contains 0.051 mg of phosphates in each drop, equivalent to 1.84 mg/ml.

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

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

Artific should only be used byocular route, as eye drops.

The recommended dose is one drop in the eye3 to5 times a day or, if necessary, more frequently. The treatment of dry eye syndrome requires an individualized dosing regimen.

Do not use after6 weeksof the first opening of the bottle.

If you use moreArtificthan you should

If you have used moreArtificthan you should, consult your doctor or pharmacist.

No adverse effects by ocular overdosing are known and no overdose effects are anticipated with the ocular administration route.

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

If you forgot to useArtific

Do not use a double dose to compensate for the missed doses.

If you interrupt the treatment withArtific

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

Like all medications,this medicationmay cause adverse effects, although not all people will experience them.

You may experience the following adverse effects:

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

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

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

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

Dispose of at6 weeksfrom the first opening of the bottle.

Do not store at a temperature above 30?°C.

Medicines should not be thrown into the drains or trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofArtific

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

Appearance of the product and contents of the packaging

Artific isa colourless, transparent and particle-free solution.

It is presented in a plastic dropper bottle containing 10 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bausch & Lomb S.A.

Avda., Valdelaparra, 4

28108 – Alcobendas, Madrid

Spain

Responsible for manufacturing

Dr. Gerhard MannBrunsbütteler Damm 165/173

13581 Berlin

GERMANY

Last review date of this leaflet: November 2020

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