Leaflet: information for the user

Artific 3,20 mg/ml eye drops in solution in single-dose container

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 it worsens or does not improve after 7 days.

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 it worsens or does not improve after 7 days.

Do not use Artific

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 consider your condition to worsen, stop using this medication and consult with your doctor or pharmacist.

Using 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 0.068 mg of phosphates in each drop, equivalent to 1.84 mg/ml.

If you suffer from 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 for this medication as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

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

This medicationdoes not contain preservatives, therefore, carriers ofsoft contact lensesdo not need to remove them before administering this medication.

1. Separate a single-use container from the blister.

2. Turn the cap and open the container

3. Instill the eye drops in the eye by placing the container perpendicularly to it.

Do not store after opening. Discard the remaining contents of the single-use 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 have been reported for ocular overdosing and no effects of overdose 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 use Artific

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

If you interrupt the treatment with Artific

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

You may experience the following adverse effects:

Rare (between 1 and 10 per 1,000 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 after use. Do not reuse.

Do not store at a temperature above 25 °C.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Artific

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

Appearance of the product and contents of the packaging

Artific is an colourless, transparent and particle-free solution

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bausch & Lomb S.A.

Avda., Valdeparra, 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/