Artific 3.20 mg/ml eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Artific 3.20 mg/ml eye drops, solution
Hypromellose
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Follow exactly the instructions for administering this medicine as described in this leaflet or as directed 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if you get worse or do not improve after 7 days.
Contents of the leaflet
- What Artific is and what it is used for
- What you need to know before using Artific
- How to use Artific
- Possible side effects
- How to store Artific
- Contents of the pack and other 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 eye irritation and dryness.
You should consult a doctor if symptoms worsen or do 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 to any of the other ingredients 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 feel your condition worsens, stop using this medicine and consult your doctor or pharmacist.
Wearers of soft contact lenses should remove them before administering this medicine and wait at least 15 minutes before reinserting them.
Use of Artific with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
To date, no interactions with other medicines have been reported with intraocular administration.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 use of machinery
No effects on the ability to drive or operate machinery have been reported with the use of Artific.
Artific contains sodium hydrogen phosphate dodecahydrate and sodium dihydrogen phosphate dihydrate
This medicine contains 0.051 mg of phosphates per drop, equivalent to 1.84 mg/ml.
If you have severe damage to the transparent layer at 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 exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Artific is for ophthalmic use only, as eye drops.
The recommended dose is one drop into the eye 3 to 5 times a day, or more frequently if necessary. 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 more Artific than you should
If you have used more Artific than you should, consult your doctor or pharmacist.
No adverse effects from ocular overdose are known, and overdose effects are not expected with ophthalmic administration.
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number 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 adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
You may experience the following adverse effects:
Uncommon (between 1 and 10 in 1,000 patients): burning sensation, blurred vision, and sticky eyelids.
Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.
By reporting adverse 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 packaging after EXP. The expiry date is the last day of the month indicated.
Discard 6 weeks after first opening the bottle.
Do not store above 30 °C.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Artific
- The active substance is hypromellose (methocel F4M); 1 ml of solution contains 3.20 mg of hypromellose.
- The other components are cetrimide, sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, edetate disodium, sorbitol (E420), and water for injections.
Appearance of the product and contents of the container
Artific is a colourless, clear, particle-free solution.
It is supplied in a plastic dropper bottle containing 10 ml of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 most recent revision of this leaflet: November 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/