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Artelac is an eye drop from Bausch & Lomb.
Indications for Artelac Eye Drops
Artelac 1.6 mg/0.5 ml eye drops are approved for the symptomatic treatment of dry eye.
Composition of Artelac Hypromellose Dry Eye Drops
The active ingredient in Artelac eye drops is hypromellose 1.6 mg, and the excipients are sorbitol, disodium phosphate dodecahydrate, monosodium phosphate dihydrate, and water for injections.
Dosage of Artelac Single-Dose Eye Drops for Dry Eye
The recommended dosage for dry eye is 4 to 6 drops per day, depending on the symptoms: dry eye, burning, and itching.
You are advised to place one drop of eye drop in the lower inner corner of the eye, looking upward and gently pulling the lower eyelid downward.
If the symptoms persist, consult a doctor. In case of overdose, rinse thoroughly with saline.
The single-dose container must be discarded after use.
Precautions for using Artalec artificial tears for dry eyes
Precautions for using Artelac eye drops include taking other medications. If you are taking or have recently taken any other medication, even if you obtained it without a prescription, speak to your doctor or pharmacist. Finally, if you are taking another eye drop at the same time, you should wait 15 minutes between instillations.
Under normal conditions of use, this medication can be used during pregnancy and breastfeeding. It is best to consult your doctor or pharmacist beforehand.
Side effects of Artelac eye drops 1.6 mg/0.5 ml
After applying Artelac, vision may be blurred for a few minutes (do not drive machinery). Side effects such as eye irritation may occur. Furthermore, in people with severely damaged corneas, phosphate-based eye drops such as Artelac may cause corneal calcification (very rarely).
You are advised to carefully read the package leaflet before use or ask your pharmacist or doctor for advice.
Packaging: Box of 60 single-dose units
If you wear contact lenses, we recommend using Elixya eye drops for dry eyes.
LEAFLET
ANSM - Updated on: 04/07/2023
Name of the medicinal product
ARTELAC 1.6 mg/0.5 mL, eye drops in single-dose container
Hypromellose
Box
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
You must always use this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse.
What is in this leaflet?
1. What is ARTELAC 1.6 mg/0.5 mL, single-dose eye drops and what is it used for?
2. What you need to know before you use ARTELAC 1.6 mg/0.5 mL, single-dose eye drops?
3. How to use ARTELAC 1.6 mg/0.5 mL, single-dose eye drops?
4. Possible side effects?
5. How to store ARTELAC 1.6 mg/0.5 mL, single-dose eye drops?
6. Contents of the pack and other information.
1. WHAT IS ARTELAC 1.6 mg/0.5 mL, single-dose eye drops AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: TEAR SUBSTITUTE - ATC code: S01X020
(S: sense organ)
This eye drop is indicated for the symptomatic treatment of dry eye.
2. WHAT YOU NEED TO KNOW BEFORE USING ARTELAC 1.6 mg/0.5 mL, single-dose eye drops?
Never use ARTELAC 1.6 mg/0.5 mL, single-dose eye drops:
· if you are allergic to hypromellose or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using ARTELAC 1.6 mg/0.5 mL, single-dose eye drops.
If you are taking another eye drop at the same time, wait 15 minutes between instillations.
Discard the single-dose container immediately after use.
Once opened, do not store the single-dose container for future use.
Children
There is no relevant use of ARTELAC 1.6 mg/0.5 mL, single-dose eye drops in pediatric patients.
Other medicines and ARTELAC 1.6 mg/0.5 mL, single-dose eye drops
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
ARTELAC 1.6 mg/0.5 mL, single-dose eye drops with food and drink
Not applicable.
Pregnancy and breastfeeding
This medicine, under normal conditions of use, can be used during pregnancy and breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
After instilling the eye drops, vision may be blurred for a few minutes.
ARTELAC 1.6 mg/0.5 mL, single-dose eye drops contain phosphates.
This medicine contains 2.82 mg of phosphates per unit volume (0.5 mL).
(See section 4 "Possible side effects").
3. HOW TO USE ARTELAC 1.6 mg/0.5 mL, single-dose eye drops?
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Dosage
As a guide, the dosage is 4 to 6 drops per day.
Method of administration
For ophthalmic use.
Place one drop of eye drops in the lower inner corner of the eye, looking upwards and gently pulling the lower eyelid downward.
Discard the single-dose container immediately after use.
Once opened, do not store the single-dose container for future use.
How often and when to administer the medication
Instill one drop of eye drops when eye problems (dryness, burning, itching) occur.
Duration of treatment
If problems persist or worsen, consult an ophthalmologist.
If you use more ARTELAC 1.6 mg/0.5 mL, single-dose eye drops than you should
In case of overdose, rinse thoroughly with sterile saline.
If you forget to use ARTELAC 1.6 mg/0.5 mL, single-dose eye drops
Not applicable.
If you stop using ARTELAC 1.6 mg/0.5 mL, single-dose eye drops
Not applicable.
If you have any further questions on 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.
· Mild, temporary stinging may be felt upon instillation.
This medicine contains 2.82 mg of phosphates per unit volume (0.5 mL).
If you have severe damage to the cornea (the transparent layer at the front of the eye), phosphates may, in very rare cases, cause vision problems due to calcium accumulation during treatment (clouding).
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: French National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE ARTELAC 1.6 mg/0.5 mL, eye drops in single-dose container?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the outer packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Discard the single-dose container immediately after use.
Once opened, do not store the single-dose container for future use.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What ARTELAC 1.6 mg/0.5 mL, eye drops in single-dose container contains
· The active substance is:
Hypromellose................................................................................................................ 1.60 mg
Per single-dose container.
· The other ingredients are:
Sorbitol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.
What ARTELAC 1.6 mg/0.5 mL eye drops in single-dose container looks like and what are the contents of the outer packaging?
ARTELAC 1.6 mg/0.5 mL eye drops are available in a 0.5 mL single-dose container.
Box of 60 single-dose containers.
Marketing Authorization Holder
CHAUVIN LABORATORY
416 SAMUEL MORSE STREET – CS99535
34961 MONTPELLIER
Marketing Authorization Holder
CHAUVIN LABORATORY
416 SAMUEL MORSE STREET – CS99535
34961 MONTPELLIER
Manufacturer
CHAUVIN LABORATORY
RIPOTIER INDUSTRIAL ZONE
50 JEAN MONNET AVE
07200 AUBENAS
OR
DR. GERHARD MANN, PHARMACY CHEMISTRY FABRIK GMBH
BRUNSBÜTTELER DAMM, 165/173
13581 BERLIN
GERMANY
OR
UNITHER LABORATORY
1 RUE DE L’ARQUERIE
50200 COUTANCES
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
This leaflet was last revised:
[to be completed subsequently by the holder]
{month YYYY}
Other
Detailed information on this medicinal product is available on the ANSM website (France).
