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Aquarest eye gel is a tear fluid substitute, commonly referred to as "artificial tears." Aquarest is available without a prescription to relieve dry eyes. This medication can be used in adults and children to treat dry eye.
The active ingredient in Aquarest is carbomer (0.2%), which forms a film that adheres to the surface of the eye. Carbomer binds to water molecules and thus stabilizes the tear film to prevent dry eyes.
Aquarest eye gel comes in single-dose forms that, in addition to carbomer, contain sorbitol, disodium phosphate dodecahydrate, medium-chain triglycerides, sodium hydroxide, and water for injections.
How to use Aquarest drops?
Depending on your discomfort, you can apply Aquarest eye drops 3 to 5 times a day, more often at bedtime. If necessary, you can use this lubricating eye gel more often: this dosage is individual.
You must take a new single-dose of Aquarest with each instillation. Start by washing your hands, then tilt your head slightly back while looking at the ceiling. Place a drop of Aquarest in the conjunctival sac: a small hollow formed by pulling on the lower edge of the eyelid. Close your eyelid and slowly move your eye to spread the eye gel evenly over the ocular surface.
If your doctor has prescribed multiple eye drops or ointments, you must leave at least 15 minutes between each instillation, always finishing with Aquarest.
Precautions for using Aquarest eye drops
In cases of dry eye, wearing contact lenses is often not recommended. However, if your ophthalmologist allows it, you must remove your lenses before inserting Aquarest eye gel and wait 15 minutes before reinserting them.
Aquarest eye drops should be used only under medical supervision during pregnancy and breastfeeding.
Immediately after applying the eye gel, vision may be temporarily blurred. Wait until your vision returns to normal before driving or operating machinery.
If in doubt, read the instructions before using Aquarest.
Packaging: Box of 60 single-dose containers.
To combat dry eyes, it may be beneficial to take Nutrilarm capsules for dry eyes in addition.
LEAFLET
ANSM - Updated on: 01/12/2024
Name of the medicinal product
AQUAREST 0.2%, ophthalmic gel in single-dose container
Carbomer
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 after 3 days.
What is in this leaflet?
1. What is AQUAREST 0.2% eye gel in single-dose container and what is it used for?
2. What you need to know before using AQUAREST 0.2% eye gel in single-dose container?
3. How to use AQUAREST 0.2% eye gel in single-dose container?
4. Possible side effects?
5. How to store AQUAREST 0.2% eye gel in single-dose container?
6. Contents of the pack and other information.
1. WHAT IS AQUAREST 0.2% eye gel in single-dose container AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: Ophthalmic agent, Tear substitute - ATC code: S01XA
This medication is a tear substitute.
It is indicated for the symptomatic treatment of dry eye.
You should consult your doctor if you do not experience any improvement or if you feel worse after 3 days of treatment.
2. WHAT YOU NEED TO KNOW BEFORE USING AQUAREST 0.2%, ophthalmic gel in single-dose container?
Never use AQUAREST 0.2% single-dose ophthalmic gel:
· if you are allergic to carbomer or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using AQUAREST 0.2% single-dose ophthalmic gel:
· if you wear contact lenses. In cases of dry eye syndrome, wearing contact lenses is often not recommended.
If your ophthalmologist allows you to do so, remove your lenses before instilling AQUAREST 0.2% single-dose ophthalmic gel and wait at least 15 minutes before reinserting them.
Children and adolescents up to 18 years of age
The safety and efficacy of AQUAREST 0.2% single-dose ophthalmic gel in children and adolescents, at the recommended adult dosage, has been established through clinical experience, but no clinical trial data are available.
Other medicines and AQUAREST 0.2% single-dose ophthalmic gel
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
No interactions are currently known.
Note:
If you use AQUAREST 0.2% single-dose ophthalmic gel at the same time as other eye drops, leave at least 15 minutes between applications.
If you use AQUAREST 0.2% eye gel in single-dose container at the same time as other eye ointments, leave a 15-minute interval between applications.
AQUAREST 0.2% eye gel in single-dose container may prolong the duration of other eye drops and thus enhance their effectiveness. To avoid this, AQUAREST 0.2% eye gel in single-dose container should always be the last medication to be applied.
AQUAREST 0.2% eye gel in single-dose container with food and drink
No interactions are currently known.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.
For AQUAREST 0.2% eye gel in single-dose container, no clinical data on use during pregnancy are available. However, there are no known risk factors that would prevent the use of AQUAREST 0.2% eye gel in single-dose container during pregnancy or breastfeeding.
Driving and using machines
Blurred vision, due to streaking lasting a few minutes, may occur after instilling this gel into the conjunctival sac; therefore, do not drive, work unsafely, or operate machinery during this period.
AQUAREST 0.2% eye gel in single-dose container contains phosphates.
This medicine contains 0.00831 mg of phosphates in each drop, which is equivalent to 1 mg/g.
If you suffer from 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).
3. HOW TO USE AQUAREST 0.2% Ophthalmic Gel in Single-Dose Container
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.
Treatment of dry eye syndrome requires individualized dosing.
Depending on the severity and intensity of symptoms, instill one drop into the conjunctival sac 3 to 5 times a day, or more frequently, and at bedtime.
Use a new single-dose container for each application.
Consult an ophthalmologist if your dry eye treatment is long-term or permanent.
AQUAREST 0.2% ophthalmic gel in a single-dose container is suitable for long-term treatment.
Tilt your head back and gently pull down your lower eyelid with one of your index fingers. With the other hand, hold the single-dose container upright above your eye (without touching it) and instill one drop into the conjunctival sac. Close your eyelid slowly and move your eye to evenly distribute the ophthalmic gel.
1. Carefully separate a single-dose container from the strip.
2. Open by twisting the cap of the single-dose container (without pulling).
3. Tilt your head back slightly and gently pull down your lower eyelid.
4. Hold the single-dose container upright with the opening facing downward.
5. Gently squeeze the single-dose container, avoiding touching the eye or the surrounding skin, until a drop falls into the conjunctival sac. This will prevent injury to the eye or contamination of the gel.
6. Close your eye and move it from side to side to distribute the ophthalmic gel evenly over the surface of the eye.
Use in children and adolescents up to 18 years of age
The safety and efficacy of AQUAREST 0.2% ophthalmic gel in single-dose containers in children and adolescents, at the recommended adult dosage, have been established through clinical experience, but no clinical trial data are available.
If you use more AQUAREST 0.2% single-dose eye gel than you should
If you accidentally use more than the recommended dose, this may cause blurred vision, which may resolve quickly.
If you forget to use AQUAREST 0.2% single-dose eye gel
Do not take a double dose to make up for a forgotten dose; continue taking the prescribed dose at the prescribed time. If necessary, you can also use AQUAREST 0.2% single-dose eye gel between scheduled instillations.
If you stop using AQUAREST 0.2% single-dose eye gel
You should expect the typical symptoms of dry eye to recur. It is best not to stop taking your treatment without first consulting your doctor.
If you have any further questions about using 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.
Intolerance reactions may occur in rare cases (may affect up to 1 in 10,000 people), such as a burning sensation in the eye.
If you suffer from severe damage to the cornea (the clear layer at the front of the eye), phosphates may, in very rare cases, cause vision problems due to calcium buildup 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 AQUAREST 0.2%, eye gel in single-dose container?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the carton and single-dose container after EXP. The expiry date refers to the last day of that month.
AQUAREST 0.2%, eye gel in single-dose container does not contain a preservative. Do not store an opened single-dose container. Discard any unused contents of the single-dose container after use.
Do not store this medicine above 25°C.
Store this medicine in the original outer packaging, away from light.
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 PACKAGE AND OTHER INFORMATION
What AQUAREST 0.2% eye gel contains in single-dose containers
· The active ingredient is:
Carbomer (viscosity 40,000-60,000 mPa.s)........................................................................ 2 mg
Per 1 g of eye gel
· The other ingredients are:
Sorbitol, medium-chain triglycerides, disodium phosphate dodecahydrate, sodium hydroxide, water for injections.
What is AQUAREST 0.2% eye gel in single-dose container and contents of the outer packaging?
AQUAREST 0.2% eye gel in single-dose container is a whitish, cloudy, liquid gel.
Boxes of 10, 30, 60, and 120 single-dose containers of 0.6 g of eye gel.
Not all pack sizes may be marketed.
Marketing Authorization Holder
LABORATOIRE CHAUVIN
416 RUE SAMUEL MORSE – CS99535
34961 MONTPELLIER
Marketing Authorization Holder
LABORATOIRE CHAUVIN
416 RUE SAMUEL MORSE – CS99535
34961 MONTPELLIER
Manufacturer
DR. GERHARD MANN CHEM. PHARM. FABRIK GMBH
BRUNSBÜTTELER DAMM, 165/173
13581 BERLIN
GERMANY
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names: In accordance with current regulations.
[To be completed later by the holder]
This leaflet was last revised:
[To be completed later by the holder]
{month YYYY}.
Other
Detailed information on this medicine is available on the ANSM (France) website.
Health Education Advice:
It is important that you see your ophthalmologist regularly for follow-up examinations, as dry eye can lead to serious illness if treated incorrectly or inadequately.
