SUMMARY OF PRODUCT FEATURES
ANSM - Updated on: 01/12/2024
1. NAME OF THE MEDICINE
AQUAREST 0.2%, ophthalmic gel in single-dose container
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbomer................................................................................................................................. 2 mg
For 1g of ophthalmic gel
1 g of ophthalmic gel contains 2 mg of carbomer (viscosity 40,000-60,000 mPa.s).
Excipient with known effect:
AQUAREST 0.2% ophthalmic gel in single-dose container contains 0.00831 mg of phosphates in each drop, which is equivalent to 1 mg/g.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye gel.
Liquid, whitish, cloudy gel.
4. CLINICAL DATA
4.1. Therapeutic indications
Symptomatic treatment of dry eye.
4.2. Dosage and method of administration
Dosage
Treatment of dry eye syndrome requires individualized dosage.
Depending on the severity and intensity of symptoms, instill one drop into the conjunctival sac 3 to 5 times a day or more frequently if necessary and at bedtime.
Take care to administer small drops by gently pressing the unit-dose container and holding it vertically.
Avoid contact of the single-dose container with the eye and eyelids.
Consult an ophthalmologist if dry eye treatment is long-term or permanent. If dry eye symptoms persist or worsen, stop using this medication and consult your doctor.
Mode of administration
Ophthalmic route.
Pediatric population
The safety and efficacy of AQUAREST 0.2% single-dose ophthalmic gel in children and adolescents, at the recommended adult dosage, has been established by clinical experience, but no clinical trial data are available.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Contact lens wearers should remove their lenses before instilling AQUAREST 0.2% single-dose ophthalmic gel and wait 15 minutes before reinserting them.
4.5. Interactions with other medicinal products and other forms of interaction
No known interactions.
Please note:
If you use AQUAREST 0.2% eye gel in single-dose container at the same time as other eye drops, leave an interval of 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 an interval of 15 minutes between applications.
AQUAREST 0.2% eye gel in single-dose container may prolong the persistence of other eye drops and thus increase their effectiveness. To avoid this, AQUAREST 0.2% eye gel in single-dose container should always be the last medication to be applied.
4.6. Fertility, pregnancy and breastfeeding
Fertility
No fertility data are available for carbomer. However, systemic exposure following the use of AQUAREST 0.2% ophthalmic gel in single-dose container is expected to be low and effects on fertility are unlikely.
Pregnancy
For AQUAREST 0.2% ophthalmic gel in single-dose container, no clinical data on use during pregnancy are available. Carbomer is probably absorbed only in small proportions and systemic exposure is therefore expected to be low.
Breastfeeding
No effects on breastfed children are expected given the low systemic exposure to carbomer in breastfeeding women. AQUAREST 0.2% ophthalmic gel in single-dose container can be used during breastfeeding.
Generally, this medication should not be used during pregnancy or breastfeeding unless a doctor has carefully considered all the potential risks and benefits.
4.7. Effects on ability to drive and use machines
AQUAREST 0.2% ophthalmic gel in single-dose container has minor to moderate influence on the ability to drive and use machines for 5 minutes after instillation. Blurred vision, due to streaking for a few minutes, may occur after instillation of this gel into the conjunctival sac. Therefore, patients should not operate machinery, work unsafely or drive vehicles during this period.
4.8. Adverse effects
Adverse reactions are categorized by frequency as follows:
· Very common (≥ 1/10)
· Common (≥ 1/100 to < 1/10)
· Uncommon (≥ 1/1,000 and < 1/100)
· Rare (≥ 1/10,000 and < 1/1,000)
· Very rare (< 1/10,000)
· Frequency not known (cannot be estimated from the available data)
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Immune system disorders
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Very rare (< 1/10,000)
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Intolerance reactions to any of the components of this medicine.
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Eye conditions
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Frequency undetermined
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As with all eye preparations, blurred vision may occur shortly after instillation.
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Frequency undetermined
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Other reactions such as itching and burning have been observed in studies with comparable products.
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Very rare (< 1/10,000)
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A few very rare cases of corneal calcification have been reported in association with the use of phosphate-containing drops in some patients with severely damaged corneas.
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Reporting of suspected adverse reactions
Reporting suspected adverse reactions after drug authorization is important. It allows for continued monitoring of the drug's benefit/risk balance. Healthcare professionals report any suspected adverse reactions via the national reporting system: 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/ .
4.9. Overdose
No cases of overdose have been reported.
Any ocular or oral overdose that may occur has no clinical consequences.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmic agent, tear substitute, ATC code: S01XA .
The active substance carbomer forms a hydrophilic film that adheres to the ocular surface. It binds to water molecules and stabilizes the tear film.
5.2. Pharmacokinetic properties
During pharmacokinetic studies, radioactive carbomer was administered to rats. It was shown that only a small amount of carbomer is absorbed. After a single administration, 0.75% of the administered dose was detected as carbon dioxide in expired air, and 0.63% in urine. Most of the carbomer (92%) was detected in feces 24 hours after dosing.
Due to the macromolecular structure of carbomer, it is assumed that this proportion is eliminated without being metabolized, that is, it does not pass into the enterohepatic circulation.
5.3. Preclinical safety data
Non-clinical data for the carbomer used in AQUAREST 0.2% Ophthalmic Gel in Single-Dose Container, as well as for identical polyacrylic acids, reveal no special hazard for humans based on conventional studies of subacute and chronic toxicity, genotoxicity, reproductive toxicity and local tolerance. No eye irritation was observed in acute toxicity studies in rabbits and dogs after single and repeated doses of AQUAREST 0.2% Ophthalmic Gel in Single-Dose Container.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Sorbitol
Medium-chain triglycerides
Disodium phosphate dodecahydrate
Sodium hydroxide
Water for injections.
6.2. Incompatibilities
Not applicable.
6.3. Retention period
Unopened containers of this gel have a shelf life of 2 years.
AQUAREST 0.2%, ophthalmic gel in single-dose container does not contain preservative.
Do not store a single-dose container that has already been opened.
Discard any unused contents of the single-dose container after application.
6.4. Special storage precautions
Store at a temperature not exceeding 25°C.
Store in the original outer packaging, away from light.
6.5. Nature and contents of outer packaging
Single-dose container (LDPE) of 0.6 g, boxes of 10, 30, 60 and 120.
Not all presentations may be marketed.
6.6. Special precautions for disposal and handling
Any unused medicine or waste material should be disposed of in accordance with local regulations.
For single use only.
7. MARKETING AUTHORISATION HOLDER
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE – CS 99535
34961 MONTPELLIER
8. MARKETING AUTHORISATION NUMBER(S)
· 34009 391 995 6 6: 0.6 g of gel in single-dose container (LDPE), box of 10.
· 34009 391 565 1 4: 0.6 g of gel in single-dose container (LDPE), box of 30.
· 34009 391 566 8 2: 0.6 g of gel in single-dose container (LDPE), box of 60.
· 34009 391 567 4 3: 0.6 g of gel in single-dose container (LDPE), box of 120.
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
[to be completed later by the holder]
10. DATE OF TEXT UPDATE
[to be completed later by the holder]
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND DELIVERY
Drug not subject to medical prescription.
NOTICE
ANSM - Updated on: 01/12/2024
Name of the drug
AQUAREST 0.2%, ophthalmic gel in single-dose container
Carbomer
Boxed
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as directed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Contact your pharmacist for any 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 should contact your doctor if you do not feel any improvement or if you feel worse after 3 days.
What does this leaflet contain?
1. What is AQUAREST 0.2%, ophthalmic gel in single-dose container and what is it used for?
2. What you need to know before using AQUAREST 0.2%, ophthalmic gel in single-dose container?
3. How to use AQUAREST 0.2%, ophthalmic gel in single-dose container?
4. What are the possible side effects?
5. How to store AQUAREST 0.2%, ophthalmic gel in single-dose container?
6. Package contents and other information.
1. WHAT IS AQUAREST 0.2%, ophthalmic gel in single-dose container AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: Ophthalmic agent, Tear substitute - ATC code: S01XA
This medicine is a tear fluid substitute.
It is indicated in the symptomatic treatment of dry eye.
You should contact your doctor if you do not feel any improvement or if you feel worse after 3 days of treatment.
2. WHAT INFORMATION DO YOU NEED TO KNOW BEFORE USING AQUAREST 0.2%, ophthalmic gel in single-dose container?
Never use AQUAREST 0.2%, ophthalmic gel in single-dose container:
· 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%, eye gel in single-dose container :
· if you wear contact lenses. In cases of dry eye syndrome, wearing contact lenses is often not recommended.
However, if your ophthalmologist allows you to do so, remove your lenses before instilling AQUAREST 0.2%, ophthalmic gel in single-dose container and wait at least 15 minutes before putting them back in.
Children and adolescents up to 18 years old
The safety and efficacy of AQUAREST 0.2% single-dose ophthalmic gel in children and adolescents, at the recommended adult dosage, has been established by clinical experience, but no clinical trial data are available.
Other medicines and AQUAREST 0.2%, ophthalmic gel in single-dose container
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 interaction is known to date.
Please note:
· If you use AQUAREST 0.2% eye gel in single-dose container at the same time as other eye drops, leave an interval of 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 an interval of 15 minutes between applications.
· AQUAREST 0.2% eye gel in single-dose container may prolong the persistence of other eye drops and thus increase their action. To avoid this, AQUAREST 0.2% eye gel in single-dose container should always be the last medicine to be applied.
AQUAREST 0.2%, ophthalmic gel in single-dose container with food and drinks
No interaction is known to date.
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 for advice before taking this medicine.
For AQUAREST 0.2%, ophthalmic gel in single-dose container, no clinical data on use during pregnancy are available, but on the other hand, there are no known risk factors arguing against the use of AQUAREST 0.2%, ophthalmic gel in single-dose container during pregnancy or breastfeeding.
Driving and operating machinery
Blurred vision, due to the formation of streaks for a few minutes, may appear after instilling this gel into the conjunctival sac; therefore, do not drive, do not work outside of safe conditions, do not operate machinery during this period.
AQUAREST 0.2%, ophthalmic 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 have severe damage to the cornea (the clear layer at the front of the eye), phosphates can, in very rare cases, cause vision problems due to calcium buildup 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 your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
Treatment of dry eye syndrome requires individualized dosage.
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 single-dose container can be used 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 distribute the eye gel evenly.
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1. Carefully separate a single-dose container from the strip.
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2. Open by twisting the cap of the single-dose container (without pulling).
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3. Tilt your head back slightly and gently pull the lower eyelid down.
4. Hold the single-dose container upright with the opening facing down.
5. Gently squeeze the single-dose container, avoiding touching the eye or the skin around the eye, 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 right to left to spread the eye gel evenly over the surface of the eye.
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Use in 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 by clinical experience, but no clinical trial data are available.
If you use more AQUAREST 0.2% eye gel in single-dose container than you should
If you accidentally use more than the recommended dose, it can cause blurred vision, but it will clear up quickly.
If you forget to use AQUAREST 0.2% eye gel in single-dose container
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% eye gel in single-dose containers between scheduled instillations.
If you stop using AQUAREST 0.2% eye gel in single-dose container
You should expect typical dry eye symptoms to recur. It's best to continue taking this medication without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE 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), e.g. burning sensation in the eye.
If you have severe damage to the cornea (the clear layer at the front of the eye), phosphates can, 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: 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%, ophthalmic 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 which is stated on the carton and single-dose container after EXP. The expiry date refers to the last day of that month.
AQUAREST 0.2% ophthalmic gel in single-dose containers does not contain a preservative. Do not store an opened single-dose container. Discard any unused contents of the single-dose container after application.
Store this medicine at a temperature not exceeding 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 you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What AQUAREST 0.2% ophthalmic gel in single-dose container contains
· The active substance is:
Carbomer (viscosity 40,000-60,000 mPa.s)........................................................................... 2 mg
For 1 g of ophthalmic gel
· The other components are:
Sorbitol, medium chain triglycerides, disodium phosphate dodecahydrate, sodium hydroxide, water for injections.
What is AQUAREST 0.2%, ophthalmic gel in single-dose container and contents of the outer packaging?
AQUAREST 0.2%, ophthalmic gel in single-dose container is a liquid, whitish, cloudy gel.
Boxes of 10, 30, 60 and 120 single-dose containers of 0.6 g of ophthalmic gel.
Not all presentations may be marketed.
Marketing Authorisation Holder
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE – CS99535
34961 MONTPELLIER
Marketing Authorization Operator
CHAUVIN LABORATORY
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 medicine in the member states of the European Economic Area
This medicine 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]
The last date this notice was revised is:
[to be completed later by the holder]
{month YYYY}.
Others
Detailed information on this medicine is available on the ANSM (France) website.
Health Education Council:
It is important that you visit your ophthalmologist regularly for follow-up examinations, as dry eye can lead to serious illness if treated improperly or insufficiently.
