NOTICE
ANSM - Updated on: 01/17/2019
Name of the drug
DACRYOSERUM, solution for ophthalmic lavage in single-dose container
Borax / Boric acid
Framed
Read all of this leaflet carefully before using this medicine because it contains important information for you.
You should always use this medicine by carefully following the information given 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 get any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement or if you feel less well.
Keep this medicine out of the reach of children.
What does this booklet contain ?
1. What is DACRYOSERUM, solution for ophthalmic washing in a single-dose container and in which cases is it used?
2. What should I know before using DACRYOSERUM, solution for ophthalmic washing in a single-dose container?
3. How to use DACRYOSERUM, solution for ophthalmic washing in a single-dose container?
4. What are the possible side effects ?
5. How to store DACRYOSERUM, solution for ophthalmic washing in a single-dose container?
6. Contents of the pack and other information.
1. WHAT IS DACRYOSERUM, solution for ophthalmic lavage in a single-dose container AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: LOCAL ANTISEPTIC / LIGHT ASTRINGENT FOR OPHTHALMIC USE - ATC code: S: sensory organ
Eye wash in case of conjunctival irritation.
2. WHAT YOU NEED TO KNOW BEFORE USING DACRYOSERUM, solution for ophthalmic washing in a single-dose container?
Never use DACRYOSERUM, solution for ophthalmic washing in a single-dose container:
· If you are allergic (hypersensitive) to boric acid, borax or any of the other ingredients of this medication mentioned in section 6.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Warnings and Precautions
Talk to your doctor or pharmacist before using DACRYOSERUM, solution for ophthalmic washing in a single-dose container .
Do not inject, do not swallow.
This product can be used in patients with contact lenses, however, it is advisable to remove them before washing the eyes.
Due to the risk of rapid bacterial contamination, an opened single-dose container should never be reused for subsequent administrations, this product does not contain a preservative.
Discard the single-dose container immediately after use.
It is advisable to seek medical advice in the event of eye problems, unusual eye symptoms, reduced visual acuity and eye pain.
If symptoms persist or worsen, or if new symptoms appear, stop treatment and consult a doctor.
Children and adolescents
Not applicable.
Other medicines and DACRYOSERUM, solution for ophthalmic lavage in single-dose container
Tell your doctor or pharmacist if you are using, have recently taken or might use any other medicines.
DACRYOSERUM, solution for ophthalmic washing in a single-dose container with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
This drug should be used with caution during pregnancy and lactation.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice. or pharmacist before taking this medicine.
Sportsmen
Not applicable.
Driving and using machines
Use with caution when driving a vehicle or machinery as immediately after use your vision may be affected. In this case, it is advisable not to drive or use machines until normal vision returns.
DACRYOSERUM, solution for ophthalmic washing in a single-dose container contains sodium chloride, distilled rose water and purified water.
3. HOW TO USE DACRYOSERUM, solution for ophthalmic washing in a single-dose container?
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
The recommended dose is 1 to 3 eye washes per day.
The washes are done directly by jet by inverting the single-dose container and pressing it lightly, taking care not to bring the single-dose container into contact with the surface of the eye and wiping off the excess with a compress or cotton wool.
Local route.
IN EYE WASH
Wash hands thoroughly.
Avoid touching the eye or eyelids with the tip of the single-dose container.
You can use the same single-dose container to treat both eyes.
Use the single-dose container immediately after opening and discard after use.
Do not reuse an already opened single-dose container.
In the event of concomitant treatment with eye drops, wait 15 minutes before instillation.
If you have used more DACRYOSERUM, solution for ophthalmic washing in a single-dose container than you should and you experience side effects, rinse with sterile physiological saline and immediately consult your doctor or pharmacist. If swallowed, seek medical advice or contact a poison control center immediately.
If you forget to use DACRYOSERUM, solution for ophthalmic washing in a single-dose container:
Not applicable.
If you stop using DACRYOSERUM, solution for ophthalmic washing in a single-dose container:
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare common side effects (occurs in 1 to 10 in 10,000 people):
· Eye irritation
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DACRYOSERUM, solution for ophthalmic washing in a single-dose container?
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package.
After use, the single-dose container should be discarded.
Do not reuse an already opened single-dose container.
Do not throw away any medicine via wastewater or household waste . Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What DACRYOSERUM contains, solution for ophthalmic washing in a single-dose container
· The active substances are:
Borax................................................. .................................................. ................................. 1.20 g
Boric acid................................................ .................................................. ...................... 1.80 g
For 100 ml.
· The other ingredients are: sodium chloride, distilled rose water, purified water.
What is DACRYOSERUM, solution for ophthalmic washing in a single-dose container and contents of the outer packaging?
This medication is in the form of an ophthalmic lavage solution.
Box of 10, 20 or 30 single-dose containers.
Not all presentations may be marketed.
Marketing authorization holder
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN
Marketing authorization operator
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN
Maker
UNITHER LABORATORY
North Industrial Space
151 André Durouchez Street
CS 28028
80084 AMIENS CEDEX 2
Or
UNITHER
ZI DE LA GUERIE
50211 COUTANCES CEDEX
Names of the drug in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medication is available on the ANSM website (France).