NOTICE
ANSM - Updated: 06/06/2018
Name of the drug
DACUDOSES, Solution for ophthalmic lavage in single-dose container
Boric acid, Borax
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is DACUDOSES, solution for ophthalmic lavage in single-dose container and in which cases is it used?
2. What you need to know before taking DACUDOSES, ophthalmic lavage solution in single-dose container.
3. How to take DACUDOSES, solution for ophthalmic lavage in single-dose container?
4. What are the possible side effects?
5. How to store DACUDOSES, solution for ophthalmic lavage in single-dose container?
6. Contents of the package and other information.
1. WHAT DACUDOSES is, solution for ophthalmic lavage in single-dose container AND WHAT IT IS USED FOR?
Pharmacotherapeutic group OTHER ANTI-INFECTIOUS (S: Sensory organs). - ATC code: S01AX
This medicine is an antiseptic solution for washing the eyes. It is used in case of irritation of the eye (conjunctival irritation).
You should talk to your doctor if you do not feel better or if you feel worse.
2. BEFORE YOU TAKE DACUDOSES, solution for ophthalmic lavage in single-dose container?
Never use DACUDOSES, Solution for ophthalmic lavage in single-dose container:
· if you are allergic (hypersensitive) to boric acid, borax, or any of the other ingredients of this medicine, listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using DACUDOSES, an ophthalmic lavage solution in a single-dose container .
Do not inject, do not swallow.
If eye irritation persists without improvement or worsens after 2 days of treatment, seek medical attention.
This treatment is not a treatment of irritation due to contact lenses.
If you are a wearer of contact lenses, you can use this product, however, it is necessary to remove them before washing the eye.
Avoid touching the eye or eyelids with the tip of the vial.
The single-dose container should be discarded immediately after use and should not be stored for reuse in subsequent administrations due to the rapid risk of bacterial contamination, as this product does not contain a preservative.
Children and adolescents.
Not applicable.
Other medicines and DACUDOSES, solution for ophthalmic lavage in single-dose container
The effectiveness of an eye drop can be disturbed by the simultaneous instillation of another eye drop. In this case, wait 15 minutes before performing the second instillation.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
DACUDOSES, solution for ophthalmic washing in single-dose container with food and drink and alcohol
Not applicable.
Pregnancy and breast feeding
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 using this medicine.
Driving and using machines
Immediately after use, your vision may be disturbed. Be careful if you drive vehicles or use machines.
DACUDOSES, ophthalmic lavage solution in a single-dose container contains Turkish rose concentrate, sodium chloride and purified water.
This medicine contains a fragrance containing allergens: citronellol, geraniol, benzyl alcohol, linalool, eugenol, which can cause allergic reactions.
3. HOW TO TAKE DACUDOSES, solution for ophthalmic lavage 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 in doubt.
The recommended dose is 1 to 4 washes or applications per day, as needed.
Each single-dose container contains a sufficient amount of medication for treatment of both eyes.
Administration mode
This drug is intended to be administered in the eye (eye wash)
1- Wash your hands thoroughly before handling the single dose container,
2- Unscrew the head of the single-dose container,
3- Pull the lower eyelid slightly down and look up,
4- Wash your eye with gentle pressure by gently pressing on the single-dose container
5- Wipe excess with a compress or cotton wool,
6 Discard the single-dose container immediately after use. Do not reuse a single-dose container already started.
If you take more DACUDOSES, ophthalmic lavage solution in a single-dose container than you should
Not applicable.
If you forget to take DACUDOSES, solution for ophthalmic lavage in single-dose container
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking DACUDOSES, ophthalmic lavage solution in a single-dose container
Not applicable.
If you have any further questions about 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.
Passive visual discomfort after instillation of the ophthalmic solution.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned 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: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE DACUDOSES, solution for ophthalmic lavage 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 bottle.
The expiry date refers to the last day of this month.
Discard the single-dose container immediately after use.
Do not reuse a single-dose container already started.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What contains DACUDOSES, solution for ophthalmic washing in single-dose container
· The active substances are:
Boric acid................................................ .................................................. .................... 0.180 g
Borax................................................. .................................................. ............................... 0.120 g
For a single-dose container of 10 mL
· The other components are:
Turkish Rose Concentrate *, Sodium Chloride, Purified Water.
* Composition of Turkish rose concentrate : citronellol, nerol, geraniol, benzyl alcohol, linalool, linalyl acetate, ethyldiglycol, nerolidol, phenylethyl alcohol, eugenol.
What is DACUDOSES, ophthalmic wash solution in single-dose container and contents of the pack
This medication is in the form of an eyewash solution in a single-dose container. Box of 8, 16, 24 or 32.
Marketing Authorization Holder
GIFRER BARBEZAT
8 to 10, RUE PAUL BERT
69150 DECINES-CHARPIEU
Operator of the marketing authorization
THEA PHARMA
12, RUE LOUIS BLERIOT
ZI DU BREZET
63100 CLERMONT-FERRAND
LA FRANCE
Maker
UNITHER LABORATORIES
ZI LONGPRE
10 RUE ANDRE DUROUCHEZ
80052 AMIENS CEDEX 2
or
GIFRER BARBEZAT
8 to 10, RUE PAUL BERT
69150 DECINES-CHARPIEU
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).