NOTICE
ANSM - Updated on : 24/01/2024
Product name
BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, ophthalmic lavage solution in single-dose container
Borax/Boric acid
Sidebar
- Please read this leaflet carefully before using this medicine, as it contains important information for you.
- Always use this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects 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 out of the reach of children.
What does this leaflet contain?
1. What is BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in a single-dose container and what is it used for?
2. What do I need to know before using BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in a single-dose container?
3. How do I use BORAX/BORIC ACID VIATRIS 12 mg/18 mg/mL, ophthalmic solution in a single-dose container?
4. What are the possible side effects?
5. How to store BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in a single-dose container?
6. Package contents and other information.
1. WHAT IS BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in a single-dose container AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: LOCAL ANTISEPTIC/LIGHTASTRINGENT FOR OPHTHALMIC USE - ATC code: S: sensory organ
Eyewash in case of conjunctival irritation.
2. WHAT DO I HAVE TO KNOW BEFORE USING BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in a single-dose container?
Never use BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in a single-dose container:
- If you are allergic (hypersensitive) to boric acid, borax or any of the other ingredients listed in section 6.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
Talk to your doctor or pharmacist before using BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in single-dose containers.
Do not inject or swallow.
This product may be used in patients wearing contact lenses, but it is advisable to remove them before eyewashing.
Because of the risk of rapid bacterial contamination, an opened unit-dose container should never be reused for subsequent administrations. This product contains no preservatives.
Discard the container immediately after use.
Medical advice should be sought in the event of eye disorders, unusual eye symptoms, reduced visual acuity or eye pain.
If symptoms persist or worsen, or if new symptoms appear, discontinue treatment and consult a doctor.
Children and adolescents
Not applicable.
Other drugs and BORAX/BORIC ACID VIATRIS 12 mg/18 mg/mL, ophthalmic solution in single-dose container
Tell your doctor or pharmacist if you are using, have recently used or may use any other medicines.
BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in a single-dose container with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
This medicine should be used with caution during pregnancy and breast-feeding.
If you are pregnant or breastfeeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advicebefore taking this medicine.
Sportsmen
Not applicable.
Driving vehicles and operating machinery
Use with caution when driving a vehicle or operating machinery, as your vision may be blurred immediately after use. In this case, you are advised not to drive or operate machinery until your vision returns to normal.
BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in single-dose container contains
Not applicable.
3. HOW TO USE BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in a single-dose container?
Always use this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is 1 to 3 eye washes per day.
Washes are made directly by jet by turning the container upside down and pressing lightly on it, taking care not to bring the container into contact with the surface of the eye, and wiping off any excess with a compress or absorbent cotton.
Local use.
FOR EYEWASH
Wash hands thoroughly.
Avoid touching the eye or eyelids with the tip of the unit-dose container.
The same container can be used for both eyes.
Use immediately after opening and discard after use.
Do not reuse a previously opened container.
In the event of concomitant treatment with eye drops, wait 15 minutes before instilling.
If you have used more BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in a single-dose container than you should have and you experience any undesirable effects, rinse with sterile saline solution and consult your doctor or pharmacist immediately. If swallowed, seek medical advice or contact a Poison Control Centre immediately.
If you forget to use BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in single-dose container:
Not applicable.
If you stop using BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in a single-dose container :
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Rare adverse reactions (occurring in 1 to 10 people out of 10,000):
- Eye irritation
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO USE BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in single-dose container?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box or single-dose container after EXP. The expiration date refers to the last day of that month.
No special storage precautions are required.
After use, discard the container.
Do not reuse an opened unit-dose container.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, ophthalmic solution in single-dose container contains
The active ingredients are :
Borax.................................................................................................................................... 12 mg
Boric acid ....................................................................................................................... 18 mg
For 1 mL solution.
Other ingredients are :
Sodium chloride, distilled rose water, purified water.
What is BORAX/ACIDE BORIQUE VIATRIS 12 mg/18 mg/mL, solution for ophthalmic lavage in a single-dose container and what does it contain?
This medicine comes in the form of an ophthalmic solution.
Boxes of 10, 20 or 30 single-dose containers of 5 mL.
Not all presentations may be marketed.
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
LABORATOIRE UNITHER
151 RUE ANDRE DUROUCHEZ
ESPACE INDUSTRIEL NORD CS 28028
80084 AMIENS CEDEX 2
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.