NOTICE
ANSM - Updated: 23/05/2017
Name of the drug
Borax Boric Acid Biogaran 12mg / 18mg per ml12mg / 18mg / ml ophthalmic wash solution
Borax Boric Acid
framed
Read all of this leaflet carefully before you use Borax Boric Acid Biogaran this medicine because it contains important information for you.
You should always use Borax Boric Acid Biogaran , Ophthalmic Wash Solution in a single-dose container for this medicine, carefully following the information provided in this leaflet or by <,> or .
· 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 <,> or . This also applies to any undesirable effects that are 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 Borax Boric Acid Biogaran, solution for ophthalmic lavage in single-dose container and in which cases is it used?
2. What information do you need to know before using Borax Boric Acid Biogaran, solution for ophthalmic lavage in single-dose container?
3. How to use Borax Boric acid Biogaran, solution for ophthalmic lavage in single-dose container?
4. What are the possible side effects?
5. How to store Borax Boric acid Biogaran, solution for ophthalmic lavage in single-dose container?
6. Contents of the package and other information.
1. WHAT IS xxx AND WHAT IT IS USED FOR
Pharmacotherapeutic class LOCAL ANTISEPTIC / LIGHT ASTRINGENT FOR OPHTHALMIC USE , - ATC code: S: sensory organ.
Eye wash in case of conjunctival irritation.
You should talk to your doctor if you do not feel better or if you feel worse.
2. BEFORE YOU USE BORAX BORIC ACID BIOGARAN 12mg / 18mg per ml, OPHTHALMIC WASH SOLUTION?
Never use Borax Boric Acid Biogaran 12mg / 18mg / ml, solution for ophthalmic lavage in single-dose container.
· if you are allergic to Borax or Boric acid or to any of the other ingredients of this medicine, listed in section 6.1
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Borax Boric Acid Biogaran 12mg / 18mg / ml, ophthalmic lavage solution in a single-dose container.
Children and adolescents
Not applicable.
Other medicines and Borax Biogaran Boric Acid 12mg / 18mg / ml, solution for ophthalmic lavage in single-dose container .
Tell your doctor or pharmacist if you are using or might use any other medicines.
Pregnancy and lactation and fertility.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Use with caution when driving a vehicle or machinery because immediately after use, your vision may be disturbed. In this case, it is advisable not to drive or use machines until the return of normal vision.
Borax Boric Acid Biogaran 12mg / 18mg / ml, solution for ophthalmic lavage in single-dose container contains
Sodium Chloride, rose water concentrate, purified water.
3. HOW TO USE BORAX BORIC ACID BIOGARAN 12mg / 18mg per ml, OPHTHALMIC WASH SOLUTION?
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 not sure.
The recommended dose is 1 to 3 eye washes per day.
The washes are done directly by jet by inverting the bottle and pressing lightly on it, taking care not to put the bottle in contact with the surface of the eye and wiping the excess with a compress or hydrophilic cotton.
Local way. EYEWASH
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 for the treatment of both eyes.
Use the single-dose container immediately after opening and discard.
Do not reuse a single-dose container already opened.
If concomitant treatment with eye drops, wait 15 minutes before instillation.
If you have used more Borax Boric Acid Biogaran 12mg / 18mg / ml, ophthalmic wash solution in a single-dose container that you should have
Not applicable.
If you forget to use B orax Boric Acid Biogaran 12mg / 18mg / ml, solution for ophthalmic lavage in single-dose container .
Not applicable.
If you stop using Borax Boric Acid Biogaran 12mg / 18mg / ml, solution for ophthalmic lavage in single-dose container .
Not applicable.
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 not sure.
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.
Rare side effects (occurs in 1 to 10 out of 10,000 people):
· Eye irritation
Declaration of side effects
If you get any side effects, talk to <<> your pharmacist> . This also applies to any undesirable effects that are 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 on the safety of the medicine.
5. HOW TO STORE BORAX BORIC ACID BIOGARAN 12mg / 18mg per ml, OPHTHALMIC WASH SOLUTION?
Keep this medicine out of the sight and reach of children.
Before opening : No special precautions for storage.
After opening : Discard the single-dose container after use.
Do not use this medicine after the expiry date which is stated on the vial label or carton. The expiry date refers to the last day of this month.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medication in the sewage system or garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What Borax Boric Acid contains Biogaran 12mg / 18mg / ml, solution for Ophthalmic lavage.
· Borax: ............................................................................................................ 1.2 g
· Boric acid: ............................................................................................. 1.8 g
For 100 ml of solution.
The other ingredients are : Sodium Chloride, Rose Water Concentrate, Purified Water.
What Borax Boric Acid Biogaran 12mg / 18mg / ml, Ophthalmic Wash Solution and Package Content
This medicine is in the form of an ophthalmic lavage solution in a single-dose container of 5 ml and 10 ml.
Box of 10, 20, 30 or 100 single-dose containers.
Not all presentations may be marketed.
Marketing Authorization Holder
ALEPT
9 CHEMIN DE SAINT GERMAIN
38700 CORENC
la France
Operator of the marketing authorization
BIOGARAN Laboratories
15 BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
Maker
UNITHER LABORATORY
ZI LONGPRE
10 RUE ANDRE DUROUCHEZ
80084 AMIENS CEDEX 2
Or
LAPHAL INDUSTRIES
AVENUE OF PROVENCE
13190 ALLAUCH
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
MAY 2017
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
Eye irritation is a benign and common condition.
Eyewashing is a therapeutic action that can be enough to relieve superficial irritation of the eye.
Indeed, the eye wash facilitates the elimination of foreign bodies that irritate the eye, such as sand, midges, dust, makeup debris ..., and helps to reduce the feeling of discomfort.
Other factors may cause irritation and may not respond to eyewashing. In this case, it is necessary to consult your doctor.
Tracking notebook:
Not applicable.