BORAX/BORIC ACID BIOGARAN 12 mg/18 mg/ml Solution for ophthalmic rinsing in single-dose container 20Single-dose/5ml

Borax.............................................................................................................................................................. 12 mg

Boric Acid................................................................................................................................................ 18 mg

For 1 ml of solution.

Eye irrigation in case of conjunctival irritation.

Dosage

For eye irrigation

1 to 3 eye irrigations per day.

Paediatric population

No data are available.

Method of administration

Topical use.

Irrigation is performed directly by jet, by turning the single-dose container upside down and gently pressing on it, 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 absorbent cotton.

Use the single-dose container immediately after opening and discard after use.

The single-dose container may be used for treatment of both eyes.

Do not reuse an opened single-dose container.

In case of concomitant treatment with eye drops, it is advisable to wait 15 minutes before instilling them.

Hypersensitivity to boric acid, borax or to any of the excipients listed in section Composition.

Do not inject, do not swallow.

This product does not contain a preservative. This product may be used in patients wearing contact lenses; however, it is advised to remove them before performing eye irrigation.

Due to the risk of rapid bacterial contamination, an opened single-dose container must never be reused for subsequent administrations.

Discard the single-dose container immediately after use

In case of concomitant treatment with eye drops containing a different active substance, space the instillations by 15 minutes.

Use with caution in pregnant or breastfeeding women, due to a lack of usable clinical data.

A transient visual disturbance may occur after instillation of the eye solution and may affect the ability to drive vehicles or operate machinery. In this case, it is advised not to drive or operate machinery until normal vision returns.

Adverse effects identified during clinical trials and after marketing with this product are listed within organ systems by frequency in the table below according to the following convention:

Very common (≥1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated from the available data).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

No cases of overdose have been reported.

In case of irritation, rinse with sterile physiological saline.

Pharmacotherapeutic class: LOCAL ANTISEPTIC/MILD ASTRINGENT FOR OPHTHALMIC USE, ATC code: , S (sensory organs).

Single-dose container of 5 ml: 30 months

Single-dose container of 10 ml: 36 months

Before opening: This medicine does not require any particular storage precautions.

After opening: The single-dose container must be used immediately and then discarded. Do not reuse a single-dose container that has already been opened.

No special requirements for disposal.