CROMOGLICATE DE SODIUM BIOGARAN 2 % Eye drops solution Bottle/5ml

Sodium cromoglicate....................................................................................................................................2 g

For 100 ml of eye drops in solution.

Excipient with known effect: benzalkonium chloride.

For the full list of excipients, see section Composition.

Symptomatic treatment of allergic ophthalmic conditions.

Dosage

Adults and children: depending on the severity of symptoms, instil 1 drop of eye drops 2 to 6 times a day, at regular intervals, into the conjunctival sac of the affected eye, looking upwards, and gently pulling the eyelid downwards.

In children, medical advice is necessary.

Method of administration

Ophthalmic use.

FOR OCULAR INSTILLATION.

Wash hands thoroughly before proceeding with instillation.

Avoid contact of the tip with the eye or eyelids.

Reseal the bottle after use.

Hypersensitivity to the active substance or to any of the excipients mentioned in section Composition.

DO NOT INJECT, DO NOT SWALLOW.

Do not exceed the recommended dose.

In the absence of improvement or if symptoms persist, seek medical advice.

Avoid contact of the tip with the eye or eyelids.

Reseal the bottle after use.

This medicine contains 0,5 mg of benzalkonium chloride per bottle of 5 ml of eye drops.

Benzalkonium chloride may be absorbed by soft contact lenses and change their colour. Remove contact lenses before application and wait at least 15 minutes before reinserting them.

Benzalkonium chloride may also cause eye irritation, especially if you suffer from dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience abnormal sensation, tingling or pain in the eyes after using this medicine, contact your doctor.

In case of concomitant treatment with another eye drops, wait 15 minutes between each instillation.

Pregnancy

There is little or no data on the use of eye drops containing sodium cromoglicate in pregnant women. Animal studies do not show any direct or indirect harmful effect on reproductive function (see section Preclinical safety).

Given the low systemic absorption after topical ocular administration, no undesirable effects on pregnancy are expected. SODIUM CROMOGLICATE BIOGARAN may be used during pregnancy.

Breast-feeding

Given the low systemic passage following topical ocular administration, no adverse effects are expected. CROMOGLICATE DE SODIUM BIOGARAN can be used during breast-feeding.

Fertility

Given the low systemic passage following topical ocular administration, no effect on fertility in humans is expected. Data in animals do not show any effect on fertility (see section Preclinical safety).

A transient visual disturbance may be felt after instillation of the eye drops in solution.

In this case, it is advised not to drive or use machines until normal vision returns.

The adverse effects reported with sodium cromoglicate are listed below by System Organ Class (SOC) and by frequency.

*Transient stinging and burning sensations may occur after instillation. Other symptoms of local irritation have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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/.

In case of overdose, rinse with sterile physiological saline.

Pharmacotherapeutic class: LOCAL ANTI-ALLERGIC, ATC code: S01GX01.

Sodium cromoglicate has recognised anti-allergic properties at the level of the mucous membranes; by stabilising the mast cell membrane, it prevents the release of the chemical mediators responsible for anaphylactic reactions.

Sodium cromoglicate is partly absorbed through the mucous membrane. It is not metabolised. It is excreted unchanged in the bile and urine.

Preclinical data reveal no particular risk for administration of sodium cromoglicate in humans, based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenesis, and reproductive and developmental toxicity. Sodium cromoglicate is well tolerated after ocular application; slight transient conjunctival irritation was observed in rabbits. In preclinical models, sodium cromoglicate does not induce sensitisation or photosensitisation, and does not interfere with corneal healing processes.

Before opening: 3 years.

After opening: the opened bottle can be stored for 28 days.

This medicine does not require any particular storage precautions.

No special requirements.