CROMABAK

Symptomatic treatment of ophthalmic conditions of allergic origin.

Hypersensitivity to sodium cromoglicate or to any of the constituents of the eye drops.

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

Pregnancy

There is little or no data on the use of the product OPTICRON 2 POUR CENT, collyre in pregnant women. Animal studies do not show any direct or indirect adverse effect on reproductive functions (see section 5.3).

Given the low systemic passage after topical ocular administration, no adverse effect on pregnancy is expected. OPTICRON 2 POUR CENT, collyre can be used during pregnancy.

Breastfeeding

Given the low systemic passage after topical ocular administration, no adverse effect is expected. OPTICRON 2 POUR CENT, collyre can be used during breastfeeding.

Fertility

Given the low systemic passage after topical ocular administration, no effect on fertility in humans is expected. Animal data do not show any effect on fertility (see section 5.3).

Transient visual discomfort 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 OPTICRON 2 %, eye drops 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 effects

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