ALLERGOCOMOD Eye drops solution Pump bottle/10ml

Sodium cromoglycate ........................................................................................................ 2,000 g

Quantity corresponding to cromoglycic acid ............................................................................1,830 g

For 100 ml

Symptomatic treatment of allergic ophthalmic conditions.

Topical route

FOR OCULAR INSTILLATION

Wash hands thoroughly before proceeding with instillation.

Avoid contact of the tip with the eye or eyelids.

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 lower eyelid down.

Recap the bottle after use.

Paediatric population

In children, medical advice is required.

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

Special precautions for use:

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.

Recap the bottle after use.

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

Pregnancy

Studies performed in animals have not demonstrated a teratogenic effect.

In the absence of a teratogenic effect in animals, a malformative effect in humans is not expected. Indeed, to date, substances responsible for malformations in humans have proven teratogenic in animals in well-conducted studies in two species.

Clinically, analysis of a large number of exposed pregnancies apparently revealed no particular malformative or foetotoxic effect of sodium cromoglycate. However, only epidemiological studies would make it possible to verify the absence of risk.

Consequently, sodium cromoglycate may be prescribed during pregnancy if needed.

Breast-feeding

There are no data on the passage of sodium cromoglycate into breast milk. However, due to very partial absorption at the respiratory mucosa on the one hand, negligible digestive absorption on the other hand, and given the absence of toxicity, breastfeeding is possible during treatment with this medicine.

A temporary visual disturbance may be felt after instillation of the eye drops. In this case, wait until the symptoms have subsided before driving a vehicle or operating a machine.

Possibility of hypersensitivity reactions to sodium cromoglycate or to one of the constituents of the eye drops.

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 are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.signalement-sante.gouv.fr.

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

(S = Sensory organs)

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

Before opening, 3 years.

After the first opening of the bottle, the sterile ophthalmic solution must not be used for more than 12 weeks.

Store at a temperature not exceeding 25 °C.

No special requirements.