HUMEX 2 % Collyre en sol conjonctivite allergique en récipient unidose 2Sach/5unid

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

For 100 ml.

Seasonal or non-seasonal allergic conjunctivitis.

Ophthalmic route

Wash hands thoroughly before proceeding with instillation.

Avoid contact of the tip with the eye or eyelids.

Each single-dose container contains a sufficient quantity of eye drops to treat both eyes.

Adults and children over 15 years of age : 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 upward, and gently pulling the eyelid downward.

In children under 15 years of age, medical advice is necessary.

Discard the single-dose container after each use. Do not keep it for later use.

If concomitant treatment with another eye drop is used, wait 15 minutes between each instillation.

If there is no improvement after 7 days of treatment, it is necessary to seek medical advice.

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

Precautions for use

DO NOT INJECT, DO NOT SWALLOW.

The eye drops must not be administered by peri- or intra-ocular injection.

Do not exceed the recommended dose.

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

Wash hands thoroughly before instilling.

Avoid contact of the tip with the eye or eyelids.

This eye drop does not contain a preservative.

Discard the single-dose container after each use. Do not keep it for later use.

Furthermore, if symptoms persist or worsen, the patient should be seen by a doctor.

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.

In clinical practice, there is currently no sufficiently relevant data to assess a possible malformative or foetotoxic effect of sodium cromoglicate when administered during pregnancy.

Consequently, as a precautionary measure, it is preferable not to use sodium cromoglicate during pregnancy.

Breast-feeding

There is no data on the passage of sodium cromoglicate into breast milk.

However, given the absence of toxicity, breastfeeding is possible during treatment with this medicine.

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

In this case, wait until the symptoms have ended before driving a vehicle or using a machine.

Possible occurrence of:

• hypersensitivity reactions to sodium cromoglicate,

• transient visual discomfort after instillation 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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

Pharmacotherapeutic class: Other antiallergics, 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 by the mucous membrane, resulting in a low systemic passage. It is not metabolised; it is excreted unchanged in bile and urine.

3 years.

After opening the single-dose container: the product must be used immediately.

Discard the single-dose container after each use.

Do not keep for later use.

No special requirements.