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

Eye drops in solution.

Sodium cromoglicate ................................................................................................................ 2,00 g

For 100 mL.

Excipient with known effect: This medicine contains 0,1 mg of benzalkonium chloride per mL of eye drops.

Excipients:

Symptomatic treatment of allergic ophthalmic conditions.

Method of administration

Topical use.

FOR OCULAR INSTILLATION.

Wash hands thoroughly before proceeding with instillation.

Avoid contact of the tip with the eye or eyelids.

Replace the cap on the bottle after use.

Dosage

Adults and children: depending on the severity of the 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.

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

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.

Replace the cap on the bottle after use.

This medicine contains 0,1 mg of benzalkonium chloride per millilitre of eye drops.

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

Benzalkonium chloride may also cause eye irritation, especially if the patient suffers from dry eye syndrome or corneal disorders (the transparent layer at the front of the eye).

If abnormal sensation, stinging or pain in the eyes occurs after using this medicine, the patient should contact a doctor.

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 SODIUM CROMOGLICATE VIATRIS 2 %, eye drops in solution in pregnant women. Animal studies do not show direct or indirect harmful effects on reproductive functions (see section Preclinical safety).

Given the low systemic absorption after topical ocular administration, no adverse effect on pregnancy is expected. SODIUM CROMOGLICATE VIATRIS 2 %, eye drops in solution may be used during pregnancy.

Breast-feeding

Given the low systemic passage after topical ocular administration, no adverse effects are expected. CROMOGLICATE DE SODIUM VIATRIS 2 %, eye drops in solution may be used during breastfeeding.

Fertility

Given the low systemic passage after 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 CROMOGLICATE DE SODIUM VIATRIS 2 %, eye drops in solution are listed below by System Organ Class (SOC) and by frequency.

Frequencies cannot be estimated from the available data (frequency not known). SOC (MedDRA)	Frequency	Adverse reaction
Immune system disorders	Not known	Hypersensitivity (see section Contraindications).
Eye disorders	Not known	Eye irritation, eye pain*

*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 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/.

In case of overdose, rinse with sterile physiological saline.

Pharmacotherapeutic class: LOCAL ANTI-ALLERGIC

(S = sensory organ)

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 do not reveal any particular risk for the administration of CROMOGLICATE DE SODIUM VIATRIS 2 %, eye drops in solution in humans, based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenesis, and reproductive and developmental toxicity. CROMOGLICATE DE SODIUM VIATRIS 2 %, eye drops in solution is well tolerated after ocular application; a slight transient irritation of the conjunctiva was observed in rabbits. In preclinical models, the product does not induce sensitisation or photosensitisation, and does not interfere with corneal wound healing processes.

Before opening: 2 years.

After first opening: the bottle must be used within 28 days and must be stored at a temperature not exceeding 25°C.

Store in the original outer packaging.

No special requirements.

Marketing authorisation (AMM)

CIP 3400927893223 (Bottle/5 mL). CIP 3400927893391 (Bottle/10 mL).

Price:

2,46 euros (Fl/5ml). 4,22 euros (Fl/10ml).

Reimbursed by Social Security at 30% on the basis of the TFR: 2.46 euros (Fl/5ml), 4.22 euros (Fl/10ml) in the indications:

• Indication(s) appearing in the marketing authorisation (AMM) on the date of publication of this decree (Fl/5ml, Fl/10ml)

Collection.