Flarex (Drops) Instructions for Use

Marketing Authorization Holder

Alcon-Couvreur N.V., S.A. (Belgium)

ATC Code

S01BA07 (Fluorometholone)

Active Substance

Fluorometholone (Rec.INN registered by WHO)

Dosage Form

Flarex

Eye drops suspension 0.1%: dropper bottle 5 ml

Dosage Form, Packaging, and Composition

5 ml – plastic dropper bottle (1) – cardboard packs.

Clinical-Pharmacological Group

Topical corticosteroids for ophthalmology

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

Glucocorticosteroid for topical use.

The therapeutic efficacy is due to its anti-inflammatory, antiallergic, and anti-exudative (due to a vasoconstrictor effect) action.

Indications

Treatment of inflammatory diseases of the conjunctiva, cornea, and anterior segment of the eye.

ICD codes

Dosage Regimen

Shake the bottle well before each use to ensure a uniform suspension.

Instill one drop into the conjunctival sac of the affected eye(s) two to four times daily.

During the initial 24 to 48 hours, the dosing frequency may be increased to one drop every hour, as directed by a physician, for severe inflammation.

Gradually taper the dosage and frequency of application as the inflammatory condition improves.

Avoid abrupt discontinuation after prolonged therapy; follow the prescribed tapering schedule.

Do not allow the dropper tip to contact any surface, including the eye, to prevent contamination.

If using other topical ophthalmic products, administer them at least 15 minutes apart.

The duration of treatment is determined individually by the physician based on the therapeutic response.

Do not use for longer than prescribed; typical treatment courses for anterior segment conditions are generally short-term.

Discontinue use and consult a physician immediately if no improvement is observed within two days or if condition worsens.

Adverse Reactions

Possible glaucoma, damage to the optic nerve, decreased visual acuity, visual field defects, cataract formation, development of a secondary infection, perforation of the eye tissues.

Contraindications

Hypersensitivity to fluorometholone; viral diseases, tuberculosis, fungal infections, untreated bacterial infections.

Use in Pregnancy and Lactation

The safety of fluorometholone use during pregnancy has not been studied.

It is not known whether Fluorometholone is excreted in human breast milk.

During pregnancy and breastfeeding, it can be used according to indications in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Special Precautions

With prolonged use, the risk of developing glaucoma, damage to the optic nerve, visual acuity impairment, and secondary eye infection increases.

If ulcerative lesions of the cornea appear during the use of corticosteroids, the possibility of fungal invasion should be considered.

In diseases causing thinning of the cornea or sclera, prolonged use of corticosteroids may lead to perforation of these structures.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.