Sodium cromoglicate

SOURCE: UK SPC for ONE product - sodium cromoglicate 2% w/v eye drops (PL158720010, FDC International Ltd). SPC 4.2 verbatim: 'Adults and Children: One or two drops into each eye up to four times a day or as indicated by the doctor. Elderly: There is no current evidence for alteration of the dose. Route of administration: Topical ophthalmic.' The SPC prints no separate maximum dose beyond 'up to four times a day', so no maxDose is given. SCOPE - OCULAR ROUTE ONLY: 4.1 licenses this product only for the prevention and treatment of acute, seasonal and perennial allergic conjunctivitis. This page also lists inhaled and oral routes (brands Intal and Nalcrom); this SPC covers neither, so no inhaled or oral dose is given and those products' regimens and indications differ. CAUTIONS (4.4): the eye drops contain benzalkonium chloride 0.1 mg/ml (4.5 micrograms per dose) which may be deposited in soft contact lenses - do not use while wearing them; remove lenses before instillation and do not re-insert earlier than 15 minutes after use; benzalkonium chloride may cause eye irritation and symptoms of dry eyes and may affect the tear film and corneal surface - use with caution in dry eye patients and where the cornea may be compromised; patients should be monitored in case of prolonged use; ocular solutions can become contaminated if handled improperly; patients who develop an intercurrent ocular condition (e.g. trauma, ocular surgery or infection) should seek their physician's advice about continued use of the present multi-dose container. SOURCE LIMITS: text came from a PDF; no section is marked truncated; this bundle has no section 2 (composition) - the 2% w/v strength is taken from the product name.

THIS IS THE LABEL'S OWN STATEMENT, NOT A SCALED ADULT DOSE: SPC 4.2 gives one regimen headed 'Adults and Children'. The SPC prints no minimum age or age band, so this card makes no statement for neonates or infants - seek specialist/paediatric advice for them.