Sodium cromoglicate

Sodium Cromoglicate 2% w/v Eye Drops

Sodium Cromoglicate 2% w/v

Eye drops, solution. A clear, colourless solution.

The prevention and treatment of acute, seasonal and perennial allergic conjunctivitis.

Adults, Elderly & Children : One or two drops into each eye up to four times a day.

Patients with known hypersensitivity to any of the ingredients.

This formulation of Sodium Cromoglicate Eye Drops contains benzalkonium chloride as a preservative. Benzalkonium chloride may be deposited in soft contact lenses. Hence, Sodium Cromoglicate Eye Drops should not be used while wearing these lenses. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use. Patients should also be instructed that ocular solutions, if handled improperly can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Patients should also be advised that if they develop any intercurrent ocular condition (e.g. trauma, ocular surgery or infection), they should immediately seek their physician's advice concerning the continued use of present multi-dose container. There have been reports of bacterial keratitis associated with the use of topical ophthalmic products.

None known

There are no adequeate and well-controlled studies of Sodium Cromoglicate eye drops in pregnant women. Therefore, use during pregnancy is not recommended unless the benefit outweighs the potential risk. It is not known whether Sodium Cromoglicate is excreted in human milk. Therefore caution should be exercised when the eye drops are administered to nursing mothers.

Transient stinging or blurring of vision may occur on instillation of the drops. Do not drive or use machinery until normal vision is restored.

Transient stinging and burning on instillation of the drops. Rarely, other symptoms of local irritation. Reporting of suspected adverse reactionsReporting 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 Yellow card scheme at www.mhra.gov.uk/yellowcard.

Medical observation is recommended in cases of overdosage.Sodium cromoglicate is poorly absorbed both from the eye and from the gastrointestinal tract.

Sodium cromoglicate inhibits the degranulation of sensitised mast cells which normally occurs after exposure to allergens and thereby prevents the release of allergic mediators such as histamine.

Sodium cromoglicate is poorly absorbed from the eye (approximately 0.03% in healthy volunteers) due to its lipid insolubility. Orally, it is poorly absorbed from the gastrointestinal tract with a reported bioavailability of 1%. Systemically, sodium cromoglicate is excreted unchanged in the bile and urine.Trace amounts have been detected in the aqueous humour of rabbit eyes up to 24 hours after administration.

Pre-clinical safety data does not add anything of further significance to the prescriber.

Benzalkonium chlorideDisodium edetate Sodium chloridePolysorbate 80 Water for injection

Benzalkonium chloride may be deposited in and is known to discolour soft contact lenses. These lenses should therefore be removed before instillation of the eye drops and not reinserted earlier than 15 minutes after use.

Do not store above 30°C. Protect from direct sunlight. To avoid contamination do not touch dropper tip to any surface

The container is a bottle of low density polyethylene (LDPE) with a polystyrene spiked cap closure which contains 13.5ml of Sodium Cromoglicate 2% w/v Eye Drops solution.

No special instructions.

FDC International Ltd Unit 6 Fulcrum 1 Solent WayWhiteleyFareham HantsPO15 7FEUnited Kingdom

PL 15872/0010

16 May 2007 / 05 March 2012

22 June 2016