ILUBE 5% w/v Eye Drops, Solution

Acetylcysteine 5.0% w/v

For excipients, see 6.1.

Eye Drops, Solution

A clear and colourless eye drops, solution.

Ilube Eye Drops are artificial tears with mucolytic and lubricant properties, indicated for the relief of dry eye syndromes associated with deficient tear secretion, impaired or abnormal mucus production.

Ilube Eye Drops are administered by topical instillation into the conjunctival sac.

The usual dose is 1 or 2 drops instilled into the affected eye three or four times daily.

Known hypersensitivity to any component.

Ilube Eye Drops contain benzalkonium chloride as preservative and, therefore, should not be used to treat patients who wear soft contact lenses. Discontinue use if discomfort, increased reddening or irritation occurs and persists.

None known.

Not applicable.

None known

None known.

None known.

Pharmacotherapeutic Group: Other Ophthalmologicals

ATC Code: S01X A08

Acetylcysteine, a derivative of the naturally occurring amino acid L-cysteine, is neither an enzyme nor a detergent.

Acetylcysteine has been shown to dramatically reduce the viscosity and tenacity of sputum. The liquefying action is due to the presence of a free sulphydryl group which opens up disulphide bonds present in mucus. This pharmacological action of acetylcysteine is of benefit to patients suffering from ocular mucus abnormality.

Acetylcysteine has marked mucolytic properties which reduce the viscosity and tenacity of mucus in the eyes. This combined with the emollient properties of hypromellose, ensures lubrication and soothing relief for dry eye syndrome.

No specific work has been carried out on the pharmacokinetic properties of acetylcysteine when used as a topical preparation for the eye. Acetylcysteine has marked mucolytic properties which reduce the viscosity and tenacity of mucus in the eye. This, combined with the emollient properties of hypromellose, ensures lubrication and soothing relief for dry eye syndromes.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Disodium edetate,

Hypromellose,

Benzalkonium chloride,

Sodium hydroxide,

Purified water.

None known.

2 years (unopened), 28 days (after first opening).

Do not store above 25°C.

Keep in the outer carton.

Keep container tightly closed.

10 ml amber type I glass bottle with polypropylene screw cap lined with a rubber wad. The bottle and cap are closed with a tamper evident shrink-sleeve (alternatively tamper evidence is provided by the presence of a sticker covering the opening edge of the outer carton). The dropper assembly comprises a rubber teat, a plastic cap and a polycarbonate pipette.

Discard 28 days after first opening the pack.

Alcon Laboratories (UK) Ltd.,

Pentagon Park,

Boundary Way,

Hemel Hempstead,

Herts., HP2 7UD.

U.K.

PL 00649/0144

22 December 1995

01/05/2008