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, suitable 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(s) 3 or 4 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.

Medical advice must be sought before taking Ilube Eye Drops with any medication, including medicines obtained without a prescription.

This product should not be taken if the patient is pregnant, might get pregnant, or breast-feeding without seeking medical advice.

Patients must be advised that their vision may be blurred after using Ilube Eye Drops and must not drive or use any machines unless their vision is clear.

Patient may experience itching, redness and/ or irritation in their eye(s)

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 liquifying 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 syndromes.

No specific work has been carried out on the pharmacokinetic properties of acetylcysteine when used as a topical preparation for the eye. Acetylcysteine reduces 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 and protect from light.

Keep container tightly closed.

A lipped Type I amber glass vial with a push-in closure (chlorobutyl bung) containing 10 ml of solution. The bung is held in place by a polypropylene and aluminium overseal. The bung and overseal form a single integral closure (“flipcap”). Immediately before use, the overseal and bung are removed and replaced with a polyvinyl chloride integral cap and dropper assembly, which fits over the lip of the vial. The integral cap and dropper assembly has an aperture at the end for the delivery of the product, which is closed with a small high density polyethylene screw cap.

Discard 28 days after first opening the pack.

Moorfields Eye Hospital NHS Foundation Trust

trading as Moorfields Pharmaceuticals,

34 Nile Street,

London,

N1 7TP,

U.K.

PL 11412/0003

25 June 2007

July 2011