SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

ILUBE 5% w/v Eye Drops, Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Acetylcysteine 5.0% w/v

For excipients, see 6.1.

3    PHARMACEUTICAL FORM

Eye Drops, Solution

A clear and colourless eye drops, solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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.

4.2 Posology and method of administration

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.

4.3 Contraindications

Known hypersensitivity to any component.

4.4 Special warnings and precautions for use

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.

4.5    Interaction with other medicinal products and other forms of interaction

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

4.6    Pregnancy and lactation

This product should not be    taken    if the patient is pregnant, might get pregnant,

or breast-feeding without seeking medical advice.

4.7    Effects on ability to drive    and use machines

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.

4.8    Undesirable effects

Patient may experience itching, redness and/ or irritation in their eye(s). Reporting of suspected adverse reactions

Reporting 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

Website: www.mhra.gov.uk/yellowcard

Overdose

None known

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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.

Preclinical safety data

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Disodium edetate Hypromellose Benzalkonium chloride Sodium hydroxide Purified water

6.2 Incompatibilities

None known

6.3 Shelf life

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

6.4 Special precautions for storage

Do not store above 25°C.

Keep in the outer carton and protect from light. Keep container tightly closed.

Nature and contents of container

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.

6.6 Special precautions for disposal

Discard 28 days after first opening the pack.

7. MARKETING AUTHORISATION HOLDER

Moorfields Eye Hospital NHS Foundation Trust trading as Moorfields Pharmaceuticals,

25 Provost Street London N1 7NH United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL11412/0003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

31/01/1993 / 15/05/2003

10 DATE OF REVISION OF THE TEXT

19/11/2015