Viscotears Liquid Gel.

2.0mg/g Carbomer (polyacrylic acid).

For a full list of excipients, see section 6.1 List of excipients

Eye drops.

Substitute of tear fluid for management of dry eye conditions including keratoconjunctivitis sicca, and for unstable tear film.

For ocular use.

Adults:

1 drop 3 - 4 times daily or as required, depending upon the severity of the disease

Elderly:

No dosage amendment is necessary in the elderly

Children:

No specific studies with Viscotears have been performed in children. Use in these patients, is therefore, at the responsibility of the physician.

Viscotears Liquid Gel contains a sterile gel until the original closure is broken. The tip of the container should not come into contact with any surface including the eye, as this may cause injury to the eye and contaminate the gel. Discard four weeks after first opening.

Patients with known hypersensitivity to carbomer (polyacrylic acid) or to any of the excipients.

Contact lenses should not be worn during instillation of the drug. After instillation there should be an interval of at least 30 minutes before reinsertion.

In case of any additional local ocular treatment (eg glaucoma therapy) there should be an application interval of at least 5 minutes between the two medications, Viscotears Liquid Gel always should be the last medication instilled.

There is no experience regarding the safety of Viscotears Liquid Gel in human pregnancy or lactation. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.

Viscotears Liquid Gel may temporarily influence the visual acuity. Patients with blurred vision driving a vehicle or operating machines should be alerted to the possibility of impaired reactions.

The following adverse events have been occasionally reported:

Common

• transient eye irritation

• sticky eyelids

• blurred vision after instillation of the gel

Unknown

• Hypersensitivity

• Ocular hyperaemia

• Eye swelling

• Eyelid oedema

• Eye pruritis

• Eye pain

Not applicable.

Viscotears Liquid Gel is a liquid gel containing Carbomer . After local instillation it spreads rapidly over the conjunctiva and cornea and forms a lubricating film with prolonged contact time.

The retention times of Viscotears Liquid Gel and a conventional tear substitute based on polyvinylalcohol were studied in 30 healthy volunteers with fluorescein staining. The retention time of Viscotears Liquid Gel was approximately 16 minutes compared with approximately 2 minutes for the conventional artificial tears eye drops.

Tear film stability was maintained for a period of up to 6 hours. Data of clinical studies on healthy volunteers, patients with dry eye and patients in intensive care or during operation suggest evidence that Viscotears Liquid Gel improves tear film stability and prolongs tear break-up time (BUT).

There are no controlled animal or human pharmacokinetic studies available. However, absorption or accumulation in eye tissues can presumably be excluded due to the high molecular weight of polyacrylic acid (4 mio D).

The results of the preclinical tests do not add anything of further significance to the prescriber.

Cetrimide, sodium hydroxide, sorbitol and water for injections.

None known.

Do not store above 25°C.

Polyfoil (laminate) tube with cannula and closure containing 10g of liquid gel.

None stated.

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

PL 00101/0605

07 December 2004

7 December 2011