Viscotears Single Dose Unit 2.0mg/g Eye Gel

2.0mg/g Carbomer (polyacrylic acid)

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

Eye Gel

Substitute tear fluid for the 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 SDU 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

Viscotears Single Dose Unit should be used immediately after opening and discarded after use.

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

Although the product contains no preservative, contact lenses should not be worn during instillation of the drug due to the viscosity. 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 Single Dose Unit always should be the last medication instilled.

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

Viscotears 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.

Adverse events with Viscotears Single Dose Unit are rare. However, based on experience with similar but preserved products, the following adverse events may be expected to occur with Viscotears Single Dose Unit:

Signs of local irritation such as:

• mild, transient eye irritation

• sticky eyelids

• blurred vision after instillation of the gel

The following adverse events have been reported in post marketing experience (frequency not known):

Unknown

• Hypersensitivity

• Ocular hyperaemia

• Eye swelling

• Eyelid oedema

• Eye pruritis

• Eye pain

Not applicable.

Viscotears Single Dose Unit is a preservative-free 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 (a similar product containing a preservative) 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.

Sorbitol, sodium hydroxide and water for injections.

Not applicable.

2 years.

For single use only. Use immediately after first opening.

Do not store above 25°C. Keep containers in outer carton.

Transparent LDPE single-dose container containing 0.6ml of gel.

Available in packs of 5, 15, and 30 single dose units

Not applicable

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

PL 00101/0652

7 December 2004

7 December 2011

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