VISCOTEARS Single Dose Unit 2.0mg / g Eye Gel

1. Name Of The Medicinal Product

Viscotears Single Dose Unit 2.0mg/g Eye Gel

2. Qualitative And Quantitative Composition

2.0mg/g Carbomer (polyacrylic acid)

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

3. Pharmaceutical Form

Eye Gel

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

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.

4.8 Undesirable Effects

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:

• mild, transient eye irritation

• sticky eyelid

• blurred vision after instillation of the gel

Ocular hyperaemia, eye swelling, eyelid oedema, eye pruritis and eye pain have been reported during post-marketing experience.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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).

5.2 Pharmacokinetic Properties

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).

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sorbitol, sodium hydroxide and water for injections.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years.

For single use only. Use immediately after first opening.

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

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

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

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

8. Marketing Authorisation Number(S)

PL 00101/0652

9. Date Of First Authorisation/Renewal Of The Authorisation

7 December 2004

10. Date Of Revision Of The Text

25 November 2010

LEGAL CATEGORY

P