Novartis Pharmaceuticals UK Ltd

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:

Signs of local irritation such as:

·         mild, transient eye irritation

·         sticky eyelids

·         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.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

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.

The exterior of the single-dose container is not sterile.  To avoid contamination of the contents, do not touch the tip of the container to any surface.

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.