Liquifilm^® Tears Preservative Free

or

Refresh Ophthalmic^TM

Polyvinyl alcohol 1.4% w/v.

Eye drops, solution

Symptomatic relief of dry eye and symptomatic relief of eye irritation associated with deficient tear production.

Ensure container is intact. Twist off tab and apply eyedrops.

Dosage schedule: Apply one or two drops in each eye as needed, or as directed. No special dosage for the elderly or for children.

Route of administration: Ocular instillation.

Hypersensitivity to the active substance polyvinyl alcohol or any of the other excipients.

If irritation, pain, redness and changes in vision occur or worsen, treatment should be discontinued and a new assessment considered.

To avoid contamination, the dropper tip should not be allowed to touch the eye or any other surface.

Contact lenses should be removed before each application and may be reinserted after 15 minutes.

Concomitant ocular medication should be administered 15 minutes prior to the instillation of Liquifilm Tears Preservative Free or Refresh Ophthalmic.

No interaction studies have been performed.

The constituents of Liquifilm Tears Preservative Free or Refresh Ophthalmic have been used as pharmaceutical agents for many years with no untoward effects. No special precautions are necessary for the use of Liquifilm Tears Preservative Free or Refresh Ophthalmic in pregnancy and lactation.

Liquifilm Tears Preservative Free or Refresh Ophthalmic has minor or moderate influence on the ability to drive and use machines as it may cause transient blurring of vision. Do not drive or use hazardous machinery unless vision is clear.

Liquifilm Tears Preservative Free or Refresh Ophthalmic may cause transient stinging or irritation on instillation.

The frequency of the following undesirable effects is not known (cannot be estimated from the available data).

Eye disorders

• Eye irritation

• Eye pain

• Ocular hyperaemia

• Vision blurred

• Eye pruritus

• Foreign body sensation

• Eye discharge

• Hypersensitivity

No case of overdose has been reported. Accidental overdose will not present any hazard.

Liquifilm® Tears Preservative Free / or Refresh Ophthalmic^TM exerts a mechanical, not a pharmacological action. The viscosity enhancing agent is polyvinyl alcohol and the lubricating-enhancing agent is povidone.

Not applicable

The constituents of Liquifilm® Tears Preservative Free / or Refresh Ophthalmic^TM have been used safely in pharmaceutical products for many years. Topical administration in animals studies showed no untoward effects.

Povidone

Sodium chloride

Sodium hydroxide or hydrochloric acid (to adjust pH)

Purified water

None known.

24 months (unopened).

Do not store opened container.

Store at 25ºC or below.

Low density polyethylene unit dose vials containing 0.4 ml of Liquifilm® Tears Preservative Free / or Refresh Ophthalmic^TM.

Cartons contain 2, 5, 10, 15, 30 or 50 units per pack.

Ensure container is intact. Twist off tab and apply eyedrops.

Allergan Limited

Marlow International

The Parkway

Marlow

Bucks, SL7 1YL

UK

PL 00426/0063

14^th August 2003

23^rd July 2008