This information is intended for use by health professionals

1. Name of the medicinal product

Liquifilm® Tears Preservative Free

or

Refresh OphthalmicTM

2. Qualitative and quantitative composition

Polyvinyl alcohol 1.4% w/v.

3. Pharmaceutical form

Eye drops, solution

4. Clinical particulars
4.1 Therapeutic indications

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

4.2 Posology and method of administration

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.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

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.

4.8 Undesirable effects

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

4.9 Overdose

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

5. Pharmacological properties
5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

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

6. Pharmaceutical particulars
6.1 List of excipients

Povidone

Sodium chloride

Sodium hydroxide or hydrochloric acid (to adjust pH)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

24 months (unopened).

Do not store opened container.

6.4 Special precautions for storage

Store at 25ºC or below.

6.5 Nature and contents of container

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

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

6.6 Special precautions for disposal and other handling

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

7. Marketing authorisation holder

Allergan Limited

Marlow International

The Parkway

Marlow

Bucks, SL7 1YL

UK

8. Marketing authorisation number(s)

PL 00426/0063

9. Date of first authorisation/renewal of the authorisation

14th August 2003

10. Date of revision of the text

23rd July 2008