Liquifilm Tears 1.4% w/v eye drops, solution

Polyvinyl alcohol 1.4% w/v

Excipient: Benzalkonium chloride 0.005% w/v

For a full list of excipients, see section 6.1.

Eye drops, solution

A clear, colourless solution.

As an ocular lubricant for the relief of dry eye and dry eye symptoms.

Dosage schedule: One to two drops as required or directed for all ages.

Route of administration: Topical instillation into conjunctival sac.

Hypersensitivity to the active substance or to any of the excipients.

Not for use with soft contact lenses.

If irritation, pain, redness and changes in vision occur or worsen or persist for more than 72 hours, 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.

Liquifilm Tears contain benzalkonium chloride which is irritant to the eye and could cause discolouration of soft lenses. Avoid contact with soft contact lenses. Remove contact lenses before Liquifilm Tears is used and wait for at least 15 minutes before reinsertion.

Concomitant ocular medication should be administered 15 minutes prior to the instillation of Liquifilm Tears.

No interaction studies have been performed.

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

No studies on the effects on the ability to drive and use machines have been performed.

Based upon the information available, Liquifilm Tears has no or negligible influence on the ability to drive and use machines. However, it may cause transient blurring of vision. Do not drive or use hazardous machinery unless vision is clear.

The following undesirable effects have been reported since Liquifilm Tears was marketed.

Frequency:

Not known: the incidence cannot be determined from available information.

Eye disorders:

Not known: Eye irritation, eye pain, ocular hyperaemia, lacrimation increased, foreign body sensation, eye pruritus.

Immune system disorders:

Not known: hypersensitivity

No case of overdose has been reported.

Pharmacotherapeutic group: Artificial tears and other indifferent preparations, ATC code: S01AX20.

Not applicable. Liquifilm Tears contains no pharmacologically active ingredient.

Not applicable. Liquifilm Tears contains no pharmacologically active ingredient.

The constituents of Liquifilm Tears have been used safely in pharmaceutical products for many years. Topical administration in animal studies showed no untoward effects.

Sodium chloride

Sodium phosphate dibasic

Sodium phosphate monobasic

Benzalkonium chloride

Edetate disodium

Hydrochloric acid or sodium hydroxide (to adjust pH)

Purified water

None known.

24 months unopened.

Discard 28 days after opening.

Do not store above 25°C. Do not refrigerate or freeze.

Low density polyethylene (LDPE) bottle and tip and medium impact polystyrene (MIPS) screw cap. Safety seal to ensure integrity of the container.

Liquifilm Tears is available in 15ml bottles.

No special requirements.

Allergan Ltd

Marlow International

The Parkway

Marlow

Bucks

SL7 1YL

UK

PL 00426/0009R

Date of first authorisation: 19^th September 1974

Date of latest renewal: 10^th October 2005

15 July 2009