Summary of Product Characteristics last updated on medicines.ie: 13/5/2010
Liquifilm Tears Ocular Lubricant, 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 with a pH of 6.0-7.5 and osmolality of 200-260 mOsm/kg.
4.1 Therapeutic indications
As a lubricant and artificial tear in dry eye and other ocular irritation syndromes.
4.2 Posology and method of administration
Dosage schedule: One to two drops as required or directed.
Route of administration: Topical instillation into conjunctival sac.
Hypersensitivity to the active substance or to any of the excipients.
Use with soft contact lenses.
4.4 Special warnings and precautions for use
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.
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 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.
4.7 Effects on ability to drive and use machines
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.
4.8 Undesirable effects
The following undesirable effects have been reported since Liquifilm Tears was marketed.
Not known: the incidence cannot be determined from available information.
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.
Accidental overdosage will not present any hazard.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Artificial tears and other indifferent preparations, ATC code: S01AX20.
Liquifilm Tears exerts a mechanical, not a pharmacological action. The viscosity and lubricating enhancing agent is polyvinyl alcohol.
Liquifilm Tears lowers the surface tension at the surface of the corneal epithelium, providing a lubricant layer that enhances patient comfort. Liquifilm Tears can help to restore normal tear film tonicity and to act as a wetting agent for lipid-, aqueous- and mucin-deficient eyes.
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
The constituents of Liquifilm Tears have been used safely in pharmaceutical products for many years. Topical administration in animal studies showed no untoward effects.
6.1 List of excipients
Sodium phosphate dibasic
Sodium phosphate monobasic
Hydrochloric acid or sodium hydroxide (for pH adjustment)
6.3 Shelf life
2 years in the unopened container.
Discard any unused contents 28 days after opening the bottle.
6.4 Special precautions for storage
Do not store above 25°C.
Do not refrigerate or freeze.
6.5 Nature and contents of container
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.
6.6 Special precautions for disposal and other handling
No special requirements.
Allergan Pharmaceuticals Ireland
Date of first authorisation: 1st November 1982
Date of last renewal: 4th July 2008
28th January 2009