Liquifilm Tears
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Liquifilm Tears
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Polyvinyl alcohol 1.4% w/v USP
Also contains benzalkonium chloride. For full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Eye Drops
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As an ocular lubricant for the relief of dry eye and dry eye symptoms.
4.2 Posology and method of administration
Dosage schedule: One to two drops as required or directed for all ages. Route of administration: Topical instillation into conjunctival sac.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
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 Fertility, 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.
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
4.9 Overdose
No case of overdose has been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable. Liquifilm Tears contains no pharmacologically active ingredient.
5.2 Pharmacokinetic Properties
Not applicable. Liquifilm Tears contains no pharmacologically active ingredient.
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 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride EP Sodium phosphate dibasic USP Sodium phosphate monobasic USP Benzalkonium chloride EP Edetate disodium EP
Hydrochloric acid or sodium hydroxide (to adjust pH) EP Purified water EP
6.2 Incompatibilities
None known.
6.3 Shelf Life
24 months unopened.
Discard 28 days after opening.
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 l5ml bottles.
Instruction for Use/Handling
6.6
Not applicable
7 MARKETING AUTHORISATION HOLDER
Allergan Ltd
Marlow International
The Parkway
Marlow
Bucks
SL7 1YL
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00426/0009R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19th September 1974/ May 1988/ May 1993
10 DATE OF REVISION OF THE TEXT
15/07/2009