Refresh Ophthalmic
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Liquiflim® Tears Preservative Free or Refresh Ophthalmic TM
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
Liquiflim® Tears Preservative Free/REFRESH OPHTHALMIC™ 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 Liquiflim® Tears Preservative Free/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 25 °C or below.
6.5 Nature and Content of Container
Low density polyethylene unit dose vials containing 0.4 ml of Liquifilm® Tears Preservative Free/REFRESH OPHTHALMIC™.
Cartons contain 2, 5, 10, 15, 30 or 50 units per pack.
6.6 Instruction for Use, Handling and Disposal
Ensure container is intact. Twist off tab and apply eyedrops.
7 MARKETING AUTHORISATION HOLDER
Allergan Ltd
Marlow International
The Parkway
Marlow
Bucks
SL7 1YL
UK
8. MARKETING AUTHORISATION NUMBER
PL 00426/0063
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 10/12/2007
10 DATE OF REVISION OF THE TEXT
23/07/2008