GELTEARS Eye gel

Active ingredients: Carbomer

Product name and form

GelTears.

Pharmaceutical Form

Eye gel.

Qualitative and quantitative composition

Clear, colourless gel containing 0.2% w/w carbomer 980 Ph.Eur.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Carbomer is a hydrophilic, high molecular weight polymer of carboxyvinylic acid. The gel forms a transparent lubricating and moistening film on the surface of the eye. The preparation has a pH similar to that found in the normal tear film and is slightly hypotonic with respect to tears. Carbomer relieves the symptoms of irritation linked with dry eye syndromes and protects the cornea against drying out.

List of Excipients

Benzalkonium chloride 0.01% w/w (as a preservative)
Water for ╬╣njection
Sorbitol
Sodium hydroxide for pH adjustment

Pack sizes and marketing

Sterile ophthalmic gel presented in 5g and 10g plasticised, lacquered aluminium tubes, closed with a tamper evident polyethylene cap. Each tube is individually cartonned with a patient information leaflet.

Marketing authorization holder

Bausch & Lomb UK Limited, Bausch & Lomb House, 106 London Road, Kingston-upon-Thames, Surrey, UK, KT2 6TN

Marketing authorization dates and numbers

PL 03468/0043

25/05/2008

Drugs

Drug
Countries
Ireland, United Kingdom