Iopidine 0.5% Ophthalmic solution

Product name and form

IOPIDINE 5mg/ml Eye Drops, Solution.

Pharmaceutical Form

Eye drops, solution.

A colourless to pale yellow solution.

Qualitative and quantitative composition

1 ml of solution contains Apraclonidine 5 mg (as hydrochloride).

Excipients: 1 ml of solution contains 0.1 mg benzalkonium chloride

For a full list of excipients, see section 6.1.

List of Excipients

Benzalkonium chloride
Sodium acetate (trihydrate)
Sodium chloride
Hydrochloric acid and/or Sodium hydroxide (for pH adjustment)
Purified water

Pack sizes and marketing

5 ml and/or 10 ml white LDPE DROP-TAINER dispensers with a natural LDPE dispensing plug and white polypropylene closure.

Not all pack sizes may be marketed.

Marketing authorization holder

Alcon Laboratories (UK) Limited
Pentagon Park
Boundary Way
Hemel Hempstead
Hertfordshire HP2 7UD
United Kingdom

Marketing authorization dates and numbers

PL 00649/0132

29 December 1994/Renewed 20 October 2010

Drugs

Drug
Countries
Austria, Australia, Canada, Finland, France, Ireland, Netherlands, New Zealand, Tunisia, United Kingdom, United States