TEOPTIC Eye drops, solution

Active ingredients: Carteolol

Product name and form

Teoptic 1% w/v Eye Drops, Solution.

Pharmaceutical Form

Eye drops solution.

A clear, colourless solution.

Qualitative and quantitative composition

Carteolol hydrochloride 1% w/v.

Excipients with known effect: Benzalkonium chloride 0.005%.

For the full list of excipients, see Section 6.1.

Active Ingredient
Description

Carteolol is a non-selective beta-adrenergic blocking agent with associated intrinsic sympathomimetic activity (ISA) and without significant membrane stabilizing activity. Carteolol reduces normal and elevated intraocular pressure whether or not accompanied by glaucoma.

List of Excipients

Benzalkonium chloride 0.005%
Sodium chloride 0.7%
Sodium phosphate dibasic 0.1%
Sodium phosphate monobasic 0.04%
Water for injection to 100%

Pack sizes and marketing

1 X 5ml polyethylene dropper bottle
3 X 5ml polyethylene dropper bottle

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratories Thea, 12 Rue Louis Blériot, 63017, Clermont-Ferrand Cedex 2, France

Marketing authorization dates and numbers

PL 20162/0007

Date of first authorisation: 25 October 1991
Date of latest renewal: 27 November 2003