OPTILAST Eye drops

Active ingredients: Azelastine

Product name and form

Optilast.

0.5 mg/ml, Eye Drops, solution.

Pharmaceutical Form

Eye drops, solution.

Clear, colourless solution.

Qualitative and quantitative composition

Azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg azelastine hydrochloride.

Excipient with known effect: 1 ml contains 0.125 mg benzalkonium chloride.

For the full list of excipients see section 6.1.

Active Ingredient
Description

Azelastine, a phthalazinone derivative is classified as a potent long-acting anti-allergic compound with selective H1 antagonist properties. An additional anti-inflammatory effect could be detected after topical ocular administration. Data from in vivo (pre-clinical) and in vitro studies show that azelastine inhibits the synthesis or release of the chemical mediators known to be involved in early and late stage allergic reactions e.g. leukotriene, histamine, PAF and serotonin.

List of Excipients

Benzalkonium chloride (preservative)
Disodium edetate
Hypromellose
Sorbitol
(crystallising) Sodium hydroxide
Water for injections

Pack sizes and marketing

10 ml opaque HDPE bottle and LDPE dropper with white HDPE screw cap. One bottle contains either 6 ml, 8 ml or 10 ml solution. Not all volume fill sizes are marketed in all Member States.

Marketing authorization holder

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0136

1st August 2009

Drugs

Drug
Countries
Ireland, United Kingdom