RELESTAT Eye drops, solution Ref.[51046] Active ingredients: Epinastine

Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: AbbVie Limited, Citywest Business Campus, Co Dublin 24, Ireland

Product name and form

Relestat, 0.5 mg/ml, eye drops, solution.

Pharmaceutical Form
Eye drops, solution. A clear colourless sterile solution.

Qualitative and quantitative composition

One ml of eye drops, solution, contains 0.5 mg of epinastine hydrochloride. (equivalent to 0.436 mg epinastine)

Excipient(s) with known effect: benzalkonium chloride 0.1 mg/ml and phosphate 4.75 mg/ml

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Epinastine	Epinastine is a topically active, direct H₁-receptor antagonist and an inhibitor of the release of histamine from the mast cell. Epinastine is selective for the histamine H₁-receptor and has affinity for the histamine H₂~~receptor. Epinastine also possesses affinity for the α₁, α₂~~, and 5-HT₂–receptors.

List of Excipients
Benzalkonium chloride Disodium edetate Sodium chloride Sodium dihydrogen phosphate dihydrate Sodium hydroxide/hydrochloric acid (pH adjustment) Purified water

Pack sizes and marketing

10 ml polyethylene bottle with a white polystyrene screw cap.

The fill volume is 5 ml.

Marketing authorization holder

AbbVie Limited, Citywest Business Campus, Co Dublin 24, Ireland

Marketing authorization dates and numbers

PA1824/018/001

Date of first authorisation: 22^nd August 2003
Date of last renewal: 18^th October 2007

Drugs

Drug	Countries
RELESTAT	Austria, Brazil, Spain, Hong Kong, Ireland, Israel, New Zealand, Poland, Singapore, Turkey, United Kingdom, South Africa

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