MYDRILATE 1.0% Eye drops Ref.[7206] Active ingredients: Cyclopentolate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Esteve Pharmaceuticals Ltd, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berks SL6 6PT, United Kingdom

Product name and form

Mydrilate 1.0% Eye Drops.

Cyclopentolate Hydrochloride 1.0% w/v Eye Drops, Solution.

Pharmaceutical Form

Eye drops.

Qualitative and quantitative composition

Cyclopentolate Hydrochloride BP 1.0% w/v.

Excipient(s) with known effect: Each millilitre contains 0.1 mg benzalkonium chloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cyclopentolate

Cyclopentolate is an antimuscarinic agent used topically in the eye as a mydriatic and cycloplegic. The effects are similar to those of atropine, but with a more rapid onset and a shorter duration of action.

List of Excipients

Boric acid
Potassium chloride
Benzalkonium chloride solution
Purified water

Pack sizes and marketing

5 ml dropper bottle of 1.0% solution.

Bottle: LDPE, natural colour.

Cap: White plastic.

Marketing authorization holder

Esteve Pharmaceuticals Ltd, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berks SL6 6PT, United Kingdom

Marketing authorization dates and numbers

PL 17509/0008

8 August 2001

Drugs

Drug Countries
MYDRILATE Ireland, United Kingdom

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