COSOPT PRESERVATIVE-FREE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-04-2023
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Active ingredient:
DORZOLAMIDE TIMOLOL
Available from:
Merck Sharp & Dohme Ireland (Human Health) Limited
Dosage:
20/5 Mg/Ml
Pharmaceutical form:
Eye Drops Solution
Authorization date:
2006-09-01
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
COSOPT Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution, single-dose container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 22.26 mg of dorzolamide hydrochloride corresponding to 20 mg dorzolamide and 6.83 mg of timolol
maleate corresponding to 5 mg timolol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution, single dose container
Clear, colourless to nearly colourless, slightly viscous solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Indicated in the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or
pseudoexfoliative glaucoma when topical beta-blocker monotherapy is not sufficient.
4.2 Posology and method of administration
The dose is one drop of COSOPT Preservative-Free in the (conjunctival sac of the) affected eye(s) two times
daily.
If another topical ophthalmic agent is being used, COSOPT Preservative-Free and the other agent should be
administered at least ten minutes apart.
COSOPT Preservative-Free is a sterile solution that does not contain a preservative. The solution from one
individual single dose container is to be used immediately afte
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