COSOPT PRESERVATIVE-FREE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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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
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 after opening for administration to the affected eye
(s). Since sterility cannot be maintained after the individual single dose container is opened, any remaining
contents must be discarded immediately after administration.
Patients should be instructed to avoid allowing the tip of the container to come into contact with the eye or
surrounding structures.
Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by
common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of visio
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