DORZOLAMIDE/TIMOLOL MYLAN
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE
Available from:
McDermott Laboratories Ltd t/a Gerard Laboratories
Dosage:
20+5 Mg/Ml
Pharmaceutical form:
Eye Drops Solution
Authorization date:
2011-08-12
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dorzolamide/Timolol Mylan 20mg/ml + 5mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20 mg dorzolamide (as Dorzolamide hydrochloride) and 5 mg timolol (as timolol maleate).
Excipients: each ml of eye drops solution contains 0.075 mg benzalkonium chloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, slightly viscous, colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dorzolamide/Timolol Mylan 20mg/ml + 5mg/ml eye drops, solution is indicated in the treatment of elevated intra-
ocular pressure (IOP) in patients with open-angle glaucoma or pseudo-exfoliative glaucoma when topical beta-blocker
monotherapy is not sufficient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dose is one drop of Dorzolamide/Timolol Mylan 20mg/ml + 5mg/ml eye drops, solution in the (conjunctival sac of
the) affected eye(s) two times daily.
If another topical ophthalmic medicinal product is being used, the other agent should be administered at least ten
minutes apart.
_Paediatric population:_
Efficacy in paediatric patients has not been established.
Safety in paediatric patients below the age of two years has not been established. (For information regarding safety in
paediatric patients
2 and < 6 years of age, see section 5.1).
Patients should be instructed to wash their hands before use and avoid allowing the tip of the dispensing container to
contact the eye or surrounding structures.
In order to secure correct dosage - the dropper tip should not be enlarged.
Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common
bacteria known to cause ocular infections. Serious d
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