Page 25 - MEMENTO THERAPEUTIQUE RCP 2024

DE/H/3682/001/IA/020_approved_common_SPC

1. NAME OF THE MEDICINAL PRODUCT

DUOKOPT 20 mg/ml + 5 mg/ml, eye drops, solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains 22.25 mg of dorzolamide hydrochloride corresponding to 20 mg
dorzolamide and 6.83 mg of timolol maleate corresponding to 5 mg timolol.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Eye drops, solution.

Clear colourless to slightly yellow solution, with a pH between 5.3 and 5.9, and an osmolality
of 240-300 mOsmol/kg.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

DUOKOPT is 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

Posology

The dose is one drop of DUOKOPT in the (conjunctival sac of the) affected eye(s) two times
daily.

This medicinal product is a sterile solution that does not contain a preservative.

Paediatric population
The efficacy of combined dorzolamide / timolol formulation in children aged 0 to 18 years
has not been established. The safety in children aged 0 to 2 years has not been established.
(For information regarding safety in paediatric patients ≥ 2 and < 6 years of age, see section
5.1).

Method of administration:

If another topical ophthalmic medicinal product is being used, DUOKOPT and the other
medicinal product should be administered at least ten minutes apart.

Patients should be instructed to avoid allowing the tip of the bottle to come into contact with
the eye or surrounding structures.

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