Medicinal Products

DORZOLAMIDE / TIMOLOL 20 mg / 5 mg / mL

Generic drug of Cosopt 20 MG / ML + 5 MG / ML
Therapeutic class: Ophthalmology
active ingredients: Dorzolamide, Timolol
laboratory: EG Labo

Eye drops in solution
Box of 1 dropper bottle of 5 ml
All forms

Indication

Dorzolamide / TIMOLOL EG is indicated for the treatment of high intraocular pressure (IOP) in patients with open angle glaucoma, or pseudoexfoliative glaucoma, when ocular beta-blocker monotherapy is insufficient. .

Dosage DORZOLAMIDE / TIMOLOL 20 mg / 5 mg / ml Eye drops in solution Box of 1 dropper bottle of 5 ml

The dose is one drop of Dorzolamide / TIMOLOLEG in (the conjunctival cul de sac) of the affected eye (s), twice daily.

If used concomitantly with another eye drop, the other eye drops should be administered at least 10 minutes apart.

Use in children:

Efficacy has not been established in children.

Tolerance in children under 2 years has not been established. (See section 5.1 Pharmacodynamic properties for more information on tolerance in children aged 2 years and over and over 6 years of age).

Patients should be advised to wash their hands before using eye drops and avoid contacting the tip of the vial with the eye or surrounding areas.

To ensure proper dosage, the tip hole should not be enlarged.

Patients should also be informed that ophthalmic solutions, if improperly handled, may be contaminated by common bacteria known to cause eye infections. The use of contaminated solutions can cause serious eye damage and subsequent loss of vision.

Patients should be informed about the proper handling of Dorzolamide / TIMOLOLEG vials .

Manual:

1. Before using the medication for the first time, make sure that the tamper evident ring at the neck of the vial is not broken. A space between the bottle and the stopper is normal on an unopened vial.

2. Unscrew the bottle cap.

3. The patient should tilt the head back and gently pull the lower eyelid down to form a pocket between the eyelid and the eye.

4. The vial should be inverted and squeezed until only one drop falls into the eye. DO NOT TOUCH THE EYE OR EYE WITH THE BOTTLE PIPE.

5. Steps 3 and 4 should be repeated for the other eye if necessary.

6. Replace the cap by turning until it closes after use.

Against indications

Dorzolamide / TIMOLOLEG is contraindicated in patients with:

· Reactive airway disease including asthma or a history of asthma, or severe chronic obstructive pulmonary disease.

· Sinus bradycardia, second or third degree atrioventricular block, patent heart failure, cardiogenic shock.

· Severe renal insufficiency (CrCl <30 ml / min) or hyperchloremic acidosis.

· Hypersensitivity to one or both of the active ingredients or to any of the excipients.

The above contraindications come from those of each of the constituents and are not only specific to the association.

Adverse effects Dorzolamide / Timolol EG

In clinical studies, no specific adverse effects of dorzolamide / timolol were observed; adverse effects were limited to those previously reported with dorzolamide hydrochloride and / or timolol maleate. In general, frequent adverse events were mild to moderate and did not result in treatment discontinuation.

In clinical studies, 1, 035 patients were treated with dorzolamide / timolol eye drops solution. Approximately 2.4% discontinued treatment with Dorzolamide / TIMOLOL eye drops in solution due to ocular adverse events and approximately 1.2% of patients discontinued treatment due to local adverse events suggestive of ocular adverse events. allergy or hypersensitivity (such as eyelid inflammation and conjunctivitis).

The following undesirable effects have been reported with dorzolamide / timolol, solution eye drops or any of its components either in clinical studies or since the time of marketing:

[Very common: (≥1 / 10), Common: (≥1 / 100 to <1/10), Uncommon: (≥1 / 1000 to <1/100), Rare: (≥1 / 10, 000 to < 1/1000), Very rare (<1 / 10, 000) and Frequency unknown (can not be estimated from the available data).

Nervous system and psychiatric disorders:

Dorzolamide hydrochloride, eye drops in solution:

Frequent: headache *.

Rare: dizziness *, paresthesia *.

Timolol maleate eye drops in solution:

Frequent: headache *.

Uncommon: dizziness *, depression *.

Rare: insomnia *, nightmares *, memory loss, paresthesia *, aggravation of signs and symptoms of myasthenia, decreased libido *, cerebrovascular accidents *.

Eye disorders:

Dorzolamide / Timolol eye drops in solution:

Very common: burns and tingling.

Common: conjunctival hyperemia, blurred vision, corneal erosion, itchy eyes, watery eyes.

Dorzolamide hydrochloride, eye drops in solution:

Frequent: palpebral inflammation *, eyelid irritation *.

Uncommon: iridocyclitis *.

Rare: irritation including redness *, pain *, palpebral crusted lesions *, transient myopia (which disappeared upon discontinuation of treatment), corneal edema *, ocular hypotonia *, choroidal detachment (after surgical treatment) *.

Timolol maleate, eye drops in solution:

Common: signs and symptoms of eye irritation including blepharitis *, keratitis *, hypoesthesia and dry eye *.

Uncommon: visual disturbances including changes in refraction (sometimes due to discontinuation of miotics) *.

Rare: ptosis, diplopia, choroidal detachment (after surgical treatment) *.

Ear and ear canal disorders:

Timolol maleate, eye drops in solution:

Rare : ear whistles *.

Cardiac and vascular disorders:

Timolol maleate, eye drops in solution:

Uncommon: bradycardia *, syncope *.

Rare: hypotension *, chest pain *, palpitations *, edema *, arrhythmia *, congestive heart failure *, atrioventricular block *, cardiac arrest *, cerebral ischemia, claudication, Raynaud's phenomenon *, coldness of the extremities.

Respiratory, thoracic and mediastinal disorders:

Dorzolamide / Timolol Collyre in solution:

Frequent: sinusitis.

Rare: shortness of breath, respiratory failure, rhinitis.

Dorzolamide hydrochloride, eye drops in solution:

Rare: epistaxis *.

Timolol maleate, eye drops in solution:

Uncommon: dyspnea *.

Rare: bronchospasm (especially in patients with pre-existing bronchospastic disease) *, cough *.

Gastrointestinal disorders:

Dorzolamide / Timolol, eye drops in solution:

Very common: taste alteration ..

Dorzolamide hydrochloride, eye drops in solution:

Frequent: nausea *.

Rare: diarrhea, dry mouth *.

Timolol maleate, eye drops in solution:

Uncommon: nausea *, dyspepsia *.

Rare: diarrhea, dry mouth *.

Skin and subcutaneous tissue disorders:

Dorzolamide / Timolol, eye drops in solution:

Rare : contact dermatitis.

Dorzolamide hydrochloride, eye drops in solution:

Rare: eruptions *.

Timolol maleate, eye drops in solution:

Rare: alopecia *, psoriasiform rash or worsening of psoriasis *.

Musculoskeletal and connective tissue disorders:

Timolol maleate, eye drops in solution:

Rare: systemic lupus erythematosus.

Renal and urinary disorders:

Dorzolamide / Timolol, eye drops in solution:

Uncommon: urolithiasis.

Reproductive system and breast disorders:

Timolol maleate, eye drops in solution:

Rar e: Peyronie's disease *.

General disorders and accidents related to the site of administration:

Dorzolamide / Timolol, eye drops in solution:

Rare: signs and symptoms of allergic reactions, including angioedema, urticaria, pruritus, rash, anaphylaxis, rarely bronchospasm.

Dorzolamide hydrochloride, eye drops in solution:

Frequent: asthenia / fatigue *.

Timolol maleate, eye drops in solution:

Uncommon: asthenia / fatigue *.

* These side effects have also been observed with Dorzolamide / TIMOLOLEG since it was placed on the market.

Biological examinations:

Dorzolamide / Timolol, eye drops in solution has not been associated with electrolyte disturbances in clinical studies.

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