Medicinal Products

DORZOLAMIDE / TIMOLOL BIOGARAN 20 mg / 5 mg / mL

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

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

Indication

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

The dose is one drop of DORZOLAMIDE / TIMOLOL BIOGARAN in the conjunctival sac of the affected eye (s), twice daily.

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

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.

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 subsequently loss of vision.

Manual:

1. Before using this eye drop for the first time, make sure the safety tab is not torn.

2. To open the bottle, unscrew the cap.

3. Tilt your head back and gently pull your lower eyelid down to form a pocket between your eyelid and your eye.

4. Tip the vial and gently squeeze the sides of the vial until only one drop falls into the eye as directed by your doctor.

DO NOT TOUCH EYE OR EYE WITH BOTTLE BIT.

5. Repeat steps 3 and 4 for the other eye if your doctor has prescribed it.

6. Screw the cap back in until it is firmly in contact with the bottle.

7. The tip is designed to deliver a pre-calibrated drop; therefore, DO NOT enlarge the hole in the mouthpiece.

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 older and under 6 years of age).

Against indications

DORZOLAMIDE / TIMOLOL BIOGARAN is contraindicated in patients with:

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

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

· Severe renal impairment (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 Biogaran

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 clinical studies, 1, 035 patients were treated with dorzolamide / timolol. Approximately 2.4% of them discontinued dorzolamide / timolol therapy because of ocular adverse events and approximately 1.2% of patients discontinued treatment due to local adverse events suggestive of allergy or hypersensitivity (such as inflammation of the eyelid and conjunctivitis).

The following undesirable effects have been reported with dorzolamide / timolol or any of its components either in clinical studies or since the time of placing on the market:

Very common (≥1 / 10), common (≥1 / 100 and <1/10), uncommon (≥1 / 1, 000 and <1/100), and rare (≥1 / 10, 000 and <1/1000) )

Musculoskeletal and connective tissue disorders:

Timolol maleate, eye drops in solution:

Rare: systemic lupus erythematosus.

Nervous system 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 the signs and symptoms of myasthenia, decreased libido *, cerebrovascular accidents *.

Eye disorders:

Dorzolamide / timolol:

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:

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:

Very common: taste alteration.

Dorzolamide hydrochloride, eye drops in solution:

Frequent: nausea *.

Rare: throat irritation, dry mouth *.

Timolol maleate, eye drops in solution:

Uncommon: nausea *, dyspepsia *.

Rare: diarrhea, dry mouth *.

Skin and subcutaneous tissue disorders:

Dorzolamide / timolol:

Rare: contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Dorzolamide hydrochloride, eye drops in solution:

Rare: rash *.

Timolol maleate, eye drops in solution:

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

Renal and urinary disorders:

Dorzolamide / timolol:

Uncommon: urolithiasis.

Reproductive system and breast disorders:

Timolol maleate, eye drops in solution:

Rare: Peyronie's disease *.

General disorders and accidents related to the site of administration:

Dorzolamide / timolol:

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 / TIMOLOL BIOGARAN since it was placed on the market.

Biological examinations:

Dorzolamide / timolol has not been associated with electrolyte disturbances in clinical studies.

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