Medicinal Products

DORZOLAMIDE / TIMOLOL MYLAN 20 mg / 5 mg / mL

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

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

Indication

This drug is indicated for the treatment of high intraocular pressure (IOP) in patients with open-angle glaucoma, or pseudo-exfoliative glaucoma, when ocular beta-blocker monotherapy is insufficient.

Dosage DORZOLAMIDE / TIMOLOL MYLAN 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 MYLAN in the conjunctival sac of the affected eye (s), twice daily.

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

Systemic absorption is reduced by nasolacrimal compression or by closure of

eyelids for two minutes. This may result in a decrease in systemic adverse effects and

an increase in local activity.

Use in children

Efficacy has not been established in children.

Tolerance in children under 2 years of age has not been established (see section 5.1 Pharmacodynamic properties for more information on safety in children aged 2 years or older and under 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 the delivery of a proper dose, the tip should not be expanded.

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.

Patients should be informed of the correct handling of DORZOLAMIDE / TIMOLOL MYLAN vials.

Manual

1. The tamper evident collar at the neck of the vial must not be broken before the first use of the eye drops. A space between the bottle and the stopper is normal on an unopened vial.

2. The vial cap should be removed.

3. The patient should tilt their head back and their lower eyelid should be slightly pulled down to form a small pocket between the eyelid and the eye.

4. Turn the vial upside down and squeeze until only one drop falls into the eye. THE EYE OR EYE SHOULD NOT BE TOUCHED WITH THE DROPPER TIP.

5. Repeat steps 3 & 4 for the other eye if necessary.

6. Replace the cap and close the bottle immediately after use.

Against indications

DORZOLAMIDE / TIMOLOL MYLAN 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 atrio-venticular sinus syndrome, uncontrolled by cardiac simulator, patent heart failure, cardiogenic shock.

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

· Hypersensitivity to 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 Mylan

In clinical studies, no specific adverse effects of DORZOLAMIDE / TIMOLOL MYLAN were observed; adverse effects were limited to those previously reported with dorzolamide hydrochloride and / or timolol maleate. In general, the common side effects are moderate and did not lead to discontinuation of treatment.

In clinical studies, 1, 035 patients were treated with DORZOLAMIDE / TIMOLOL. Approximately 2.4% of them discontinued DORZOLAMIDE / TIMOLOL due to 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).

Like other ophthalmic drugs for topical use, Dorzolamide / Timolol passes into the systemic circulation. This may result in the same side effects as with systemic beta-blockers. After topical ophthalmic administration, the frequency of adverse effects is lower than after systemic administration. The undesirable effects mentioned include adverse reactions observed within the Ophthalmic Beta Blockers class.

The following undesirable effects have been reported with DORZOLAMIDE / TIMOLOL or one of its components either in clinical studies or since the time of marketing:

Very common (≥1 / 10).

Frequent (≥1 / 100 and <1/10).

Uncommon (≥1 / 1, 000 and <1/100).

Rare (≥1 / 10, 000 and <1/1000).

Very rare (≤ 10, 000).

Not known: can not be estimated from the available data.

Data from clinical studies, including frequencies (if applicable).

Other side effects have been observed with ophthalmic beta-blockers and are likely to occur with Dorzolamide / Timolol:

Immune system disorders:

Timolol maleate eye drops:

Systemic allergic reactions: angio-neurotic edema, urticaria, localized or generalized rash, pruritus, anaphylactic reactions

Metabolism and nutrition disorders:

Timolol maleate eye drops:

hypoglycemia

Psychiatric disorders:

Timolol maleate eye drops:

Rare: Insomnia, depression, nightmares, memory loss

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 *, syncope

Rare: paresthesia *, worsening signs and symptoms of myasthenia gravis, decreased libido *, stroke *, ischemic stroke.

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 (eg, burning, tingling, itching, tearing, rushing), 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 * (see Warnings and Precautions ) section. Blurred vision, erosion of the cornea.

Ear and ear canal disorders

Timolol maleate, eye drops in solution:

Rare: ear whistles *.

Cardiac disorders

Timolol maleate, eye drops in solution:

Uncommon: bradycardia *.

Rare: chest pain *, palpitations *, edema *, arrhythmia *, congestive heart failure *, heart failure, atrioventricular block *, cardiac arrest *, claudication, atrioventricular block.

Vascular diseases:

Timolol maleate, eye drops in solution:

Rare: hypotension, Raynaud's phenomenon, coldness of the extremities.

Respiratory, thoracic and mediastinal disorders

Dorzolamide / Timolol eye drops 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: throat irritation, dry mouth *.

Timolol maleate, eye drops in solution:

Uncommon: nausea *, dyspepsia *.

Rare: diarrhea, dry mouth *, dysgeusia, abdominal pain, vomiting.

Skin and subcutaneous tissue disorders

Dorzolamide / Timolol eye drops in solution:

Rare: contact dermatitis.

Dorzolamide hydrochloride, eye drops in solution:

Rare: rash *.

Timolol maleate, eye drops in solution:

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

Musculoskeletal and Connective Tissue Disorders

Timolol maleate, eye drops in solution:

Rare: systemic lupus erythematosus, myalgia.

Renal and urinary disorders

Dorzolamide / Timolol eye drops in solution:

Uncommon: urolithiasis.

Disorders of the reproductive organs and breasts

Timolol maleate, eye drops in solution:

Rare: Peyronie's disease *.

Sexual dysfunction, low libido.

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 / TIMOLOL MYLAN since it was placed on the market.

Biological examinations

DORZOLAMIDE / TIMOLOL eye drops in solution has not been associated with electrolyte disorders in clinical studies.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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