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International Nonproprietary Name - Brimonidinum+Brinzolamidum Generic Name: Brinzolamide+Brimonidine Country of Manufacture: Belgium Manufacturer: Alcon Prescription Status: Prescription Only SIMBRINZA 10 mg/ml + 2 mg/ml Eye Drops, Suspension Composition: 1 ml of suspension contains 10 mg of brinzolamide and 2 mg of brimonidine tartrate equivalent to 1.3 mg of brimonidine. Preservative: 1 ml of suspension contains 0.03 mg of benzalkonium chloride. Excipients: Benzalkonium chloride, propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tyloxapol, hydrochloric acid or sodium hydroxide and purified water. Indications: Elevated intraocular pressure. Open-angle glaucoma in adults. Dosage and Administration: Adults and elderly: The recommended dose is 1 drop of SIMBRINZA eye drops in the affected eye, twice daily. Safety and efficacy in the age group of 2-17 years have not been established, therefore the drug is not recommended for this age group. Not for use in children under 2 years of age. For ophthalmic use, shake the bottle before use. After removing the cap, the tamper-evident ring must be removed before using the product. To avoid contamination of the dropper tip and suspension, do not touch the bottle tip to the eyelid or surrounding surfaces. The cap should be tightly closed after instillation. To reduce the risk of systemic absorption and side effects after instillation, it is recommended to apply pressure to the inner corner of the eye for 2 minutes. SIMBRINZA eye drops may be used concurrently with other topical ophthalmic medications. A 5-minute interval should be observed between their administrations, with ophthalmic ointments being administered last. If a dose is missed, treatment should be continued according to the usual schedule. If replacing other antiglaucoma medications with SIMBRINZA eye drops, discontinue the other medication and start SIMBRINZA the following day. Contraindications: Hypersensitivity to the active substances or any of the excipients, or to sulfonamides. Patients on MAO inhibitor therapy, taking antidepressants, with impaired renal function, hyperchloremic acidosis, neonates and children under 2 years of age. Interactions with other drugs: Potentiates the CNS depressant effects of alcohol, barbiturates, opiates, sedatives or anesthetics. Use with caution when used with tricyclic antidepressants, such as chlorpromazine, methylphenidate, reserpine, serotonin-norepinephrine reuptake inhibitors. Use with caution also in combination with antihypertensive drugs and cardiac glycosides, ketoconazole, itraconazole, clotrimazole, ritonavir and troleandomycin, may interact with isoprenaline, prazosin; simultaneous use of SIMBRINZA eye drops and oral carbonic anhydrase inhibitors is not recommended.