The medicinal product should not be injected. Patients should be instructed not to swallow SIMBRINZA.
Ocular effects: SIMBRINZA has not been studied in patients with narrow-angle glaucoma and its use is not recommended in these patients.
The possible role of brinzolamide on corneal endothelial function has not been investigated in patients with compromised corneas (particularly in patients with low endothelial cell count). Specifically, patients wearing contact lenses have not been studied and careful monitoring of these patients when using brinzolamide is recommended, since carbonic anhydrase inhibitors may affect corneal hydration and wearing contact lenses might increase the risk for the cornea. Careful monitoring of patients with compromised corneas, such as patients with diabetes mellitus or corneal dystrophies, is recommended. SIMBRINZA may be used while wearing contact lenses with careful monitoring (see as follows under 'Benzalkonium chloride').
Brimonidine tartrate may cause ocular allergic reactions. If allergic reactions are observed, treatment should be discontinued. Delayed ocular hypersensitivity reactions have been reported with brimonidine tartrate, with some reported to be associated with an increase in IOP.
The potential effects following cessation of treatment with SIMBRINZA have not been studied. While the duration of IOP-lowering effect for SIMBRINZA has not been studied, the IOP-lowering effect of brinzolamide is expected to last for 5-7 days. The IOP-lowering effect of brimonidine may be longer.
Systemic effects: SIMBRINZA contains brinzolamide, a sulphonamide inhibitor of carbonic anhydrase and, although administered topically, is absorbed systemically. The same types of adverse reactions that are attributable to sulphonamides may occur with topical administration. If signs of serious reactions or hypersensitivity occur, the use of this medicinal product should be discontinued.
Cardiac disorders: Following administration of SIMBRINZA, small decreases in blood pressure were observed in some patients. Caution is advised when using medicinal products such as antihypertensives and/or cardiac glycosides concomitantly with SIMBRINZA or in patients with severe or unstable and uncontrolled cardiovascular disease (see Interactions).
SIMBRINZA should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.
Acid/base disturbances: Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors. SIMBRINZA contains brinzolamide, an inhibitor of carbonic anhydrase, and although administered topically, is absorbed systemically. The same types of adverse reactions that are attributable to oral carbonic inhibitors (i.e., acid-base disturbances) may occur with topical administration (see Interactions).
Use with caution in patients with risk of renal impairment because of the possible risk of metabolic acidosis. SIMBRINZA is contraindicated in patients with severe renal impairment (see Contraindications).
Hepatic impairment: SIMBRINZA has not been studied in patients with hepatic impairment; caution should be used in treating such patients (see Dosage & Administration).
Mental alertness: Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/or physical coordination in elderly patients. SIMBRINZA is absorbed systemically and therefore this may occur with topical administration (see Effects on ability to drive and use machines as follows).
Benzalkonium chloride: SIMBRINZA contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Contact with soft contact lenses should be avoided. Patients must be instructed to remove contact lens prior to application of SIMBRINZA and wait at least 15 minutes before reinsertion.
Benzalkonium chloride has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Close monitoring is required with frequent or prolonged use.
Effects on ability to drive and use machines: SIMBRINZA has a moderate influence on the ability to drive and use machines.
SIMBRINZA may cause dizziness, fatigue and/or drowsiness, which may impair the ability to drive or use machines.
Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation the patient must wait until the vision clears before driving or using machines.
Oral carbonic anhydrase inhibitors may impair the ability of elderly patients to perform tasks requiring mental alertness and/or physical coordination (see previously mentioned).
Paediatric population: The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years has not been established. Symptoms of brimonidine overdose (including loss of consciousness, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea) have been reported in neonates and infants receiving brimonidine eye drops as part of medical treatment of congenital glaucoma. SIMBRINZA is therefore contraindicated in children below 2 years of age (see Precautions).
Treatment of children 2 years and above (especially in those in the 2-7 age range and/or weighing <20 kg) is not recommended because of the potential for central nervous system-related side effects (see Overdosage).