SIMBRINZA

Posology Use in adults, including the elderly The recommended dose is one drop of SIMBRINZA in the affected eye(s) two times daily. Missed dose If a dose is missed, treatment should be continued with the next dose as planned. 4). SIMBRINZA has not been studied in patients with severe renal impairment (CrCl <30 mL/min) or in patients with hyperchloraemic acidosis.

3). Paediatric population The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years have not been established. No data are available. 3). Method of administration For ocular use. Patients should be instructed to shake the bottle well before use.

When nasolacrimal occlusion is used and the eyelids are closed for 2 minutes, systemic absorption is reduced. 4). To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.

Patients should be instructed to keep the bottle tightly closed when not in use. SIMBRINZA may be used concomitantly with other topical ophthalmic medicinal products to lower intraocular pressure. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart.

Summary of the safety profile In clinical trials involving SIMBRINZA dosed twice daily the most common adverse reactions were ocular hyperaemia and ocular allergic type reactions occurring in approximately 6 7% of patients, and dysgeusia (bitter or unusual taste in the mouth following instillation) occurring in approximately 3% of patients.

Tabulated summary of adverse reactions The following adverse reactions have been reported during clinical studies with SIMBRINZA twice-daily dosing and during clinical studies and post-marketing surveillance with the individual components brinzolamide and brimonidine.

They are classified according to the subsequent convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) or not known (cannot be estimated from the available data).

Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. 4%). It is likely to be caused by passage of the eye drops in the nasopharynx via the nasolacrimal canal and is mainly attributable to the brinzolamide component of SIMBRINZA.

2). SIMBRINZA contains brinzolamide, which is a sulphonamide inhibitor of carbonic anhydrase with systemic absorption. Gastrointestinal, nervous system, haematological, renal and metabolic effects are generally associated with systemic carbonic anhydrase inhibitors.

The same type of adverse reactions attributable to oral carbonic anhydrase inhibitors may occur with topical administration. Adverse reactions commonly associated with the brimonidine component of SIMBRINZA include the development of ocular allergic type reactions, fatigue and/or drowsiness, and dry mouth.

The use of brimonidine has been associated with minimal decreases in blood pressure. Some patients who dosed with SIMBRINZA experienced decreases in blood pressure similar to those observed with the use of brimonidine as monotherapy.

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 effect 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 (for further instructions on wearing contact lenses, see below under “Benzalkonium chloride”).

Careful monitoring of patients with compromised corneas, such as patients with diabetes mellitus or corneal dystrophies, is recommended. 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 drug reactions that are attributable to sulphonamides may occur with topical administration, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions.

1. 4). 5). g. 5). 4). Patients with hyperchloraemic acidosis. 4).