Posology: Use in adults, including the elderly: The recommended dose is one drop of SIMBRINZA in the affected eye(s) two times daily.
Hepatic and/or renal impairment: SIMBRINZA has not been studied in patients with hepatic impairment and caution is therefore recommended in this population (see Precautions).
SIMBRINZA has not been studied in patients with severe renal impairment (CrCl <30 mL/min) or in patients with hyperchloraemic acidosis. Since the brinzolamide component of SIMBRINZA and its metabolite are excreted predominantly by the kidney, SIMBRINZA is contraindicated in such patients (see Contraindications).
Paediatric population: The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years has not been established. No data are available. SIMBRINZA is not recommended in children or adolescents (see Precautions).
SIMBRINZA must not be used in neonates and infants aged less than 2 years because of safety concerns (see Contraindications).
Method of administration: For ocular use.
Patients should be instructed to shake the bottle well before use.
When using nasolacrimal occlusion and closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity (see Precautions).
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.
If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed 1 drop in the affected eye(s) 2 times daily.