Brinzolamide 10mg Timolol 5mg Eye Drops 5ml

Brinzolamide/Timolol Accord 10mg/ml + 5mg/ml eye drops, suspension

One ml of suspension contains 10mg brinzolamide and timolol maleate corresponding to 5mg timolol.

Excipient with known effect:

One ml of suspension contains 0.10mg benzalkonium chloride.

Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction

Posology

Use in adults, including the elderly:

The dose is one drop of Brinzolamide/Timolol in the conjunctival sac of the affected eye(s) twice daily.

When using nasolacrimal occlusion or closing the eyelids, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4).

If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) twice daily.

When substituting another ophthalmic antiglaucoma medicinal product with Brinzolamide/Timolol, the other medicinal product should be discontinued and Brinzolamide/Timolol should be started the following day.

Special populations

Paediatric population

The safety and efficacy of Brinzolamide/Timolol in children and adolescents aged 0 to 18 years has not yet been established. No data is available.

Hepatic and renal impairment

No studies have been conducted with Brinzolamide/Timolol or with timolol 5mg/ml eye drops in patients with hepatic or renal impairment. No dosage adjustment is necessary in patients with hepatic impairment or in patients with mild to moderate renal impairment.

Brinzolamide/Timolol has not been studied in patients with severe renal impairment (creatinine clearance <30 ml/min) or in patients with hyperchloraemic acidosis (see section 4.3). Since brinzolamide and its main metabolite are excreted predominantly by the kidney, Brinzolamide/Timolol is therefore contraindicated in patients with severe renal impairment (see section 4.3).

Brinzolamide/Timolol should be used with caution in patients with severe hepatic impairment (see section 4.4).

Method of administration

For ocular use.

Patients should be instructed to shake the bottle well before use. After cap is removed, if tamper evident snap collar is loose, remove before using product.

To prevent contamination of the dropper tip and the suspension, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. Instruct patients to keep the bottle tightly closed when not in use.

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart. Eye ointments should be administered last.