SIMBRINZA EYE DROPS, SUSPENSION 10 MG/ML + 2 MG/ML

4.1. Therapeutic indications

SIMBRINZA® eye drops contains brinzolamide, a carbonic anhydrase (CA-II) inhibitor, and brimonidine tartrate, an alpha-2 adrenergic agonist.

Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3. Contraindications

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to sulphonamides (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),
• Patients receiving monoamine oxidase (MAO) inhibitor therapy (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),
• Patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin) (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),
• Patients with severe renal impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),
• Patients with hyperchloraemic acidosis,
• Neonates and infants younger than 2 years old (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2. Posology and method of administration

Posology

Use in adults (including the elderly)

The recommended dose is 1 drop of SIMBRINZA eye drops in the affected eye(s) 2 times daily.

Use in children and adolescents

The safety and efficacy of SIMBRINZA eye drops in children and adolescents aged 2 to 17 years has not been established. No data are available. SIMBRINZA eye drops is not recommended in children or adolescents (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

SIMBRINZA eye drops must not be used in neonates and infants aged less than 2 years because of safety concerns (see section 4.3).

Use in patients with hepatic and/or renal impairment

SIMBRINZA eye drops has not been studied in patients with hepatic impairment and caution is therefore recommended in this population (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

SIMBRINZA eye drops 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 eye drops and its metabolite are excreted predominantly by the kidney, SIMBRINZA eye drops is contraindicated in such patients (see section 4.3).

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, this should be removed before using the product.

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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

To avoid contamination, the dropper tip should not touch any surface. The dropper tip should also not come into contact with the eye as this may cause injury to the eye. Patients should be instructed to keep the bottle tightly closed when not in use.

SIMBRINZA eye drops 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. Eye ointments should be administered last.

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.

When substituting another ophthalmic antiglaucoma agent with SIMBRINZA eye drops, the other agent should be discontinued and SIMBRINZA eye drops should be started the following day.