SIMBRINZA Eye drops, suspension (eye drops) Ref.[50759] Active ingredients: Brimonidine Brinzolamide

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.

Hepatic and/or renal impairment

SIMBRINZA has not been studied in patients with hepatic impairment and caution is therefore recommended in this population (see section 4.4).

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 section 4.3).

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.

SIMBRINZA is contraindicated in neonates and infants aged less than 2 years in the decrease of elevated intraocular pressure (IOP) with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction because of safety concerns (see section 4.3).

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. This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4).

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.

If overdose with SIMBRINZA occurs treatment should be symptomatic and supportive. The patient’s airway should be maintained.

Due to the brinzolamide component of SIMBRINZA, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur. Serum electrolyte levels (particularly potassium) and blood pH levels must be monitored.

There is very limited information regarding accidental ingestion with the brimonidine component of SIMBRINZA in adults. The only adverse reaction reported to date was hypotension. It was reported that the hypotensive episode was followed by rebound hypertension.

Oral overdoses of other alpha-2-agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression and seizure.

Paediatric population

Serious adverse reactions following inadvertent ingestion with the brimonidine component of SIMBRINZA by paediatric subjects have been reported. The subjects experienced symptoms of CNS depression, typically temporary coma or low level of consciousness, lethargy, somnolence, hypotonia, bradycardia, hypothermia, pallor, respiratory depression and apnoea, and required admission to intensive care with intubation if indicated. All subjects were reported to have made a full recovery, usually within 6-24 hours.

2 years.

4 weeks after first opening.

This medicinal product does not require any special storage conditions.

8 mL round, opaque, low density polyethylene (LDPE) bottles with a LDPE dropper tip and white polypropylene screw cap containing 5 mL suspension.

Carton containing 1 or 3 bottles.

Not all pack sizes may be marketed.

No special requirements for disposal.