Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
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. If signs of serious reactions or hypersensitivity occur, SIMBRINZA should be withdrawn immediately.

Cardiac disorders

Following administration of SIMBRINZA, small decreases in blood pressure were observed in some patients. Caution is advised when using medicinal products such as antihypertensives and/or cardiac glycosides concomitantly with SIMBRINZA or in patients with severe or unstable and uncontrolled cardiovascular disease (see section 4.5).

SIMBRINZA should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.

Acid/base disturbances

Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.
SIMBRINZA contains brinzolamide, an inhibitor of carbonic anhydrase, and although administered topically, is absorbed systemically. The same types of adverse reactions that are attributable to oral carbonic inhibitors (i.e. acid-base disturbances) may occur with topical administration (see section 4.5).

SIMBRINZA should be used with caution in patients with risk of renal impairment because of the possible risk of metabolic acidosis. SIMBRINZA is contraindicated in patients with severe renal impairment (see section 4.3).

Hepatic impairment

SIMBRINZA has not been studied in patients with hepatic impairment; caution should be used in treating such patients (see section 4.2).

Mental alertness

Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/or physical coordination in elderly patients. SIMBRINZA is absorbed systemically and this may therefore occur with topical administration (see section 4.7).

Paediatric population

The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years have not been established. Symptoms of brimonidine overdose (including loss of consciousness, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea) have been reported in neonates and infants receiving brimonidine eye drops as part of medical treatment of congenital glaucoma. SIMBRINZA is therefore contraindicated in children below 2 years of age (see section 4.3).

Treatment of children 2 years and above (especially those in the 2-7 age range and/or weighing <20 kg) is not recommended because of the potential for central nervous system-related side effects (see section 4.9).

Benzalkonium chloride

SIMBRINZA contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Contact with soft contact lenses should be avoided. Patients must be instructed to remove contact lens prior to application of SIMBRINZA and wait at least 15 minutes before reinsertion.

Benzalkonium chloride has been reported to cause eye irritation and symptoms of dry eyes and may affect the tear film and corneal surface. It should be used with caution in dry eye patients and in patients whose cornea may be compromised.
Patients should be monitored in case of prolonged use.




Effects on Driving

4.7 Effects on ability to drive and use machines

SIMBRINZA has a moderate influence on the ability to drive and use machines.
SIMBRINZA may cause dizziness, fatigue and/or drowsiness, which may impair the ability to drive or use machines.

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation the patient must wait until the vision clears before driving or using machines.

Oral carbonic anhydrase inhibitors may impair the ability of elderly patients to perform tasks requiring mental alertness and/or physical coordination (see section 4.4).