Simbrinza · 4.8 Undesirable effects · 1

HOS-216663 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile In clinical trials involving SIMBRINZA dosed twice daily the most common adverse reactions were ocular hyperaemia and ocular allergic type reactions occurring in approximately 6-7% of patients, and dysgeusia (bitter or unusual taste in the mouth following instillation) occurring in approximately 3% of patients. Tabulated summary of adverse reactions The following adverse reactions have been reported during clinical studies with SIMBRINZA twice- daily dosing and during clinical studies and post-marketing surveillance with the individual components brinzolamide and brimonidine. They are classified according to the subsequent convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000) or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. 6 System Organ Adverse reactions Classification Infections and Uncommon: nasopharyngitis2, pharyngitis2, sinusitis2 infestations Not known: rhinitis2 Blood and lymphatic Uncommon: red blood cells decreased2, blood chloride increased2 system disorders Immune system disorders Uncommon: hypersensitivity3 Psychiatric disorders Uncommon: apathy2, depression2,3, depressed mood2, insomnia1, libido decreased2, nightmares2, nervousness2 Nervous system disorders Common: somnolence1, dizziness3, dysgeusia1 Uncommon: headache1, motor dysfunction2, amnesia2, memory impairment2, paraesthesia2 Very rare: syncope3 Not known: tremor2, hypoaesthesia2, ageusia2 Eye disorders Common: eye allergy1, keratitis1, eye pain1, ocular discomfort1, blurred vision1, abnormal vision3, ocular hyperaemia1, conjunctival blanching 3 Uncommon: corneal erosion 1, corneal oedema2, blepharitis1, corneal deposits (keratic precipitates)1, conjunctival disorder (papillae)1, photophobia1, photopsia2, eye swelling2, eyelid oedema1, conjunctival oedema1, dry eye1, eye discharge1, visual acuity reduced2, lacrimation

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HOS-216659 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Hypersensitivity to sulphonamides (see section 4.4). Patients receiving monoamine oxidase (MAO) inhibitor therapy (see section 4.5). Patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin) (see section 4.5). Patients with severe renal impairment (see section 4.4). Patients with hyperchloraemic acidosis. Neonates and infants under the age of 2 years (see section 4.4).

HOS-216658 · has-indication-information · PDF-Seite 2

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).

HOS-216661 · has-interaction-information · PDF-Seite 5

No specific drug interaction studies have been performed with SIMBRINZA. SIMBRINZA is contraindicated in patients receiving monoamine oxidase inhibitors and in patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin), (see section 4.3). Tricyclic antidepressants may blunt the ocular hypotensive response of SIMBRINZA. Caution is advised due to the possibility of an additive or potentiating effect with CNS depressants (e.g. alcohol, barbiturates, opiates, sedatives or anaesthetics). No data on the level of circulating catecholamines after SIMBRINZA administration are available. However, caution is advised in patients taking medicinal products which can affect the metabolism and uptake of circulating amines (e.g. chlorpromazine, methylphenidate, reserpine, serotonin- norepinephrine reuptake inhibitors). Alpha adrenergic agonists (e.g. brimonidine tartrate), as a class, may reduce pulse and blood pressure. 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. Caution is advised when initiating (or changing the dose of) concomitant systemic medicinal products (irrespective of pharmaceutical form) which may interact with α-adrenergic agonists or interfere with their activity, i.e. agonists or antagonists of the adrenergic receptor (e.g. isoprenaline, prazosin). Brinzolamide is a carbonic anhydrase inhibitor and, although administered topically, is absorbed systemically. Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors. The potential for interactions must be considered in patients receiving SIMBRINZA. There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and topical brinzolamide. The concomitant administration of SIMBRINZA and oral carbonic anhydrase inhibitors is not recommended. The cytochrome P-450 isozymes responsible for metabolism of brinzolamide include CYP3A4 (main), CYP2A6, CYP2B6, CYP2C8 and CYP2C9. It is expected that inhibitors of CYP3A4 such as ketoconazole, itraconazole, clotrimazole, ritonavir and troleandomycin will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly. However, accumulation of brinzola

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HOS-216662 · has-pregnancy-information · PDF-Seite 6

Pregnancy There are no or limited amount of data from the use of SIMBRINZA in pregnant women. Brinzolamide was not teratogenic in rats and rabbits, following systemic administration (oral gavage). Animal studies with oral brimonidine do not indicate direct harmful effects with respect to reproductive toxicity. In animal studies, brimonidine crossed the placenta and entered into the foetal circulation to a limited extent (see section 5.3). SIMBRINZA is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding It is unknown whether topical SIMBRINZA is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown that following oral administration, minimal levels of brinzolamide are excreted in breast milk. Brimonidine administered orally is excreted in breast milk. SIMBRINZA should not be used by women who are breast-feeding. Fertility Non-clinical data do not show any effects of brinzolamide or brimonidine on fertility. There are no data on the effect of topical ocular administration of SIMBRINZA on human fertility.

HOS-216660 · has-warning-information · PDF-Seite 3

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. 3 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 (se

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