Ganfort · 4.5 Interaction with other medicinal products and other forms of interaction · 2

HOS-094306 · has-adverse-reaction-information · PDF-Seite 17

Summary of the safety profile The adverse reactions reported in the clinical study using GANFORT single-dose were limited to those earlier reported for either GANFORT (multi-dose formulation) or for the single active substances bimatoprost or timolol. No new adverse reactions specific for GANFORT single-dose have been observed in clinical studies. The majority of adverse reactions reported with GANFORT single-dose were ocular, mild in severity and none were serious. Based on a 12-week study of GANFORT single-dose administered once daily, the most commonly reported adverse reaction with GANFORT single-dose was conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in approximately 21% of patients and led to discontinuation in 1.4% of patients. Tabulated list of adverse reactions Table 1 presents the adverse reactions that have been reported during clinical studies with all GANFORT formulations (multi-dose and single-dose) or in the post-marketing period. Possible adverse reactions are listed by MedDRA system organ class and are based on the following 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) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1: List of adverse reactions with all GANFORT formulations (multi-dose and single-dose) System Organ Class Frequency Adverse reaction Immune system disorders Not known Hypersensitivity reactions including signs or symptoms of allergic dermatitis, angioedema, eye allergy 17 Psychiatric disorders Not known Insomnia2, nightmare2 Nervous system disorders Common Headache Not known Dysgeusia2, dizziness Eye disorders Very common Conjunctival hyperaemia Common Punctuate keratitis, corneal

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HOS-094300 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The adverse reactions reported in clinical studies using GANFORT were limited to those earlier reported for either of the single active substances bimatoprost and timolol. No new adverse reactions specific for GANFORT have been observed in clinical studies. The majority of adverse reactions reported in clinical studies using GANFORT were ocular, mild in severity and none were serious. Based on 12-month clinical data, the most commonly reported adverse reaction was conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in approximately 26% of patients and led to discontinuation in 1.5% of patients. Tabulated list of adverse reactions Table 1 presents the adverse reactions that have been reported during clinical studies with all GANFORT formulations (multi-dose and single-dose) or in the post-marketing period. Possible adverse reactions are listed by MedDRA system organ class and are based on the following 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) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1: List of adverse reactions with all GANFORT formulations (multi-dose and single-dose) System Organ Class Frequency Adverse reaction Immune system disorders Not known Hypersensitivity reactions 6  including signs or symptoms of allergic dermatitis, angioedema, eye allergy Psychiatric disorders Not known Insomnia2, nightmare2 Nervous system disorders Common Headache Not known Dysgeusia2, dizziness Eye disorders Very common Conjunctival hyperaemia. Common Punctuate keratitis, corneal erosion2, burning sensation2,

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HOS-094302 · has-contraindication-information · PDF-Seite 14

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. • Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pace-maker. Overt cardiac failure, cardiogenic shock.

HOS-094296 · has-contraindication-information · PDF-Seite 3

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. • Sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third degree atrioventricular block, not controlled with pace-maker. Overt cardiac failure, cardiogenic shock.

HOS-094301 · has-indication-information · PDF-Seite 13

Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

HOS-094295 · has-indication-information · PDF-Seite 2

Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

HOS-094304 · has-interaction-information · PDF-Seite 16

No specific interaction studies have been performed with the bimatoprost / timolol fixed combination. There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blocker solution is administered concomitantly with oral calcium channel blockers, guanethidine, beta-adrenergic blocking agents, parasympathomimetics, anti-arrhythmics (including amiodarone) and digitalis glycosides. Potentiated systemic beta-blockade (e.g. decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol. Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.

HOS-094298 · has-interaction-information · PDF-Seite 5

No specific interaction studies have been performed with the bimatoprost / timolol fixed combination. There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral calcium channel blockers, guanethidine, beta-adrenergic blocking agents, parasympathomimetics, anti-arrhythmics (including amiodarone) and digitalis glycosides. Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol. Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.

HOS-094299 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no adequate data from the use of the bimatoprost / timolol fixed combination in pregnant women. GANFORT should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see section 4.2. Bimatoprost No adequate clinical data in exposed pregnancies are available. Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3). Timolol Epidemiological studies have not revealed malformative effects but shown a risk for intra uterine growth retardation when beta-blockers are administered by the oral route. In addition, signs and 5 symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. If GANFORT is administered until delivery, the neonate should be carefully monitored during the first days of life. Animal studies with timolol have shown reproductive toxicity at doses significantly higher than would be used in clinical practice (see section 5.3). Breast-feeding Timolol Beta-blockers are excreted in breast milk. However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant. To reduce the systemic absorption, see section 4.2. Bimatoprost It is not known if bimatoprost is excreted in human breast milk but it is excreted in the milk of the lactating rat. GANFORT should not be used by breast-feeding women. Fertility There are no data on the effects of GANFORT on human fertility.

HOS-094305 · has-pregnancy-information · PDF-Seite 16

Pregnancy There are no adequate data from the use of the bimatoprost / timolol fixed combination in pregnant women. GANFORT single-dose should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see section 4.2. Bimatoprost No adequate clinical data in exposed pregnancies are available. Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3). Timolol Epidemiological studies have not revealed malformative effects but have shown a risk for intra uterine growth retardation when beta-blockers are administered by the oral route. In addition, signs and symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. If GANFORT single-dose is administered until delivery, the neonate should be carefully monitored during the first days of life. Animal studies with timolol have shown reproductive toxicity at doses significantly higher than would be used in clinical practice (see section 5.3). 16 Breast-feeding Timolol Beta-blockers are excreted in breast milk. However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant. To reduce the systemic absorption, see section 4.2. Bimatoprost It is not known if bimatoprost is excreted in human breast milk but it is excreted in the milk of the lactating rat. GANFORT single-dose should not be used by breast-feeding women. Fertility There are no data on the effects of GANFORT single-dose on human fertility.

HOS-094297 · has-warning-information · PDF-Seite 3

Like other topically applied ophthalmic medicinal products, the active substances (timolol/ bimatoprost) in GANFORT may be absorbed systemically. No enhancement of the systemic absorption of the individual active substances has been observed. Due to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions as seen with systemic beta-blockers may occur. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. To reduce the systemic absorption, see section 4.2. Cardiac disorders In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension, therapy with beta-blockers should be critically assessed and therapy with other active substances should be considered. Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions. Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block. Vascular disorders Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud’s disease or Raynaud’s syndrome) should be treated with caution. Respiratory disorders Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic beta-blockers. GANFORT should be used with caution, in patients with mild/moderate chronic obstructive pulmonary disease (COPD) and only if the potential benefit outweighs the potential risk. Endocrine disorders Beta-adrenergic blocking medicinal products should be administered with caution in patients subject to spontaneous hypoglycemia or to patients with labile diabetes as beta-blockers may mask the signs and symptoms of acute hypoglycemia. Beta-blockers may also mask the signs of hyperthyroidism. Corneal diseases 3 Ophthalmic β-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution. Other beta-blocking agents The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be potentiated when timolol is given to the patients already receiving a systemic beta-blocking agent. The response of these patients should be closely observed. The use of two topical beta-adrenergic blocking agents is not recomm

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HOS-094303 · has-warning-information · PDF-Seite 14

Like other topically applied ophthalmic medicinal products, the active substances (timolol/ bimatoprost) in GANFORT single-dose may be absorbed systemically. No enhancement of the systemic absorption of the individual active substances has been observed with GANFORT (multi-dose formulation). Due to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions (ADRs) as seen with systemic beta-blockers may occur. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. To reduce the systemic absorption, see section 4.2. Cardiac disorders In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension, therapy with beta-blockers should be critically assessed and therapy with other active substances should be considered. Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions. Due to the negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block. Vascular disorders Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud’s disease or Raynaud’s syndrome) should be treated with caution. Respiratory disorders Respiratory reactions, including death due to bronchospasm in patients with asthma, have been reported following administration of some ophthalmic beta-blockers. GANFORT single-dose should be used with caution in patients with mild/moderate chronic obstructive pulmonary disease (COPD) and only if the potential benefit outweighs the potential risk. Endocrine disorders Beta-adrenergic blocking medicinal products should be administered with caution in patients subject to spontaneous hypoglycaemia or in patients with labile diabetes as beta-blockers may mask the signs and symptoms of acute hypoglycemia. Beta-blockers may also mask the signs of hyperthyroidism. 14 Corneal diseases Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution. Other beta-blocking agents The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be potentiated when timolol is given to patients already receiving a systemic beta-blocking agent. The response of these patients should be closely observed.

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