DuoTrav · 4.1 Therapeutic indications · 1

HOS-154136 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile In clinical studies involving 2,170 patients treated with DuoTrav the most frequently reported treatment-related adverse reaction was ocular hyperaemia (12.0%). Tabulated summary of adverse reactions The adverse reactions listed in the table below were observed in clinical studies or with post-marketing experience. They are ranked according to system organ class and classified according to 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), or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness. 7 System organ class Frequency Adverse reactions Immune system disorders Uncommon Hypersensitivity Psychiatric disorders Rare Nervousness Not known Hallucinations*, Depression Nervous system disorders Uncommon Dizziness, headache Not known Cerebrovascular accident, syncope, paraesthesia Eye disorders Very common Ocular hyperaemia Common Punctate keratitis, eye pain, visual disturbance, vision blurred, dry eye, eye pruritus, ocular discomfort, eye irritation Uncommon Keratitis, iritis, conjunctivitis, anterior chamber inflammation, blepharitis, photophobia, visual acuity reduced, asthenopia, eye swelling, lacrimation increased, erythema of eyelid, growth of eyelashes, eye allergy, conjunctival oedema, eyelid oedema Rare Corneal erosion, meibomianitis, conjunctival haemorrhage, eyelid margin crusting, trichiasis, distichiasis Not known Macular oedema, eyelid ptosis, lid sulcus deepened,

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HOS-154132 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substances, or to any of the excipients listed in section 6.1. Hypersensitivity to other beta blockers. Reactive airway disease including bronchial asthma, or a history of bronchial asthma, severe chronic obstructive pulmonary disease. Sinus bradycardia, sick sinus syndrome, including sino-atrial block, second- or third-degree atrioventricular block not controlled with pacemaker. Overt cardiac failure, cardiogenic shock. Severe allergic rhinitis and corneal dystrophies.

HOS-154131 · has-indication-information · PDF-Seite 2

DuoTrav is indicated in adults for the decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta blockers or prostaglandin analogues (see section 5.1).

HOS-154134 · has-interaction-information · PDF-Seite 6

No specific drug interaction studies have been performed with travoprost or timolol. 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, beta-adrenergic blocking agents, antiarrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics or guanethidine. The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta blockers. 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. Beta blockers may increase the hypoglycaemic effect of antidiabetic medicinal products. Beta blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4).

HOS-154135 · has-pregnancy-information · PDF-Seite 6

Women of childbearing potential/contraception DuoTrav must not be used in women of child-bearing age/potential unless adequate contraceptive measures are in place (see section 5.3). Pregnancy Travoprost has harmful pharmacological effects on pregnancy and/or the foetus/newborn child. There are no or limited amount of data from the use of DuoTrav or the individual components in pregnant women. Timolol should not be used during pregnancy unless clearly necessary. Epidemiological studies have not revealed malformative effects but show a risk for intrauterine 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 DuoTrav is administered until delivery, the neonate should be carefully monitored during the first days of life. DuoTrav should not be used during pregnancy unless clearly necessary. For information on how to reduce systemic absorption, see section 4.2. 6 Breast-feeding It is unknown whether travoprost from eye drops is excreted in human breast milk. Animal studies have shown excretion of travoprost and metabolites in breast milk. Timolol is excreted in breast milk and has the potential to cause serious adverse reactions in the breast-fed infant. 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. For information on how to reduce systemic absorption, see section 4.2. The use of DuoTrav by breast-feeding women is not recommended. Fertility There are no data on the effects of DuoTrav on human fertility. Animal studies showed no effect of travoprost on fertility at doses up to 75 times the maximum recommended human ocular dose, whereas no relevant effect of timolol was noted at this dose level.

HOS-154133 · has-warning-information · PDF-Seite 3

Systemic effects Like other topically applied ophthalmic agents, travoprost and timolol are absorbed systemically. Due to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking medicinal products may occur. The incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. For information on how to reduce 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 their negative effect on conduction time, beta blockers should only be given with caution to patients with first-degree heart block. 3 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. DuoTrav 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. Hypoglycaemia/diabetes Beta blockers 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 hypoglycaemia. Muscle weakness Beta-adrenergic blocking medicinal products have been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g. diplopia, ptosis and generalised weakness). Corneal diseases Ophthalmic beta blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution. Choroidal detachment Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures. Other beta-blocking agents The effect on intra-ocular pressure or the known effects of systemic beta blockade may be pot

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