DuoTrav

Posology Use in adults, including the elderly The dose is one drop of DuoTrav in the conjunctival sac of the affected eye(s) once daily, in the morning or evening. It should be administered at the same time each day. If a dose is missed, treatment should be continued with the next dose as planned.

The dose should not exceed one drop in the affected eye(s) daily. Special populations Hepatic and renal impairment No studies have been conducted with DuoTrav or with timolol 5 mg/mL eye drops in patients with hepatic or renal impairment.

Travoprost has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 mL/min). No dose adjustment was necessary in these patients. 2). 3 Paediatric population The safety and efficacy of DuoTrav in children and adolescents below the age of 18 years have not been established.

No data are available. Method of administration For ocular use. The patient should remove the protective overwrap immediately prior to initial use. 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.

When nasolacrimal occlusion is used or the eyelids are closed for 2 minutes, systemic absorption is reduced. 4). 5). When substituting another ophthalmic antiglaucoma medicinal product with DuoTrav, the other medicinal product should be discontinued and DuoTrav should be started the following day.

4).

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. 8 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, iris hyperpigmentation, corneal disorder Cardiac disorders Uncommon Bradycardia Rare Arrhythmia, heart rate irregular Not known Cardiac failure, tachycardia, chest pain, palpitations Vascular disorders Uncommon Hypertension, hypotension Not known Oedema peripheral Respiratory, thoracic and mediastinal disorders Uncommon Dyspnoea, postnasal drip Rare Dysphonia, bronchospasm, cough, throat irritation, oropharyngeal pain, nasal discomfort Not known Asthma Gastrointestinal disorders Not known Dysgeusia Hepatobiliary disorders Rare Alanine aminotransferase increased, aspartate aminotransferase increased Skin and subcutaneous tissue disorders Uncommon Dermatitis contact, hypertrichosis, skin hyperpigmentation (periocular) Rare Urticaria, skin discolouration, alopecia Not known Rash Musculoskeletal and connective tissue disorders Rare Pain in extremity Renal and urinary disorders Rare Chromaturia General disorders and administration site conditions Rare Thirst, fatigue * adverse reactions observed with timolol.

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. 2. 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.

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.

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. 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 potentiated when timolol is given to patients already receiving a systemic beta-blocking medicinal product.

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.