VISUTRAX

Posology Use in adults, including elderly population The dose is one drop of Visutrax in the conjunctival sac of the affected eye(s) once daily. Optimal effect is obtained if the dose is administered in the evening. Nasolacrimal occlusion or gently closing the eyelid after administration is recommended.

This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions. 5). 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. When substituting another ophthalmic antiglaucoma medicinal product with Visutrax, the other medicinal product should be discontinued and Visutrax should be started the following day.

Hepatic and 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). 2). Paediatric population Visutrax can be used in paediatric patients from 2 months to < 18 years at the same posology as in adults.

1). The safety and efficacy of Visutrax in children below the age of 2 months have not been established. No data are available. Method of Administration For ocular use. 4.

Summary of the safety profile In clinical trials with travoprost, the most common adverse reactions were ocular hyperaemia and iris hyperpigmentation, occurring in approximately 20% and 6% of patients respectively. Tabulated list of adverse reactions The following adverse reactions are 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 (frequency cannot be estimated from the available data).

Within each frequency group, adverse reactions are presented in decreasing order of seriousness. The adverse reactions were obtained from clinical studies and postmarketing data with travoprost. System Organ Class Frequency Adverse Reactions Immune system disorders Uncommon hypersensitivity, seasonal allergy Psychiatric disorders Not known depression, anxiety Uncommon headacheNervous system disorder Rare Dysgeusia, dizziness, visual field defect Very common ocular hyperaemia Common iris hyperpigmentation, eye pain, ocular discomfort, dry eye, eye pruritus, eye irritation Uncommon corneal erosion, uveitis, iritis, anterior chamber inflammation, keratitis, punctate keratitis, photophobia, eye discharge , blepharitis, erythema of eyelid, periorbital oedema, eyelids pruritus, visual acuity reduced, vision blurred, lacrimation increased, conjunctivitis, ectropion, cataract, eyelid margin crusting, growth of eyelashes, Rare iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids, conjunctival oedema, halo vision, conjunctival follicles, hypoaesthesia eye, trichiasis, meibomianitis, anterior chamber pigmentation, mydriasis, astehenopia, eyelash hyperpigmentation, eyelash thickening Eye disorders Not known macular oedema, lid sulcus deepened Ear and labyrinth disorders Not known vertigo, tinnitus Uncommon palpitations Rare heart rate irregular, heart rate decreased Cardiac disorders Not known chest pain, bradycardia, tachycardia, arrhythmia Vascular disorders Rare blood pressure diastolic decreased, blood pressure systolic increased, hypotension, hypertension Respiratory, thoracic and mediastinal Uncommon cough, nasal congestion, throat irritation Rare dyspnoea, asthma, respiratory disorder, oropharyngeal pain, dysphonia, rhinitis allergic, nasal dryness disorders Not known asthma aggravated, epistaxis Rare peptic ulcer reactivated, gastrointestinal disorder, constipation, dry mouth Gastrointestinal disorders Non known diarrhoea, abdominal pain, nausea, vomiting Uncommon skin hyperpigmentation (periocular), skin discolouration, hair texture abnormal, hypertrichosis Rare dermatitis allergic, dermatitis contact, erythema, rash, hair colour changes, madarosis Skin and subcutaneous tissue disorders Not known pruritus, hair growth abnormal Musculoskeletal and connective tissue disorders Rare musculoskeletal pain, arthralgia Renal and urinary disorders Not known dysuria, urinary incontinence General disorders and administration site conditions Rare asthenia Investigations Not known prostatic specific antigen increased Paediatric Population In a 3month phase 3 study and a 7 days pharmacokinetic study, enrolling 102 paediatric patients exposed to travoprost, the types and characteristics of adverse reactions reported were similar to what has been observed in adult patients.

Eye colour change Visutrax may gradually change the iris colour by increasing the number of melanosomes (pigment granules) in melanocytes. Before treatment is instituted, patients must be informed of the possibility of a permanent change in iris colour.

Unilateral treatment can result in permanent heterochromia. The long term effects on the melanocytes and any consequences thereof are currently unknown. The change in iris colour occurs slowly and may not be noticeable for months to years.

, blue-brown, grey-brown, yellow-brown and green-brown); however, it has also been observed in patients with brown eyes. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may be become more brownish.

After discontinuation of therapy, no further increase in brown iris pigment has been observed. 4% of patients. Periorbital and lid changes including deepening of the eyelid sulcus have also been observed with prostaglandin analogues.

Visutrax may gradually change eyelashes in the treated eye(s); these changes were observed in about half of the patients in clinical trials and include: increased length, thickness, pigmentation, and/or number of lashes. The mechanism of eyelash changes and their long term consequences are currently unknown.

Travoprost has been shown to cause slight enlargement of the palpebral fissure in studies in the monkey. However, this effect was not observed during the clinical trials and is considered to be species specific. There is no experience of travoprost in inflammatory ocular conditions; nor in neovascular, angle-closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma.

Visutrax should therefore be used with caution in patients with active intraocular inflammation. Aphakic patients Macular oedema has been reported during treatment with prostaglandin F2a analogues. Caution is recommended when using Visutrax in aphakic patients, pseudophakic patients with a torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.

1.