TRAVOPROST SANDOZ

For ocular use. Posology Use in adults, including elderly population The dose is one drop of Travoprost 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 travoprost, the other medicinal product should be discontinued and travoprost 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 Travoprost 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 travoprost in children below the age of 2 months have not been established. No data are available. Method of administration For ocular use. For patients who wear contact lenses, please refer to section

Summary of the safety profile In clinical trials with travoprost, the most common adverse reactions were ocular hyperemia and iris hyperpigmentation, occurring in approximately 20% and 6% of patients respectively. 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 ≤1/1000), very rare (≤1/10,000), not known (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 Classification Frequency Adverse Reactions Immune system disorders Uncommon hypersensitivity, seasonal allergy Psychiatric disorders Not known depression, anxiety, insomnia Uncommon headacheNervous system disorders Rare dysgeusia, dizziness, visual field defect System Organ Classification Frequency Adverse Reactions Very common ocular hyperaemia Common iris hyperpigmentation, eye pain, ocular discomfort, dry eye, eye pruritus, eye irritation Eye disorders 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, eyelash discolouration Rare iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eyelids eczema, conjunctival oedema, halo vision, conjunctival follicles, hypoaesthesia eye, trichiasis, meibomianitis, anterior chamber pigmentation, mydriasis, eyelash hyperpigmentation, eyelash thickening, asthenopia Not known macular oedema, sunken eyes Ear and labyrinth disorders Not known vertigo, tinnitus Cardiac disorders Uncommon palpitations Rare heart rate irregular, heart rate decreased Not known chest pain, bradycardia, tachycardia, arrhythmia Vascular disorders Rare diastolic blood pressure decreased, systolic blood pressure increased, hypotension, hypertension Respiratory, thoracic and mediastinal disorders Uncommon cough, nasal congestion, throat irritation Rare dyspnoea, asthma, respiratory disorder, oropharyngeal pain, dysphonia, rhinitis allergic, nasal dryness System Organ Classification Frequency Adverse Reactions Not known asthma aggravated, epistaxis Gastrointestinal disorders Rare peptic ulcer reactivated, gastrointestinal disorder, constipation, dry mouth Not known diarrhoea, abdominal pain, nausea, vomiting Uncommon skin hyperpigmentation (periocular), skin discolouration, hair texture abnormal, hypertrichosis Skin and subcutaneous tissue disorders Rare dermatitis allergic, dermatitis contact, erythema, rash, hair colour changes, madarosis 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 3 month phase 3 study and a 7 days pharmacokinetic study, involving 102 paediatric patients exposed to travoprost, the types and characteristics of adverse reactions reported were similar to what has been observed in adult patients.

4. 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.

1. 4 Special warnings and precautions for use Eye colour change Travoprost may gradually change the eye 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 eye 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.

Travoprost 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.

1.