TRAVOPROST RAFARM

Posology Use in adults, including elderly population) The dose is one drop of Travoprost RAFARM 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 RAFARM, the other agent should be discontinued and Travoprost RAFARM 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

5%. No serious ophthalmic or systemic undesirable effects related to the product were reported in any of the clinical studies. 0%), which included ocular, conjunctival, or scleral hyperaemia. 6% of those patients who experienced it. Almost all patients (98%) who experienced hyperaemia did not discontinue therapy as a result of this event.

In phase III clinical studies ranging from 6 to 12 months in duration, hyperaemia decreased over time. In a post approval long-term clinical study of 5 years duration involving 502 patients, Travoprost was administered once daily. No serious ophthalmic or systemic undesirable effects related to Travoprost were reported in the clinical study.

4). 0% with 2% of patients reporting hyperemia of the eye discontinuing study participation due to the undesirable effect. The following adverse reactions were assessed to be treatment-related with Travoprost (benzalkonium chloride-preserved) monotherapy and 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), or very rare (≤1/10,000).

Within each frequency group, adverse reactions are presented in decreasing order of seriousness. The adverse reactions were obtained from clinical studies and post- marketing data with travoprost. Travoprost (benzalkonium chloride-preserved) System Organ Classification Frequency Preferred Term Infections and infestations Uncommon herpes simplex, keratitis herpetic Immune system disorders Uncommon hypersensitivity, drug hypersensitivity, seasonal allergy Common headacheNervous system disorder Uncommon dysgeusia, dizziness, visual field defect Very common ocular hyperaemia, iris hyperpigmentation Common punctate keratitis, anterior chamber inflammation, eye pain, photophobia, eye discharge, ocular discomfort, visual acuity reduced, vision blurred, dry eye, eye pruritus, lacrimation increased, erythema of eyelid, eyelid oedema, growth of eyelashes, eyelash discolouration Eye disorders Uncommon corneal erosion, uveitis, keratitis, eye inflammation, photopsia, blepharitis, conjunctival oedema, halo vision, conjunctivitis, conjunctival follicles, hypoaesthesia eye, meibomianitis, ectropion, anterior chamber pigmentation, mydriasis, cataract, eyelid margin crusting, asthenopia Cardiac disorders Uncommon heart rate irregular, palpitations, heart rate decreased Vascular disorders Uncommon blood pressure decreased, blood pressure increased, hypotension, hypertension Respiratory, thoracic and mediastinal disorders Uncommon dyspnoea, asthma, respiratory disorder, oropharyngeal pain, cough, dysphonia, nasal congestion, throat irritation Gastrointestinal disorders Uncommon peptic ulcer reactivated, gastrointestinal disorder, constipation Common skin hyperpigmentation (periocular)Skin and subcutaneous tissue disorders Uncommon dermatitis allergic, periorbital oedema, dermatitis contact, erythema, rash, hair colour changes, hair texture abnormal, hypertrichosis, madarosis Musculoskeletal, connective tissue and bone disorders Uncommon musculoskeletal pain General disorders and administrative site conditions Uncommon asthenia, malaise 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 TRAVATAN, 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 RAFARM 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 RAFARM 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 RAFARM 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 RAFARM 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.