TRAVOPROST MYLAN

Posology Use in adults, including elderly population The dose is one drop of Travoprost Mylan 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 eye drops, the other medicinal product should be discontinued and travoprost eye drops 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 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 post-marketing data with travoprost. System Organ Class Frequency Adverse Reactions Immune system disorders Uncommon hypersensitivity, seasonal allergy Psychiatric disorders Not known depression, anxiety, insomnia System Organ Class Frequency Adverse Reactions Uncommon headacheNervous system disorders Rare dizziness, visual field defect, dysgeusia 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, asthenopia, 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 Uncommon cough, nasal congestion, throat irritation System Organ Class Frequency Adverse Reactions Rare dyspnoea, asthma, respiratory disorder, oropharyngeal pain, dysphonia, rhinitis allergic, nasal dryness mediastinal disorders Not known asthma aggravated, epistaxis Rare peptic ulcer reactivated, gastrointestinal disorder, constipation, dry mouth Gastrointestinal disorders Not 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 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. After cap is removed, if the tamper evident snap collar is loose, remove before using the medicinal product. 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. Immediately before using a bottle for the first time, tear off the overwrap sachet and take out the bottle. Write the date of opening on the carton or bottle label in the space provided 2. Wash your hands 3. Twist off the cap 4. After cap is removed, if tamper evident snap collar is loose, remove before using the product 5.

Hold the bottle, pointing down, between your thumb and fingers 6. Tilt your head or your child’s head gently back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here.

7. Bring the bottle tip close to the eye. Use a mirror if it helps. 8. Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops. 9. Gently squeeze the bottle to release one drop of Travoprost Mylan at a time 10.

After using Travoprost Mylan, keep the eyelid closed, apply gentle pressure by pressing a finger into the corner of your eye, by the nose for at least 1 minute. This helps to stop Travoprost Mylan getting into the rest of the body 11.

If you use drops in both eyes, repeat the steps for your other eye 12. Close the bottle cap firmly immediately after use 13. Only use one bottle at a time. If a drop misses your eye, try again. If you or your child are using other eye preparations such as eye drop or eye ointment, wait for at least 5 minutes between putting in Travoprost Mylan and the other eye preparations.

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.

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