TRAVOPROST ASPIRE

Posology Use in adults, including elderly patients 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. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart.

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 30 μg/ml has not been studied in patients with hepatic or renal impairment. However, travoprost 40 μg/ml 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). Therefore, no need for dose adjustment at the lower concentration of active ingredient is anticipated. 1). The safety and efficacy of travoprost 30 μg/ml in children below the age of 3 years have not been established. 1 but no recommendation on a posology below the age of 3 years can be made.

Method of administration For ocular use. For patients who wear contact lenses, please refer to section

Summary of the safety profile In a clinical trial of 3 months duration (N = 442) involving travoprost 30 μg/ml as monotherapy, the most common adverse reaction observed was hyperaemia of the eye (ocular or conjunctival) reported in approximately 12% of the patients.

Tabulated list of adverse reactions The following adverse reactions were assessed to be related with travoprost 30 μg/ml 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 <1/1,000) and very rare (<1/10,000).

Within each frequency grouping in Table 1, adverse reactions are presented in decreasing order of seriousness.

Table 1:

Travoprost 30 μg/ml eye drops, solution System Organ class Frequency Adverse reaction Very common ocular hyperaemia Common dry eye, eye pruritus, ocular discomfort Eye disorders Uncommon punctate keratitis, anterior chamber inflammation, blepharitis, eye pain, photophobia, visual impairment, vision blurred, conjunctivitis, eyelid oedema, eyelid margin crusting, eye discharge, dark circles under eyes, growth of eyelashes, eyelash thickening Skin and subcutaneous tissue disorders Uncommon pruritus, rash The following adverse reactions were assessed to be related with Travoprost 40 μg/ml eye drops, solution (either BAK or Polyquad- preserved) 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 <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Within each frequency grouping in Table 2, adverse reactions are presented in decreasing order of seriousness.

Table 2:

Travoprost 40 μg/ml eye drops, solution System Organ class Frequency Adverse reaction Infections and infestations Uncommon herpes simplex, keratitis herpetic Immune system disorders Uncommon hypersensitivity, drug hypersensitivity, seasonal allergy Nervous system disorders Common headache 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 irritation 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 Eye disorders Not known macular oedema, sunken eyes Ear and labyrinth disorders Not known vertigo, tinnitus Uncommon heart rate irregular, palpitations, heart rate decreased Cardiac disorders Not known chest pain, bradycardia, tachycardia Vascular disorders Uncommon blood pressure decreased, blood pressure increased, hypotension, hypertension Uncommon dyspnoea, asthma, respiratory disorder, oropharyngeal pain, cough, dysphonia, nasal congestion, throat irritation Respiratory, thoracic and mediastinal disorders Not known asthma aggravated Gastrointestinal disorders Uncommon peptic ulcer reactivated, dry mouth gastrointestinal disorder, constipation Common skin hyperpigmentation (periocular), skin discolouration Uncommon dermatitis allergic, periorbital oedema, dermatitis contact, erythema, rash, hair colour changes, hair texture abnormal, hypertrichosis, madarosis Skin and subcutaneous tissue disorders Not known hair growth abnormal Musculoskeletal, connective tissue and bone disorders Uncommon musculoskeletal pain General disorders and administrative site conditions Uncommon asthenia, malaise 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 (aged between 3 months and 17 years) exposed to travoprost 40 μg/ml eye drops, solution, 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 sachet immediately prior to initial use. After cap is removed, Travoprost eye drops solution is ready for 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 become more brownish.

After discontinuation of therapy, no further increase in brown iris pigment has been observed. 2% of patients. Periorbital and lid changes including deepening of the eyelid sulcus have 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. 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.