Izba · 4.1 Therapeutic indications · 1

HOS-216524 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile In a clinical trial of 3 months duration (N=442) involving IZBA 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 IZBA 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 Eye disorders Very common ocular hyperaemia Common dry eye, eye pruritus, ocular discomfort 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 Uncommon pruritus, rash tissue disorders The following adverse reactions were assessed to be related with travoprost 40 µg/mL eye drops, solution (either benzalkonium chloride [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. 5 Table 2 Travoprost 40 µg/mL eye drops, solution System Organ class Frequency Adverse reaction Immune system disorders Uncommon hypersensitivity, seasonal allergy Psychiatric disorders Not known depression, an

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HOS-216520 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-216519 · has-indication-information · PDF-Seite 2

Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1). Decrease of elevated intraocular pressure in paediatric patients aged 3 years to <18 years with ocular hypertension or paediatric glaucoma (see section 5.1).

HOS-216522 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed.

HOS-216523 · has-pregnancy-information · PDF-Seite 4

Women of childbearing potential/contraception Travoprost must not be used in women of childbearing age/potential unless adequate contraceptive measures are in place (see section 5.3). Pregnancy Travoprost has harmful pharmacological effects on pregnancy and/or the foetus/new-born child. Travoprost should not be used during pregnancy unless clearly necessary. 4 Breast-feeding It is unknown whether travoprost from eye drops is excreted in human breast milk. Animal studies have shown excretion of travoprost and metabolites in breast milk. The use of travoprost by breast-feeding mothers is not recommended. Fertility There are no data on the effects of travoprost on human fertility. Animal studies showed no effect of travoprost on fertility at doses more than 250 times the maximum recommended human ocular dose.

HOS-216521 · has-warning-information · PDF-Seite 3

Eye colour change IZBA 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. The change in eye colour has predominantly been seen in patients with mixed coloured irides, i.e., 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. Periorbital and eye lid changes In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of IZBA has been reported in 0.2% of patients. Periorbital and lid changes including deepening of the eyelid sulcus have been observed with prostaglandin analogues. IZBA 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. 3 There is no experience of IZBA 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. IZBA 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 IZBA 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. Iritis/uveitis In patients with known predisposing risk factors for iritis/uveitis, IZBA should be used with caution. Contact with the skin Skin contact with IZB

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