Catiolanze · 4.1 Therapeutic indications · 1

HOS-100303 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The majority of adverse reactions relate to the ocular system. In an open 5-year safety study with preserved latanoprost eye drops, solution, 33% of patients developed iris pigmentation (see section 4.4). Other ocular adverse reactions are generally transient and occur on dose administration. Safety data specific for Catiolanze are available from 330 patients. The most common adverse reactions were ocular hyperaemia (1.6%) and conjunctival hyperaemia (1.0%). There were no serious adverse reactions during the studies specific for Catiolanze. Long term safety data are available from a Phase 3 study in which 118 patients received Catiolanze at least for 360 days. The long term safety profile did not differ from that observed during the first 3 months of treatment. The most common ocular adverse reactions reported during long term use were ocular and conjunctival hyperaemia (4.4%), abnormal sensation in eye (2.2%) and growth of eyelashes (2.2%). Tabulated list of adverse reactions The table below describes adverse reactions for preserved latanoprost eye drops, solution from clinical trials and postmarketing data. Adverse reactions occurring with a different frequency observed in clinical trials with Catiolanze eye drops emulsion product are labelled in the table with ¥. The adverse reactions are categorised by frequency as follows: 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), not known (frequency cannot be estimated from the available data). System organ Very common Common Uncommon Rare Very rare class ≥1/10 ≥1/100 to ≥1/1 000 to ≥1/10 000 to <1/10 000 <1/10 <1/100 <1/1 000 Infections and Herpetic infestations keratitis*§ Nervous Headache*; system dizziness* disorders 6  Eye disorders Iris Mild to Eyelid Iritis*; Periorbital hyperpigmentati moderate oedema¥; corneal oedema*; and lid on

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HOS-100299 · has-contraindication-information · PDF-Seite 3

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

HOS-100298 · has-indication-information · PDF-Seite 2

Catiolanze is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension. Catiolanze is indicated for the reduction of elevated IOP in children from 4 years of age and adolescents with elevated IOP and paediatric glaucoma.

HOS-100301 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed in adults. There have been reports of paradoxical elevations in IOP following the concomitant ophthalmic administration of two prostaglandin analogues. Therefore, the use of two or more prostaglandins, prostaglandin analogues or prostaglandin derivatives is not recommended. Paediatric population No interaction studies have been performed in the paediatric population.

HOS-100302 · has-pregnancy-information · PDF-Seite 5

Pregnancy The safety of this medicinal product for use in human pregnancy has not been established. It has potential hazardous pharmacological effects with respect to the course of pregnancy, to the unborn or the neonate. Therefore, Catiolanze should not be used during pregnancy. Breast-feeding Latanoprost and its metabolites may pass into breast milk. Catiolanze should therefore not be used in breast-feeding women or breast feeding should be stopped. 5 Fertility Latanoprost has not been found to have any effect on male or female fertility in animal studies (see section 5.3).

HOS-100300 · has-warning-information · PDF-Seite 3

Change in eye colour Catiolanze may gradually change eye colour by increasing the amount of brown pigment in the iris. Before treatment is instituted, patients should be informed of the possibility of a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia. This change in eye colour has predominantly been seen with latanoprost in patients with mixed coloured irides, i.e. blue-brown, grey-brown, yellow-brown and green-brown. In studies with latanoprost, the onset of the change is usually within the first 8 months of treatment, rarely during the second or third year, and has not been seen after the fourth year of treatment. The rate of progression of iris pigmentation decreases with time and is stable for five years. The effect of increased pigmentation beyond five years has not been evaluated. In an open 5-year latanoprost safety study, 33% of patients developed iris pigmentation (see section 4.8). The iris colour change is slight in the majority of cases and often not observed clinically. The incidence in patients with mixed colour irides ranged from 7 to 85%, with yellow-brown irides having the highest incidence. In patients with 3 homogeneously blue eyes, no change has been observed and in patients with homogeneously grey, green or brown eyes, the change has only rarely been seen. The colour change with latanoprost treatment is due to increased melanin content in the stromal melanocytes of the iris and not to an increase in number of melanocytes. 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. No further increase in brown iris pigment has been observed after discontinuation of latanoprost treatment. It has not been associated with any symptom or pathological changes in clinical trials to date. Neither naevi nor freckles of the iris have been affected by latanoprost treatment. Accumulation of pigment in the trabecular meshwork or elsewhere in the anterior chamber has not been observed with latanoprost in clinical trials. Based on 5 years clinical experience with latanoprost, increased iris pigmentation has not been shown to have any negative clinical sequelae and Catiolanze can be continued if iris pigmentation ensues. However, patients should be monitored regularly and if the clinical situation warrants, Catiolanze treatment may be dis

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