VILATO

Reduction of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma and ocular hypertension (including the elderly).

Reduction of elevated IOP in pediatric patients with elevated IOP and suffering from pediatric glaucoma.

No conclusive results of interaction of LATANOPROST VIATRIS with other medicines are available to date.

Paradoxical elevations of IOP have been reported 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.

Pediatric population

Interaction studies have only been performed in adults.

Pregnancy

There are no safety data concerning the use of this specialty during pregnancy. It has potentially dangerous pharmacological effects on the course of pregnancy, the foetus or the newborn. Consequently, LATANOPROST VIATRIS must not be used during pregnancy.

Breastfeeding

Latanoprost and its metabolites may pass into breast milk and consequently, LATANOPROST VIATRIS must not be used in women who are breastfeeding, or breastfeeding must be discontinued.

Fertility

No effect of latanoprost on male or female fertility has been observed during studies in animals (see section 5.3).

LATANOPROST VIATRIS has a minor influence on the ability to drive vehicles and use machines. As with any ophthalmic preparation, the instillation of eye drops may be followed by transient visual disturbances. In this case, patients must not drive or use machines until vision returns to normal.

a. Summary of the safety profile

The majority of adverse effects relate to the ocular system. In an open clinical trial studying the tolerability of latanoprost over 5 years, 33 % of patients developed an increase in iris pigmentation (see section 4.4). Other ocular adverse effects are generally transient and occur upon administration of the dose.

b. List of adverse effects

Adverse effects are classified according to their frequency of occurrence, as follows: very frequent (≥1/10), frequent (≥1/100, <1/10), uncommon (≥1/ 1 000 , <1/100), rare (≥1/ 10 000 , <1/ 1 000 ) and very rare (<1/ 10 000) , unknown frequency (the frequency cannot be estimated on the basis of available data).

*Adverse effects identified after marketing

§Frequency of the adverse effect estimated using “The rule of 3”

Cases of corneal calcification have been very rarely reported during the use of eye drops containing phosphate in patients presenting with significant corneal lesions.

c. Description of selected adverse effects

Not applicable.

d. Paediatric population

In 2 short-term clinical trials (≤ 12 weeks) including 93 (25 and 68) paediatric patients, the safety profile was comparable to that of adults and no new adverse effect was identified. Short-term safety profiles in the different paediatric subgroups remained comparable (see section 5.1).

The adverse effects observed more frequently in children than in adults are: rhino-pharyngitis and fever.

In a long-term observational pediatric study involving 115 patients, the safety profile was consistent with that reported in previous pediatric studies and no new adverse event was identified (see section 5.1).

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorization of the medicinal product is important. It allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/ .