AKANTIOR Eye drops Ref.[113673] Active ingredients: Polihexanide

AKANTIOR may cause mild to moderate eye discomfort (such as eye pain) and eye redness. The patient should be advised to contact the doctor in case of concern or a severe eye reaction.

No data are available on the use of AKANTIOR in subjects with immunodeficiency disorders or requiring systemic immunosuppressive therapy.

Excipients

AKANTIOR contains phosphates. Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

No interaction studies have been performed. Local interactions with other medicinal products cannot be excluded.

If more than one topical ophthalmic product is being used, AKANTIOR must be administered at least 5 minutes after the last administration.

As systemic absorption of polihexanide after use of AKANTIOR is negligible or not detectable, no interactions with systemic medicinal products are expected.

Pregnancy

There are no data from the use of polihexanide in pregnant women. Animal studies using oral administration do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of AKANTIOR during pregnancy.

Breast-feeding

It is unknown whether polihexanide is excreted in human milk.

A decision must be made as to whether to discontinue breast-feeding or to discontinue/abstain from AKANTIOR therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data on the effects of polihexanide on human fertility.

AKANTIOR has minor influence on the ability to drive and use machines, as it may cause temporary blurred vision or other visual disturbances, which is expected to last a few minutes after instillation. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.

Summary of safety profile

The most common adverse reactions are eye pain (13.0%) and ocular hyperaemia (11.6%). The most serious are corneal perforation (1.4%), corneal transplant (1.4%) and visual impairment (1.4%), which are also part of the natural history of the disease.

Tabulated list of adverse reactions

The adverse reactions listed below were observed in clinical trials in patients treated with AKANTIOR with a reasonable possibility of causality to the medicinal product. Adverse reactions are presented according to MedDRA system organ classification (SOC and Preferred Term Level).

They are classified according to the subsequent 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 available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1. Adverse reactions observed in clinical trial 043/SI:

Adverse reactions reported in phosphate containing eye drops

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Not applicable.