Polihexanide interacts in the following cases:
No data are available on the use of polihexanide in subjects with immunodeficiency disorders or requiring systemic immunosuppressive therapy.
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.
As a precautionary measure, it is preferable to avoid the use of polihexanide during pregnancy.
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 polihexanide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
There are no data on the effects of polihexanide on human fertility.
Polihexanide 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.
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.
The adverse reactions listed below were observed in clinical trials in patients treated with polihexanide 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.
Adverse reactions observed in clinical trial 043/SI:
| System organ class | Frequency | Adverse reactions |
|---|---|---|
| Infections and infestations | Common | Conjunctivitis Eye infection |
| Eye disorders | Very common | Eye pain Ocular hyperaemia |
| Common | Corneal perforation Visual impairment Ulcerative keratitis Corneal epithelium defects Corneal infiltrates Punctate keratitis Tearing Conjunctival hyperaemia Eye inflammation Eye irritation Photophobia Conjunctival papillae Eye pruritus Eye discharge Eye swelling Foreign body sensation Ocular discomfort Dry eye | |
| General disorders and administration site conditions | Common | Condition aggravated Application site pain Application site discomfort Product intolerance Application site pruritus |
| Injury, poisoning and procedural complications | Common | Persistent epithelial defect Toxicity to various agents |
| Surgical and medical procedures | Common | Corneal transplant |
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.
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