Polihexanide: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: November 28, 2025🚩 Report this page

Polihexanide

Active ingredient · 2 therapeutic classes

Sold as Akantior

GB MHRAEU EMA

Drug class: Biguanides and Amidines
Availability: See label
Markets covered: 2
Products on record: 2

D08ACBiguanides and Amidines S01AXOther Antiinfectives

Overview

Polihexanide is an active pharmaceutical ingredient in the Biguanides and Amidines group (D08AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	November 28, 2025
EU European Union	EMA	1	November 29, 2024

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised November 28, 2025[1]

AKANTIOR is indicated for the treatment of Acanthamoeba keratitis in adults and children from 12 years of age.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised November 29, 2024[2]

AKANTIOR is indicated for the treatment of Acanthamoeba keratitis in adults and children from 12 years of age.

How to take

Sources & citations

[1]MHRA (UK) · PL360780007 · revised November 28, 2025
[2]European Medicines Agency · EMEA/H/C/005858 · revised November 29, 2024

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised November 28, 2025[1]

6%). 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 System organ class Frequency Adverse reactions Infections and infestations Common Conjunctivitis Eye infection Very common Eye pain Ocular hyperaemia Eye disorders 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 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised November 28, 2025[1]

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.

This is not medical advice. Consult a qualified healthcare professional.