HEXOMEDINE 1 PER THOUSAND cutaneous spray in pressurised can, spray can/75 mL

Hexamidine diisethionate.................................................................................................................................... 0,100 g

For 100 ml of solution

Excipient with known effect: ethanol 96 % (V/V)

Adjunctive treatment of skin conditions that are primarily bacterial or likely to become superinfected.

Remark :

Antiseptic agents are not sterilising: they temporarily reduce the number of micro-organisms on the skin and mucous membranes.

CUTANEOUS ROUTE.

Spray the solution onto the lesion or lesions to be treated, 2 to 3 times per day. No rinsing is required after application.

Duration of use after opening: see section Warnings and precautions.

Maximum duration of treatment: 5 days

• Hypersensitivity to hexamidine or to the chemical class of diamidines or to any of the components.
• This preparation must not be used:
  • for antisepsis before sampling (puncture or injection)
  • for any invasive procedure requiring surgical-type antisepsis (lumbar puncture, central venous route, etc.).
  • for disinfection of medical and surgical equipment.
• Do not apply to mucous membranes.

Warnings

Although transcutaneous absorption is very low, the risk of systemic effects cannot be excluded. Systemic effects are all the more to be feared when the antiseptic is used over a large surface area, under an occlusive dressing, on damaged skin (particularly burns), a mucous membrane, or the skin of premature infants or infants (due to the surface-area-to-weight ratio and the occlusive effect of nappies in the diaper area).

Risk of sensitisation to hexamidine.

After first use of the medicinal product, microbial contamination is possible.

Take care not to keep an opened bottle of antiseptic for too long.

Precautions for use

This medicine contains 54,23 mg of ethanol per dose, equivalent to 247,62 mg/ml (24,762 % w/v). This may cause a burning sensation on damaged skin.

No interaction studies with other medicinal products have been performed.

Given the possible interferences (antagonism/inactivation), simultaneous or successive use of antiseptics should be avoided.

Pregnancy

There are no data on the use of hexamidine diisethionate in pregnant women. Animal studies evaluating reproductive toxicity are not available. However, the transcutaneous passage of hexamidine diisethionate into the systemic circulation is very limited.

It is preferable to avoid the use of HEXOMEDINE 1 POUR MILLE, cutaneous spray solution in a pressurised container in pregnant women.

Breast-feeding

Excretion of hexamidine diisethionate (or its metabolites) into breast milk is not known. A risk to the breastfed infant or child is not expected since systemic exposure of the mother to hexamidine diisethionate is negligible. Hexamidine diisethionate may be used during breastfeeding.

Fertility

Effects on fertility have not been evaluated.

Hexamidine may cause sensitisation.

Its frequency varies with the pharmaceutical form and the degree of epidermal alteration: the hydro-alcoholic solution, frequently applied to eroded or damaged epidermis, is more often responsible than other pharmaceutical forms.

Contact dermatitis to hexamidine presents certain features suggestive of an Arthus phenomenon and suggesting humoral mechanisms.

Its clinical appearance usually differs from classic contact eczema: the eruption is most often infiltrated, consisting of isolated or grouped hemispherical papular or papulovesicular lesions. More numerous and coalescent at the site of application of the antiseptic, they spread as isolated elements.

Regression is slow.

Mild manifestations of local intolerance may be encountered: tingling sensation, itching, burning, cutaneous dryness. They only exceptionally lead to discontinuation of treatment.

Due to the presence of alcohol, frequent applications to the skin may cause irritation and dryness of the skin.

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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.signalement-sante.gouv.fr.

In case of massive oral ingestion, perform gastric lavage. Contact a poison control centre.

Pharmacotherapeutic class: ANTISEPTIC and DISINFECTANTS, ATC code: D08AC04 (D. Dermatology).

Hexamidine belongs to the diamidine family.

It behaves as a cationic antibacterial agent and has surface-active properties.

Bactericidal and levuricidal activity.

The bactericidal activity of the solution is not inhibited by a standard exudate that reproduces in vitro the conditions observed in practice upon contact with pus, serum and organic debris.

Transcutaneous absorption of hexamidine through healthy skin is very low.

The passage of hexamidine diisethionate into breast milk is not known. As systemic exposure of the breastfeeding woman to hexamidine diisethionate is very limited after topical application, passage into breast milk may be considered very low and no adverse effects in the breastfed infant/child are expected.

 Available animal data are derived from the literature. Hexamidine does not induce systemic toxicity after topical application.

The Ames tests and the in vitro chromosomal aberration study did not reveal any genotoxic risk.

No carcinogenesis data are available.

The effects of hexamidine diisethionate on fertility, reproduction and foetal development have not been evaluated in animals.

Hexamidine diisethionate may cause skin irritation.

3 years.

Pressurised container. Protect from sunlight and do not expose to a temperature above 50°C.

Do not puncture or burn, even after use.

Do not spray towards a flame or an incandescent body.

Keep away from any flame or source of sparks or ignition.

Do not smoke.

This medicine contains ethanol. Do not use this medicine near an open flame, a cigarette or certain appliances (for example, hair dryers).