Bialcol Med 0.1% cutaneous solution 300ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Antisepsis and disinfection of the skin in case of abrasions and superficial wounds of limited extension.

CONTRAINDICATIONS

Hypersensitivity to the active substance benzoxonium chloride or to any of the excipients listed in section 6.1 or to other quaternary ammonium compounds. Do not use on severely damaged skin. Do not use in the external acoustic meatus. Do not use for disinfection of mucous membranes. Do not use in body cavities or for enemas. Do not use for disinfection of soft contact lenses.

WARNINGS AND PRECAUTIONS FOR USE

For external use only; must not be ingested. Avoid contact with eyes, ears (ear canal), mucous membranes (such as mouth and nose) and deep wounds. In case of accidental contact, rinse well with plenty of water. Not to be used in body cavities or for enemas. If symptoms persist or the condition worsens (the wound is swollen, painful or accompanied by fever) or if a skin reaction occurs, discontinue use and consult your doctor. Do not use it frequently or for a long period of time without consulting your doctor. Do not apply to the breasts during breastfeeding.

INTERACTIONS

No interaction studies have been performed. However, the potential for interaction with medicinal products is considered low as benzoxonium chloride is poorly absorbed after topical application. Avoid the simultaneous use of other antiseptics or detergents.

SIDE EFFECTS

Security Profile Summary: In rare cases, skin irritation may occur which has no consequences and does not require a change in treatment. Prolonged and repeated application of the product on the skin is not recommended as urticaria, angioedema and anaphylactic reactions may occur. Tabulated list of adverse reactions: Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: 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) or not known (frequency cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Classes Organ Systems / Frequency | Adverse reactions

Immune system disorders

Very rare | Adverse reactions: Anaphylactic reaction, angioedema, urticaria

Pathologies of the skin and subcutaneous tissue

Rare | Adverse reactions: Skin irritation

Not known | Adverse reactions: Contact dermatitis

Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazionireazioni-avverse.