Bialcol Med 0.1% cutaneous solution 300ml

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

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

ACTIVE INGREDIENTS

BIALCOL MED 1 mg/ml cutaneous solution: 100 ml of solution contains: active ingredient benzoxonium chloride 100 mg. For the full list of excipients, see section 6.1

EXCIPIENTS

Isopropyl alcohol; acetone; ethyl acetate; glacial acetic acid; pine essence; diethylene ether monoethyl ether; octylphenol ethoxylate; sodium hydroxide; purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

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.

DOSAGE

Dosage: For cutaneous use. Method of administration: Apply a small amount locally, directly or using sterile gauze/cotton, making sure that the liquid does not accumulate in the patient's skin folds, after having cleansed the affected area with warm water and dried by touching lightly with a soft cloth. Repeat the application 4-5 times a day or as needed. Do not exceed the recommended doses and use only for short treatment periods (3 days).

CONSERVATION

Keep the bottle tightly closed. This medicine does not require any particular storage temperature.

WARNINGS

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.

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.

OVERDOSE

Symptoms The low systemic absorption of a topical application of BIALCOL MED makes overdose very unlikely. While accidental ingestion is unlikely to cause systemic effects due to poor absorption of benzoxonium chloride, ingestion of high concentrations may cause esophageal damage and necrosis with symptoms such as nausea and vomiting. Symptoms of intoxication following the ingestion of significant quantities of quaternary ammonium compounds include: dyspnoea, cyanosis, asphyxia resulting from paralysis of the respiratory muscles, depression of the Central Nervous System (CNS), hypotension and coma. In humans the lethal dose is approximately 1-3 g. Treatment Treatment of poisoning is symptomatic. Administer, if necessary, emollients and diluents. Avoid vomiting and gastric lavage. Avoid alcohol as it promotes absorption. The immediate administration of milk or egg whites beaten in water is recommended. Activated charcoal may be considered if the patient is treated within one hour of ingestion. Corticosteroids can reduce oropharyngeal edema.

PREGNANCY AND BREASTFEEDING

Pregnancy: There are no adequate data on the use of benzoxonium chloride in pregnant/pregnant women. Fetal toxicity studies in animals suggest no adverse effects (see section 5.3). The potential risks for humans are not known but are probably very low as benzoxonium chloride is poorly absorbed after topical application (see paragraph 5.2). BIALCOL MED can be used during pregnancy in small quantities (on small wounds). Breastfeeding: It is not known whether benzoxonium chloride is excreted in breast milk. However, it is unlikely that benzoxonium chloride would be present in breast milk in clinically significant quantities, as the product is poorly absorbed after topical application. BIALCOL MED can be used during breastfeeding in small quantities (on small wounds) except on the breasts. Newborns should not come into contact with treated skin. Fertility: No effect of benzoxonium chloride on fertility was seen in animal studies (see section 5.3).

EFFECTS ON DRIVING ABILITY

Bialcol Med has no or negligible influence on the ability to drive and use machinery.