Bialcol Med 0.1% cutaneous solution 300ml

Bialcol Med 0.1% Cutaneous Solution is an antiseptic for external use indicated for the disinfection of the skin and superficial wounds . Thanks to the presence of benzalkonium chloride , it has an antibacterial action and helps prevent infections, protecting the skin from pathogenic microorganisms.

Indicated for wounds, scratches, abrasions and skin irritations , Bialcol Med is ideal for daily use in case of small injuries. Its alcohol-free formulation makes it gentle on the skin, avoiding burning upon application. The practical 300ml format ensures prolonged use and effective protection for the whole family.

ACTIVE INGREDIENTS

Active ingredients contained in Bialcol Med 0.1% skin solution 300ml - What is the active ingredient of Bialcol Med 0.1% skin solution 300ml?

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

EXCIPIENTS

Composition of Bialcol Med 0.1% cutaneous solution 300ml - What does Bialcol Med 0.1% cutaneous solution 300ml contain?

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

DIRECTIONS

Therapeutic indications Bialcol Med 0.1% cutaneous solution 300ml - Why is Bialcol Med 0.1% cutaneous solution 300ml used? What is it for?

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

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Bialcol Med 0.1% cutaneous solution 300ml - When should Bialcol Med 0.1% cutaneous solution 300ml not be used?

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 auditory canal. Do not use for the disinfection of mucous membranes. Do not use in body cavities or for enemas. Do not use for the disinfection of soft contact lenses.

DOSAGE

Quantity and method of taking Bialcol Med 0.1% cutaneous solution 300ml - How to take Bialcol Med 0.1% cutaneous solution 300ml?

Dosage : For cutaneous use. Method of administration : Apply a small amount locally, directly or using a sterile gauze/cotton, ensuring that the liquid does not accumulate in the patient's skin folds, after cleaning the affected area with warm water and drying by tapping 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 periods of treatment (3 days).

CONSERVATION

Storage Bialcol Med 0.1% cutaneous solution 300ml - How do you store Bialcol Med 0.1% cutaneous solution 300ml?

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

WARNINGS

Warnings Bialcol Med 0.1% cutaneous solution 300ml - About Bialcol Med 0.1% cutaneous solution 300ml it is important to know that:

For external use only; not to be swallowed. Avoid contact with eyes, ears (ear canal), mucous membranes (such as mouth and nose) and deep wounds. In case of accidental contact, rinse thoroughly with plenty of water. Should not 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 frequently or for a long period of time without consulting your doctor. Do not apply to the breasts during breastfeeding.

INTERACTIONS

Interactions Bialcol Med 0.1% cutaneous solution 300ml - Which medicines or foods can modify the effect of Bialcol Med 0.1% cutaneous solution 300ml?

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

SIDE EFFECTS

Like all medicines, Bialcol Med 0.1% cutaneous solution 300ml can cause side effects - What are the side effects of Bialcol Med 0.1% cutaneous solution 300ml?

Summary of Safety Profile : 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 to 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.

Reporting of suspected adverse reactions . Reporting suspected adverse reactions that occur 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 reactions via the national reporting system at www.aifa.gov.it/content/segnalazionireazioni-avverse.

OVERDOSE

Overdose Bialcol Med 0.1% cutaneous solution 300ml - What are the risks of Bialcol Med 0.1% cutaneous solution 300ml in case of 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 the 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 ingestion of significant quantities of quaternary ammonium compounds include: dyspnoea, cyanosis, asphyxia resulting from respiratory muscle paralysis, Central Nervous System (CNS) depression, 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. It is recommended to immediately administer milk or egg white beaten in water. Activated charcoal may be considered if the patient is treated within one hour of ingestion. Corticosteroids may reduce oropharyngeal edema.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Bialcol Med 0.1% cutaneous solution 300ml

Pregnancy : There are no adequate data from the use of benzoxonium chloride in pregnant women. Foetal toxicity studies in animals suggest no adverse effects (see section 5.3). The potential risks for humans are unknown but are probably very low since benzoxonium chloride is poorly absorbed after topical application (see section 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 human milk. However, it is unlikely that benzoxonium chloride could be present in human milk in clinically significant quantities, since 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 has been seen in animal studies (see section 5.3).

DRIVING AND USE OF MACHINERY

Taking Bialcol Med 0.1% cutaneous solution 300ml before driving or using machinery - Does Bialcol Med 0.1% cutaneous solution 300ml affect driving or using machinery?

Bialcol Med does not alter or alters negligibly the ability to drive vehicles and use machines.