BIALCOL MED*SOL CUT300ML1MG/ML

Bialcol Med 1 mg/ml cutaneous solution
benzoxonium chloride

What it is and what it is used for
Bialcol Med contains the active ingredient benzoxonium chloride, a substance used as a skin disinfectant.

Bialcol Med is used to disinfect intact skin and superficial wounds of limited extent.

Consult your doctor if you do not feel better or if you feel worse (for example, if the wound is swollen, painful and if you have a fever or if a skin reaction occurs) after 3 days.

What you need to know before taking the medicine
Do not use Bialcol Med
• if you are allergic to benzoxonium chloride, to other disinfectants containing quaternary ammonium compounds or to any of the other ingredients of this medicine (listed in section 6)
• if you have a deep wound
• inside the ear
• to disinfect mucous membranes
• in body cavities or to clean the intestine
• to disinfect soft contact lenses

Warnings and precautions
Talk to your doctor or pharmacist before using Bialcol Med.

Pay particular attention:
• do not ingest Bialcol Med, it is for external use only
• do not use Bialcol Med in body cavities or for enemas
• avoid contact with eyes, ears (ear canal), mucous membranes of the mouth and nose and deep wounds. In case of accidental contact, rinse the affected area thoroughly with plenty of water
• do not use Bialcol Med on your breast if you are breastfeeding. Infants must not come into contact with skin treated with Bialcol Med
• if symptoms persist or the condition worsens, for example if the wound is swollen, painful and if you have a fever or if a skin reaction occurs, stop using Bialcol Med and contact your doctor immediately
• do not use Bialcol Med frequently or for more than 3 days without first consulting your doctor. Prolonged and repeated use of this medicine can cause allergic skin reactions, even severe ones, which may be accompanied by swelling of the skin or mucous membranes
• the ingestion or inhalation of some disinfectants, such as Bialcol Med, can have serious, even fatal, consequences. In case of accidental ingestion of Bialcol Med, contact your doctor immediately.

Children
Infants must not come into contact with skin treated with Bialcol Med.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects (may affect up to 1 in 1,000 people)
• skin irritation

Very rare side effects (may affect up to 1 in 10,000 people)
• allergic reactions, anaphylactic reactions
• skin reactions, including urticaria
• swelling of the skin or mucous membranes

Side effects with unknown frequency (frequency cannot be estimated from the available data)
• contact dermatitis (skin inflammation caused by contact with irritants or allergens)

Adherence to the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.