Citrosil 0.175% 100 ml spray skin solution

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

INDICATIONS

Disinfection and cleaning of skin, including damaged skin (wounds, abrasions, abrasions, burns).

ACTIVE INGREDIENTS

100 ml of skin solution contains: ACTIVE INGREDIENT: benzalkonium chloride 0.175 g. For the full list of excipients, see section 6.1.

EXCIPIENTS

Lemon essence, thyme essence, ethyl alcohol, polysorbate 20, tetrasodium edetate, quinoline yellow (E 104), patent blue (E 131), hydrochloric acid, purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Do not administer to children under 1 year of age.

DOSAGE

Method of administration Solution Ready-to-use solution. It must be used pure. Intact skin: rub the affected area with gauze soaked in the solution. Superficial lesions: apply the product with a sterile gauze compress. Apply two – three times a day. Sprays Spray on the area to be treated two – three times a day. DO NOT EXCEED THE RECOMMENDED DOSES.

CONSERVATION

Store in the original package to protect the medicine from light and heat. For storage conditions after first opening see paragraph 6.3.6.5

WARNINGS

The product is for external use only. Avoid contact with eyes, brain, meninges and middle ear. Do not use for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor. Do not use for disinfection of mucous membranes. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena; in this case stop treatment and consult your doctor. Accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal, consequences. Avoid exposure to ultraviolet rays (sun or artificial sources) after applying the product.

INTERACTIONS

Avoid the simultaneous use of other antiseptics and detergents. Pediatric population Interaction studies have only been carried out in adults.

SIDE EFFECTS

The following adverse reactions have been identified since the authorization for use of benzalkonium chloride. Since these reactions arise from spontaneous reports, it is not always possible to define their frequency. It is possible, in some cases, to cause intolerance (burning or irritation), however without consequences, which does not require modification of treatment. Pediatric population The same frequency, type and severity of side effects are expected in the pediatric population as in the adult population. 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.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

Under normal conditions of use, no damage from overdose has been reported. Accidental ingestion may cause 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, CNS depression, hypotension and coma. In humans the lethal dose is approximately 1–3g. Treatment of poisoning is symptomatic: administer soothing medications if necessary. Avoid emesis and gastric lavage.

PREGNANCY AND BREASTFEEDING

Pregnancy The product should only be used in cases of actual necessity. During the breastfeeding period, avoid applying the product to the breast to avoid ingestion of the product by the infant.

EFFECTS ON DRIVING ABILITY

Citrosil does not affect the ability to drive or use machines.