Boric acid AFOM 3% 500 ml skin solution

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

INDICATIONS

Antiseptic for the disinfection of minor burns and irritated or chapped skin areas. The solution is also used in the form of local tampons with a decongestant action. Boric acid is indicated as an antibacterial for the treatment of acne.

ACTIVE INGREDIENTS

100 ml of solution contains: Active ingredient: boric acid 3 g. For the full list of excipients, see section 6.1.

EXCIPIENTS

Purified water

CONTRAINDICATIONS AND SIDE EFFECTS

Boric acid is contraindicated in case of: - hypersensitivity to the active ingredient or to any of the excipients; - extensive skin lesions; - children under 3 years of age.

DOSAGE

External use: apply as needed to the affected area. Adults: Boric acid can be applied directly once or twice daily to inflamed areas for chapped, irritated or dry skin, abrasions, mild sunburn, sunburn, windburn or insect bites. Children over 3 years: Boric acid can be applied directly once or twice daily to inflamed areas associated with chapped, irritated, or dry skin, diaper rash, mild sunburn, sunburn, windburn, or insect bites.

CONSERVATION

Store below 25°C. Keep the container tightly closed in order to protect the medicine from light

WARNINGS

Excessive and prolonged application on large areas or damaged skin may cause accumulation toxicity. Keep out of reach of children, as deaths have occurred following accidental ingestion. The medicine must not be used for ophthalmic use

INTERACTIONS

There are no known interactions between boric acid for external use and other medicines

SIDE EFFECTS

The absorption of boric acid through intact skin is less than 0.5%; however, it may increase if accidentally administered systemically or applied to wounds or lesions. The following are the side effects of boric acid that occurred in case of accumulation toxicity, after prolonged exposure and following systemic absorption. These effects are organized according to the MedDRA system organic classification. There is insufficient data to establish the frequency of the individual effects listed. Pathologies of the skin and subcutaneous tissue: Dermatitis, skin rashes, alopecia. Gastrointestinal disorders: Gastro-intestinal disorders: nausea, vomiting, diarrhoea. Metabolism and nutrition disorders: Anorexia. Endocrine disorders: Menstrual disorders. Pathologies of the blood and lymphatic system: Anemia. Musculoskeletal system and connective tissue disorders: Weakness. Psychiatric disorders: Confusion. Nervous system disorders: Convulsions.

OVERDOSE

The risk of acute intoxication via the skin appears to be a negligible event given its low transcutaneous absorption index. Boric acid can be absorbed in toxic quantities through the gastrointestinal tract, by inhalation or through skin lesions. Symptoms Following the use of large quantities of boric acid on wounds or sores, cases of poisoning and death have occurred, especially in children. The mechanism of toxic action is unknown and numerous organs and systems are affected, in particular the skin, kidney and digestive tract. The toxic effects also affect the CNS and the lung with lesions, mainly haemorrhagic, of obscure genesis. The main symptoms of boric acid poisoning are vomiting, diarrhea, visceral pain, skin erythema followed by desquamation, CNS stimulation followed by depression, restlessness, headache. Metabolic acidosis and serious salt and water imbalances are also frequent. Furthermore, boric acid in these situations can cause convulsions, changes in body temperature and kidney damage which can be evidenced by oliguria. Death, following circulatory collapse and untreated shock, can occur within 3 to 5 days. Cyanosis, delirium, seizures, and coma (HSDB) may also occur. Cases of serious intoxication manifested themselves with gastrointestinal disorders (73%), central nervous system disorders (67%) and skin lesions (76%). Symptoms of chronic poisoning include anorexia, confusion, debilitation, dermatitis, menstrual disorders, anemia, convulsions and alopecia (see section 4.8). Treatment No treatment is necessary if the dose taken is less than 50 mg/kg. For ingestion of higher doses, gastric lavage is performed with suspension of activated charcoal and saline purgative. If the absorbed quantity exceeds 100 mg/kg, even if the patient is still asymptomatic, forced diuresis must be instituted immediately, in order to accelerate elimination and protect the kidney from toxic effects; at the first signs of renal failure and water overdose, forced diuresis should be replaced with peritoneal dialysis or hemodialysis. The remaining therapy is symptomatic and resuscitative.

PREGNANCY AND BREASTFEEDING

Pregnancy: No clinical data on exposed pregnancies are available. Animal studies are insufficient to demonstrate effects on embryonic/foetal development (see section 5.3). The potential risk for humans is not known, however if the medicine is used in accordance with the instructions for use, absorption is poor and, therefore, the risk of systemic effects is minimal. Breastfeeding: No data are available on the use of the medicine during breastfeeding and it is not known whether this active ingredient passes into breast milk. However, since the absorption of the drug can be considered negligible, it is very unlikely that significant quantities reach the breast milk

EFFECTS ON DRIVING ABILITY

Boric acid does not affect the ability to drive or use machines.