BORIC ACID MV 3% UNG 30G

ACIDO BORIDO MARCO VITI 3% UNGUENT

active ingredients

100 g ointment contain: active ingredient: boric acid 3 g. For the full list of excipients, see paragraph 6.1.

Excellent

White Vaseline.

Therapeutic indications

Antiseptic for disinfection of minor burns and irritated or screpolated skin areas. The ointment also has a decongesting action. Boric acid is indicated as an antibacterial for acne treatment.

Contraindications

Boric acid is contraindicated in the case of: - hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1; - extensive skin lesions; - children under 3 years of age.

Population

External use: apply to the need on the affected area. Adults: Boric acid can be applied directly one or two times a day on inflamed areas in case of skin cracked, irritated or dry, abrasions, mild burns, sunburns, windburns or insect bites. Children over 3 years: Boric acid can be applied directly one or two times a day on the inflamed areas associated with screpolated, irritated or dry skin, diaper dermatitis, mild burns, sunburns, windburns or insect bites.

Conservation

Keep the container well closed to protect the medicine from light.

Warnings

Excessive and prolonged application on extended areas or on loose skin can cause accumulation toxicity. Keep away from the reach of children, as deaths occurred as a result of accidental ingestion. The medicinal product should not be used for ophthalmic use.

Interactions

There is no known interaction between boric acid for external use and other medicines.

Effects

The absorption of boric acid through the skin is less than 0.5%; however it may increase if administered accidentally by systemic or applied on wounds or injuries. Below are the undesirable effects of boric acid verified in case of accumulation toxicity, after prolonged exposure and following systemic absorption. These effects are organized according to the organic systemic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Pathologies of skin and subcutaneous tissue: Dermatitis, rashes, alopecia. Gastrointestinal diseases. Gastro-intestinal disorders: nausea, vomiting, diarrhea. Disorders of metabolism and nutritionAnorexia. Endocrine diseases: Menstrual disorders. Emolinfopoietic system pathologiesAnemia. Skeletal muscle and connective tissue system pathologies: Boldness. Psychiatric disorders: Confusion. Diseases of the nervous systemConvulsions. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

The risk of acute intoxication by skin appears 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. Synonyms Following the use of large amounts of boric acid on wounds or wounds, especially in children, cases of poisoning and death occurred. The mechanism of toxic action is unknown and numerous are the organs and systems affected in particular the skin, kidney and digestive tube. The toxic effects also affect the SNC and the lung with lesions, mainly hemorrhagic, of dark genesis. The main symptoms of boric acid poisoning are vomiting, diarrhea, visceral pain, skin erythema from desquamation, stimulation of the SNC followed by depression, restlessness, cephalea. Frequent are also metabolic acidosis and serious hydrosaline imbalances. Moreover, boric acid in these situations can cause seizures, changes in body temperature and kidney damage that can be highlighted with oliguria. Death, following circular collapse and untreated shock, can occur within 3-5 days. Cyanosis, delirium, seizures and coma (HSDB) can also be checked. Cases of severe intoxication occurred with gastrointestinal disorders (73%), central nervous system (67%) and skin injuries (76%). Chronic poisoning symptoms include anorexia, confusion, debilitation, dermatitis, menstrual disorders, anemia, seizures and alopecia (see paragraph 4.8). Treatment No treatment is necessary if the dose taken is less than 50 mg/kg. For ingestion of higher doses, the gastric lavender is carried out with suspension of activated charcoal and purgating saline. If the absorbed amount exceeds 100 mg/kg, even if the patient is still asymptomatic, a forced diuresis must be established immediately, in order to accelerate the elimination and protect the kidney from toxic effects; the first signs of kidney failure and overdose of water must be replaced by forced diuresis with peritoneal or hemodialysis. The remaining therapy is symptomatic and reanimation.

Pregnancy: Clinical data relating to exposed pregnancy are not available. Animal studies are insufficient to highlight the effects on embryo/fetal development (see paragraph 5.3). The potential risk for man is not known, however, if the medicinal product is used in accordance with the methods of use, absorption is poor and the risk of systemic effects is minimal. Food: Data on the use of the medicinal product during breastfeeding are not available and is not known if this active ingredient passes into breast milk. However, since the absorption of the drug can be considered negligible, it is very unlikely that relevant quantities reach breast milk.

Source: Farmadati