SALICIAL ACIDO NA 2% UNG 30G

HEALTH ACIDO NA UNGUENT

active ingredients

HEALTH ACIDO NA 2% ointment. 100 g ointment contain: Active ingredient: salicylic acid 2 g. SALICILic acid NA 5% ointment. 100 g ointment contain: Active ingredient: salicylic acid 5 g. SALICILic acid NA 10% ointment. 100 g ointment contain: Active ingredient: salicylic acid 10 g. For the full list of excipients, see paragraph 6.1.

Excellent

Excipients: white vaseline.

Therapeutic indications

- Treatment of psoriasis, acne vulgaris, seborrhea in adults and children; - removal of warts and calluses in adults and children; - local treatment of certain forms of eczema and ittyosis in adults.

Contraindications

• Hypersensitivity to the active ingredient, salicylates or any of the excipients (hypersensitivity to salicylates, such as acetylsalicylic acid, propylsalicylate, bromosalicylic acid, salicylate zinc, can also be hypersensitive to salicylic acid); • children under 2 years of age; • diabetes (see paragraph 4.8); • peripheral vasculopathy.

Population

Apply the minimum amount of ointment locally in relation to the area to be treated with a light massage. Start the treatment by applying the medicine only on a small portion of skin or once a day, so as not to irritate the skin.

Conservation

Do not store at temperature above 25°C. Keep the medicine in the container well closed away from light, away from heat sources or free flames.

Warnings

The medicinal product should not be ingested. Salicylic acid is irritating and may cause dermatitis (see paragraph 4.8). In the treatment of calluses and warts it is necessary to protect the surrounding skin to minimize the absorption of the active ingredient. Salicylic acid should not be used for long periods of time, at high concentrations, on extended areas of the body, or on skin lexed or inflamed, as excessive absorption of the active ingredient may cause systemic poisoning from salicylates (see paragraph 4.9) mainly in children, which may be fatal. Avoid contact with mouth, eyes, genitals and other mucosa. Use carefully in children as the experience of using salicylic acid in this population is limited. It is possible to observe an improvement of the treated skin after 6 weeks of therapy or after 12 weeks in case of removal of a wart. The medicine could be flammable. Do not use to store near free flames or any heat source (see paragraph 6.4). Important information about some excipients: not relevant.

Interactions

Salicylic acid can interact with the following medicines: - Cucumin antiagulants (acenocumarol, dicumarol, fenprocumon and warfarin) and 1,3-hydrandioni derivatives (anisindione, phenydione), as salicylic acid can inhibit pyasteric aggregation and smooth them from their site of bonding with plasma proteins, thus causing an increase in the risk of bleeding. - Factor X inhibitors activated by coagulation (eparine and eparinoids), since in case of neuroaxial anesthesia (spineal or epidural), the contemporary use of salicylic acid can cause a rapid increase in the risk of bleeding and hematoma. - Gliburide, because, for an unknown mechanism, excessive hypoglycemia could occur. - Probenecid, as salicylic acid may cause the reversal of the uricosuric effects of this drug. - Acetazolamide, as an increase in the side effects of salicylate may occur. - Vaccino della Varicella, as salicylic acid may cause an increase in the risk of developing Reye syndrome. - In addition, salicylic acid should not be used simultaneously with tamarind (a tropical tree belonging to the family of Fabaceae) and the Salvia miltiorrhiza or Tan-Shen (plant of the family of Labiatae), since a rapid increase in plasma levels of salicylate could occur, resulting in increased toxicity.

Effects

Below are the undesirable effects of salicylic acid, organized according to the MedDRA systemic classification. No sufficient data is available to determine the frequency of the individual effects listed. Disorders of metabolism and nutritionHypoglycemia. Pathologies of skin and subcutaneous tissue: Irritation, dermatitis, burning, itching, erythema, skin dequamation, scars on the face. 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 the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

There were no overdose cases from locally applied salicylic acid. However, in case of excessive absorption of the active ingredient (e.g. prolonged application on extended areas of the body or on skins that are slow and inflamed) a state of salicylism could occur. Symptoms of salicylism are nausea, vomiting, acumen (or tinnitus) and dizziness. Rarely you can check: gastric ulcer, asthma, hepatotoxicity, kidney failure and pancreatic toxicity.

There is no adequate data on the use of salicylic acid in pregnant and nursing women. Therefore, solutions and ointments of salicylic acid should not be used during pregnancy and lactation, if not in case of absolute necessity. Animal studies showed reproductive toxicity (see paragraph 5.3). While, the potential risk for human beings is not known. However, it should be considered that although it is used locally, salicylic acid is absorbed at a systemic level, it easily crosses the placenta finding itself in higher concentrations in fetal plasma and is excreted in breast milk (see paragraph 5.2).

Source: Farmadati