Nova Argentia Silicic Acid 5% Ointment Tube 30g

Therapeutic indications

- Treatment of psoriasis, acne vulgaris, seborrhea in adults and children; - removal of warts and corns in adults and children; - local treatment of some forms of eczema and ichthyosis in adults.

Dosage

Apply locally the minimum quantity of ointment 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 the skin or once a day, so as not to irritate the skin.

Overdose

There have been no reports of overdose with locally applied salicylic acid. However, in case of excessive absorption of the active ingredient (eg prolonged application on large areas of the body or on injured and inflamed skin) a state of salicylism could occur. Symptoms of salicilism are: nausea, vomiting, tinnitus (or tinnitus) and dizziness. Rarely, gastric ulcer, asthma, hepatotoxicity, renal failure and pancreatic toxicity can occur.

Contraindications

• Hypersensitivity to the active substance, to salicylates or to any of the excipients (patients hypersensitive to salicylates, such as acetylsalicylic acid, propylsalicylate, bromosalicylic acid, zinc salicylate, may also be hypersensitive to salicylic acid); • children under the age of 2; • diabetes (see section 4.8); • peripheral vascular disease.

Side effects

The following are the side effects of salicylic acid, organized according to the MedDRA systemic classification. Insufficient data are available to establish the frequency of the individual effects listed. Metabolism and nutrition disorders Hypoglycemia. Skin and subcutaneous tissue disorders Irritation, dermatitis, burning, itching, erythema, skin peeling, scarring on the face.

Pregnancy and breastfeeding

There are no adequate data from the use of salicylic acid in pregnant and lactating women. Therefore, salicylic acid solutions and ointments should not be used during pregnancy and lactation unless absolutely necessary. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. However, it should be noted that despite being used locally, salicylic acid is absorbed systemically, easily crosses the placenta to higher concentrations in fetal plasma and is excreted in breast milk (see section 5.2).

Special warnings

The medicine should not be ingested. Salicylic acid is irritating and may cause dermatitis (see section 4.8). In the treatment of corns and warts it is necessary to protect the surrounding intact skin to minimize the absorption of the active ingredient. Salicylic acid should not be used for long periods of time, at high concentrations, on large areas of the body, or on injured or inflamed skin, as excessive absorption of the active ingredient can cause systemic salicylate poisoning (see section 4.9). mainly in children, which can be fatal. Avoid contact with mouth, eyes, genitals and other mucous membranes. Use with caution in children as experience with the use of salicylic acid in this population is limited. An improvement in the treated skin can be observed after 6 weeks of therapy or after 12 weeks in case of removal of a wart. The medicine may be flammable. Do not use store near open flames or any heat source (see section 6.4). Important information about some of the excipients: not relevant.

Expiry and Retention

Do not store above 25 ° C. Keep the medicine in the container tightly closed away from light, away from heat sources or open flames.

Active principles

SALICYLIC ACID NA 2% ointment 100 g of ointment contain: Active ingredient : 2 g salicylic acid. SALICYLIC ACID NA 5% ointment 100 g of ointment contain Active ingredient : salicylic acid 5 g. SALICYLIC ACID NA 10% ointment 100 g of ointment contain Active ingredient : 10 g salicylic acid. For the full list of excipients, see section 6.1.

Excipients

Excipients: white petroleum jelly.