Treatment of psoriasis, acne vulgaris, seborrhea in adults and children; – Removal of warts and calluses in adults and children; – Local treatment of some forms of eczema and ichthyosis in adults.
Active Ingredients
Salicylic acid Marco Viti 2% ointment 100 g of ointment contain Active ingredient : salicylic acid 2 g. Salicylic acid Marco Viti 5% ointment 100 g of ointment contain Active ingredient : salicylic acid 5 g. Salicylic acid Marco Viti 10% ointment 100 g of ointment contain Active ingredient : salicylic acid 10 g. For the full list of excipients, see section 6.1.
Excipients
White Vaseline.
Dosage
Apply locally the minimum amount 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 skin or only once a day, so as not to irritate the skin.
Warnings
The medicinal product should not be swallowed. Salicylic acid is irritating and may cause dermatitis (see section 4.8); In the treatment of corns and warts, the surrounding intact skin should be protected to minimise absorption of the active substance. Salicylic acid should not be used for long periods of time, at high concentrations, on large areas of the body, or on damaged or inflamed skin, as excessive absorption of the active substance may cause systemic salicylate poisoning (see section 4.9), mainly in children, which may be fatal. Avoid contact with the 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. Improvement of the treated skin may be observed after 6 weeks of therapy or after 12 weeks in case of removal of a wart.
Conservation
Store in a tightly closed container, away from light.
Contraindications
– hypersensitivity to the active substance, to salicylates or to any of the excipients (patients hypersensitive to salicylates, such as acetylsalicylic acid, propyl salicylate, bromosalicylic acid, zinc salicylate, may also be hypersensitive to salicylic acid); – children under 2 years of age; – diabetes (see section 4.8); – peripheral vascular disease.
Side effects
The following are the adverse reactions of salicylic acid, organized according to the MedDRA systemic classification. There are insufficient data to determine the frequency of the individual effects listed. Metabolism and nutrition disorders Hypoglycaemia. Skin and subcutaneous tissue disorders Irritation, dermatitis, burning, pruritus, erythema, skin peeling, facial scarring.
Overdose
No cases of overdose from salicylic acid applied locally have been reported. However, in case of excessive absorption of the active ingredient (e.g. prolonged application on large areas of the body or on damaged and inflamed skin) a state of salicylism could occur. The symptoms of salicylism are: nausea, vomiting, tinnitus and dizziness. Rarely, the following may occur: gastric ulcer, asthma, hepatotoxicity, renal failure and pancreatic toxicity.
Pregnancy
There are no adequate data regarding the use of salicylic acid in pregnant and breast-feeding women. Therefore, salicylic acid solutions and ointments should not be used during pregnancy and breast-feeding unless clearly necessary. Studies in animals have shown reproductive toxicity (see section 5.3). While the potential risk for humans is unknown. However, it should be considered that despite being used locally, salicylic acid is absorbed systemically, easily crosses the placenta, being found in higher concentrations in fetal plasma, and is excreted in breast milk (see section 5.2).
