Farmaiod 10% cutaneous solution 100 ml bottle

FARMAIOD * 10% SOLUZ CUT FL100ML

Therapeutic indications

Disinfection of the skin in the presence of small superficial wounds; Disinfection of intact skin; Delimitation of the operating field.

Dosage and method of use

The product is to be used as it is on damaged skin and intact skin (see section 4.1). Dab the skin with plenty of cotton soaked in the solution. Repeat, if necessary, up to 3-4 times a day. DO NOT EXCEED THE RECOMMENDED DOSE.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Children under the age of 6 months. Hyperthyroidism. Do not apply on mucous membranes, on severely damaged skin and on large surfaces (see section 4.4). Do not use for peritoneal lavage in the treatment of purulent peritonitis: in these situations, iodine concentrations in the blood and consequently in the urine can significantly increase.

Side effects

Undesirable effects may occur with an unknown frequency (frequency cannot be estimated from the available data), following which treatment must be discontinued: • intolerance (burning or irritation); • allergic reactions (such as tuberous dermatitis, dermatitis, etc.); • iodism (see sections 4.4 and 4.9); • delayed healing of the injured tissues; • interference with thyroid function tests.Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

The product is for external use only. Do not swallow. Ingestion or inhalation can lead to serious, sometimes fatal consequences. Avoid contact with eyes. Do not use for prolonged treatments: the use, especially if prolonged, of products for local use, can give rise to hypersensitization phenomena, in this case stop the treatment and establish the appropriate symptomatic treatment. Avoid use on excessively large surfaces and do not apply with occlusive dressing. Extensive iodine uptake associated with the use of povidone iodine, which cannot be eliminated via the kidney or metabolized, may cause systemic adverse effects (e.g. metabolic acidosis, neutropenia), including well-known ones on thyroid function, such as transient hypothyroidism, or, in cases of latent hyperthyroidism, the danger of destabilization and thyrotoxic crisis. If prolonged use or on large surfaces is necessary, it is advisable to perform thyroid function tests, especially in patients with thyroid dysfunction and in younger subjects. Discontinue treatment at least 10 days before performing a labeled iodine scan. The absorption of iodine can interfere with the thyroid function tests or with those for finding occult blood in the faeces and urine, due to the strong oxidative properties of iodine. In pediatric age use only in case of real need. Cases of hypothyroidism have been reported following the application of povidone iodine on newborns. In neonates, application of topical, full-term and preterm iodine antiseptics has been shown to cause transient thyroid dysfunction (see section 4.3). Heating the solution above 43 ° C causes the release of toxic iodine vapors, due to a weakening of the bond between iodine and povidone. After a short period of treatment with no appreciable results, medical evaluation is required.

Pregnancy and breastfeeding

Use only in case of real need and under direct medical supervision.

Expiration and retention

Store at a temperature not exceeding 30 ° C, in the original packaging to protect the product from light.

Interactions with other drugs

Avoid the simultaneous use of other antiseptics and / or detergents. Do not use soaps or ointments containing mercury or benzoin compounds on the treated area at the same time.

Overdose

No overdose syndromes were found under normal conditions of use. Application to burns or large areas devoid of epithelium can produce the systemic effects of iodine. If the recommended doses are exceeded voluntarily or accidentally, hypothyroidism or hyperthyroidism may occur. Metallic taste, increased salivation, burning or pain of the mouth and throat, irritation or swelling of the eyes, skin rashes, gastrointestinal disturbances and diarrhea, metabolic acidosis, hypernatremia, impaired renal function, pulmonary edema may also occur. Establish symptomatic and supportive treatment with special attention to electrolyte balance and renal function impairment.

Active principles

100 g contain Active Ingredient: Iodopovidone (10% of available iodine) 10.00 g. For the full list of excipients, see section 6.1

Excipients

Ethoxylated alcohol, dibasic sodium phosphate, anhydrous citric acid, glycerin, sodium hydroxide, purified water.