Active ingredients

100 ml contain Active ingredients: Iodine 7 g Potassium iodide 5 g For the full list of excipients, see section 6.1.

Excipients

Ethanol, purified water.

Therapeutic indications

Disinfection of intact skin for occasional treatments.

Contraindications

Hypersensitivity to the active substances or to any of the excipients. Generally contraindicated in pregnancy (see section 4.6). Do not use in children under 6 months of age.

Dosage

Brush on the area to be treated.

Warnings and precautions

For external use only. Do not ingest. Avoid contact with eyes. Prolonged application may cause irritation and causticity of the treated surface, therefore the medicine should not be used for prolonged treatments. The medicine should be applied only on intact and undamaged skin, since in addition to causing irritation, it delays the healing of wounds and abrasions. Use, especially if prolonged, may give rise to sensitization phenomena. In this case, stop treatment and adopt appropriate therapeutic measures. To avoid excessive absorption of iodine, do not cover the treated skin area with occlusive dressings. In case of use for prolonged periods on large body surfaces, on mucous membranes or under occlusive dressings, particularly in children and patients with thyroid disorders, it is necessary to perform thyroid function tests. Since iodine can alter thyroid function, it is recommended to use with caution in subjects with thyroid pathologies, in patients over 45 years of age or with goiter. In pediatric age, use only in case of real need and under medical supervision. Stop treatment at least 10 days before performing a scintigraphy with labeled iodine. Following treatment, the results of thyroid function tests may be altered, especially in premature infants.

Interactions

Elemental iodine forms a pungent irritant compound when it comes into contact with acetone. The possible systemic effects of iodine should be considered when considering interactions with other drugs, although when administered topically as recommended it is absorbed only in small amounts. The effects of iodine and iodides on the thyroid may be altered by other compounds including amiodarone and lithium.

Side effects

The following are the adverse reactions of iodine, organized according to the MedDRA system organ classification. There are insufficient data to establish the frequency of the individual effects listed. Skin and subcutaneous tissue disorders Burning or irritation, acneiform eruptions, iododerma, delayed healing of damaged tissue. Inhalation of iodine vapors is very irritating to mucous membranes. Immune system disorders Hypersensitivity reactions including urticaria, angioedema, skin haemorrhages or purpura, fever, arthralgia, lymphadenopathy and eosinophilia. Iodine, when administered locally in the recommended manner, is absorbed only in small quantities with minimal systemic effects. However, the following are the adverse reactions due to systemic effects of the drug, which may occur in cases of anomalous absorption (abundant, prolonged use or with occlusion of the treated skin area). Endocrine disorders Effects on the thyroid may cause goiter and hypothyroidism, as well as hyperthyroidism (Basedow's disease). Goiter and hypothyroidism may also occur in newborns exposed to iodides during pregnancy. Iodine may interfere with thyroid function tests. Psychiatric disorders Depression, insomnia. Nervous system disorders Headache. Gastrointestinal disorders Nausea, vomiting, diarrhea. Reproductive system and breast disorders Impotence. Injury, poisoning and procedural complications Prolonged use may cause a series of adverse effects collectively referred to as "iodism", some of which may be due to hypersensitivity. These adverse effects include metallic taste, increased salivation, burning and sore mouth; acute rhinitis, coryza-like syndrome, swelling and inflammation of the throat, irritation and swelling of the eyes and increased lacrimation may also occur. Pulmonary edema, dyspnea and bronchitis may develop.

Pregnancy and breastfeeding

Iodine is poorly absorbed when used as directed. Iodine that reaches the systemic circulation crosses the placenta, and excess iodine is harmful to the fetus: iodine use during pregnancy has been associated with goiter, hypothyroidism, respiratory problems, enlarged heart, compression of the trachea, and neonatal death. Iodine is excreted in breast milk. Use of excessive doses of iodine by nursing mothers may increase the iodine level in breast milk and cause transient hypothyroidism in infants. The use of iodine, even when applied topically, is generally avoided during pregnancy and breastfeeding.