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Iodine New.Fa.Dem. 7% + 5% alcoholic cutaneous solution, 20 ml bottle
Iodine New.Fa.Dem. 7% + 5% alcoholic cutaneous solution, 1000 ml bottle
What it is and what it is used for
Disinfection of intact skin for occasional treatments.
What you need to know before taking the medicine
Hypersensitivity to the active ingredients or to any of the excipients.
Generally contraindicated during pregnancy (see Special warnings).
Do not use in children under 6 months of age.
Warnings and precautions
Prolonged application can cause irritation and caustic burns to the treated surface; therefore, the medicine should not be used for prolonged treatments.
The medicine should only be applied to intact, unbroken skin, as in addition to causing irritation, it delays the healing of wounds and abrasions. Prolonged use, in particular, can lead to sensitization phenomena. In this case, discontinue treatment and contact your doctor, who can adopt appropriate therapeutic measures. To avoid excessive iodine absorption, do not cover the treated skin area with occlusive bandages. In case of use for prolonged periods on large body surfaces, on mucous membranes or under occlusive dressing, especially in children and patients with thyroid disorders, thyroid function tests should be performed. Since iodine can alter thyroid function, it is recommended to use with caution in subjects with thyroid disorders, in patients over 45 years of age or with goiter. In pediatric age, use only when strictly necessary and under medical supervision. Discontinue treatment at least 10 days before performing a scintigraphy with marked iodine. After treatment, the results of thyroid function tests may be altered, especially in premature neonates. After a short period of treatment without appreciable results, consult your doctor.
For external use only. Do not ingest. Avoid contact with eyes.
Possible side effects
Like all medicines, iodine can cause side effects, although not everyone experiences them. The side effects of iodine are listed below. There is 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 injured tissues. Inhalation of iodine vapors is very irritating to mucous membranes.
Immune system disorders - Hypersensitivity reactions including urticaria, angioedema, skin hemorrhages or purpura, fever, arthralgia, lymphadenopathy and eosinophilia.
Iodine, when administered topically as recommended, is absorbed only in small quantities with minimal systemic effects. However, adverse reactions due to systemic effects of the drug, which could occur in cases of abnormal absorption (abundant, prolonged or occluded use of the treated skin area), are listed below.
Endocrine disorders - Effects on the thyroid: can cause goiter and hypothyroidism, as well as hyperthyroidism (Basedow's disease). Goiter and hypothyroidism can also occur in newborns exposed to iodides during pregnancy. Iodine can 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 can cause a series of adverse effects collectively called "iodism," some of which may be due to hypersensitivity. These adverse effects include metallic taste, increased salivation, burning and pain in the mouth; acute rhinitis, coryza-like syndrome, swelling and inflammation of the throat, irritation and swelling of the eyes, and increased tearing may also occur. Pulmonary edema, dyspnea and bronchitis can develop.
Following the instructions in the package leaflet reduces the risk of side effects. If any of the side effects get worse, or if you notice any side effect not listed in this package leaflet, tell your doctor or pharmacist.

