IODINE SOL ALCO I*50ML

Iodio Sella 7%/5% alcoholic cutaneous solution

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 in pregnancy (see Special warnings).
Do not use in children under 6 months of age.

Warnings and precautions
Prolonged application may cause irritation and cauterization of 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.
Use, especially if prolonged, may give rise to sensitization phenomena. In this case, stop the treatment and contact your doctor who may 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 extensive body surfaces, on mucous membranes or under occlusive dressing, particularly in children and in 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 diseases, in patients over 45 years of age or with goiter.
In pediatric age, use only in cases of actual need and under medical supervision. Stop treatment at least 10 days before performing a scintigraphy with marked iodine.
Following 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 not enough data available to establish the frequency of the individual effects listed.

Skin and subcutaneous tissue disorders
Burning or irritation, acneiform eruptions, iododerma, delayed healing of damaged tissues.
Inhalation of iodine vapors is very irritating to mucous membranes.

Immune system disorders
Hypersensitivity reactions including urticaria, angioedema, cutaneous hemorrhage or purpura, fever, arthralgia, lymphadenopathy, and eosinophilia.

Iodine, when administered topically as recommended, is absorbed only in small quantities with minimal systemic effects. However, the adverse reactions due to systemic effects of the drug, which could manifest in cases of abnormal absorption (abundant, prolonged uses or with occlusion 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 occur in neonates 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 a 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 leaflet, tell your doctor or pharmacist.