IODINE SOL ALCO I "7%/5% ALCOHOL SKIN SOLUTION" 1 BOTTLE 50 ML"

Name
Iodine 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 substances or to any of the excipients.
Generally contraindicated in pregnancy (see Special warnings).
Do not use in children under 6 months.


Warnings and precautions
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 unbroken 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 contact your doctor who can adopt appropriate therapeutic measures.
To avoid excessive absorption of iodine, do not cover the treated skin area with occlusive dressings.
In case of prolonged use on large body surfaces, on mucous membranes or under occlusive dressings, particularly in children and patients with thyroid disorders, thyroid function tests should be performed.
Since iodine can alter thyroid function, it is recommended to use it with caution in subjects with thyroid disease, in patients over 45 years of age or with goiter.
In pediatric age use only in cases of real need and under medical supervision. Stop treatment at least 10 days before performing a scintigraphy with labeled iodine.
Treatment may alter the results of thyroid function tests, especially in premature infants.
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 everybody gets them.
The following are the side effects of iodine. There are insufficient data to determine 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 could occur in cases of anomalous absorption (abundant, prolonged use or with occlusion of the treated skin area).

Endocrine pathologies
Effects on the thyroid can cause goiter and hypothyroidism, as well as hyperthyroidism (Basedow's disease).
Goiter and hypothyroidism may occur in newborns exposed to iodides during pregnancy.
Iodine can interfere with thyroid function tests.

Psychiatric disorders
Depression, insomnia.

Nervous system disorders
Heachache.

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 called “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.

Following the instructions in the package leaflet reduces the risk of side effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.