Iodine Nova Argentia 7% / 5% Alcoholic Cutaneous Solution 1 L

Skin solution based on iodine and potassium iodide.

Therapeutic indications

The 7% / 5% Iodine Tincture Skin Solution is used in the disinfection of intact skin for occasional treatments.

Dosage and posology

Brush on the part to be treated. It reacts energetically with essences in general, iron filings and with white and yellow precipitates of mercury. It is incompatible with silver, mercury and lead salts, with alkalis, carbonates, alkaloids and their salts.

Overdose

Abundant application of the medicinal product to very large areas of the skin, use of bandages or prolonged use may result in increased iodine absorption. In these circumstances, undesirable effects will be more common. Accidental ingestion or inhalation can have serious, sometimes fatal, consequences. If the recommended doses are exceeded, voluntarily or accidentally, hypothyroidism or hyperthyroidism may occur.

Metallic taste, increased salivation, inflammation of the salivary glands, burning or pain of the mouth and throat, irritation or swelling of the eyes, skin rashes, gastrointestinal disturbances with vomiting, abdominal pain and diarrhea, metabolic acidosis, hypernatremia, deficiency of the kidney function. Circulatory insufficiency and swelling of the epiglottis can also occur, which can cause asphyxia, pneumonia and pulmonary edema and can be fatal. Retinal toxicity with overdose has also been observed.

Symptomatic and supportive treatment with special attention to electrolyte balance and impaired renal function is necessary. Symptomatic treatment of allergic reactions may be required, although symptoms usually subside rapidly after discontinuation of administration. In case of accidental ingestion / intake of an excessive dose of Nova Argentia Iodine, notify your doctor immediately or go to the nearest hospital.

Contraindications

• Hypersensitivity to the active substances or to any of the excipients.
• Generally contraindicated in pregnancy.
• Do not use in children under 6 months of age.

Side effects

Like all medicines, iodine can cause side effects, although not everybody gets them. Below are the side effects of iodine. Insufficient data are available 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 the mucous membranes.
• Immune system disorders: hypersensitivity reactions including hives, angioedema, skin bleeding or purpura, fever, arthralgia, lymphadenopathy and eosinophilia.

Iodine, when administered locally as recommended, is absorbed only in small amounts with minimal systemic effects. However, the following are listed the adverse reactions due to systemic effects of the drug, which could occur in cases of abnormal absorption (abundant, prolonged use or with occlusion of the treated skin area).

• Endocrine disorders: effects on the thyroid gland can cause goiter and hypothyroidism, as well as hyperthyroidism (Graves' disease). Goiter and hypothyroidism can also occur in infants 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, chorionic-like syndrome, swelling and inflammation of the throat, irritation and swelling of the eyes, and increased tearing may also occur. Pulmonary edema, dyspnoea and bronchitis can develop.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

• Pregnancy

Iodine is poorly absorbed when used as intended. Iodine reaching the systemic circulation crosses the placenta and an excess of iodine is harmful to the fetus: iodine use during pregnancy has been associated with goiter, hypothyroidism, breathing problems, enlarged heart, tracheal compression and neonatal death.

• Feeding time

Iodine is excreted in breast milk. The use of excessive doses of iodine in breastfeeding mothers can increase the level of iodine in breast milk and cause transient hypothyroidism in infants. The use of iodine, even when applied topically, is generally to be avoided during pregnancy and breastfeeding.

Special warnings

Prolonged application can cause irritation and caustication of the treated surface, therefore the medicine should not be used for prolonged treatments. The medicine should only be applied to intact and unbroken skin, as in addition to causing irritation, it delays the healing of wounds and abrasions. The use, especially if prolonged, can give rise to sensitization phenomena. In this case, stop the treatment and contact the doctor who will be able to adopt suitable therapeutic measures.

To avoid excessive absorption of iodine, 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, particularly in children and patients with thyroid disorders, it is necessary to perform thyroid function tests. Since iodine can impair thyroid function, it is recommended to use with caution in subjects with thyroid disease, in patients over the age of 45 or with goiter.

In pediatric age use only in cases of real need and under medical supervision. Discontinue treatment at least 10 days before performing a labeled iodine scan. Following treatment, the results of thyroid function tests may be altered, especially in premature babies. After a short period of treatment without appreciable results, consult your doctor

For external use only. Do not swallow. Avoid contact with eyes.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

100 ml of Nova Argentia Iodine Tincture 7% / 5% cutaneous solution contain:

Active principles

Iodine 7 g, Potassium iodide 5 g.

Excipients

Ethyl alcohol, purified water.