IODINE AND ALCOHOL 50 ML

IODINE SELLA 7%/5% ALCOOLICAL CUTAN

active ingredients

100 ml contain: Active ingredients: Iodine 7 g Potassium ioduro 5 g For the complete list of excipients, see par. 6.1.

Excellent

Ethyl alcohol, purified water

Therapeutic indications

Skin disinfection integrates for occasional treatments.

Contraindications

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

Population

Brush on the part to be treated.

Conservation

Store in the original packaging (hate resistant material) to repair the medicine from light and direct heat

Warnings

For exclusive outdoor use. Don't swallow. Avoid contact with eyes. Prolonged application may cause irritation and causticization of the treated surface, so the medicinal product should not be used for prolonged treatment. The medicinal product must be applied only on skins that are integral and not soothing, since in addition to causing irritation, it delays the healing of wounds and abrasions. Prolonged species use can give rise to awareness-raising phenomena. In this case, stop the treatment and take appropriate therapeutic measures. To avoid excessive absorption of iodine, do not cover with occlusive bandages the treated skin area. In case of prolonged periods on extended body surfaces, on mucosa or under occlusive bandage, especially in children and patients with thyroid disorders, it is necessary to perform thyroid function tests. Since iodine can alter the function of thyroid, it is recommended to use with precaution in subjects with thyroid pathologies, in patients aged 45 years or with goiter. In pediatric age use only in cases of actual need and under medical control. Stop the treatment at least 10 days before making a spark with marked iodine. As a result of the treatment, the results of thyroid function tests may be altered, especially in premature infants.

Interactions

If it comes into contact with acetone, elementary iodine forms an irritating pungent compound. When assessing interactions with other drugs, it is necessary to consider the possible systemic effects of iodine, although when administered locally in the recommended methods it is only absorbed in small quantities. The effects of iodine and iodine on thyroid can be altered by other compounds including amiodarone and lithium.

Effects

Below are the side effects of iodine, organized according to the organic systemic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Pathologies of skin and subcutaneous tissue Burning or irritation, acneiform eruptions, iododerm, lag of scarring of lexious tissues. Inhalation of iodine vapors is very irritating for mucosa. Immune system disorders Hypersensitivity reactions that include hives, angioedema, skin hemorrhage or purple, fever, arthralgia, lymphadenopathy and eosinophilia. Iodine, when administered locally in the recommended modes, is only absorbed in small amounts with minimal systemic effects. The following are however listed the adverse reactions due to systemic effects of the drug, which could occur in case of abnormal absorption (full, prolonged or with occlusion of the treated skin area). Endocrine diseases Effects on thyroid can cause goiter and hypothyroidism, as well as hyperthyroidism (Basedow's tree). Gozzo and hypothyroidism can manifest in infants exposed to iodines in pregnancy. Iodine can interfere with thyroid function tests. Psychiatric disorders Depression, insomnia. Diseases of the nervous system Cephalea. Gastrointestinal diseases Nausea, vomit, diarrhea. Pathologies of the reproductive apparatus and of the breast Impotence. Traumatism, poisoning and procedure complications Prolonged use may cause a series of adverse effects called as a whole "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, symilcoriza syndrome, swelling and inflammation of the throat, irritation and swelling in the eyes and increased tearing. Pulmonary, dispnea and bronchitis can be developed.

Overdosing

The abundant application of medicinal products on very extensive areas of the skin, the use of bandages or prolonged use may result in an increase in the absorption of iodine. In these circumstances the appearance of side effects will be more frequent (see par. 4.8). Ingestion or accidental inhalation may have serious, sometimes fatal consequences. In case of overcoming, voluntary or accidental doses, hypothyroidism or hyperthyroidism may occur. They may also appear metallic flavor, increased salivation, inflammation of the salivary glands, burning or pain of the oral cavity and throat, irritation or swelling of the eyes, rashes, gastrointestinal turbes with vomiting, abdominal pain and diarrhea, metabolic acidosis, hypernatremia, kidney function deficit. Circular insufficiency and swelling of epiglottis can also occur, which can cause asphyxia, pneumonia and pulmonary edema. Retinal toxicity with overdose has also been observed. It is necessary to establish a symptomatic and support treatment with special attention to the electrolytic budget and the kidney function deficit. Symptomatic treatment of allergic reactions may be necessary, although symptoms usually regress quickly once the administration is suspended.

Iodine is poorly absorbed when used in the intended modes. Iodine reaching systemic circulation crosses the placenta and an excess of iodine is harmful to the fetus: the use of iodine during pregnancy was associated with gozzo, hypothyroidism, respiratory problems, enlarged heart, compression of trachea and neonatal death. Iodine is excreted in breast milk. The use of excessive doses of iodine in mothers during breastfeeding can increase iodine level in breast milk and cause transient hypothyroidism in infants. The use of iodine, even when applied locally, is generally to be avoided during pregnancy and nursing.

Source: Farmadati