Sella Tincture Of Iodine 7% Alcoholic Solution I 50ml

NAME
IODINE SADDLE 7% / 5% ALCOHOLIC SKIN SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Antiseptics and disinfectants.

ACTIVE PRINCIPLES
Iodine; potassium iodide.

EXCIPIENTS
Ethyl alcohol, purified water.

INDICATIONS
Disinfection of intact skin for occasional treatments.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the excipients; generally contraindicated in pregnancy; Do not use in children 'diet under 6 months.

DOSAGE
Brush on the part to be treated.

STORAGE
Store in the original package (iodine-resistant material) to protect the medicine from direct light and heat.

WARNINGS
For external use only. Do not swallow. Avoid contact with eyes. 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 it delays the healing of wounds and abrasions as well as causing irritation. The use, especially if prolonged, can give rise to sensitization phenomena. In this case, interrupt the treatment and 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 bandages, in particular in children and in patients with thyroid disorders, it is necessary to perform thyroid function tests. Since iodine can alter the function of the thyroid gland, 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. 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.

INTERACTIONS
If it comes into contact with acetone, elemental iodine forms an irritating pungent compound. In evaluating interactions with other drugs, the possible systemic effects of iodine should be taken into consideration, although when administered locally in the recommended modalities it is absorbed only in small quantities. The effects of iodine and iodides on the thyroid can be altered by other compounds including amiodarone and lithium.

SIDE EFFECTS
The following are the undesirable effects of iodine, organized according to the MedDRA system organ class. 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 urticaria, angioedema, skin bleeding or body, fever, arthralgia, lymphadenopathy and eosinophilia. Iodine, when administered locally in the recommended modalities, is absorbed only in small quantities with minimal systemic effects. However, the following are listed the adverse reactions due to systemic effects of the drug, which could occur in case of abnormal absorption (abundant, prolonged use or with occlusion of the treated skin area). Endocrine Disorders: Effects on the thyroid can cause goiter and hypothyroidism, as well as hyperthyroidism (Basedow's disease). Goiter and hypothyroidism can 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, similcoriza 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
Iodine is poorly absorbed when used in the prescribed manner. The iodine that reaches the systemic circulation passes through the placenta and an excess of iodine is harmful to the fetus: the use of iodine during pregnancy has been associated with goiter, hypothyroidism, respiratory problems, enlarged heart, compression of the trachea and stillbirth. 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.