IODINE OS SOLUTION MV "2%/2.5% ORAL SOLUTION"1 BOTTLE 25 ML"

Active ingredients

100 ml of solution contain Active ingredients: Iodine 2 g Potassium iodide 2.5 g For the full list of excipients, see section 6.1.

Excipients

Ethanol, purified water.

Therapeutic indications

As an antiseptic and disinfectant of the oral cavity. Treatment of iodine deficiency states in case of increased need or poor absorption.

Contraindications

Hypersensitivity to the active substances or to any of the excipients. Generally contraindicated in pregnancy (see section 4.6). Do not use in children under 6 months. As a mouthwash it should not be used in children under 6 years of age.

Dosage

Antiseptic and disinfectant of the oral cavity 2–3 daily mouthwashes with 10–20 drops diluted in half a glass of water. In case of mouth ulcers or other abrasions of the oral mucosa, apply directly by dabbing with a swab or a cotton ball. Treatment of iodine deficiency Take the medicine diluted in water according to the doctor's prescription. One drop of Iodine Marco Viti contains approximately 2 mg of iodine. The daily values ​​of iodine recommended by the Italian Society of Human Nutrition (LARN) for age and sex are given below. Children (males and females)

Age	LARN
6 – 12 months	50 mcg
1 – 3 years	70 mcg
4 – 6 years	90 mcg
7 – 10 years	120 mcg

Adolescents and adults (males)

Age	LARN
11 – 14 years	150 mcg
15 – 17 years old	150 mcg
18 – 29 years old	150 mcg
30 – 59 years old	150 mcg

Adolescents and adults (female)

Age	LARN
11 – 17 years old	150 mcg
18 – 49 years old	150 mcg
50+	150 mcg
Pregnancy	150 mcg

Warnings and precautions

Avoid contact with eyes. Do not take the medicine for long periods of time. Use, especially if prolonged, may give rise to sensitization phenomena. In this case, stop treatment and adopt appropriate therapeutic measures. Since iodine and iodide 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. Although iodine is required for the production of thyroid hormones, excessive quantities can cause hyperthyroidism or even paradoxical goiter and hypothyroidism. In pediatric age, use only in case of real need and under medical supervision. It is advisable to avoid the use of gargle preparations in children, who are almost never able to gargle without swallowing a good part of the preparation (see section 4.3). The medicine should not be used in adolescent patients given the potential induction of acne and the effects on the thyroid. Discontinue treatment at least 10 days before performing a scintigraphy with labelled iodine. The results of thyroid function tests may be altered following treatment, especially in premature infants. Important information about some of the excipients: The product contains ethanol (alcohol), in quantities up to 100 mg per dose.

Interactions

Elemental iodine forms a pungent irritant when it comes into contact with acetone. The effects of iodine and iodides on the thyroid can be altered by other compounds including amiodarone and lithium. Lithium carbonate, used in the treatment of manic-depressive psychosis, causes abnormally low thyroid activity. Iodine should not be taken by individuals taking lithium carbonate because iodine suppresses the functions of the thyroid gland.

Side effects

The following are adverse reactions of iodine, organized according to the MedDRA system organ classification. There are insufficient data to determine the frequency of the individual effects listed.

Systems and organs	Adverse reaction
Pathologies of the haemolymphopoietic system	Eosinophilia, lymphadenopathy
Immune system disorders	Hypersensitivity
Endocrine pathologies	Hyperthyroidism (Basedow's disease), hypothyroidism, goiter. Iodine may interfere with thyroid function tests
Skin and subcutaneous tissue disorders	Urticaria, angioedema, skin haemorrhage. Inhalation of iodine vapours is very irritating to the mucous membranes.
Metabolism and nutrition disorders	Metabolic acidosis
Psychiatric disorders	Depression, insomnia
Nervous system disorders	Metallic taste, headache
Cardiac and vascular pathologies	Hypotension, tachycardia
Respiratory, thoracic and mediastinal pathologies	Dyspnea, pulmonary edema, bronchospasm
Gastrointestinal disorders	Nausea, vomiting, diarrhea, abdominal pain
Kidney and urinary disorders	Renal failure
Reproductive system and breast disorders	Impotence
Systemic disorders and conditions related to the administration site	Fever
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 soreness in the 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.

Pregnancy and breastfeeding

Iodine after oral absorption crosses the placenta and excess iodine is harmful to the fetus: iodine use during pregnancy is associated with goiter, hypothyroidism, respiratory problems, enlarged heart, compression of the trachea and neonatal death. Iodine is excreted in breast milk. The use of excessive doses of iodine in mothers during breastfeeding 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.