IODIO SOL ALCO II 20ML 2%/2.5%

IODINE NEW.FA.DEM. 2% + 2.5% ORAL DEAL

active ingredients

100 ml of solution contain active ingredients: iodine 2 g; iodine potassium 2,5 g. For full list of excipients, see par. 6.1.

Excellent

Purified water, ethanol 96%.

Therapeutic indications

As an antiseptic and disinfectant of the oral cable Treatment of deficiencies of iodine in case of increased requirements or poor absorption.

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. As a collutory it should not be used in children under 6 years of age.

Population

Antiseptic and oral cable disinfectant 2 – 3 daily swacqui of the oral cable with 10 – 20 drops diluted in half a glass of water. In case of aphthes or other abrasions of the oral mucosa apply directly by means of touches with a tampon or a cotton ball. Treatment of iodine deficiency states Take the medicine diluted in water according to the doctor's prescriptions. A drop of Iodine New.Fa.Dem. contains about 2 mg of iodine. Below are the daily values of iodine recommended by the Italian Society of Human Nutrition (LARN) for age and sex.

Children (males and females)		Teenagers and adults (males)		Teenagers and adults (female)
Age	LARNING	Age	LARNING	Age	LARNING
6–12 months	50 mc	11–14 years	150 mc	11–17 years	150 mc
1–3 years	70 mc	15–17 years	150 mc	18–49 years	150 mc
4–6 years	90 mc	18–29 years	150 mc	More than 50 years	150 mc
7–10 years	120 mcg	30–59 years	150 mc	Pregnancy	150 mc

Conservation

Store at a temperature not exceeding 30 ° C. Store in the original packaging ( iodine-resistant material) to repair the medicine from light and direct heat

Warnings

Avoid contact with eyes. Do not take the medicine for long periods of time. Prolonged species use can give rise to awareness-raising phenomena. In this case, stop the treatment and take appropriate therapeutic measures. Since iodine and iodine can alter the function of thyroid, it is recommended to use with precaution in subjects with thyroid pathologies, in patients over 45 years old or with goiter. Although iodine is required for the production of thyroid hormones, excessive amounts may cause hyperthyroidism or even paradox goiter and hypothyroidism. In pediatric age use only in cases of actual need and under medical control. It is advisable to avoid the use of gargarism preparations in children, who almost never manage to perform a gargarism without swallowing much of the medicine (see par. 4.3). The drug should not be used in adolescent patients considering the potential induction of acne and the effects on thyroid. 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. Important information about some excipients: The product contains ethanol (alcohol), in quantities up to 100 mg per dose.

Interactions

If it comes into contact with acetone, elementary iodine forms an irritating pungent compound. The effects of iodine and iodine on thyroid can be altered by other compounds including amiodarone and lithium. Carbonated lithium, used in the treatment of depressive maniac psychosis, causes an abnormal low thyroid activity. Iodine should not be taken by subjects in treatment with lithium carbonate to prevent iodine from repressing the functions of the thyroid gland.

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.

Systems and organs	Undesirable effect
Emolinfopoietic system pathologies	Eosinophilia, lymphadenopathy
Immune system disorders	Hypersensitivity
Endocrine diseases	Hyperthyroidism (Basow Moor), hypothyroidism, gozzo. Iodine can interfere with thyroid function tests
Pathologies of skin and subcutaneous tissue	Orticaria, angioedema, skin hemorrhage. Inhalation of iodine vapors is very irritating for mucosa
Disorders of metabolism and nutrition	Metabolic acidosis
Psychiatric disorders	Depression, insomnia
Diseases of the nervous system	Metal taste, headache
Heart and vascular disease	Hypotension, tachycardia
Respiratory, chest and mediastinic pathologies	Dispnea, pulmonary edema, bronchospasmo
Gastrointestinal diseases	Nausea, vomiting, diarrhea, abdominal pain
Kidney and urinary pathologies	Renal insufficiency
Pathologies of the reproductive apparatus and of the breast	Impotence
Systemic pathologies and conditions for administration	Feb

Traumatism, poisoning and procedure complications: prolonged use may result in 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, symil–coriza syndrome, swelling and inflammation of the throat, irritation and swelling in the eyes and increased tearing. Pulmonary, dispnea and bronchitis can be developed.

Overdosing

Ingestion or accidental inhalation may have serious, sometimes fatal consequences. In case of overcoming, voluntary or accidental, recommended doses may occur hypothyroidism or ipertiroidismo.Possono 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, skin rashes, gastrointestinal turbes with vomiting, abdominal pain and diarrhea, metabolic acidosis, hypernatriemia, 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 after oral absorption 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