Iodine Nova Argentia

PACKAGE LEAFLET

IODIO NOVA ARGENTIA 2% / 2.5% oral solution

PHARMACOTHERAPEUTIC CATEGORY
Other mineral preparations.

THERAPEUTIC INDICATIONS
As an antiseptic and disinfectant for the oral cavity.
Treatment of iodine deficiency states in cases of increased requirement or poor absorption.

CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
Generally contraindicated during pregnancy (see Special Warnings).
Do not use in children under 6 months of age.
When used as a mouthwash, it must not be used in children under 6 years of age.

PRECAUTIONS FOR USE
Do not take this medicine for prolonged periods.
Prolonged use, especially, may lead to sensitization phenomena. In such cases, discontinue treatment and adopt appropriate therapeutic measures.
Since iodine and iodide may alter thyroid function, caution is advised in patients with thyroid disorders, in patients over 45 years of age, or with goitre.
Although iodine is required for the production of thyroid hormones, excessive amounts may cause hyperthyroidism or even paradoxical goitre and hypothyroidism.
In paediatric patients, use only when strictly necessary and under medical supervision.
It is advisable to avoid using gargling preparations in children, who almost never succeed in gargling without swallowing a significant portion of the medicinal product (see Contraindications).
The medicine should not be used in adolescent patients due to the potential induction of acne and effects on the thyroid gland.
Discontinue treatment at least 10 days before performing a scintigraphy with radiolabelled iodine.
Following treatment, thyroid function test results may be altered, particularly in premature neonates.
If no improvement is observed after a short period of treatment, consult a physician.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those not requiring a prescription.
If elemental iodine comes into contact with acetone, it forms an irritating, pungent compound.
The effects of iodine and iodides on the thyroid may 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 patients undergoing treatment with lithium carbonate, to avoid iodine-induced suppression of thyroid gland function.

SPECIAL WARNINGS
Avoid contact with the eyes.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
After oral absorption, iodine crosses the placenta and excess iodine is harmful to the fetus: iodine use during pregnancy has been associated with goitre, hypothyroidism, respiratory problems, enlarged heart, tracheal compression, and neonatal death.
Iodine is excreted in breast milk. Excessive iodine intake by nursing mothers may increase iodine levels in breast milk and cause transient hypothyroidism in infants.
Iodine use, even when applied locally, should generally be avoided during pregnancy and breastfeeding.

Effects on ability to drive vehicles and use machinery
IODIO NOVA ARGENTIA does not alter or alters negligibly the ability to drive vehicles or operate machinery.

Important information about some excipients
The product contains ethanol (alcohol), in amounts up to 100 mg per dose.

DOSAGE, ROUTE AND DURATION OF ADMINISTRATION
Antiseptic and disinfectant of the oral cavity
2–3 mouth rinses daily, using 10–20 drops diluted in half a glass of water.
In case of aphthae or other abrasions of the oral mucosa, apply directly by dabbing with a swab or cotton ball.

Treatment of iodine deficiency states
Take the medicine diluted in water according to the physician's instructions.
One drop of IODIO NOVA ARGENTIA contains approximately 2 mg of iodine. Below are the daily iodine intake values recommended by the Italian Society of Human Nutrition (LARN), according to age and sex.

Children (males and females)

Adolescents and adults (males)

Adolescents and adults (females)

Do not combine with alkaloids, arsenites, arseniates, lead or mercury salts, oxine sulfates, ammonia,
essential oils, turpentine oil, ichthammol.

OVERDOSE
Accidental ingestion or inhalation may have serious, sometimes fatal, consequences.
Exceeding the recommended doses, whether intentionally or accidentally, may result in hypothyroidism
or hyperthyroidism.
Additional symptoms may include metallic taste, increased salivation, inflammation of the salivary
glands, burning or pain in the oral cavity and throat, eye irritation or swelling, skin eruptions,
gastrointestinal disturbances with vomiting, abdominal pain and diarrhea, metabolic acidosis,
hypernatremia, and impaired renal function.
Furthermore, circulatory failure and epiglottal swelling may occur, potentially leading to asphyxia,
pneumonia, and pulmonary edema, which may also be fatal.
Retinal toxicity has also been observed in cases of overdose.

Symptomatic and supportive treatment must be initiated, with special attention to electrolyte balance and
renal function impairment. Symptomatic treatment of allergic reactions may be required, although
symptoms usually resolve rapidly once administration is discontinued.

In case of accidental ingestion or overdose of IODIO NOVA ARGENTIA, contact a physician immediately or
go to the nearest hospital.

If you have any doubts about the use of IODIO NOVA ARGENTIA, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, iodine can cause undesirable effects, although not everybody experiences them.
The following are the undesirable effects associated with iodine. There are insufficient data available
to determine the frequency of individual listed effects.

Following the instructions in this leaflet reduces the risk of adverse effects.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date stated on the packaging.
The expiry date refers to the product in its original, unopened packaging, correctly stored.
WARNING: do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging (iodine-resistant material) to protect the medicine from light and direct heat.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep the medicine out of the reach and sight of children.

COMPOSITION
100 ml of solution contain:
Active substances: Iodine 2 g.
Potassium iodide 2.5 g.
Excipients: Ethanol, Purified water.
PHARMACEUTICAL FORM AND CONTENT
Oral solution.
20 ml bottle.
MARKETING AUTHORISATION HOLDER
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via Lovanio, 5 – Milan.
MANUFACTURER
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via Pascoli, 1 - Gorgonzola (MI).
REVISION OF THE LEAFLET BY THE ITALIAN MEDICINES AGENCY:
May 2013.

INSTRUCTIONS FOR USE

IODIO NOVA ARGENTIA 7% / 5% alcoholic cutaneous solution

PHARMACOTHERAPEUTIC CATEGORY
Antiseptics and disinfectants
THERAPEUTIC INDICATIONS
Disinfection of intact skin for occasional treatments.
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
Generally contraindicated during pregnancy (see Special Warnings).
Do not use in children under 6 months of age.
PRECAUTIONS FOR USE
Prolonged application may cause irritation and cauterization of the treated surface; therefore, the medicinal product must not be used for prolonged treatments.
The medicinal product must be applied only on intact, undamaged skin, as it may cause irritation and delay healing of wounds and abrasions.
Prolonged use, especially, may lead to sensitization reactions. If this occurs, discontinue treatment and contact the physician, who may initiate appropriate therapeutic measures.
To avoid excessive absorption of iodine, do not cover the treated skin area with occlusive dressings.
When used for prolonged periods over large body surfaces, on mucous membranes, or under occlusive dressings—particularly in children and patients with thyroid disorders—thyroid function tests should be performed.
Since iodine may affect thyroid function, caution is recommended in patients with thyroid disorders, in individuals over 45 years of age, or with goiter.
In pediatric patients, use only when clearly necessary and under medical supervision.
Discontinue treatment at least 10 days before undergoing scintigraphy with radioactive iodine.
Following treatment, results of thyroid function tests may be altered, especially in premature neonates.
If no improvement is observed after a short period of treatment, consult a physician.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including
those not requiring a prescription.
If it comes into contact with acetone, elemental iodine forms an irritating, pungent compound.
When assessing interactions with other medicinal products, possible systemic effects of iodine should be considered, although when administered topically as recommended, absorption is minimal.
The effects of iodine and iodides on the thyroid may be altered by other compounds, including amiodarone and lithium.
SPECIAL WARNINGS
For external use only. Do not ingest. Avoid contact with the eyes.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicinal product.
Iodine is poorly absorbed when used as directed.
Iodine that enters systemic circulation crosses the placenta, and excess iodine is harmful to the fetus: iodine use during pregnancy has been associated with goiter, hypothyroidism, respiratory problems, enlarged heart, tracheal compression, and neonatal death.
Iodine is excreted in breast milk. Excessive iodine intake by nursing mothers may increase iodine levels in breast milk and cause transient hypothyroidism in infants.
The use of iodine, even when applied topically, should generally be avoided during pregnancy and breastfeeding.
Effects on ability to drive vehicles and use machinery
Not applicable.
Important information about some excipients: not applicable.

DOSAGE, ADMINISTRATION, AND DURATION OF TREATMENT
Apply by brushing onto the affected area.
Reacts vigorously with essential oils in general, iron filings, and white and yellow mercury precipitates. It is incompatible with silver, mercury, and lead salts, alkalis, carbonates, alkaloids, and their salts.
OVERDOSE
Abundant application of the medicinal product over large skin areas, use of dressings, or prolonged use may increase iodine absorption. Under these circumstances, adverse effects (see Undesirable Effects) may occur more frequently.
Accidental ingestion or inhalation may have serious, sometimes fatal, consequences.
In case of intentional or accidental overdose, hypothyroidism or hyperthyroidism may occur.
Additional symptoms may include metallic taste, increased salivation, inflammation of the salivary glands, burning or pain in the mouth and throat, eye irritation or swelling, skin eruptions, gastrointestinal disturbances with vomiting, abdominal pain and diarrhea, metabolic acidosis, hypernatremia, and impaired renal function. Circulatory failure and epiglottic swelling may also occur, potentially leading to asphyxia, pneumonia, and pulmonary edema, which may be fatal.
Retinal toxicity has also been observed in cases of overdose.
Symptomatic and supportive treatment should be initiated, with particular attention to electrolyte balance and renal function. Treatment of allergic reactions may be required, although symptoms usually resolve rapidly once administration is discontinued.
In case of accidental ingestion/overdose of IODIO NOVA ARGENTIA, contact a physician immediately or go to the nearest hospital.
If you have any doubts about the use of IODIO NOVA ARGENTIA, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicinal products, iodine may cause adverse effects, although not everyone experiences them.
Listed below are the adverse effects associated with iodine. There are insufficient data to determine the frequency of individual effects listed.

Skin and subcutaneous tissue disorders
Burning or irritation, acneiform eruptions, iododerma, delayed healing of injured tissues.
Inhalation of iodine vapors is highly irritating to mucous membranes.
Immune system disorders
Hypersensitivity reactions including urticaria, angioedema, skin hemorrhages or purpura, fever, arthralgia, lymphadenopathy, and eosinophilia.
When administered topically as recommended, iodine is absorbed only in small amounts, resulting in minimal systemic effects. Nevertheless, the following adverse reactions due to systemic effects of the drug are listed, which may occur in cases of abnormal absorption (e.g., abundant, prolonged use, or occlusion of the treated skin area).
Endocrine disorders
Effects on the thyroid may cause goiter and hypothyroidism, as well as hyperthyroidism (Graves' disease). Goiter and hypothyroidism may also occur in neonates exposed to iodides during pregnancy.
Iodine may 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 may cause a series of adverse effects collectively known as "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, cold-like syndrome, swelling and inflammation of the throat, eye irritation and swelling, and increased lacrimation may also occur. Pulmonary edema, dyspnea, and bronchitis may develop.
Following the instructions in this leaflet reduces the risk of adverse effects.
If any of the adverse effects worsens, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
The expiry date refers to the product in unopened packaging, stored correctly.
WARNING: do not use the medicinal product after the expiry date stated on the packaging.
Storage conditions
Store in the original container (iodine-resistant material) to protect the medicinal product from light and direct heat.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicinal products. This will help protect the environment.
Keep the medicinal product out of the reach and sight of children.
COMPOSITION
100 ml of solution contains
Active substances: Iodine 7 g
Potassium iodide 5 g
Excipients: Ethanol, Purified water.

PHARMACEUTICAL FORM AND CONTENTS
Cutaneous solution. Also known as tincture of iodine.
Bottle of 10 ml, 25 ml, 50 ml, 1000 ml.
MARKETING AUTHORIZATION HOLDER
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via Lovanio, 5 - Milan
MANUFACTURER
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via Pascoli, 1 - Gorgonzola (MI)
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY (AIFA):
AIFA decision of 23 April 2012