Iodine New.Fa.Dem.

PACKAGE LEAFLET IODIO NEW.FA.DEM.

A) PACKAGE LEAFLET IODIO NEW.FA.DEM. 7% + 5% ALCOHOLIC CUTANEOUS SOLUTION
Iodio New.Fa.Dem. 7% + 5% alcoholic cutaneous solution, 20 ml bottle
Iodio New.Fa.Dem. 7% + 5% alcoholic cutaneous solution, 1000 ml bottle
THERAPEUTIC PHARMACOLOGICAL 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 caustic effects on the treated surface; therefore, the medicinal product must not be used for prolonged treatments.
The medicinal product must be applied only to intact, non-damaged skin, as it may cause irritation and delay healing of wounds and abrasions. Use, especially if prolonged, may lead to sensitization phenomena. In such cases, discontinue treatment and contact the physician, who may adopt appropriate therapeutic measures. To avoid excessive iodine absorption, 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 alter thyroid function, caution is recommended in patients with thyroid disorders, in individuals over 45 years of age, or with goitre. In pediatric patients, use only when strictly necessary and under medical supervision. Discontinue treatment at least 10 days before performing a scintigraphy with radiolabeled iodine. Following treatment, results of thyroid function tests may be altered, especially in premature neonates. Consult the physician after a short period of treatment without noticeable improvement.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other
medicinal product, including those without a prescription.
Contact with acetone causes elemental iodine to form an irritating, pungent compound.
When evaluating interactions with other medicinal products, potential systemic effects of iodine should be considered, although when administered topically as recommended, it is absorbed only in small amounts. 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 reaching systemic circulation 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. The use of iodine, even when applied locally, should generally be avoided during pregnancy and breastfeeding.
Effects on ability to drive vehicles and use machinery – Not applicable
Important information about some excipients: none in particular
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Apply by brushing onto the area to be treated.
Reacts vigorously with essential oils in general, iron filings, and with white and yellow mercury precipitates. Incompatible with silver, mercury, and lead salts, alkalis, carbonates, alkaloids, and their salts.
OVERDOSE
Excessive 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 Adverse Reactions) may occur more frequently. Accidental ingestion or inhalation may have serious, sometimes fatal, consequences. In case of exceeding recommended doses, either voluntarily or accidentally, hypothyroidism or hyperthyroidism may occur. Symptoms may include metallic taste, increased salivation, inflammation of salivary glands, burning or pain in the mouth and throat, eye irritation or swelling, skin eruptions, gastrointestinal disturbances with vomiting, abdominal pain and diarrhoea, metabolic acidosis, hypernatraemia, and renal function impairment. Circulatory failure and epiglottis swelling may also occur, potentially leading to asphyxia, pneumonia, and pulmonary oedema, which may be fatal. Retinal toxicity has also been observed with overdose. Symptomatic and supportive treatment is required, with special attention to electrolyte balance and renal function impairment. Symptomatic treatment of allergic reactions may be necessary, although symptoms usually resolve rapidly once administration is discontinued. In case of accidental ingestion/overdose of Iodio New.Fa.Dem., contact a physician immediately or go to the nearest hospital. If you have any doubts about the use of Iodio New.Fa.Dem., consult your doctor or pharmacist.
ADVERSE REACTIONS
Like all medicinal products, iodine may cause adverse reactions, although not everyone experiences them. Below are the adverse reactions associated with iodine. There are insufficient data to determine 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 vapours is highly irritating to mucous membranes.
Immune system disorders – Hypersensitivity reactions including urticaria, angioedema, skin haemorrhages or purpura, fever, arthralgia, lymphadenopathy, and eosinophilia.
Iodine, when administered topically as recommended, is absorbed only in small amounts, resulting in minimal systemic effects. However, the following adverse reactions due to systemic effects of the drug are listed, which may occur in cases of abnormal absorption (excessive, prolonged use, or occlusion of the treated skin area).
Endocrine disorders – Effects on the thyroid: may cause goitre and hypothyroidism, as well as hyperthyroidism (Graves' disease). Goitre 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, diarrhoea.
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, coriza-like syndrome, swelling and inflammation of the throat, eye irritation and swelling, and increased lacrimation may also occur. Pulmonary oedema, dyspnoea, and bronchitis may develop.
Following the instructions provided in this leaflet reduces the risk of adverse reactions.
If any of the adverse reactions worsens, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date indicated on the packaging. The expiry date refers to the product in unopened packaging, correctly stored. Warning: do not use the medicinal product after the expiry date stated on the packaging.
Storage conditions – Store at a temperature not exceeding 30 °C. Keep in the original packaging (material resistant to iodine) 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 contains:
Active substances: iodine 7 g; potassium iodide 5 g
Excipients: purified water 5 g; ethanol 96% q.s. to 100 ml.
PHARMACEUTICAL FORM AND CONTENT
Cutaneous solution. Also known as tincture of iodine.
7% + 5% alcoholic cutaneous solution – 20 ml bottle with carton.
7% + 5% alcoholic cutaneous solution – 1000 ml bottle.
MARKETING AUTHORISATION HOLDER
New.Fa.Dem. srl Farmaceutici e Chimici, with registered office and manufacturing site at Viale Ferrovie dello Stato, zona A.S.I., Giugliano in Campania, NA
MANUFACTURER
New.Fa.Dem. srl Farmaceutici e Chimici, with registered office and manufacturing site at Viale Ferrovie dello Stato, zona A.S.I., Giugliano in Campania, NA
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
AIFA Determination No. 602 of 23/04/2012

B) PACKAGE LEAFLET IODIO NEW.FA.DEM. 2% + 2.5% ORAL SOLUTION

Iodio New.Fa.Dem. 2% + 2.5% oral solution, 20 ml bottle, 1000 ml bottle

THERAPEUTIC PHARMACOLOGICAL CATEGORY
Other mineral preparations.
THERAPEUTIC INDICATIONS
As an antiseptic and disinfectant of 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, must not be used in children under 6 years of age.
PRECAUTIONS FOR USE
Do not take the medicinal product for long periods. Use, especially if prolonged, 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 recommended in patients with thyroid disorders, in individuals over 45 years of age, or with goitre. Although iodine is required for thyroid hormone production, excessive amounts may cause hyperthyroidism or even paradoxical goitre and hypothyroidism. In pediatric patients, use only when strictly necessary and under medical supervision. It is advisable to avoid using gargle preparations in children, who almost never manage to gargle without swallowing a significant portion of the medicinal product (see Contraindications). The medicinal product should not be used in adolescent patients due to the potential induction of acne and effects on the thyroid. Discontinue treatment at least 10 days before performing a scintigraphy with radiolabeled iodine. Following treatment, results of thyroid function tests may be altered, especially in premature neonates. Consult the physician after a short period of treatment without noticeable improvement.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other
medicinal product, including those without a prescription.
Contact with acetone causes elemental iodine to form 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 must 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 medicinal product.
Orally absorbed 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. The use of iodine, even when applied locally, should generally be avoided during pregnancy and breastfeeding.
Effects on ability to drive vehicles and use machinery
Iodio New.Fa.Dem. does not affect or has negligible effect on the ability to drive vehicles or use machinery.
Important information about some excipients – The product contains ethanol (alcohol), up to 100 mg per dose.
DOSAGE, METHOD 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 oral mucosa abrasions, apply directly by dabbing with a swab or cotton ball.
Treatment of iodine deficiency states
Take the medicinal product diluted in water according to the physician's instructions. One drop of Iodio New.Fa.Dem. 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.

Do not associate with alkaloids, arsenites, arseniates, Pb or Hg salts, oxyquinoline sulfates,
ammonia, essences, turpentine essence, ichthammol.
OVERDOSAGE
Accidental ingestion or inhalation may have serious, sometimes fatal, consequences.
Exceeding the recommended doses, whether intentionally or accidentally, may result in
hypothyroidism or hyperthyroidism. 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 may also occur. Additionally,
circulatory failure and epiglottic swelling may occur, potentially leading to asphyxia, pneumonia,
and pulmonary edema, which can also be fatal. Retinal toxicity has also been observed in cases of overdose.
It is necessary to initiate symptomatic and supportive treatment, with special attention to electrolyte
balance and renal function impairment. Treatment of allergic reactions may be required, although symptoms
usually regress rapidly once administration is discontinued. In case of accidental ingestion/overdose of
Iodio New.Fa.Dem., immediately inform a physician or go to the nearest hospital.
If you have any doubts about the use of Iodio New.Fa.Dem., consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, iodine can cause undesirable effects, although not everyone experiences them.
The undesirable effects of iodine are listed below. There are insufficient data available to determine
the frequency of the individual adverse effects listed.

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, catarrhal syndrome, throat swelling and inflammation, eye irritation and swelling, and increased lacrimation may also occur. Pulmonary edema, dyspnea and bronchitis may develop.
Following the instructions contained in this leaflet reduces the risk of adverse reactions.
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 expiry date stated on the packaging. The expiry date refers to the product in its original, unopened packaging stored under appropriate conditions.
Warning: do not use the medicine after the expiry date stated on the packaging.
Storage conditions – Store at a temperature not exceeding 30 °C.
Keep in the original packaging (material resistant to iodine) 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 properly dispose of medicines no longer in 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: purified water 2.5 g, ethanol 96% q.s. to 100 ml.
PHARMACEUTICAL FORM AND CONTENT
Oral solution.
2% + 2.5% oral solution – 20 ml bottle with carton box.
2% + 2.5% oral solution – 1000 ml bottle.
MARKETING AUTHORISATION HOLDER
New.Fa.Dem. srl Farmaceutici e Chimici, with registered office and manufacturing site at Viale Ferrovie dello Stato, zona A.S.I., Giugliano in Campania (NA)
MANUFACTURER
New.Fa.Dem. srl Farmaceutici e Chimici, with registered office and manufacturing site at Viale Ferrovie dello Stato, zona A.S.I., Giugliano in Campania (NA)
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY (AIFA)
AIFA Determination n° 602 of 23/04/2012
C) PACKAGE LEAFLET IODIO NEW.FA.DEM. 2% + 10% OINTMENT

Iodio New.Fa.Dem. 2% + 10% ointment – Jar of 250 g, 1000 g

PHARMACOTHERAPEUTIC CATEGORY
Antiseptics and disinfectants
THERAPEUTIC INDICATIONS
Disinfection of intact skin.
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
Generally contraindicated during pregnancy (see Special warnings).
PRECAUTIONS FOR USE
To avoid excessive absorption of iodine, do not cover the treated area with occlusive dressings. Prolonged application may cause irritation and cauterization of the treated surface; therefore, the medicinal product should not be used frequently.
Since iodine and its iodide salts may alter thyroid gland function, caution is recommended when using the medicinal product in patients over 45 years of age or with goitre. Furthermore, thyroid function test results may be altered.
Premature infants treated with local iodine applications may show altered results in thyroid function tests.
INTERACTIONS
If elemental iodine comes into contact with acetone, it 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, it is absorbed only in small amounts. The effects of iodine and iodides on the thyroid may be altered by other compounds, including amiodarone and lithium.
SPECIAL WARNINGS
Do not ingest. For external use only.
Pregnancy and breastfeeding
Iodine is only slightly absorbed when used as directed. Iodine reaching systemic circulation crosses the placenta. Excess iodine is harmful to the foetus: the use of potassium iodide and other iodide salts during pregnancy has been associated with goitre, hypothyroidism, respiratory problems, enlarged heart, tracheal compression and neonatal death. Iodides, even when applied locally, should generally be avoided during pregnancy.
Effects on ability to drive and use machines – Not applicable
Important information about certain excipients: none in particular
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Apply a thin layer of ointment to the area to be treated. Iodine reacts vigorously with essential oils in general, iron filings, and with white and yellow mercury precipitates. It is incompatible with silver, mercury and lead salts, alkalis, carbonates, alkaloids and their salts.
OVERDOSE
Excessive application of the medicinal product over large areas of skin, use of dressings or prolonged use may increase iodine absorption. Under these circumstances, adverse effects may occur more frequently (see Adverse effects). In case of accidental ingestion/overdose of Iodio New.Fa.Dem. ointment, contact a physician immediately or go to the nearest hospital. If you have any doubts about the use of Iodio New.Fa.Dem. ointment, consult your doctor or pharmacist.
ADVERSE EFFECTS
Like all medicinal products, Iodio New.Fa.Dem. ointment can cause adverse effects, although not everyone experiences them. The adverse effects of iodine are listed below.
There are insufficient data available to determine the frequency of the individual effects listed.
Immune system disorders
Iodine and iodides, even when applied locally as directed, may cause hypersensitivity reactions including urticaria, angioedema, skin haemorrhages or purpura, fever, arthralgia, lymphadenopathy and eosinophilia.
Skin and subcutaneous tissue disorders
Inhalation of iodine vapours is highly irritating to mucous membranes. When administered locally as recommended, iodine is absorbed only in small amounts, with minimal systemic effects. Nevertheless, the following adverse reactions due to systemic effects of the medicinal product are listed, which could occur in cases of abnormal absorption (excessive, prolonged use or occlusion of the treated skin area).
Endocrine disorders
Iodine and iodides have variable effects on the thyroid and may cause goitre and hypothyroidism, as well as hyperthyroidism (Graves' disease). Goitre and hypothyroidism may also occur in neonates exposed to iodides during pregnancy.
Psychiatric disorders
Depression, insomnia.
Nervous system disorders
Headache.
Gastrointestinal disorders
Nausea, vomiting, diarrhoea.
Skin and subcutaneous tissue disorders
Acneiform eruptions, iododerma.
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, increased lacrimation may also occur. Pulmonary oedema, dyspnoea 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 medicinal product in unopened packaging, stored correctly. WARNING: do not use the medicinal product after the expiry date stated on the packaging.
Storage conditions – Store at a temperature not exceeding 30 °C.
Keep in the original packaging (material resistant to iodine) to protect the medicinal product from light and direct heat. After first opening of the container, the medicinal product should be used within 12 months. After this period, any remaining medicinal product must be discarded.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products no longer in use. This will help protect the environment. Keep the medicinal product out of the reach and sight of children.
COMPOSITION
100 g contain:
Active substances: Iodine 2 g; Potassium iodide 10 g
Excipients: Purified water; vaseline and lanolin ointment base.
PHARMACEUTICAL FORM AND CONTENT
Ointment.
2% +10% ointment – Jar of 250 g
2% +10% ointment – Jar of 1000 g
MARKETING AUTHORISATION HOLDER
New.Fa.Dem srl Farmaceutici e Chimici, with registered office and manufacturing site at Viale Ferrovie dello Stato, zona A.S.I., Giugliano in Campania, NA
MANUFACTURER
New.Fa.Dem srl Farmaceutici e Chimici, with registered office and manufacturing site at Viale Ferrovie dello Stato, zona A.S.I., Giugliano in Campania, NA
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY (AIFA):
AIFA V&A Determination No. 1352 of 01/12/2011