Iodine Marco Viti

Iodio Marco Viti 7% / 5% cutaneous solution

Package leaflet

Marco Viti Farmaceutici S.p.A.
Iodio Marco Viti 7% / 5% 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 caustic effects on 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. In such cases, discontinue treatment and
contact the physician, who may take 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
patients 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 undergoing scintigraphy with radioactive iodine.
Following treatment, thyroid function test results 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
without prescription.
Contact with acetone may lead to the formation of a pungent, irritating compound with elemental iodine.
When evaluating 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 eyes.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicinal product.
Iodine is poorly absorbed when used as directed.
However, iodine reaching the systemic circulation crosses the placenta, and excess iodine is harmful to the
fetus: iodine use during pregnancy has been associated with fetal goitre, hypothyroidism, respiratory
problems, enlarged heart, tracheal compression, and neonatal death.
Iodio Marco Viti 7% / 5% cutaneous solution

Package leaflet

Marco Viti Farmaceutici S.p.A.
Iodine is excreted in breast milk. The use of excessive doses of iodine in 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
Dosage, method and duration of administration
Apply by painting 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 on very large areas of skin, the use of dressings or prolonged use may lead to increased absorption of iodine. Under these circumstances, adverse effects may occur more frequently (see Undesired effects).
Accidental ingestion or inhalation may have serious, sometimes fatal, consequences.
In case of exceeding, intentionally or accidentally, the recommended doses, hypothyroidism or hyperthyroidism may manifest.
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 epiglottal 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 must be initiated, 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/absorption of an excessive dose of Iodio Marco Viti, immediately inform a doctor or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF IODIO MARCO VITI, CONSULT YOUR DOCTOR OR PHARMACIST.
Undesired effects
Like all medicines, iodine may cause undesired effects, although not everybody experiences them.
Listed below are the undesired effects of iodine. There are insufficient data available to determine the frequency of the individual listed effects.
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, cutaneous haemorrhages or purpura, fever, arthralgia, lymphadenopathy and eosinophilia.
Iodio Marco Viti 7% / 5% cutaneous solution

Package leaflet

Marco Viti Farmaceutici S.p.A.
When iodine is administered topically as recommended, it 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 below, which could occur in cases of abnormal absorption (excessive or 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 newborns 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, coryza-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 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 indicated on the packaging.
The expiry date refers to the product kept in its original, undamaged packaging and stored correctly.
After first opening, the medicine should be used within 6 months. After this period, any remaining medicine must be discarded.
WARNING: do not use the medicine after the expiry date stated on the packaging.

Storage conditions
Keep the container tightly closed in its original packaging, protected from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep the medicine out of the reach and sight of children.
Iodio Marco Viti 7% / 5% cutaneous solution

Package Leaflet

Marco Viti Farmaceutici S.p.A.
Composition
100 ml contains
Active substance: 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 and 1000 ml.
Marketing Authorization Holder
Marco Viti Farmaceutici S.p.A.
Via Mentana, 38
36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A.
Via Galvani, 10
36066 Sandrigo (VI)
AIFA determination of 23 April 2012
Iodine Marco Viti 2% / 2.5% oral solution

Package Leaflet

Marco Viti Farmaceutici S.p.A.
Iodio Marco Viti 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 substance or to any of the excipients.
Generally contraindicated during pregnancy (see Special Warnings).
Do not use in children under 6 months of age.
As a mouthwash, it must not be used in children under 6 years of age.
Precautions for Use
Do not take the medicine for prolonged periods.
Use, especially if prolonged, may lead to sensitization reactions. 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 patients over 45 years of age, or with goiter.
Although iodine is required for the production of thyroid hormones, excessive amounts may cause hyperthyroidism or even paradoxical goiter and hypothyroidism.
In pediatric age, use only when clearly necessary and under medical supervision.
It is advisable to avoid the use of gargling preparations in children, who almost never succeed in gargling without swallowing a significant portion of the solution (see Contraindications).
The medicine 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 undergoing scintigraphy with radioactive iodine.
Following treatment, test results for thyroid function 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 without 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 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 Breast-Feeding
Ask your doctor or pharmacist for advice 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 goiter, hypothyroidism, respiratory problems, enlarged heart, tracheal compression, and neonatal death.
Iodio Marco Viti 2% / 2.5% oral solution

Package leaflet

Marco Viti Farmaceutici S.p.A.
Iodine is excreted in breast milk. The use of excessive doses of iodine in 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 soluzione orale Marco Viti does not affect or affects negligibly 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 for 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 Marco Viti contains approximately 2 mg of iodine. Below are the daily iodine values
recommended by the Italian Society of Human Nutrition (LARN) according to age and sex.
Children (boys and girls)

Adolescents and adults (males)

Adolescents and adults (females)

Do not combine with alkaloids, arsenites, arseniates, lead or mercury salts, oxyquinoline sulfates, ammonia, essences,
turpentine essence, 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.
Iodine Marco Viti 2% / 2.5% oral solution

Package leaflet

Marco Viti Farmaceutici S.p.A.
Metallic taste, increased salivation, inflammation of the salivary glands,
burning or pain in the oral cavity and throat, eye irritation or swelling, skin rashes, gastrointestinal disturbances
with vomiting, abdominal pain and diarrhea, metabolic acidosis, hypernatremia, impaired renal function may also occur.
Furthermore, circulatory failure and epiglottal swelling may occur, which can cause asphyxiation, pneumonia, and pulmonary edema, potentially resulting in fatal outcomes.
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 impaired renal function. Symptomatic treatment of allergic reactions may be required, although symptoms usually resolve rapidly once administration is discontinued.
In case of accidental ingestion/overdose of Iodio Marco Viti, contact a physician immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF IODIO MARCO VITI, CONSULT YOUR DOCTOR OR PHARMACIST.
Undesirable effects
Like all medicines, iodine may 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 the individual listed effects.

Marco Viti Iodine 2% / 2.5% oral solution

Package leaflet

Marco Viti Farmaceutici S.p.A.

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 and Storage
Expiry: see the expiry date stated on the packaging.
The expiry date refers to the product in its original, undamaged packaging, stored correctly.
After first opening, the medicine should be used within 6 months. After this period, any remaining medicine must be discarded.
WARNING: do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Store the container tightly closed in its original packaging, protected from light.
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 this medicine out of the reach and sight of children.
Composition
100 ml of solution contain
Active substance: Iodine 2 g
Potassium iodide 2.5 g
Excipients: Ethanol, purified water
Pharmaceutical Form and Contents
Oral solution
25 ml bottle
Marketing Authorization Holder
Marco Viti Farmaceutici S.p.A.
Via Mentana, 38
36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A.
Via Galvani, 10
36066 Sandrigo (VI)
Or
Marco Viti Farmaceutici S.p.A.
Via Tarantelli, 13/15
22076 Mozzate (CO)
Iodio Marco Viti 2% / 2.5% oral solution

Package leaflet

Marco Viti Farmaceutici S.p.A.
Aifa determination of 23 April 2012