Iodio Zeta

Iodio Zeta 7% / 5% cutaneous solution

Patient Information Leaflet

Zeta Farmaceutici S.p.A.
Iodio Zeta 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, non-damaged skin, as it may otherwise cause irritation and delay the healing of wounds and abrasions.
Prolonged use, especially, may lead to sensitization reactions. If this occurs, discontinue treatment and contact your doctor, 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 clearly needed and under medical supervision.
Discontinue treatment at least 10 days before undergoing iodine-labelled scintigraphy.
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 your doctor.
Interactions
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those
not requiring a prescription.
If iodine comes into contact with acetone, it forms a pungent, irritating 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 eyes.
Pregnancy and Breastfeeding
Consult your doctor or pharmacist before taking any medicinal product.
Iodine is poorly absorbed when used as directed.
Iodio Zeta 7% / 5% cutaneous solution

Package leaflet

Zeta Farmaceutici S.p.A.
Iodine that reaches the systemic circulation crosses the placenta, and excess iodine is harmful to the
fetus: the use of iodine during pregnancy is associated with goiter, hypothyroidism, respiratory problems,
enlarged heart, tracheal compression, and neonatal death.
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 and use machines
Not applicable
Dosage, method and timing of administration
Apply by brushing onto the affected area.
Reacts vigorously with organic substances 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
Abundant application of the medicinal product on very large skin areas, use of dressings, or prolonged use may lead to increased absorption of iodine. Under these circumstances, adverse effects may occur more frequently (see Undesirable effects).
Accidental ingestion or inhalation may have serious, sometimes fatal, consequences.
In case of exceeding the recommended doses, either intentionally or accidentally, hypothyroidism or hyperthyroidism may develop.
Other 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 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 Zeta, contact a physician immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBT ABOUT THE USE OF IODIO ZETA, CONSULT YOUR DOCTOR OR PHARMACIST.
Undesirable effects
Like all medicines, iodine can cause undesirable effects, although not everybody experiences them.
Listed below are the undesirable effects of iodine. There are insufficient data available to establish the frequency of the individual adverse 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
Iodio Zeta 7% / 5% cutaneous solution

Package leaflet

Zeta Farmaceutici S.p.A.
Hypersensitivity reactions including urticaria, angioedema, cutaneous haemorrhages or purpura, fever,
arthralgia, lymphadenopathy and eosinophilia.
When applied locally 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 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 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, coryza-like syndrome, throat swelling and inflammation, eye irritation and swelling, and increased lacrimation may also occur. Pulmonary oedema, dyspnoea and bronchitis may develop.
Following the instructions contained 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 disposed of.
WARNING: do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Keep the container tightly closed in the original packaging, protected from light.
Iodine Zeta 7% / 5% cutaneous solution

Package Leaflet

Zeta Farmaceutici S.p.A.
Medicines should 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 sight and reach of children.
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 iodine tincture.
Bottle of 10 ml, 20 ml, 30 ml and 50 ml.
Marketing Authorization Holder
Zeta 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
Iodio Zeta 2% / 2.5% oral solution

Package Leaflet

Zeta Farmaceutici S.p.A.
Iodio Zeta 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.
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 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 using gargling preparations in children, who almost never succeed in performing 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 gland.
Treatment should be discontinued at least 10 days prior to performing a scintigraphy with radiolabeled 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 medicinal products, 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 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.
Iodio Zeta 2% / 2.5% oral solution

Package leaflet

Zeta Farmaceutici S.p.A.
After oral absorption, iodine crosses the placenta and excess iodine is harmful to the fetus: the use of
iodine during pregnancy is associated with goiter, hypothyroidism, respiratory problems, enlarged heart,
tracheal compression and neonatal death.
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 and use machines
Iodio soluzione orale Zeta does not affect or affects only negligibly the ability to drive vehicles or
operate 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 with 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 Zeta 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, oxyquinoline sulfates, ammonia, essences,
turpentine essence, iodoform.
Overdose
Accidental ingestion or inhalation may have serious, sometimes fatal, consequences.
Zeta Iodine 2% / 2.5% oral solution

Package leaflet

Zeta Farmaceutici S.p.A.
In case of exceeding the recommended doses, either voluntarily or accidentally, hypothyroidism or
hyperthyroidism may occur.
Other possible symptoms 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 diarrhoea, metabolic acidosis, hypernatremia, and impaired renal function.
Furthermore, circulatory failure and swelling of the epiglottis may occur, potentially leading to asphyxia, pneumonia and pulmonary oedema, which may even result in death.
Retinal toxicity has also been observed in cases of overdose.
Symptomatic and supportive treatment should be initiated, with special attention to electrolyte balance and impaired renal function. Treatment of allergic reactions may also be required, although symptoms usually resolve quickly once administration is discontinued.
In case of accidental ingestion or overdose of Iodio Zeta, contact a doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF IODIO ZETA, 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 the individual adverse effects listed.

Iodio Zeta 2% / 2.5% oral solution

Package leaflet

Zeta Farmaceutici S.p.A.

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 and Storage
Expiry: see the expiry date stated on the packaging.
The expiry date refers to the product kept unopened 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
Store the container tightly closed in the original packaging to protect the medicine 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.

Composition
100 ml of solution contain
Active substances: Iodine 2 g
Potassium iodide 2.5 g
Excipients: Ethanol, purified water

Pharmaceutical Form and Contents
Oral solution
20 ml bottle

Marketing Authorization Holder
Zeta 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