IODINE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IODINE

Composition:

Active substance: iodine;

100 ml of solution contain 5 g of iodine;

Excipients: potassium iodide, ethanol 96%, purified water.

Pharmaceutical form. Topical solution, alcoholic.

Main physicochemical properties: red-brown liquid, transparent in a thin layer, with a characteristic odor.

Pharmacotherapeutic group.
Antiseptics and disinfectants. ATC code D08AG03.

Pharmacological properties.

The drug contains elemental iodine, which has antimicrobial, local irritant, and counterirritant effects. When applied to the skin and mucous membranes, the drug exerts an irritant effect and may cause reflex changes in body functions. Absorbed iodine actively influences metabolism and enhances dissimilation processes.

Clinical characteristics.

Indications.

Used topically as an antiseptic and irritant agent in infectious-inflammatory diseases of the skin and mucous membranes, for treatment of the surgical field, for prevention of infection in minor skin injuries, and for reduction of inflammatory processes in myositis and neuralgia (exerts a distracting effect).

Contraindications.

Hypersensitivity to iodine. The drug is also contraindicated in diabetic and trophic ulcers.

Interaction with other medicinal products and other types of interactions.

When used simultaneously with topical agents containing organic compounds, denaturation of protein components may occur.

Incompatible with essential oils, ammonia solution, and brilliant green. Incompatible with disinfectant medicinal products containing mercury compounds, alkalis, and reducing agents.

When using any other medicinal products concurrently, inform your physician.

Special precautions for use.

Caution should be exercised when applying iodine to mucous membranes, as the alcohol contained in the preparation may cause burns or severe irritation. Avoid contact of the preparation with eyes. Particular caution should be exercised when using iodine in patients with light hair.

Do not apply to large areas of skin due to the risk of developing burns.

The recommended application instructions for the medicinal product must not be violated, as this may harm health.

Use during pregnancy or breastfeeding.

The use of this medicinal product during pregnancy and breastfeeding is not recommended due to the possible risk of thyroid dysfunction in the fetus/child.

Ability to influence reaction rate when driving or operating machinery. No influence.

Method of Administration and Dosage.

For external use, moisten a cotton swab with iodine and use it to treat affected areas of the skin.

Children.

Do not use in newborns due to the possible risk of thyroid dysfunction and skin lesions.

Overdose.

In case of overdose, symptoms of iodism may occur (rhinitis, urticaria, Quincke's edema, lacrimation, salivation, acne-like skin eruptions), as well as skin burns and irritation.

Treatment is symptomatic.

Adverse reactions.

Possible occurrence of rhinitis, urticaria, Quincke's edema, salivation and lacrimation, skin rashes, contact dermatitis.

If any adverse reactions occur, consult a physician.

Shelf life. 2 years.

The product must not be used after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 ml, 20 ml, 100 ml in bottles.

Prescription status. Over-the-counter.

Manufacturer. JSC "FITOFARM" (responsible for batch release, excluding batch control/testing).

Manufacturer's address and location of its business activity.

17, Chumatska Street, Boryspil, Kyiv region, Ukraine, 08303.

Marketing Authorization Holder.

JSC "FITOFARM".

Address of the Marketing Authorization Holder.

18, Room 18, 3rd Floor, 7, Verkhovnoyi Rady Avenue, Kyiv, Ukraine, 02100.

INSTRUCTION

for medical use of the medicinal product

IODINE

Composition:

Active ingredient: iodine;

100 ml of solution contains iodine 5 g;

Excipients: potassium iodide, ethanol 96%, purified water.

Pharmaceutical form. Topical solution, alcoholic.

Main physicochemical properties: red-brown transparent liquid in a thin layer, with a characteristic odor.

Pharmacotherapeutic group.

Antiseptics and disinfectants. ATC code D08AG03.

Pharmacological properties.

The drug contains elemental iodine, which is characterized by antimicrobial, local irritant, and counterirritant effects. When applied to the skin and mucous membranes, the drug causes an irritant effect and may induce reflex changes in body functions. Penetrating into tissues, iodine actively influences metabolism and enhances dissimilation processes.

Clinical characteristics.

Indications.

Used externally as an antiseptic and irritant agent in infectious and inflammatory diseases of the skin and mucous membranes, for treatment of the surgical field, for prevention of infection in minor skin injuries, and for reduction of inflammatory processes in myositis and neuralgia (exerts a distracting effect).

Contraindications.

Hypersensitivity to iodine. The drug is also contraindicated in diabetic and trophic ulcers.

Interaction with other medicinal products and other forms of interaction.

When used simultaneously with topical agents containing organic compounds, denaturation of protein components may occur.

Incompatible with essential oils, ammonia solution, and brilliant green. Incompatible with disinfectant medicinal products containing mercury compounds, alkalis, and reducing agents.

When using any other medicinal products concurrently, inform your physician.

Special precautions for use.

Caution should be exercised when applying iodine to mucous membranes, as the alcohol contained in the preparation may cause burns or severe irritation. Avoid contact of the product with eyes. Particular caution should be exercised when using iodine in patients with light hair.

The product should not be applied to large areas of skin due to the risk of developing burns.

The recommended application instructions for the medicinal product must not be violated, as this may harm health.

Use during pregnancy or breastfeeding.

The use of this product is not recommended during pregnancy and breastfeeding due to the possible risk of thyroid dysfunction in the fetus/child.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage

For external use, soak a cotton swab with iodine and use it to treat affected areas of the skin.

Children.

Do not use in newborns due to the risk of developing thyroid dysfunction and skin lesions.

Overdose.

In case of overdose, symptoms of iodism may occur (rhinitis, urticaria, Quincke's edema, lacrimation, salivation, acne-like skin eruptions), as well as skin burns and irritation.

Symptomatic treatment.

Side effects.

Possible manifestations include rhinitis, urticaria, Quincke's edema, salivation and lacrimation, skin rash, contact dermatitis.

If any adverse reactions occur, consult a physician.

Shelf life. 2 years.

Do not use the product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 ml, 20 ml, 100 ml in bottles.

Supply classification. Over-the-counter.

Manufacturer.

JSC "FITOPHARM".

Manufacturer's address and location of business activity.

2 Sybitsieva Street, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing authorization holder.

JSC "FITOPHARM".

Address of the marketing authorization holder.

7 Verkhovnoi Rady Avenue, Kyiv, 02100, Ukraine, Building 7, Floor 3, Premises 18.