Betadine solution for external and local use 10% in a bottle with a dropper 120 ml

Active ingredient: povidone-iodine;

1 ml of solution contains 100 mg of povidone-iodine;

Excipients: glycerin (85%), nonoxynol 9, citric acid, sodium phosphate anhydrous, sodium hydroxide, purified water.

• Hypersensitivity to iodine or suspected of it or hypersensitivity to other components of the drug.
• Thyroid dysfunction.
• The drug is contraindicated before and after treatment and scintigraphy with radioactive iodine in patients with thyroid carcinoma.
• During’s dermatitis herpetiformis.
• Kidney failure.

The drug is intended for external use in dissolved and undissolved form. The drug should not be mixed with hot water. Only short-term heating to body temperature is possible.

Pregnant women

Contraindicated.

Children

In newborns and children under 1 year of age, povidone-iodine should be used only if absolutely necessary. If necessary, thyroid function should be monitored.

The following symptoms are characteristic of acute iodine intoxication:

• metallic taste in the mouth, increased salivation, burning sensation or pain in the mouth or throat;
• irritation and swelling in the eyes;
• skin reactions;
• gastrointestinal disorders and diarrhea;
• renal dysfunction and anuria;
• circulatory failure;
• laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

Treatment: symptomatic and supportive therapy should be administered with special attention to electrolyte balance, renal function and thyroid function.

• Renal and urinary disorders: renal dysfunction, acute renal failure.
• Skin and subcutaneous tissue disorders: local skin hypersensitivity reactions such as contact dermatitis with psoriatic-like red small lesions; allergic reactions including itching, redness, rash, angioedema.
• Endocrine system: hyperthyroidism. Prolonged use of povidone-iodine may lead to absorption of large amounts of iodine.
• In some cases, iodine-induced hyperthyroidism has been observed as a result of prolonged use of the drug, mainly in patients with thyroid disease.
• In some cases, generalized acute reactions with a decrease in blood pressure and/or difficulty breathing (anaphylactic reactions) are possible.

Preparations containing mercury, silver, hydrogen peroxide or taurolidine may interact with povidone-iodine complex – therefore, their joint use is not recommended.

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

Keep out of reach of children.

Shelf life – 3 years.