BETADINE*SOLUTION CUT FL 500ML 10%

BETADINE 10% cutaneous solution
Iodopovidone

What it is and what it is used for
Betadine 10% cutaneous solution contains iodopovidone, an antiseptic for topical use.

Betadine 10% cutaneous solution is indicated for the cleansing and disinfection of minor skin lesions such as small superficial wounds and minor pressure ulcers (skin lesions affecting body parts subjected to prolonged pressure) in adults and children over 2 years of age.

What you need to know before taking the medicine
Do not use Betadine 10% cutaneous solution:
- if you are allergic to iodopovidone, or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from thyroid disorders;
- before, during and after the administration of radioactive iodine (see section Other medicines and Betadine);
- if you are using mercury-containing products (see section Other medicines and Betadine);
- if the child is under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Betadine 10% cutaneous solution.
Betadine 10% cutaneous solution is for external use only and should not be applied to severely damaged skin or large areas.
Accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal, consequences.

Avoid contact with eyes.

Do not use this medicine for prolonged treatments: use, especially if prolonged, of topical products can cause allergic reactions (see section Possible side effects). In this case, stop treatment and consult your doctor, who will institute appropriate therapy.
Particular caution should be used in patients with renal insufficiency who require regular applications of Betadine to damaged skin.

Talk to your doctor if you suffer from thyroid disorders (a gland located at the base of the neck). In this case, your doctor may prescribe specific tests (including scintigraphy) to check thyroid function.
In the case of goiter, thyroid nodules or other acute and non-acute thyroid diseases, hyperthyroidism (overactive thyroid) may develop after administration of large quantities of iodine.

The use of iodopovidone can lead to temporary discoloration of the skin at the application site caused by the color of the medicine itself.

Avoid contact with jewelry, especially items containing silver.

Discontinue treatment at least 10 days before performing a scintigraphy or after a scintigraphy with marked iodine (thyroid function test) or in the treatment of thyroid carcinoma with radioactive iodine.

Children and adolescents
In children and adolescents, the use of iodopovidone should be minimized due to the higher risk of developing thyroid alterations.
Use only when strictly necessary and under medical supervision.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects (may affect up to 1 in 1,000 people):
• hypersensitivity;
• contact dermatitis (with skin rashes, small blisters and itching).

Very rare side effects (may affect up to 1 in 10,000 people):
• allergic reactions;
• angioedema (swelling of hands, feet, face, lips, tongue, throat);
• hyperthyroidism (overactive thyroid).

Side effects with unknown frequency (frequency cannot be estimated from available data):
• hypothyroidism (underactive thyroid);
• electrolyte imbalance (alteration of electrolyte content);
• metabolic acidosis (alteration of blood acid-base balance);
• exfoliative dermatitis (skin disease characterized by desquamation);
• dry skin (especially after repeated applications; the risk is greater for the genital area);
• skin discoloration;
• acute renal failure;
• abnormal blood osmolarity (alteration of the concentration of substances contained in the blood);
• contact burn;
• heat burn.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.