BETADINE*CUT SOL 125ML 10%

BETADINE 10% cutaneous solution
Iodopovidone

What it is and what it is used for
Betadine 10% cutaneous solution contains iodopovidone, a disinfectant 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 sores (skin lesions affecting body parts subjected to prolonged pressure) in adults and children over 6 months 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 to any of the other ingredients of this medicine (listed in section 6).
- If you suffer from hyperthyroidism.
- If the child is under 6 months 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: the use, especially if prolonged, of products for topical use can cause allergic reactions (see section Possible side effects).
In this case, stop the treatment and consult your doctor who will establish appropriate therapy. Particular caution should be used in patients with pre-existing 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 cases of goiter, thyroid nodules or other acute and non-acute thyroid conditions, hyperthyroidism (overactive thyroid) may develop after administration of large quantities of iodine.
Stop treatment at least 10 days before undergoing scintigraphy or after scintigraphy with marked iodine (thyroid function test) or in radioactive iodine treatment for thyroid carcinoma.

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

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are classified according to their frequency:
Very common (> 1/10)
Common (> 1/100 to < 1/10)
Uncommon (> 1/1,000 to < 1/100)
Rare (> 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Not known (frequency cannot be estimated from the available data)

Immune system disorders
Rare: Hypersensitivity
Very rare: Anaphylactic reaction

Endocrine disorders
Very rare: Hyperthyroidism* (sometimes with symptoms such as tachycardia or agitation)
Not known: Hypothyroidism ***

Metabolism and nutrition disorders
Not known: Electrolyte imbalance **
Acidosis: metabolic **

Skin and subcutaneous tissue disorders
Rare: Contact dermatitis (with symptoms such as erythema, microvesicles and itching)
Very rare: Angioedema
Not known: Exfoliative dermatitis

Renal and urinary disorders
Not known: Acute renal failure **; abnormal blood osmolarity **

*In patients with a history of thyroid disorders (see Warnings and special precautions) following high iodine uptake, for example after long-term use of iodopovidone solution for the treatment of wounds and burns on extended skin areas.
**May occur following the uptake of large quantities of iodopovidone (e.g. in the treatment of burns)
***Hypothyroidism following prolonged or extensive use of iodopovidone

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.