BETADINE 10% SKIN SOLUTION 10 SINGLE-USE 5ML HDPE VIALS

Name
BETADINE 10% cutaneous solution
Povidone-iodine


What is it and what is it for?
Betadine 10% cutaneous solution contains povidone-iodine, a disinfectant for local 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 parts of the body subjected to pressure for prolonged periods) 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 povidone-iodine, or to any of the other ingredients of this medicine (listed in section 6);
- if you suffer from thyroid disorders;
- before, during and after administration of radioactive iodine (see section "Other medicines and Betadine");
- if you are using products containing mercury (see section "Other medicines and Betadine");
- if the child is under 2 years old.


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 broken 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 of topical products, especially if prolonged, can cause allergic reactions (see section "Possible side effects"). In this case, discontinue treatment and consult your doctor who will initiate the appropriate therapy.
Particular caution should be used in patients with renal insufficiency who require regular applications of Betadine to broken skin.

Talk to your doctor if you have thyroid problems (a gland located at the base of the neck). In this case, your doctor may order specific tests (including a scan) to check your thyroid function. If you have a goiter, thyroid nodules, or other acute or non-acute thyroid conditions, you may develop hyperthyroidism following the administration of large amounts of iodine.

The use of povidone-iodine may 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.

Stop treatment at least 10 days before or after a scintigraphy with labelled iodine (thyroid function test) or during radioiodine treatment of thyroid cancer.

Children and adolescents
In children and adolescents, the use of povidone-iodine should be minimized, due to the greater risk of developing thyroid disorders.
Use only if clearly needed 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 rashes, small blisters and itching)

Very rare side effects (may affect up to 1 in 10,000 people)
• Allergic reactions
• Angioedema (swelling of the hands, feet, face, lips, tongue, throat)
• Hyperthyroidism (excessive thyroid activity)

Side effects with unknown frequency (frequency cannot be estimated from the available data)
• Hypothyroidism (reduced thyroid activity)
• Electrolyte imbalance (alteration of electrolyte content)
• Metabolic acidosis (alteration of the acid-base balance of the blood)
• Exfoliative dermatitis (skin disease characterized by flaking)
• Dry skin (especially after repeated applications; the risk is higher 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 experience 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.