BETADINE 1% MOUTHWASH 200 ML BOTTLE

Name
BETADINE 1% Mouthwash
Povidone-iodine


What is it and what is it for?
Betadine 1% Mouthwash contains the active ingredient povidone-iodine, which belongs to the category of antiseptics for local use.

Betadine 1% Mouthwash is indicated for disinfecting the oral mucosa of adults and children over 6 years of age .


What you need to know before taking the medicine
Do not use Betadine 1% Mouthwash:
- 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 the administration of radioactive iodine (see section "Other medicines and Betadine 1% Mouthwash");
- if you are using products containing mercury (see section "Other medicines and Betadine 1% Mouthwash");
- if the child is under 6 years old.


Warnings and precautions
Talk to your doctor or pharmacist before using Betadine 1% Mouthwash.

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.

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

Long-term use of povidone-iodine gargles should be avoided in pregnant women, breastfeeding mothers, and people at high risk of developing thyroid dysfunction due to excessive iodine intake.

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.

Children and adolescents
In children and adolescents, the use of povidone-iodine should be kept to a minimum. 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 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)
• Aspiration pneumonia
• Electrolyte imbalance (alteration of electrolyte content)
• Metabolic acidosis (alteration of the acid-base balance of the blood)
• Exfoliative dermatitis (skin disease characterized by flaking)
• Acute renal failure
• Abnormal blood osmolarity (alteration of the concentration of substances contained in the blood)
• 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.