BETADINE*MOUTHWASH FL 200ML 1%

BETADINE 1% Mouthwash
Iodopovidone

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

Betadine 1% Mouthwash is indicated for disinfecting the oral mucosa in 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 iodopovidone, or any of the other ingredients of this medicine (listed in paragraph 6).
- If you suffer from hyperthyroidism.
- If the child is under 6 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Betadine 1% Mouthwash.
Particular caution should be used in patients with pre-existing renal insufficiency who require regular applications of Betadine on broken skin.

The use, especially prolonged use, of products for local use can lead to allergic reactions (see paragraph “Possible side effects”). In such cases, discontinue treatment and consult your doctor, who will institute appropriate therapy.
In cases of goiter, thyroid nodules, or other acute and non-acute thyroid diseases, hyperthyroidism can develop following administration of large quantities of iodine.

Consult your doctor if used for prolonged periods, particularly in children and if you suffer from thyroid disorders (a gland at the base of the neck). In this case, your doctor may prescribe specific tests (including scintigraphy) to check thyroid function.

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

Accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal, consequences.

Avoid contact with the eyes.

Long-term use of iodopovidone for gargling should be avoided in pregnant women, nursing mothers, and individuals at high risk of developing thyroid dysfunction due to excessive iodine intake.

Children and adolescents
In children and adolescents, the use of iodopovidone should be limited to the minimum necessary. Use only when strictly necessary and under medical supervision.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone 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** Metabolic acidosis**
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 diseases (see paragraph "Warnings and precautions") following high iodine uptake, for example after long-term use of iodopovidone solution for the treatment of wounds and burns on extensive 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, tell 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.