BETADINE*VAG SOL 5FL+5F+5CAN

BETADINE 10% concentrated and solvent for vaginal solution
Iodopovidone

What it is and what it is used for
Betadine 10% concentrated and solvent for vaginal solution contains iodopovidone, an antiseptic for local use.

Betadine 10% concentrated and solvent for vaginal solution is indicated for disinfecting the vaginal mucosa (tissue lining the vagina).

What you need to know before taking the medicine
Do not use Betadine 10% concentrated and solvent for vaginal solution
If you are allergic to iodopovidone, or to any of the other ingredients of this medicine (listed in paragraph 6).
- If you are allergic to other substances that contain iodine.
- If you suffer from hyperthyroidism.

Warnings and precautions
Consult your doctor or pharmacist before using Betadine 10% concentrated and solvent for vaginal solution.
Betadine 10% concentrated and solvent for vaginal solution is for local use only, do not ingest.

The use, especially if prolonged, of products for local use can give rise to allergic reactions (see "Possible side effects" paragraph). In this case, discontinue treatment and consult your doctor who will institute appropriate therapy.
In case 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 in case of prolonged use over extensive body surfaces, particularly in children and 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.
Discontinue treatment at least 10 days before performing scintigraphy or after scintigraphy with radioactive iodine or in the treatment with radioactive iodine of thyroid carcinoma.

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

Avoid contact with eyes.

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

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The 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 disorders (see "Warnings and precautions" paragraph) following high iodine uptake, for example after long-term use of povidone-iodine 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, 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.