BETADINE*VAGINAL SOLUTION 125ML 10%

BETADINE 10% vaginal solution
Iodopovidone

What it is and what it is used for
Betadine 10% vaginal solution contains iodopovidone, a disinfectant for topical use.

Betadine 10% 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% vaginal solution
- If you are allergic to iodopovidone, or to any of the other ingredients of this medicine (listed in paragraph 6).
- If you suffer from hyperthyroidism.

Warnings and precautions
Talk to your doctor or pharmacist before using Betadine 10% vaginal solution. Betadine 10% vaginal solution is for topical use only, do not swallow.
Particular caution should be used in patients with pre-existing renal insufficiency who require regular applications of Betadine to damaged skin.

The use, especially prolonged use, of products for topical use may give rise 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 may develop following the administration of large quantities of iodine.

Consult your doctor if used for prolonged periods, especially 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 a scintigraphy or after a scintigraphy with marked iodine (thyroid function test) or in the treatment with radioactive iodine for 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 reduced to the indispensable minimum. 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.
Side effects are classified by 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 pruritus)
Very rare	Angioedema
Not known	Exfoliative dermatitis
Renal and urinary disorders
Not known	Acute kidney failure** Abnormal blood osmolarity**

*In patients with a history of thyroid disease (see paragraph "Warnings and precautions") following high iodine uptake, for example after long-term use of povidone-iodine solution for the treatment of wounds and burns on large 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.