BETADINE*10VAG TB 200MG

BETADINE 0.2 g vaginal tablets
Iodopovidone

What it is and what it is used for
Betadine 0.2 g vaginal tablets contain iodopovidone, a disinfectant for local use.

Betadine 0.2 g vaginal tablets are indicated for disinfecting the vaginal mucosa (the tissue lining the vagina).

What you need to know before taking the medicine
Do not use Betadine 0.2 g vaginal tablets
If you are allergic to iodopovidone, or to any of the other ingredients of this medicine (listed in section 6).
- If you suffer from hyperthyroidism.

Warnings and precautions
Talk to your doctor or pharmacist before using Betadine 0.2 g vaginal tablets.
Betadine 0.2 g vaginal tablets are for local use only, do not swallow.
Particular caution should be exercised in patients with pre-existing renal insufficiency who require regular applications of Betadine to broken skin.
The use, especially prolonged use, of products for local use may give rise to allergic reactions (see section "Possible side effects"). In such a case, discontinue treatment and consult your doctor, who will institute appropriate therapy.
In cases of goiter, thyroid nodules or other acute and non-acute thyroid conditions, hyperthyroidism (overactive thyroid) may develop as a result of administering large amounts of iodine.
Consult your doctor if you use it for prolonged periods, especially 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 undergoing scintigraphy or after scintigraphy with marked iodine (thyroid function test) or in the treatment of thyroid carcinoma with radioactive iodine.

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 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 everybody 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

Kidney and urinary disorders

Not known: Acute renal failure **, Abnormal blood osmolarity **

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