BETAISODONA Cream Ref.[49797] Active ingredients: Povidone iodine

For topical use only.

Posology

The cream can be applied once or several times daily.

Paediatric population

BETAISODONA Cream is contraindicated in children below the age of 1 year (see section 4.3).

Method of administration

Apply the cream to the affected area as required (once or several times daily).

The skin should be cleaned and dried before application.

The affected area may then be covered with a dressing or bandage if required.

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns or deliberate or accidental ingestion of large quantities of povidone-iodine may lead to a number of overdose effects: metallic taste in mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia, renal impairment up to anuria and circulatory collapse.

Systemic toxicity may result in renal impairment (including anuria), tachycardia, hypotension, circulatory failure, oedema of glottis resulting in asphyxia, or pulmonary oedema, seizures, fever and metabolic acidosis. Hyperthyroidism or hypothyroidism may also develop.

Treatment: Treatment is symptomatic and supportive. In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

For severe hypotension, intravenous fluid should be administered; vasopressors should be added if necessary.

Endotracheal intubation may be required if caustic injury to the upper airway results in significant swelling and oedema.

Vomiting should not be induced. Patient should be maintained in a position to keep the airways open and prevent aspiration (in case of vomiting).

If the patient is not vomiting and can tolerate oral feeding, then ingestion of starchy food (e.g. potato, flour, starch, bread) may help convert iodine to less toxic iodide. If no signs of bowel perforation are present, irrigation of the stomach with starch solution via nasogastric tube may be utilized (gastric effluent will turn dark blue-purple and the colour can be used as a guide in determining when lavage can be terminated).

Haemodialysis effectively clears iodine and should be employed in severe cases of iodine poisoning particularly if renal failure is present. Continuous venovenous haemodiafiltration is less effective than haemodialysis.

In case of thyroid dysfunction, treatment with povidone-iodine should be discontinued.

36 months.

Do not use after the expiry date (see date printed on the packing).

Store at or below 25°C.

Supplied in lacquered aluminium tubes, containing 5g, 15g or 40g of the product.

The tubes are enclosed in printed cartons.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.