BETADINE

Posology:

Adults and Children over 2 years of age: Clean the wound. Shake the can well in inverted orientation for 5 seconds before each use. Spray evenly onto the wound area for three (3) seconds from a distance of 15 cm (6 inches). If necessary, cover with a dressing.

Apply the spray once or twice a day for up to 7 consecutive days.

Recommended Cleaning After Each Use:

Clean the nozzle after each use with a fresh dry wipe. In infants and children 1-2 years of age, Betadine Cutaneous spray, powder should only be used after evaluation of risks and benefits by healthcare professional. Spray in a well-ventilated area.

Caution: do not inhale the spray and do not spray into the eyes or on areas around the eyes. Method of administration Do not use if the tamper evident seal is broken. Betadine Cutaneous spray, powder is intended for external use only.

The following frequencies are the basis for assessing undesirable effects:

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 (cannot be estimated from the available data) Within each frequency grouping adverse effects are listed in the sequence of decreasing severity.

Immune system disorders Rare Hypersensitivity Very rare Anaphylactic reaction Endocrine disorders Very rare Hyperthyroidism (sometimes with symptoms such as tachycardia or restlessness) * Unknown Hypothyroidism *** Metabolism and nutrition disorders Unknown Electrolyte imbalance ** Metabolic acidosis ** Skin and subcutaneous disorders Rare Contact dermatitis (with symptoms such as erythema, small blisters and pruritus) Very rare Angioedema Unknown Dermatitis exfoliative, Dry skin Renal and urinary disorders Unknown Acute renal failure**, Blood osmolarity abnormal ** * In patients with a history of thyroid disease (see under Special Warnings and Special Precautions for Use) following a notable uptake of iodine ** May occur following uptake of large amounts of povidone iodine *** Hypothyroidism following prolonged or extensive use of povidone iodine Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In instance of skin irritation, contact dermatitis or hypersensitivity discontinue use. Betadine Cutaneous spray, powder is not intended for oral use. Special caution is needed in pregnant and breast-feeding women. 6). Do not smoke or go near naked flames or heat sources when using the product.

The propellant gases are flammable, keep away from heat, hot surfaces, sparks, open flames. Electrocautery should only be used after spray mist has completely vanished.

1. • Thyroid dysfunction. • During radioiodine scintigraphy or radioiodine treatment. 5). • Products containing mercury should not be used concomitantly due to formation of a substance which can damage the skin. • Children below the age of 1 year.