POVIDONE-IODINE

Povidone-iodine 10% w/w Alcoholic Tincture is applied undiluted to the area to be incised and painted on thoroughly using a gauze swab. The solution may be allowed to dry to form a protective film or may be removed using a sterile gauze swab.

200ml pack size is for single use only.

Neonates:

Do not use on neonates, refer to Section

In very rare instances Povidone-iodine 10% w/w Alcoholic Tincture may produce skin reactions in iodine-sensitive subjects. These reactions subside on cessation of treatment. System Organ Class 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 data available) 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 Store.

Care should be taken with known iodine-sensitive subjects, although such people do not normally react to iodinated povidone. Povidone-iodine 10% w/w Alcoholic Tincture must not be used on broken skin because of the intense stinging caused by the alcohol present.

The application of povidone-iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia, and impairment of renal function. In neonates (pre-term and term newborn infants), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusion).

Videne Alcoholic Tincture contains the excipient macrogolglycerol hydroxystearate. This may cause skin reactions.

Children and Elderly:

There are no special dosage recommendations for children or elderly patients. 4, special warnings and precautions for use. 3 Contraindications Povidone-iodine 10% w/w Alcoholic Tincture must never be administered orally, and is contra-indicated in neonates, and during pregnancy and lactation.

Regular or prolonged use should be avoided in patients with thyroid disorders or those receiving lithium therapy. Hypersensitivity to any of the ingredients.