VIDENE ALCOHOLIC TINCTURE

Videne 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 Videne 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) Skin and Subcutaneous Tissue Disorders Skin irritation 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.

Care should be taken with known iodine-sensitive subjects, although such people do not normally react to iodinated povidone. Videne 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.

3.

Children and Elderly:

There are no special dosage recommendations for children or elderly patients. 4. 3 Contraindications Videne 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.