SAVLON DRY Cutaneous spray, powder Ref.[7985] Active ingredients: Cetrimide Chlorhexidine Povidone iodine

Avoid application of povidone-iodine into the eyes and nose. Care must be taken when Savlon Dry is used on known iodine sensitive subjects, although these do not normally react to povidone-iodine.

Povidone-iodine can be absorbed systemically during the topical treatment of burns and large areas of broken skin. The degree of absorption is proportional to the depth and extent of the burn or broken skin.

Prolonged treatment with povidone-iodine of patients with severe and extensive burns may cause metabolic acidosis, hypernatraemia and renal impairment. In patients at risk Savlon Dry should be used with caution.

Special caution is needed in patients with pre-existing renal insufficiency and in neonates and infants up to 6 months of age, pregnant and breast-feeding women. In such cases benefit/risk assessment should be performed and monitoring of thyroid function should be considered.

Absorption of iodine from povidone-iodine may interfere with thyroid function tests by causing an increase in protein bound iodine levels. Contamination with povidone-iodine of several types of tests for the detection of occult blood in urine may produce false positive results.

Do not mix or co-administer with disinfectants and/or antiseptics or other agents used for the treatment of wounds.

There is a risk of (transient) hypothyroidism after regular or prolonged use in patients on concomitant lithium therapy.

Pregnancy and breastfeeding

Limited data is available on the use of this product in pregnant women. Excessive use of povidone-iodine should be avoided in pregnant or lactating women because absorbed iodine can cross the placental barrier and is secreted in breast milk.

Under these circumstances, povidone-iodine should only be administered if clearly necessary.

Fertility

No data is available on fertility outcomes.

Povidone-iodine has no or negligible influence on the ability to drive and use machines.

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: 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) or unknown (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Immune system disorders

Rare: Hypersensitivity

Very rare: Anaphylactic reaction

Endocrine disorders

Very rare: Hyperthyroidism

Metabolism and nutrition disorders

Unknown: Metabolic acidosis, hypernatraemia

Skin and subcutaneous tissue disorders

Rare: Skin reaction localised

Renal and urinary disorders

Unknown: Renal impairment

Povidone-iodine may produce local skin reactions although it is considered to be less irritant than iodine.

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.

Alkali will reduce the anti-microbial activity of povidone-iodine.