This information is intended for use by health professionals

1. Name of the medicinal product

Savlon® Dry

Savlon Dry Antiseptic*

*Alternative name also applies throughout text

2. Qualitative and quantitative composition

Povidone Iodine 1.14% w/w

For excipients, see 6.1.

3. Pharmaceutical form

Cutaneous Spray, Powder

4. Clinical particulars
4.1 Therapeutic indications

Savlon Dry is a broad spectrum antiseptic for topical application in the treatment and prevention of infection in wounds. May be used in first aid for minor cuts, grazes, burns, abrasions and blisters.

4.2 Posology and method of administration

Shake the can before use and spray the treatment area from a distance of 6-9 inches (15-22cm) until a light dusting of powder is deposited. Savlon Dry should be used directly from the aerosol container.

Adults:

The recommended usual maximum daily adult application for regular use on broken skin is 150mg available iodine.

Children and elderly patients:

There are no special dosage recommendations for either elderly patients or children. However, povidone-iodine is not recommended for regular use in neonates and is contra-indicated in very low birth weight infants (below 1500g).

4.3 Contraindications

Savlon Dry is contraindicated in patients with:

• Hypersensitivity to povidone-iodine or to any of the excipients

• Thyroid disorders, in particular overactive thyroid (hyperthyroidism), nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis.

• Scheduled radioiodine therapy

Savlon Dry must not be used in deep wounds or in clean surgical wounds.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

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.

4.6 Fertility, pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

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.

4.9 Overdose

With normal topical application, iodine absorption is so low that the risk of overdose can be virtually excluded.

The amount of povidone-iodine contained in one aerosol can of Savlon Dry is unlikely to have any toxic effects if ingested.

Iodine ingested in large amounts can produce goitre and hypothyroidism as well as hyperthyroidism and may lead to a range of adverse effects, often called iodism, such as metallic taste, vomiting, abdominal pain or bloody diarrhoea, although some of the effects may be due to hypersensitivity.

Treatment of iodine poisoning consists of gastric lavage with a starch solution (15 g starch or flour in 500 ml water); in severe cases, with sodium thiosulphate 1 - 5% as a specific antidote. Gastric irritation can be reduced with milk. Monitoring of the fluid and electrolyte balance should be useful.

High serum iodine levels resulting from excessive use can be reduced by haemodialysis.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antiseptic and disinfectant

ATC code: D08AG02

Povidone-iodine is an antiseptic which liberates iodine in contact with the skin.

Povidone iodine is a broad spectrum anti-microbial agent with activity against a wide variety of bacteria, including acid fast bacilli and bacterial spores. It is also active against fungi, a wide range of viruses and protozoa.

5.2 Pharmacokinetic properties

Povidone-iodine administered clinically via any route can result in systemic absorption of iodine. The amount of absorbed iodine will vary according to the concentration of the povidone-iodine preparation used, the number of applications and the route of administration. Whilst absorption of iodine may occur following topical administration of all povidone-iodine preparations, the effects are dose related. In view of the fact that a 10 second burst will deliver only 7mg of available iodine, the levels of iodine likely to be absorbed following administration of Savlon Dry will be exceedingly small and the effects on the internal organs minimal.

Any increase in the blood iodine level is generally transient. In patients with a healthy thyroid, the increased iodine level does not lead to any clinically relevant changes in thyroid hormone status. When iodine metabolism is normal, increased amounts of iodine are excreted via the kidneys.

5.3 Preclinical safety data

There are no findings in the preclinical testing which are of relevance to the prescriber.

6. Pharmaceutical particulars
6.1 List of excipients

Povidone

N-Pentane

Soya lecithin

Butane 40

6.2 Incompatibilities

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

6.3 Shelf life

3 years

6.4 Special precautions for storage

PRESSURISED CONTAINER: Protect from sunlight.

DO NOT - expose to temperatures exceeding 50°C

- pierce or burn, even after use

- spray on a naked flame or any incandescent material

- apply while you are smoking.

Keep away from sources of ignition.

Do not store above 25°C

6.5 Nature and contents of container

Monobloc aluminium aerosol container, internally lacquered, containing micronised powder and propellants under pressure and fitted with a valve and actuator and transparent yellow polypropylene overcap.

6.6 Special precautions for disposal and other handling

Medicines should be kept out of the reach of children.

7. Marketing authorisation holder

Novartis Consumer Health UK Ltd

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey

GU15 3YL

Trading style: Novartis Consumer Health

8. Marketing authorisation number(s)

PL 00030/0124

9. Date of first authorisation/renewal of the authorisation

15 April 1998

10. Date of revision of the text

6th May 2014

Legal category

GSL