Septisooth Antiseptic Gel 1 g Gel

SEPTISOOTH ANTISEPTIC GEL is a general antiseptic in the treatment of:

• Skin infections.
• Decubitus ulcers.
• Wounds, cuts and abrasions.
• Burns.
• Postoperative wounds.

Posology

FOR EXTERNAL USE ONLY. Apply SEPTISOOTH ANTISEPTIC GEL liberally to the cleaned and dried affected area. Cover with a dressing or bandage if required.

• Hypersensitivity to the povidone iodine, iodine or to any of the excipients listed in section 6.1.
• Patients with non-toxic nodular colloid goitre or on neonates.
• Pregnancy and lactation (see section 4.6).

Application to large areas of broken skin should be avoided as excessive absorption of iodine may occur.

Hypersensitivity

Hypersensitivity reactions and local irritation may occur. However, treatment should be discontinued if irritation, swelling or redness occur.

Systemic absorption

Povidone iodine as in SEPTISOOTH ANTISEPTIC GEL 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 SEPTISOOTH ANTISEPTIC GEL should be used with caution.

Renal insufficiency, neonates and infants

Special caution is needed in patients with pre-existing renal insufficiency and in neonates and infants up to 6 months of age. In such cases monitoring of thyroid function should be considered.

NOTE: Stains on synthetic fabrics may be removed by washing and rinsing in dilute ammonia.

• Lithium: Use with concurrent lithium therapy has been shown to increase the risk of (transient) hypothyroidism.
• Laboratory tests: Absorption of iodine from povidone iodine through either intact skin or broken skin may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.
• Other disinfectants and/or antiseptics: Do not mix or co-administer with disinfectants and/or antiseptics or other medicines used for the treatment of wounds.

Safety and efficacy during pregnancy and lactation have not been established. Pregnant and women who are breastfeeding should not use SEPTISOOTH ANTISEPTIC GEL (see section 4.3).

SEPTISOOTH ANTISEPTIC GEL has no or negligible influence on the ability to drive and use machines.

a. Tabulated summary of adverse reactions

b. Description of selected adverse reactions

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

Iodine associated effects Severe burns or too large areas otherwise denuded of skin may produce the systemic effects associated with iodine which may include metabolic acidosis, hypernatraemia and renal impairment.

c. Paediatric population Hypothyroidism may occur after topical application to neonates.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

With normal topical application, iodine absorption is so low that the risk of overdose can be virtually excluded. If ingested, the povidone iodine contained in SEPTISOOTH ANTISEPTIC GEL is unlikely to have any toxic effects. 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 In severe cases, treat with sodium thiosulphate 1 u2013 5 % as a specific antidote. Gastric irritation can be reduced with milk. Monitoring of the fluid and electrolyte balance could be useful. High serum iodine levels resulting from excessive use can be reduced by haemodialysis.