Betadine Surgical Scrub

An antiseptic for the pre-procedural and post-procedural treatment of the skin.

Posology

Paediatric population

BETADINE u00ae SURGICAL SCRUB is contraindicated in children below the age of 2 years (see section 4.3).

Apply for a maximum of 14 consecutive days up to 5 ml up to twice a day for adults and once a day for children aged 2 years or older. Rinse off with water after application.

Method of administration

For topical administration only. NOT FOR ORAL USE. Apply up to 5 ml for surgical handwashing and for pre-operative scrubbing. Rinse off under running water.

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Thyroid dysfunction or goitre (in particular nodular colloid goitre, endemic goitre and Hashimotou2019s thyroiditis).
• During radioiodine scintigraphy or radioiodine treatment of thyroid diseases.
• Products containing mercury, should not be used concomitantly due to formation of a substance which can damage the skin.
• Children below the age of 2 years.
• Patients on concurrent lithium therapy.

In pre-operative preparation, avoid pooling beneath the patient. Prolonged exposure to wet solution may cause irritation or rarely, severe skin reactions. Chemical burns of skin due to pooling may occur.

In instances of skin irritation, contact dermatitis or hypersensitivity, discontinue use.

Do not heat prior to application.

Povidone iodine use could lead to transient skin discolouration at the application site. It may permanently discolour white gold jewellery and it is recommended that this type of jewellery be removed before using BETADINE u00ae SURGICAL SCRUB.

For external use only.

Paediatric population

BETADINE u00ae SURGICAL SCRUB should not be used in children under 2 years of age and its application in children (2 years or above) must be performed by an adult.

The PVP-iodine complex is effective at pH values of between 2.0 and 7.0. It has to be expected that the complex will react with protein and other unsaturated organic compounds, leading to impairment of its effectiveness.

The concomitant use of wound-treatment preparations containing enzymatic components leads to a weakening of the effects of both substances.

Products containing silver, hydrogen peroxide, and taurolidine may interact with povidone-iodine.

Povidone iodine products when used concomitantly or immediately after application of octenidine containing antiseptics in the same or adjacent sites may lead to transient dark discolouration in the areas involved.

Due to the oxidative effect of povidone-iodine preparations various diagnostic agents can show false-positive lab results (e.g., tests with toluidine or gum guaiac for the determination of haemoglobin or glucose in the stool or the urine).

Absorption of iodine from povidone-iodine products may lower the iodine uptake of the thyroid. This can lead to interference with various investigations (thyroid scintigraphy, determination of protein-bound iodine (PBI), radioiodine diagnostics) and can interfere with treatment of the thyroid with iodine (radioiodine therapy).

After the end of the treatment, an appropriate interval should be allowed before a new scintigram is carried out.

Povidone-iodine passes into the placenta and is secreted in breast milk. Thyroid function disorders including congenital hypothyroidism have been reported in the offspring of mothers who have received Iodine. Povidone-iodine use should be avoided.

Fertility

No data is available.

BETADINE u00ae SURGICAL SCRUB has no influence on the ability to drive and use machines.

Immune system disorders

Less frequent: Hypersensitivity, anaphylactic reaction

Endocrine disorders

Less frequent: Hyperthyroidism (sometimes with symptoms such as tachycardia or restlessness) *

Frequency unknown: Hypothyroidism ***

Metabolism and nutrition disorders

Frequency unknown: Electrolyte imbalance **, metabolic acidosis **

Skin and subcutaneous tissue disorders

Less frequent: Contact dermatitis (with symptoms such as erythema, small blisters and pruritus), angioedema

Renal and urinary disorders

Frequency unknown: Acute renal failure**, Blood osmolarity abnormal **

Injury, poisoning and procedural complications

Frequency unknown: Chemical burn of skin ****

* In patients with a history of thyroid disease (see Section 4.4) following a notable uptake of iodine e.g. following long term use of povidone u2013 iodine solution for the treatment of wounds and burns over extensive areas of the skin

** May occur following uptake of large amounts of povidone-iodine (e.g. in the treatment of burns)

*** Hypothyroidism following prolonged or extensive use of povidone iodine

**** May occur due to u201cpoolingu201d beneath the patient in pre-operative preparation

Reporting 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. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. Alternatively report to: [email protected]

Systemic toxicity may result in renal impairment (including anuria), metabolic acidosis, acute respiratory distress and congestive heart failure. In the case of deliberate or accidental ingestion of large quantities of povidone-iodine the following may manifest: oesophagitis, gastritis, chemical pulmonary oedema, transient hyperthyroidism, haemolytic anaemia, acute tubular necrosis and several acid-base disturbances. Hyperthyroidism or hypothyroidism may also develop. Treatment is symptomatic and supportive.