Dermadine Oral Antiseptic 100 ml Solution.

DERMADINE ORAL ANTISEPTIC is recommended for relief of painful infections and inflammatory conditions of the mouth and pharynx and as a routine mouthwash.

Infections: Aphthous ulcers, gingivitis, stomatitis and pharyngitis due to superficial infections. It is also recommended for use prophylactically during and after oral surgery.

DERMADINE ORAL ANTISEPTIC should not be swallowed.

As a mouthwash: Dilute one part of DERMADINE ORAL ANTISEPTIC with two parts of water, rinse mouth thoroughly and spit out, or use as directed by doctor or dentist.

For infections of mouth and throat: Use full strength and rinse or gargle for thirty seconds then spit out, repeat hourly, or as directed by doctor or dentist.

Paediatric population

For children under 3 years: Dilute one part DERMADINE ORAL ANTISEPTIC with three parts water and paint the mouth with the aid of a cotton bud.

DERMADINE ORAL ANTISEPTIC is contraindicated in:

• patients with known hypersensitivity to povidone-iodine or to any of the excipients used in the formulation of DERMADINE ORAL ANTISEPTIC (see section 6.1).
• patients with non-toxic nodular colloid goitre should not use povidone-iodine.
• pregnant or lactating women.
• patients with hyperfunction of the thyroid (hyperthyroidism), other manifested thyroid diseases (thyroid disorder) should not use povidone-Iodine.

Certain individuals may become sensitized to povidone-iodine. If irritation, swelling or redness occurs, discontinue treatment and consult your doctor. If severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea and vomiting occur, consult your doctor promptly as these symptoms may indicate a serious condition. Absorption of povidone-iodine may interfere with thyroid function tests. Regular or prolonged use should be avoided in patients with thyroid disorders.

Absorption of iodine from DERMADINE ORAL ANTISEPTIC may interfere with thyroid function tests and can make a planned treatment of the thyroid with iodine (radioiodine therapy) impossible. After the end of the treatment an appropriate interval should be allowed before a new scintigram is carried out.

Regular or prolonged use should be avoided in patients receiving concomitant lithium therapy.

Pregnancy: Not to be used in pregnancy.

Breastfeeding: Not to be used during breastfeeding.

The effects on ability to drive and use machines has not been established.

System Organ Class Frequency unknown

• Nervous system disorders: Headache
• Gastrointestinal disorders: Nausea, vomiting
• Skin and subcutaneous tissue disorders: Hypersensitivity and local irritation may occur, for example urticaria, pruritus, erythema, small blisters, angioedema, or similar manifestations.
• General disorders and administration site conditions: Irritation, swelling, redness
• Investigations: Interference with thyroid function tests.

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. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website, or to Cipla Medpro (Pty) Ltd. by email: [email protected] or telephone: 080 222 6662 (toll free).

Should ingestion occur, systemic effects such as metabolic acidosis, hypernatraemia and renal impairment may occur. Symptoms of acute poisoning are a disagreeable metallic taste, vomiting, abdominal pain and diarrhoea. Anuria may occur 1 to 3 days later; death may be due to circulatory failure, oedema of the glottis resulting in asphyxia, aspiration pneumonia or pulmonary oedema. Oesophageal stricture may occur if the patient survives the acute stage. For treatment of acute poisoning, supply patient with draughts of milk and starch mucilage. A doctor should be consulted without delay. Treatment is symptomatic and supportive.