COMPOSITION: Each 100 mL contains Mundidone* brand of povidone-iodine 1,00 g (1% m/v) equivalent to 0,1% m/v available iodine. Contains 8,5% v/v alcohol.
PHARMACOLOGICAL CLASSIFICATION: A 16.4 Naso-, Bucco-pharyngeal antiseptics.
PHARMACOLOGICAL ACTION: Povidone-iodine is a multivalent broad spectrum local antiseptic having bactericidal and fungicidal properties. The effect on vegetative cells of various bacteria and fungi is due to the liberation of free iodine from the complex. Many viruses, protozoa, yeasts, cysts and spores are also susceptible.
BETADINE* 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. Prophylaxis during and after oral surgery.
CONTRA-INDICATIONS: Sensitivity to povidone-iodine. Patients with non-toxic nodular colloid goitre or patients with a history of thyroid disease should not use povidone-iodine.
Not to be used by persons who are allergic to iodine.
Not to be used in pregnancy or by lactating women.
DOSAGE AND DIRECTIONS FOR USE:
As a mouthwash: Dilute one part of BETADINE* ORAL ANTISEPTIC with two parts of water, rinse mouth thoroughly and spit out, or use as directed by physician or dentist. For infections of mouth and throat: Use full strength and rinse or gargle for 30 seconds then spit out, repeat hourly, or as directed by physician or dentist. For children under 3 years: Dilute one part BETADINE* ORAL ANTISEPTIC with three parts water and paint the mouth with the aid of a cotton-bud.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Certain individuals may become sensitised to povidone-iodine. Hypersensitivity reactions may include urticaria, angio-oedema, cutaneous haemorrhage or purpuras, fever, arthralgia, lymphadenopathy and eosinophilia. If irritation, swelling or redness occurs, discontinue treatment and consult your physician. If severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea and vomiting occur, consult your physician promptly as these symptoms may indicate a serious condition. Absorption of povidone-iodine may interfere with thyroid function tests.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Should ingestion 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. Lavage may be attempted if there is no oesophageal damage. The patient should be taken to a doctor without delay and treatment should be symptomatic and supportive.
BETADINE* ORAL ANTISEPTIC is a clear dark-brown solution with a characteristic menthol odour and taste.
PRESENTATION: Bottles of 200 mL.
STORAGE INSTRUCTIONS: Store below 25°C. KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: C/16.4/142
NAME AND BUSINESS ADDRESS OF THE APPLICANT: ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Private Bag X69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT: March 1996
Under licence from: Mundipharma AG, Switzerland
New addition to this site: April 2004
Source: Pharmaceutical Industry