Septadine Oral Antiseptic 100 ml Solution

SEPTADINE u00ae ORAL ANTISEPTIC (SOLUTION)

Each 100 ml contains: Povidone-Iodine 1,00 g (1 % m/v ) equivalent to 0,1 % m/v available iodine. Contains 8,5 % v/v alcohol Sugar free, artificially sweetened. For full list of excipients, see section 6.1

Solution SEPTADINE u00ae ORAL ANTISEPTIC is a clear dar k - brown aqueous solution with a characteristic iodine smell, and a pleasant flavour.

4.1. Therapeutic indications
SEPTADINE u00ae ORAL ANTISEPTIC is recommended for relief of painful infections and inflammatory conditions of the mouth and pharynx, and as a routine mouthwash. Aphthous ulcers, gingivitis, stomatitis and pharyngitis due to superficial infections. Prophylaxis during and after oral surgery.

4.2 Posology and method of administration
As a mouthwash: Dilute one part of SEPTADINE u00ae 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 SEPTADINE u00ae ORAL ANTISEPTIC with three parts water and paint the mouth with the aid of a cotton-bud.

4.3 Contraindications
u2022 Hypersensitivity to Povidone-Iodine, or to any of the excipients in listed in section 6.1.
u2022 Patients with non-toxic nodular colloid goiter should not use Povidone-Iodine.
u2022 Not to be used in pregnancy or by lactating women.
u2022 Patients with hyperfunction of the thyroid (hyperthyroidism), other manifested thyroid diseases (thyroid disorder) should not use Povidone-Iodine.

4.4 Special warnings and precautions for use
Certain individuals may become sensitized to povidone-iodine. 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. Regular or prolonged use should be avoided in patients with thyroid disorders.

4.5 Interaction with other medicines and other forms of interaction
Absorption of iodine from SEPTADINE u00ae ORAL ANTISEPTIC may interfere with thyroid function tests and can make a planned treatment of the thyroid with iodine (radioidone 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.

4.6 Fertility, pregnancy and lactation
Not to be used in pregnancy or by lactating women.

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

4.8 Undesirable Effects
System Organ Class Frequency Unknown
Nervous system disorders Headache
Gastrointestinal disorders Nausea, vomiting
General disorders and administration site conditions irritation, swelling, redness
Skin and subcutaneous tissue disorders Hypersensitivity and local irritation may occur, for example urticaria, pruritus, erythema, small blisters, angioedema, or similar manifestations.
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 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

4.9 Overdose
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. Lavage may be attempted if there is no oesophageal damage. A doctor should be consulted without delay. Treatment is symptomatic and supportive.

Category and class: A 16.4 Naso-,Bucco-pharyngeal Antiseptics
Pharmacotherapeutic group: antiseptic and disinfectant
ATC code: D08AG02
Povidone-iodine is a multivalent broad spectrum local disinfectant. 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.

6.1 List of excipients
u2022 Anhydrous disodium hydrogen phosphate
u2022 Citric acid anhydrous
u2022 Ethanol
u2022 Polyethylene glycol 400
u2022 Purified water
u2022 Saccharin sodium

6.2 Incompatibilities
Not applicable

6.3 Shelf life
24 Months

6.4 Special precautions for storage
Store at or below 25 o C and protect from light.

6.5 Nature and contents of container
Bottles of 200 ml and 2,5 litres

6.6 Special precautions for disposal and other handling
Return all unused or expired medicines to your pharmacist for safe disposal. Do not dispose of unused medicines in drains or sewage systems (e.g. toilets)

Ranbaxy Pharmaceuticals (Pty) Ltd
14 Lautre Road
Stormill Ext. 1
Roodepoort 1724
South Africa

28/16.4/0650 (S.A.)

19 January 1995

24 August 2022
NSO 04/16.4/1620 (Namibia) 200ml
GS 168/016(Zambia) 200 ml