BETADINE Gargle and Mouth Wash is a yellow brown liquid.
The content of the product is 125 ml and 250 ml.
The active substance is Povidone-Iodine.
Excipients/Inactive Ingredients: The other excipients are Glycerol, Menthol, Methyl Salicylate, Ethanol, Saccharin Sodium, Purified Water.
BETADINE Gargle and Mouth Wash is indicated: for the symptomatic relief of inflammatory conditions of the mouth and pharynx, including stomatitis, gingivitis, aphthous ulcers, pharyngitis, tonsillitis, monilial infections, and sore throat due to common colds and influenza; as a prophylactic during and after surgery e.g. after tonsillectomy and dental procedures; for routine use to promote oral hygiene.
Always use this medicine exactly as prescribed. Patients must be advised to check with the doctor or pharmacist if they are not sure.
For Oromucosal use.
Adults, Elderly and Children over 6 years of age: Use undiluted or diluted with two parts of water.
For prophylactic use, the solution should be allowed to act in the mouth for a minimum of 30 seconds.
With existing lesions the mouth should be rinsed with the solution for two minutes, four times a day, especially after meals.
Do not swallow.
If there is no improvement of symptoms after 2-5 days of regular use of the product, patients must be advised to consult a doctor.
If the patient forgets to use BETADINE Gargle and Mouth Wash: If the patient forgets to use the medication, the patient should use it as soon as he/she remembers unless it's time for the next application. Then, the original instructions for use should be followed.
A double dose should not be taken to make up for a forgotten dose.
If the patient stops using BETADINE Gargle and Mouth Wash: The usual period of treatment (unless otherwise advised by the doctor) could last for about 14 days.
The duration of treatment is decided according to the indications of the problem. Patients must be advised regarding any further questions on the use of this medicine.
In the event of accidental or deliberate ingestion of large quantities of BETADINE Gargle and Mouth Wash, patients must be advised to immediately contact the doctor or nearest hospital.
Symptoms: Overdose can cause symptoms like metallic taste in the mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling in the eyes, breathing difficulties due to pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea. Metabolic acidosis, hypernatraemia and renal impairment may occur.
Systemic toxicity may result in renal impairment (including anuria), tachycardia, hypotension, circulatory failure, oedema of glottis resulting in asphyxia, or pulmonary oedema, seizures, fever and metabolic acidosis. Hyperthyroidism or hypothyroidism may also develop.
Therapy: Symptomatic and supportive treatment should be provided, with special attention to electrolyte balance and renal and thyroid function.
For severe hypotension, intravenous fluid should be administered; vasopressors should be added if necessary.
Endotracheal intubation may be required if caustic injury to the upper airway results in significant swelling and oedema.
Vomiting should not be induced. The patient should be maintained in a position to keep the airways open and prevent aspiration (in case of vomiting).
If the patient is not vomiting and can tolerate oral feeding, then ingestion of starchy food (e.g. potato, flour, starch, bread) may help convert iodine to less toxic iodide. If no signs of bowel perforation are present, irrigation of the stomach with starch solution via nasogastric tube may be utilized (gastric effluent will turn dark blue-purple and the colour can be used as a guide in determining when lavage can be terminated).
Haemodialysis effectively clears iodine and should be employed in severe cases of iodine poisoning particularly if renal failure is present. Continuous venovenous haemodiafiltration is less effective than haemodialysis.
In case of thyroid dysfunction, treatment with povidone-iodine should be discontinued.
BETADINE Gargle and Mouth Wash should not be used: if the patient is allergic to Povidone-Iodine or any of the other ingredients of this medicine (listed in Description); in patients hypersensitive to iodine or any other of the ingredients listed in Description; in patients with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis); in patients taking lithium; before, during and after radio-iodine administration; in patients using products containing mercury; in children under 6 years of age.
Patients must be advised before using BETADINE Gargle and Mouth Wash.
Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency.
Thyroid function tests may be affected using products containing iodine.
Contamination with Povidone-Iodine of several tests for detecting occult blood in faeces or blood in urine may produce false-positive results.
With false teeth, braces etc., the material from which they are made can sometimes become discoloured. It is therefore recommended to remove false teeth, braces etc. from the mouth before using BETADINE Gargle and Mouth Wash.
Driving and using machinery: No influence has been reported.
Use in Children: Do not use in children under 6 years of age.
If the patient is pregnant or breast-feeding, thinks that she may be pregnant or is planning to have a baby, advise the patient to ask the doctor or pharmacist for advice before taking this medicine. Povidone Iodine passes into the placenta and is secreted in breast milk. Povidone Iodine use should be avoided unless the potential benefit to the mother justifies the potential risk to the foetus and neonate or if a safer alternative is unavailable. During pregnancy and lactation, BETADINE Gargle and Mouth Wash should only be used under medical supervision.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rarely, irritation of the lining of the mouth and sensitivity reactions may occur. The long-term use of Povidone-Iodine can lead to an excessive absorption of iodine and may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.
Should the patient experienced any of the previously mentioned side effects or any other unusual effects, advise the patient to stop using the medicine and to consult a doctor or pharmacist at once.
Patients must be advised to inform the doctor or pharmacist if they are using, have recently used or might use any other medicines.
The concomitant use of wound-treatment preparations containing a so-called enzymatic component leads to a weakening of the effects of both substances. Products containing mercury, silver, hydrogen peroxide, and taurolidine may interact with povidone-iodine and should not be used concomitantly.
Simultaneous use with mercury products may lead to the formation of a substance, which can damage the mucosa.
Using this treatment may interfere with tests of thyroid function and can make a planned treatment of the thyroid with iodine impossible. After the end of the treatment 4 weeks should be allowed before a new scintigram is carried out.
Several types of tests for detecting occult (not visible) blood in faeces or blood in urine may be affected (i.e. produce false-positive results).
Povidone-iodine products when used before or after application of octenidine may lead to transient dark discolourations at the application site.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Store this product at or below 25°C, in the packaging that it comes in.
D08AG02 - povidone-iodine ; Belongs to the class of iodine product antiseptics. Used in the treatment of dermatological diseases.
Betadine Gargle & Mouthwash 1% w/v
125 mL x 1's;250 mL x 1's
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