BETADINE Throat Spray is a smooth yellowish-brown liquid.
The content of the product is 50 ml.
The active substance is povidone-iodine Ph Eur 0.45%w/v.
Excipients/Inactive Ingredients: The other excipients are Glycerol, Menthol, Eucalyptus Oil, Ethanol, Potassium Iodide, Purified Water.
BETADINE Throat Spray is used for the symptomatic relief of acute mucosal infections of the mouth and pharynx, and sore throat due to common cold and influenza.
For oral hygiene prior to, during and after dental and oral surgery.
Always use this medicine exactly as described in leaflet or as prescribed. Patients must be advised to check with the doctor or pharmacist if they are not sure.
Use in adults, elderly and children over 6 years of age: Topical use.
Spray to the mucous membrane of the throat several times a day (every 3-4 hours) or as directed by the doctor or dentist.
If the patient forgets to use BETADINE Throat Spray: 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 used to make up for a forgotten dose.
If the patient stops using BETADINE Throat Spray: 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 Throat Spray, patients must be advised to immediately contact the doctor or nearest hospital.
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 up to anuria and circulatory collapse. 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. 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 Throat Spray should not be used: If the patient is allergic to iodine or any of the other ingredients of this medicine (listed in Description); In patients hypersensitive to the active substance(s) or to any of the excipients listed in Description; If the patient suffers with hyperthyroidism or other acute thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis); If the patient is taking lithium; Do not use in children under 6 years of age; Before, during and after radio-iodine administration; In patients using products containing mercury.
Patients must be advised before using BETADINE Throat Spray.
Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency.
Patients with goitre, thyroid nodules, or other non-acute thyroid diseases are at risk of developing hyperthyroidism. In this patient population, BETADINE Throat Spray should not be used for extended period (e.g. not for longer than 14 days) unless strictly indicated. Even after the end of the treatment (up to 3 months) one should look for the early symptoms of possible hyperthyroidism and if necessary the thyroid function should be monitored.
BETADINE Throat Spray should not be used prior to or after radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma.
Do not heat prior to application.
Driving and using machines: No such 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 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 Throat Spray should only be used if strictly indicated and its use should be kept to the absolute minimum.
Fertility: There are limited human fertility data for Povidone iodine. No data are available on fertility outcomes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (affecting >1% of people using BETADINE Throat Spray): None stated.
Uncommon side effects (affecting <1% of people using BETADINE Throat Spray): Immune system disorders: Hypersensitivity, Anaphylactic reaction.
Endocrine disorders: Hyperthyroidism (sometimes with symptoms such as tachycardia or restlessness).
Skin and subcutaneous disorders: Contact dermatitis (with symptoms such as erythema, small blisters and pruritus), Angioedema.
Frequency not known but may also occur: Endocrine disorders: Hypothyroidism.
Metabolism and nutrition disorders: Electrolyte imbalance, Metabolic acidosis.
Renal and urinary disorders: Acute renal failure, Blood osmolarity abnormal.
Injury, poisoning and procedural complications: Chemical burn of skin.
Patients must be advised to inform the doctor or pharmacist if they are using, have recently used or might use any other medicines.
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 effect 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.
Absorption of iodine from BETADINE Throat Spray may interfere with thyroid function tests or radioiodine therapy 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), due to the oxidative effect of povidone-iodine.
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 30°C, in the packaging that it comes in.
R02AA15 - povidone-iodine ; Belongs to the class of antiseptics used in throat preparations.
Betadine Throat Spray 0.45% w/v
50 mL x 1's
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