BETADINE THROAT

Posology:

For oromucosal use only. Method of administration Adult and children aged 6 years and above: one spray onto the back of the throat or affected mouth area every 3-4 hours as needed, up to 3 sprays per day for a maximum of 7 days. Use in children between 1 year to less than 6 years of age can only be considered by healthcare professional after consideration of the patient's condition.

Administration of the dose to children should be supervised by an adult. Do not use if the tamper evident seal is broken. Instructions for Use: 1. Remove the cap from the nozzle. For a new bottle, prime the pump spray by completely pushing down the pump several times (at least 4 times).

2. Tilt the head back slightly, open the mouth and aim the nozzle towards the back of the throat or affected mouth area. Hold your breath and press the pump completely down to spray. Do not breathe in the spray. 3. After each use, wash the pump spray head under clean water and dry.

Wipe the nozzle and place the cap back after use.

The following frequencies are the basis for assessing undesirable effects: • Very common (≥ 1/10) • Common (≥ 1/100 to < 1/10) • Uncommon (≥ 1/1,000 to <1/100) • Rare (≥ 1/10,000 to < 1/1,000) • Very rare (<1/10,000) • Not known (cannot be estimated from the available data) Immune system disorders Rare Hypersensitivity Very rare Anaphylactic reaction Endocrine disorders Very rare Hyperthyroidism (sometimes with symptoms such as tachycardia or restlessness) * Unknown Hypothyroidism *** Metabolism and nutrition disorders Unknown Electrolyte imbalance **, Metabolic acidosis ** Skin and subcutaneous disorders Very rare Angioedema Respiratory, thoracic and mediastinal disorders Unknown Pneumonitis Renal and urinary disorders Unknown Acute renal failure**, Blood osmolarity abnormal** * In patients with a history of thyroid disease (see under Special Warnings and Special Precautions for Use) following a notable uptake of iodine ** May occur following uptake of large amounts of povidone iodine *** Hypothyroidism following prolonged or extensive use of povidone iodine Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In instances of local irritation or sensitivity, discontinue use. In oropharyngeal use, precautions should be taken to prevent aspiration of Betadine Throat Spray into the respiratory tract as this may cause complications such as pneumonitis.

This may particularly occur in intubated patients. This medicine contains 40 mg of alcohol (ethanol) in each dose (spray). The amount in each dose (spray) of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine should not have any noticeable effects.

Special caution is needed in pregnant and breast-feeding patients. 6). For use in the mouth and throat only.

1. - Thyroid dysfunction. - During radioiodine scintigraphy or radioiodine treatment. 5) - Products containing mercury, should not be used concomitantly due to formation of a substance which can damage the skin. - Children below the age of 1 year.