Betadine ® Throat 0,45 % Solution

BETADINE ® THROAT SPRAY is indicated for :

• the treatment of acute mucosal infections of the mouth and pharynx including stomatitis, gingivitis, aphthous ulcers, pharyngitis, tonsillitis, monilial infections, common colds and influenza.
• oral hygiene prior, during and after dental and oral surgery, e.g. after tonsillectomy and dental procedures.

Contraindications

• Hypersensitivity to iodine or povidone or to any of the excipients listed in section 6.1.
• Not to be used in hyperfunction of the thyroid (hyperthyroidism) or other manifest thyroid diseases.
• Not to be used 4 weeks before, during or 4 weeks after radioiodine administration (see section 4.4 Special warning and precautions).
• Not to be used in patients on concurrent lithium therapy.
• Children under 6 years of age.

Special warnings and precautions for use

Patients with goiter, thyroid nodules, or other non-acute thyroid diseases are at risk of developing hyperthyroidism from the administration of large amounts of iodine. In this patient population povidone-iodine should not be used for an extended period of time (e.g., for no 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. It should not be used prior to or after radioiodine scintigraphy or radioidine treatment of thyroid carcinoma until a lasting cure has been obtained. After the end of the treatment, 4 weeks should be allowed before a new scintigram or radioiodine treatment is carried out (see section 4.3). 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. Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Newborns and small infants are at increased risk of developing hypothyroidism from the administration of large amounts of iodine. Because of their increased sensitivity to iodine, the use of povidone-iodine should be kept to the absolute minimum in newborns and small infants. A check of the child’s thyroid function (e.g. T4 levels and TSH levels) may be necessary. Any possible oral ingestion of the product by the infant must be absolutely avoided. In instances of local irritation or sensitivity, discontinue use. BETADINE ® THROAT SPRAY 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 BETADINE ® THROAT SPRAY will not have any noticeable effects. Flammable, contains alcohol: keep away from open flames or heat. Do not heat prior to application. For mouth and throat only.

Method of administration

Adult and children aged 6 years and above: one spray onto the back of the throat or affected area every 3 – 4 hours as needed, up to 3 sprays per day for a maximum of 7 days.

1. Remove the cap from the nozzle.
2. Please note that the pump has to be completely pushed down before spraying.
3. Tilt your head back slightly, open your mouth and aim the nozzle towards the back of the throat.
4. Hold your breath and press the pump down to spray. Do not breathe in the spray.
5. Wipe the nozzle and place the cap back after use.

Undesirable effects

Respiratory, thoracic and mediastinal disorders

Frequency unknown: Pneumonitis

Immune system disorders

Less frequent: Hypersensitivity, anaphylactic reaction

Endocrine disorders

Less frequent: Hyperthyroidism (sometimes with symptoms such as tachycardia or restlessness)

Frequency unknown: Hypothyroidism

Metabolism and nutrition disorders

Frequency unknown: Electrolyte imbalance *, metabolic acidosis *

Skin and subcutaneous tissue disorders

Less frequent: Contact dermatitis (with symptoms such as urticaria, erythema, small blisters and pruritus), angioedema

Renal and urinary disorders

Frequency unknown: Acute renal failure*, Blood osmolarity abnormal *

Injury, poisoning and procedural complications

Frequency unknown: Chemical burn of skin

* May occur following uptake of large amounts of povidone-iodine (e.g. in the treatment of burns)

** Hypothyroidism following prolonged or extensive use of povidone-iodine

Special precautions for storage

Store at or below 30 °C. Flammable. Keep away from open flames or heat. KEEP OUT OF THE REACH OF CHILDREN.

Shelf life

3 years. Do not use this medicine after the expiry date indicated on the container. The product can be stored for 3 months after opening.