OROEZE

Posology Adults and elderly:

Rinse or gargle with 15 ml (approximately 1 tablespoonful) every 1½ to 3 hours as required for pain relief. The solution should be expelled from the mouth after use. 15% w/v Mouthwash should generally be used undiluted, but if ‘stinging’ occurs the rinse may be diluted with water.

Uninterrupted treatment should not exceed seven days, except under medical supervision. 15% w/v Mouthwash should not be used in children aged 12 years or under. Method of administration Oromucosal administration.

Adverse events are listed by System Organ Class:

Frequencies are defined using the following convention: Very common (>1/10), Common (>1/100, <1/10), Uncommon (>1/1000, <1/100), Rare (>1/10000, <1/1000), Very rare (<1/10000), Not known (cannot be estimated from available data). The most common side effects are numbness and a stinging feeling in the mouth.

System organ class Frequency Undesirable effects Immune system disorders Not known Anaphylactic reaction which can be potentially life-threatening and hypersensitivity reactionsi Respiratory, thoracic and mediastinal disorders Very rare Laryngospasm or bronchospasm Gastrointestinal disorders Uncommon Oral numbness (hypothesia) and a stinging feeling in the mouth (oral pain) Very rare Hypersensitivity reactions which may be associated with pruritus, urticaria, photosensitivity reaction and rash Skin and subcutaneous tissue disorders Not known Angiodema i) Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisations 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.

Benzydamine use is not advisable in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs Caution should be exercised in patients suffering from or with a previous history of bronchial asthma. 15% w/v Mouthwash should generally be used undiluted, but if ‘stinging’ occurs the rinse may be diluted with water.

Avoid contact with eyes. 15% w/v Mouthwash contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). It also contains propylene glycol which may cause skin irritation. 1% w/v. which is equivalent to 1215 mg per 15 ml of solution.

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