BENZYDAMINE

For oromucosal administration. ADULTS AND ELDERLY: 4 to 8 puffs, 1½-3 hourly. CHILDREN (6-12): 4 puffs, 1½-3 hourly.

CHILDREN UNDER 6:

One puff to be administered per 4 kg body weight, up to a maximum of 4 puffs, 1½-3 hourly. Because of the small amount of drug applied, elderly patients can receive the same dose as adults. The spray should be directed onto the affected area.

Uninterrupted treatment should not exceed 7 days, except under medical supervision.

Adverse events are ranked under the heading of the frequency:

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 the available data). The most common side effects are numbness and a stinging feeling in the mouth.

Respiratory, thoracic and mediastinal disorders Very rare:

Laryngospasm or bronchospasm.

Gastrointestinal disorders Uncommon:

Oral numbness and a stinging feeling in the mouth. The stinging has been reported to disappear upon continuation of the treatment, however if it persists it is recommended that treatment be discontinued.

Skin and subcutaneous tissue disorders Very rare:

Hypersensitivity reactions which may be associated with pruritus, urticaria, photosensitivity reaction and rash Frequency not known: Angioedema Immune system disorders Frequency not known: Anaphylactic reaction which can be potentially life- threatening, hypersensitivity.

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.

Avoid contact with the eyes. Hypersensitivity reaction can occur with local use of medicinal products, especially in prolonged exposure. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted.

Benzydamine use is not advisable in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs. Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma. Caution should be exercised in these patients.

Excipient Warnings:

Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed). 5mg of alcohol (ethanol) in each puff. The amount in 1 puff of this medicine is equivalent to less than 1ml beer or 1ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

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