BENZYDAMINE HYDROCHLORIDE

Posology Adults, adolescents and elderly: 4 to 8 sprays, 1½-3 hourly Children (6-12 years): 4 sprays, 1½-3 hourly Children under 6 years: One spray to be administered per 4kg bodyweight, up to a maximum of 4 sprays, 1½-3 hourly Elderly: Because of the small amount of drug applied, elderly patients can receive the same dose as adults Method of administration For oral administration.

The spray must be primed before use. No less than 3 actuations are required for priming. The full dose is obtained on the fourth actuation.

Within each frequency grouping, undesirable effects are presented in order of the decreasing seriousness The following frequency categories are used: 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) and Very rare (<1/10,000), 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 (hypoesthesia) and a stinging feeling in the mouth (oral pain). The stinging has been reported to disappear upon continuation of the of the treatment, however if it persists it is recommended that treatment be discontinued.

Skin and subcutaneous tissue disorders Very rare: pruritus, urticaria, photosensitivity reaction and a rash Frequency not known: Angioedema Immune system disorders Frequency not known: Anaphylactic reaction which can be potentially life- threatening.

Hypersensitivity reactions Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed). 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.

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.

Avoid contact with the eyes. If the condition is aggravated or not improved use should cease. Contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed) This medicine contains less than 1 mmol sodium (23 mg) per dose of 8 puffs, that is to say essentially ‘sodium-free’.

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