BENZYDAMINE HYDROCHLORIDE

Posology Adults and elderly: 4 to 8 sprays, 1½-3 hourly Paediatric population Children (6-12 years): 4 sprays, 1½-3 hourly Children under 6 years: One spray to be administered per 4 kg 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 Oromucosal 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.

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 the 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 reactions, Hypersensitivity reactions 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 of the treatment, however if it persists it is recommended that treatment be discontinued. Very rare Pruritus, urticaria, photosensitivity reaction and rash Skin and subcutaneous tissue disorders Not known Angioedema 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). 6 mg of alcohol (ethanol) in each spray. The amount in 1 spray of this medicine is equivalent to less than 1 ml beer or 1 ml wine.

The small amount of alcohol in this medicine will not have any noticeable effects. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

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