DIFFLAM

Posology Adults:

Rinse or gargle with 15 ml (approximately 1 tablespoonful) every 1½ to 3 hours as required for pain relief.

Children:

Not suitable for children aged 12 years or under.

Elderly:

No special dosage recommendations are made for elderly patients. Method of administration Rinse or gargle. The solution should be expelled from the mouth after use. Benzydamine Oral Rinse 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

Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: 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. System organ class Frequency Adverse reaction Immune system disorders Not known Anaphylactic reactions, Hypersensitivity reactions [20]. 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).

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.

Benzydamine Oral Rinse should generally be used undiluted, but if ‘stinging’ occurs the rinse may be diluted with water. Avoid contact with eyes. This medicine contains 1126 mg of alcohol (ethanol) in each 15 ml dose. The amount in 15 ml of this medicine is equivalent to less than 30 ml beer or 12 ml wine.

The small amount of alcohol in this medicine will not have any noticeable effects. 14mg/ml. Benzyl alcohol may cause allergic reactions. This medicinal product contains mint flavour with benzyl alcohol, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, limonene and linalool.

These substances may cause allergic reactions. This medicine contains less than 1 mmol sodium (23 mg) per 15 ml dose, that is to say essentially ‘sodium-free’.

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