DIFFLAM

Posology Adults, adolescents and elderly: 4 to 8 puffs every 1½-3 hourly. Children(6-12): 4 puffs every 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.

Elderly:

Because of the small amount of drug applied, elderly patients can receive the same dose as adults. Method of administration For oral use

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness The following rate values have been 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. 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 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. Skin and subcutaneous tissue disorders Very rare Pruritus, urticaria, photosensitivity reaction and rash 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.

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. This medicine contains 14 mg of alcohol (ethanol) in each puff. The amount in 1 puff 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. 14mg/ml. Benzyl alcohol may cause allergic reactions and mild local irritation. 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 dose of 8 puffs, that is to say essentially ‘sodium-free’.

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