Benzydamine

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma. Caution should be exercised in these patients.

There are no or limited amount of data from the use of benzydamine in pregnant women, and animal studies are insufficient with respect to reproductive toxicity. Benzydamine should not be used during pregnancy.

There is insufficient information on the excretion of benzydamine in human milk. Benzydamine should not be used during breastfeeding.

Benzydamine has no or negligible influence on the ability to drive and use machine, when it is used at the recommended dose.

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).

Immune system disorders

Not Known: Anaphylactic reaction, Hypersensitivity reactions

Respiratory, thoracic, and mediastinal disorders

Very rare: Laryngospasm

Gastrointestinal Disorders

Rare: Burning mouth, Dry mouth

Not known: Hypoaesthesia oral

Skin and subcutaneous tissue disorders

Uncommon: Photosensitivity

Very rare: Angioedema