Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA issues recommendations on warning labels for ambroxol- or bromhexine-containing medicines -

Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA issues recommendations on warning labels for ambroxol- or bromhexine-containing medicines
Information type: Safety alerts
Source: European Medicines Agency
Specialities: Paediatric and neonatal medicine | Respiratory disorders
Summary
The EMA has concluded that the risk of severe allergic reactions is small, but that the product information should be updated to add a warning, together with advice to discontinue treatment immediately if symptoms of allergy or severe skin reactions occur.
UKMi comment
Ambroxol and bromhexine are mainly used by mouth as expectorants to help make the mucus thinner and therefore easier to be cleared away in patients with short- or long-term diseases of the lungs or airways. Ambroxol formulations for injection are also used in premature and newborn babies to treat respiratory distress syndrome. Ambroxol- and bromhexine-containing medicines are not currently marketed in the UK.
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