Ambroxol-BP

Ambroxolum

Each tablet contains ambroxol hydrochloride 30 mg. Excipient with known effect: lactose monohydrate 171 mg.

Indication: Ambroxol-BP is indicated as a secretolytic agent in the treatment of acute bronchial disease and exacerbations of chronic bronchopulmonary disease associated with abnormal mucus secretion and impaired mucus transport.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Administration of this medicine is contraindicated in rare hereditary conditions that may be incompatible with one of its excipients (see Special warnings and precautions for use).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) have been reported in association with ambroxol hydrochloride. If symptoms or signs of a progressive skin rash appear (sometimes associated with blisters or mucosal lesions), treatment with ambroxol hydrochloride must be stopped immediately and medical advice sought. Ambroxol-BP should be used only on a doctor's recommendation in patients with renal insufficiency or severe hepatic disease. In severe renal insufficiency, accumulation of hepatically formed ambroxol metabolites is expected. This medicine contains lactose. One Ambroxol-BP 30 mg tablet contains 171 mg lactose monohydrate, equivalent to 684 mg […]