Ambroxol

Ambroxol must only be used with particular caution (i.e. at longer intervals or at a reduced dose) in impaired renal function or a severe hepatic disease. In severe renal insufficiency, an accumulation of the metabolites of ambroxol formed in the liver must be expected.

Since mucolytics may disrupt the gastric mucosal barrier ambroxol should be used with care in patients with a history of peptic ulcer disease.

Ambroxol should be used with caution in asthmatic patients with a history of bronchospasm or severe respiratory failure or active tuberculosis.

Following administration of ambroxol, the concentrations of antibiotics (amoxycillin, cefuroxime, erythromycin) in bronchopulmonary secretions and sputum are increased.

There are no sufficient data for the use of ambroxol in pregnant women. This particularly concerns the period up to the 28th week of pregnancy. Ambroxol has shown no teratogenic effects in animal-experiment studies. Ambroxol should only be used in pregnancy after careful benefit/risk evaluation, particularly during the first trimester.

Ambroxol crosses into the breast milk in animals. As there is no adequate experience in humans to date, ambroxol should only be used in lactation after careful benefit/risk assessment.

Fertility

There are no sufficient data about the influence of ambroxol on fertility in humans. In animalexperiment studies, ambroxol showed no influence on fertility.

There is no evidence for an effect on the ability to drive and use machines. Studies on the effects on the ability to drive and use machines have not been performed.

The following frequencies are taken as a basis when evaluating undesirable effects:

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
Very rare: <1/10,000
Not known: Cannot be estimated from the available data

Immune system disorders

Uncommon: Fever

Rare: Hypersensitivity reactions

Not known: Anaphylactic reactions including anaphylactic shock, angioedema and pruritus

Nervous system disorders

Common: Dysgeusia (e.g. changed taste)

Respiratory, thoracic and mediastinal disorders

Common: Oral and pharyngeal hypaesthesia

Not known: Dry throat

Gastrointestinal disorders

Common: Nausea

Uncommon: Vomiting, dry mouth, diarrhoea, dyspepsia and abdominal pain Skin and subcutaneous tissue disorders

Rare: Rash, urticaria

Not known: Severe cutaneous adverse reactions (including erythema multiforme, StevensJohnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis)