Bromhexine

Bromhexine should be used with caution in patients with active or history of gastric or duodenal ulcer.

Bromhexine should be used with caution in patients with severe liver and kidney damage.

Bronchial secretion inhibitors (anticholinergics, tricyclic antidepressants, H1 antihistamines, antiparkinsonian, MAO inhibitors, neuroleptics) may antagonize the action of bromhexine.

Bromhexine should not be given concomitantly with antitussive drugs or with drugs that have atrophic action.

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

Following the administration of bromhexine antibiotic concentrations (amoxycillin, erythromycin, oxytetracycline) in the sputum and bronchopulmonary secretions are increased.

There are limited data from the use of bromhexine in pregnant women. Pre-clinical studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of bromhexine during pregnancy.

It is unknown whether bromhexine/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in pre-clinical studies have shown excretion of bromhexine/metabolites in breast milk. A risk to the breastfed infant cannot be excluded. Bromhexine should not be used during breast-feeding.

Fertility

No studies on the effect on human fertility have been conducted with bromhexine. Based on available pre-clinical experience there are no indications for possible effects of the use of bromhexine on fertility.

No studies on the effect on the ability to drive and use machines have been performed with bromhexine.

The following side effects have been reported based on clinical trials involving 3,992 patients.

Frequencies:

Very common ≥1/10
Common ≥1/100 <1/10
Uncommon ≥1/1,000 <1/100
Rare ≥1/10,000 <1/1,000
Very rare <1/10,000
Not known cannot be estimated from the available data

Immune system disorders

Rare: Hypersensitivity reactions

Not known: Anaphylactic reactions including anaphylactic shock*

Respiratory, thoracic and mediastinal disorders

Not known: Bronchospasm*

Gastro-intestinal disorders

Uncommon: Abdominal pain upper, Nausea, Vomiting, Diarrhoea

Skin and subcutaneous tissue disorders

Rare: Rash, Urticaria*

Not known: Pruritus*, Angioedema*, Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis)

* This adverse reaction has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than rare (3/3,992), but might be lower. A precise frequency estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of 3,992 patients.