|Dosage and administration||
Patients with a known hypersensitivity to bromhexine or to any of the excipients of this medicine.
|Warnings and precautions for use||
– Bromhexine use should be avoided in combination with antitussives, drugs that reduce bronchial secretions because they may cause a risk of stagnant phlegm in the respiratory tract.
|Recommendation for pregnancy and breastfeeding||
Pregnancy: There are no adequate and controlled studies on bromhexine use in pregnant women, therefore, bromhexine is not recommended for pregnant women.
|Effects on ability to drive and use machines||
There have been no studies on the effects of bromhexine on ability to drive and use machines.
|Interactions, incompatibilities of medicine||
– Bromhexine should not be used in combination with mucolytics (including drugs that reduce bronchial secretions) such as atropine-like drugs (or anticholinergics) because they reduce the effect of bromhexine.
|Undesirable effects (ADRs)||
Uncommon, 1/1000 <ADR <1/100
|Overdose and management||
– Bromhexine is an expectorant/mucolytic agent. It activates sialomucin synthesis and disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces a less viscous mucus, which is easier to expectorate and is coughed up effectively.
– Bromhexine is rapidly absorbed from the gastrointestinal tract and undergoes extensive first-pass metabolism in the liver, so its bioavailability is only 20%. Food increases the bioavailability of bromhexine hydrochloride. Peak plasma concentrations are reached ½ hour to 1 hour after oral administration.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.
Composition: Each hard capsule contains:
Bromhexine hydrochloride . . . . . . . . . . . . .16 mg
Cardboard box containing 03 blisters of 10 hard capsules.
Cardboard box containing 10 blisters of 10 hard capsules.
For the treatment of bronchial secretion disorders, particularly in acute bronchitis, acute exacerbation of chronic bronchitis.
Bromhexine is often used as an adjunct to antibiotics, in severe respiratory infections.