Bronchospasms may occur with the use of acetylcysteine especially in patients with asthma. If bronchospasms occur, the medicinal product should be discontinued immediately.
Caution is advised in patients with a history of peptic ulcer, especially when used concomitantly with other medicinal products known to irritate the mucous membrane of the gastrointestinal tract.
Serious skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have very rarely been reported in temporal connection with the use of acetylcysteine. In most cases, at least one other suspect medicinal product, which was more likely the cause of the mucocutaneous syndrome could be identified. If cutaneous or mucosal alterations newly occur, immediate medical advice should be sought and the treatment with acetylcysteine should be discontinued immediately.
Bronchial secretions may become more fluid and increase in volume, in particular at the start of the treatment with acetylcysteine. When a patient is unable to cough up the secretions effectively, postural drainage and bronchoaspiration should be performed.
Paediatric population
Mucolytic drugs may obstruct the airways of children under 2 years of age, due to the physiological characteristics of the airways in this age group. The ability to cough up mucus may be limited. Therefore, mucolytic drugs should not be used in children under 2 years of age.
The safety and efficacy is not established in children aged 2 years and older and adolescents.
A mild sulfur odour does not indicate a change in the medicinal product, but is a property of the active substance itself.
Excipients
This medicinal product contains 115 mg sodium per effervescent tablet equivalent to 5.75% of the WHO recommended maximum daily intake of 2g for an adult.