Acetylcystein-BP

Acetylcysteinum

Each capsule contains acetylcysteine 200 mg. Hard gelatin capsules size 3, with a blue cap and a white body, containing a white or almost white powder.

Indication: A mucolytic medicine for the treatment of acute and chronic respiratory conditions associated with excessive production of viscous mucus.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications - Hypersensitivity to acetylcysteine or to any of the excipients listed in section 6.1. - Active peptic ulcer. - Oral formulations containing more than 100 mg of acetylcysteine must not be administered to children under 2 years of age (see section 4.2).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Caution is advised when acetylcysteine is used in bronchial asthma or in patients with clinically confirmed peptic ulcer. Use of acetylcysteine, particularly at the start of treatment, may liquefy and consequently increase the volume of bronchial secretions. If patients are unable to expectorate adequately, appropriate measures (such as postural drainage or aspiration) should be taken. Very rare cases of severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome (toxic epidermal necrolysis), have been reported in association with acetylcysteine administration. At the time of prescribing, patients should be advised of the signs and symptoms of severe skin reactions and should be closely monitored.