Exflem/Exflem 200 Special Precautions

Exflem: After proper administration of acetylcysteine, an increased volume of liquefied bronchial secretions may occur. If the patient cannot expectorate efficiently, postural drainage and bronchoaspiration must be used to avoid retention of secretions. Carefully observe asthmatics under treatment with acetylcysteine. If bronchospasm occurs, discontinue acetylcysteine immediately. The presence of a sulfur-like odor does not indicate an alteration of the product but is a characteristic of the drug substance contained in the preparation. Use with caution in patients with a history of peptic ulcer disease because drug-induced nausea and vomiting may increase the risk of gastrointestinal hemorrhage in patients predisposed to the condition and because of a theoretical risk that mucolytics may disrupt the gastric mucosal barrier.
Phenylketonurics: This product contains phenylalanine as one of the metabolites of aspartame.
Exflem 200: The occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome has very rarely been reported in association with the use of acetylcysteine. If cutaneous and mucosal alterations newly occur, medical advice should be sought without delay and the use of acetylcysteine be terminated (see also Adverse Reactions).
Cave during use in patients with bronchial asthma and patients with a history of ulcer.
Caution is advised in patients with histamine intolerance.
Longer-term therapy should be avoided in these patients, as Acetylcysteine has an effect on histamine metabolism and may lead to symptoms of intolerance (e.g. headache, vasomotor rhinitis, itching).
The use of acetylcysteine, especially at the beginning of treatment, may lead to an increased volume of liquefied bronchial secretion. If it can only be coughed off with difficulty, appropriate measures should be taken (e.g. postural drainage and removal of secretions).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency should not take Acetylcysteine.
1 powder sachet contains 2.7 g sucrose (sugar), equivalent to approx. 0.23 bread units. This should be taken into account in patients with diabetes mellitus.
Acetylcysteine may be damaging to teeth (caries).
Effects on Ability to Drive and Use Machines: None known.