Fluimucil Special Precautions

Capsule/Granules/Dry syrup: Patients suffering from bronchial asthma should be monitored. Should bronchospasm occur, the treatment must be immediately suspended.
Capsule/Dry syrup: Fluimucil should be taken after meals in patients with a history of gastritis.
Granules/Dry syrup: In patients with diabetes or receiving low-calorie diet, sugar content of Fluimucil should be considered.
Granules: 600 mg: Patients with asthma should be closely monitored during treatment; Patients with bronchial asthma must be closely monitored during therapy, if bronchospasm occurs, the treatment must be stopped immediately. The use of the medicinal product in patients with peptic ulcer or with a history of peptic ulcer need particular attention, especially in the case of concomitant use of other drugs with a known gastric-damaging effect. The administration of acetylcysteine, especially at the beginning of the treatment, can thin the phlegm and at the same time increase their volume.
Acetylcysteine should be used with caution for long-term treatment in patients with histamine intolerance as the intolerance symptoms may occur (headache, sneezing, nasal congestion, itching).
Important information about some of the ingredients: Fluimucil 600 mg granule contains sorbitol, dextrose, and lactose. Therefore, patients with glucose or fructose intolerance is not recommended to take the drug. Fluimucil 600 mg granule contains phenylalanine source which may harrmful for patients with phenylketonuria.
The possible presence of a sulphurous odor does not indicate alteration of the product but it is related to the specific properties of acetylcysteine.
Dry syrup: The possible presence of sulfurous odor does not indicate an alteration of Fluimucil but is due to NAC contained in the preparation.
It is not recommended for patients with diabetes mellitus, however, it may be given if the blood glucose level is under control.
The administration of Fluimucil, especially at the beginning of treatment, may liquefy the bronchial secretions and simultaneously increase the volume.
Solution for inhalation: The administration of NAC, particularly by aerosol, can at the beginning of treatment, liquefy the bronchial secretions and simultaneously increase the volume. If the patient is unable to properly expectorate, it is necessary to clear the airways by postural drainage or eventually by bronchosuction to avoid retention of secretions. Patients suffering from bronchial asthma must be closely monitored as bronchospasm may occur during the treatment. In such event, the treatment must be immediately suspended.
N-acetylcysteine aerosol may worsen cough in patients suffering from acute bronchial asthma.
The presence of sulfurous odor upon opening of the ampule does not affect the quality of Fluimucil. N-acetylcysteine solution, stored opened ampules or transferred to the aerosol equipment may assume a pink color but it does not affect the efficacy and safety of Fluimucil.
Ability to operate the machinery: Granules: 600 mg: There are no evidence shown that the drug may affect the concentration while driving.
Use in Pregnancy & Lactation: In either animal or human, studies shown that the administration of NAC does not cause teratogenic effect or other side effects, however, the administration of Fluimucil during pregnancy and lactation should be done under the supervision of physicians. In some cases, the physicians should evaluate the risk and benefit ratio.
Use in Children: In pediatric patients <1 year and breastfed infants, Fluimucil should be given only in life-threatening cases and always under strict medical supervision. Fluimucil should not be given to children <6 years.
Granules: 600 mg: The safety and efficacy of the drug in children ≥2 years old & adolescents has not been established.