Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**POSOLOGY** Adults and children above 6 years - 1 tablet of Fluimucil® A Effervescent Tablet 600 mg a day. - 1 sachet of Fluimucil® Granules 600mg a day The duration of treatment should be 5 to 10 days in the acute treatment, whereas it may be continued in the chronic states for several months, according to the advice of the physician. **MODALITY OF USE** Dissolve the tablet or the content of the sachet in a glass containing a small quantity of water, mixing it, if necessary, with a spoon. A palatable solution is thus obtained to be drunk immediately.
ORAL
Medical Information
**INDICATIONS** Fluimucil® A Effervescent Tablets 600mg and Fluimucil® Granules 600mg are indicated as an adjuvant treatment in certain clinical condition characterized by the presence of thick and viscous mucoid or mucopurulent secretions such as: - Chronic bronchopulmonary diseases (chronic obstructive pulmonary disease, emphysema with bronchitis, chronic asthmatic bronchitis, bronchiectasis); - Acute bronchopulmonary diseases (asthma with bronchial mucus plugging, bronchitis, bronchopneumonia, tracheobronchitis, bronchiolitis, pulmonary complications of cystic fibrosis, pulmonary complications associated with surgery).
**CONTRAINDICATIONS** - Known hypersensitivity to acetylcysteine or to any of the excipients (please see below the section Warning and Precaution – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Children under 2 years of age. - Fluimucil® A Effervescent Tablets 600mg and Fluimucil® Granules 600mg contain aspartame, thus it is contraindicated in patients suffering from phenylketonuria.
R05CB01
acetylcysteine
Manufacturer Information
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
ZAMBON SWITZERLAND LTD
Active Ingredients
Documents
Patient Information Leaflets
Fluimucil A 600 effervescent tablet PIL.pdf
Approved: November 16, 2017