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HSA Approval

FLUIMUCIL GRANULES 100 mg/sachet

SIN03414P

FLUIMUCIL GRANULES 100 mg/sachet

FLUIMUCIL GRANULES 100 mg/sachet

June 17, 1989

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

Regulatory Information

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

Therapeutic

Pharmacy Only

Formulation Information

GRANULE

**POSOLOGY** Adults and children above 6 years - 1 sachet FLUIMUCIL® 200mg or 2 sachets FLUIMUCIL® 100mg, 2–3 times a day; Children (2–6 years of age) - 1 sachet FLUIMUCIL® 100 mg from 2 to 4 times a day, according to the age. 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 contents of the sachets 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® is 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 Precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) Children under 2 years of age.

R05CB01

acetylcysteine

Manufacturer Information

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

ZAMBON SWITZERLAND LTD

Active Ingredients

ACETYLCYSTEINE

100 mg/sachet

Acetylcysteine

Documents

Patient Information Leaflets

Fluimucil Sachet 100mg an 200mg PIL.pdf

Approved: December 19, 2017

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