Fluifort 2.7g/10ml Syrup

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CARBOCISTEINE

Available from:

Dompe Farmaceutici SpA Via San Martino 12, 20122, Milan, Italy

ATC code:

R05CB03

INN (International Name):

CARBOCISTEINE 2.7 g

Pharmaceutical form:

SYRUP

Composition:

CARBOCISTEINE 2.7 g

Prescription type:

POM

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2010-09-27

Patient Information leaflet

PACK ENGINEERING OFFICE 
F. IPPOLITI
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TEXT CONTROL OFFICE 
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CARTOTECHNIQUE 
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148 mm
203,2 mm
NAME OF THE MEDICINAL PRODUCT
FLUIFORT 2.7 g/10 ml syrup
Carbocysteine monohydrate lysine salt 
PHARMACOTHERAPEUTIC GROUP
Cough and cold preparation. Mucolytics. 
THERAPEUTIC INDICATIONS
Mucolytic, fluidifying agent in the acute and chronic diseases
of the respiratory system.
CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the
excipients. Gastric duodenal ulcer. Pregnancy and
lactation (see section Special warnings).
Pediatric patients (patients less than 11 years).
PRECAUTIONS FOR USE
No tolerance or dependence phenomena are known
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS
OF INTERACTION 
Within controlled clinical trials no interactions with the medicines
most commonly used for the treatment of
upper and lower airways disorders nor with food and laboratory tests
have been noticed.
SPECIAL WARNINGS
The medicine contains methyl-para-hydroxybenzoate and
propyl-para-hydroxybenzoate, known for the possibility
of causing urticaria. Para-hydroxybenzoates may generally cause
delayed reactions, such as contact dermatitis,
and rarely immediate reactions with urticaria and bronchospasm.
The medicinale contains sorbitol and may cause gastric disease and
diarrhoea.
Fluifort 2.7 g/10 ml syrup do not affect hypocaloric or controlled
diets and may be administered also to diabetic
patients.
Fluifort 2.7 g/10 ml syrup do not contain aspartame; therefore, it may
be administered to patients suffering from
phenylketonuria.
Fluifort 2.7 g/10 ml syrup do not contain gluten; therefore, it may be
administered to patients suffering from
celiac disease.
PREGNANCY AND LACTATION
Although the active ingredient is neither teratogenic nor mutagenic
and has not shown negative effect on the
reproductive function in animals, Fluifort should not be administer

Summary of Product characteristics

Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.    
NAME OF THE MEDICINAL PRODUCT 

Fluifort 2.7 g/10 ml syrup 

2.    
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each single-dose container of 10 ml syrup at a 27% concentration contains: 

active  ingredient:    carbocysteine  monohydrate  lysine  salt  corresponding  to  2.7  g 
carbocysteine lysine salt 

            For the excipients, see 6.1.  

3.    
PHARMACEUTICAL FORM 

Syrup   

4.    
CLINICAL PARTICULARS 
4.1 
THERAPEUTIC INDICATIONS 

Mucolytic, fluidifying agent in the acute and chronic diseases of the respiratory system. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

1 single-dose container on a daily basis or according to medical prescription. 
Fluifort 2.7 g/10 ml syrup, based on its innovative packaging, assures dose precision, 
hygiene, convenience and easiness of administration and is particularly indicated in the 
acute phase of diseases where short-term treatment is expected. 
Given the pharmacokinetic characteristics and the high tolerability, the recommended 
posology may be maintained even in patients with renal and liver impairment. 
DURATION OF TREATMENT: Carbocysteine monohydrate lysine salt may be used even for 
prolonged periods of time; in such a case, physician advice should be followed.  

4.3  
CONTRAINDICATIONS 

Hypersensitivity to the active ingredient or to any of the excipients. Gastric-duodenal ulcer. 
Pregnancy and lactation. Children below 11 years. 

4.4

SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
No tolerance or dependence phenomena are known. 
The  product  contains  methyl  and  propyl  parahydroxybenzoates  which  are  known  for  the 
possibility  of  causing  urticaria.  Generally,  parahydroxybenzoat