Mucosolvan

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMBROXOL HYDROCHLORIDE

Available from:

Boehringer Ingelheim Ellas A.E. Ellinikou 2, 167 77 Elliniko, Athens, Greece

ATC code:

R05CB06

INN (International Name):

AMBROXOL HYDROCHLORIDE 30 mg

Pharmaceutical form:

TABLET

Composition:

AMBROXOL HYDROCHLORIDE 30 mg

Prescription type:

POM

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-08-30

Patient Information leaflet

1.
SPECIFICATION OF THE MEDICINAL PRODUCT
1.1 NAME OF THE MEDICINAL PRODUCT: MUCOSOLVAN
1.2 COMPOSITION:
TABLETS: Active ingredient: Ambroxol Hydrochloride
Excipients: Lactose monohydrate, Starch maize, Silicon dioxide
colloidal,
Magnesium Stearate.
SYRUP: Active ingredient: Ambroxol Hydrochloride
Excipients: Hydroxyethylcellulose, Sorbitol solution 70%, Glycerol
85%,
Benzoic acid, Raspberry flavour D 9599, Propylene glycol, Tartaric
acid,
Purified water
1.3 PHARMACEUTICAL FORM:
Tablets, Syrup
1.4 QUANTITY OF ACTIVE INGREDIENT:
Each tablet contains 30mg trans-4-[(2-amino-3,5 dibromobenzyl) amino]
cyclohexanol  hydrochloride (=Ambroxol hydrochloride )
5ml of syrup contain 15mg   trans-4-[(2-amino-3,5-dibromobenzyl)
amino] cyclohexanol hydrochloride (=Ambroxol hydrochloride )
1.5 DESCRIPTION AND PACKAGING:
TABLETS: White with score, imprinted with code 67C and company logo,
diameter approximately 9 mm. Tablets 30mg in a box of 20.
SYRUP: Clear or almost clear, colourless slightly viscous syrup.
Syrup in a
glass bottle of 125 ml.  
1.6 PHARMACOTHERAPEUTIC GROUP:
Mucolytic, improves mucus transportation.
1.7 RESPONSIBLE FOR PLACING THE PRODUCT IN THE MARKET :
Boehringer Ingelheim Ellas Α.Ε
Ellinikou 2
167 77 Elliniko (Athens)
Tel.: [phone]
1.8 MANUFACTURER:
Boehringer Ingelheim Ellas Α.Ε.
Koropi, Attika, Greece
1.9 PACKAGER:
Boehringer Ingelheim Ellas Α.Ε.
Koropi, Attika, Greece.
2.  WHAT YOU SHOULD KNOW ABOUTTHE MEDICINE YOUR DOCTOR 
PRESCRIBED TO YOU
The information provided by this leaflet is only for this
particular medicine.
Please read this leaflet carefully. Because this leaflet does not
contain the
complete information about your medicine, if you have any questions
or
you are not sure about something,
ask your doctor or your pharmacist. 
2.1 GENERAL INFORMATION:
Mucosolvan improves mucus transportation (stimulates
ciliarry activity
and as a result enhances mucus clearance) and has secretolytic
properties.
It facilitates the removal of tracheob

Summary of Product characteristics

Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  NAME OF THE MEDICINAL PRODUCT 

   MUCOSOLVAN
®

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

   trans-4-[(2-amino-3,5-dibromobenzyl) amino] cyclohexanol
hydrochloride 
   (=Ambroxol hydrochloride ) 

   1 tablet = 30 mg    

For excipients see 6.1 

3. PHARMACEUTICAL FORM 

   Tablets 

4. CLINICAL PARTICULARS 

4.1.  THERAPEUTIC INDICATIONS 
As adjuvant for the fluidization of the mucus secretions of the
respiratory tract in cases of 
acute and chronic bronchopulmonary diseases (bronchitis, emphysema,
tracheobronchitis, 
chronic asthmatic bronchitis).   
Also is indicated for the prevention of respiratory complications
after surgical operations 
of the chest.  
During acute exacerbations of bronchitis must be administrated as
concomitant therapy 
with the appropriate antibiotic.  

4.2.     POSOLOGY AND METHOD OF ADMINISTRATION 
           Adults and children over 12 years: 1 – 2 tablets
2 times daily.      
           The above mentioned dose is indicated in acute
conditions of the respiratory system and 
for the initiation of the treatment of chronic conditions, and can
be continued for a period 
of 10 days. If the treatment must be continued for more than ten
days the dose must be 
reduced to the half.      

4.3.     CONTRAINDICATIONS  
         Not  to be used during pregnancy and lactation 
         Mucosolvan should not be used in patients known to be
hypersensitive to ambroxol or 
other components of the formulation. 

4.4.     SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 
During administration can provoke increase of the fluidizated
mucus secretions and if they 
are not removed by cough, is better to proceed to intubation of the
patient in order the 
respiratory tract to be kept open.  

Page 2 of 4 
CAUTION DURING ADMINISTRATION  
The concomitant admini