Sinecod 1.5mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

butamirate citrate 1.5 mg/ml

Available from:

Novartis Consumer Health UK Limited

ATC code:

R05DB13

INN (International Name):

butamirate citrate

Pharmaceutical form:

syrup

Authorization status:

Authorised

Authorization date:

2007-04-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER  

 SINECOD 0.15% SYRUP  
 Butamirate citrate 

READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU. 
Always use Sinecod exactly as described in this leaflet or as your
pharmacist has told you. You 
should check with your doctor or pharmacist if you are not
sure. 

  Keep this leaflet. You may need to read it again. Note that
this leaflet is revised on a regular 
basis with the latest information on your medicine. Please refer
to the date at the end of this 
leaflet. 

  Ask your pharmacist if you need more information or advice. 

  You must contact a doctor if your signs of illness worsen or do
not improve. 


If you get any of the side effects which worry you (even
side effect not listed in this leaflet), 
please talk to your doctor or pharmacist. 

IN THIS LEAFLET 
1  WHAT SINECOD IS AND WHAT IT IS USED FOR  
2  BEFORE YOU TAKE SINECOD  
3  HOW TO TAKE SINECOD 
4  POSSIBLE SIDE EFFECTS 
5  HOW TO STORE SINECOD 
6  FURTHER INFORMATION 

1 
WHAT SINECOD IS AND WHAT IT IS USED FOR  
Sinecod contains the active substance butamirate citrate which belongs to a group of medicines 
called cough suppressants. 
Sinecod is used for the symptomatic treatment of cough of various
origins. 

2 
BEFORE YOU TAKE SINECOD  

DO NOT TAKE SINECOD IF YOU 

  are allergic to butamirate citrate or any of the other
ingredients of this medicine listed in 
Section 6 and at the end of Section 2.  

WARNINGS AND PRECAUTIONS  
Ask your doctor or pharmacist if the cough persists
for more than 7 days. 
CHILDREN 
Do not give Sinecod drops to children under 2 years old, unless on
the advice of a doctor. 

TAKING OTHER MEDICINES WITH SINECOD 
Please avoid taking simultaneously other cough medicines, because it may lead to stagnation of 
mucus in 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 
1 
NAME OF THE MEDICINAL PRODUCT 
Sinecod 0.15% syrup  
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Active ingredient: Butamirate citrate (INN). 

One  teaspoonful  (5  ml)  of  Sinecod  0.15%  syrup  contains  7.5  mg  of  butamirate 
citrate.  
Excipient(s): sorbitol (E 420), ethanol. 

For a full list of excipients see section 6.1 
3 
PHARMACEUTICAL FORM 
Syrup 

Clear, colorless with vanilla aroma, sweet and slightly bitter. 
4 
CLINICAL PARTICULARS 
4.1         THERAPEUTIC INDICATIONS 
Symptomatic treatment of cough of various origins. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

The maximum duration of treatment without a doctor’s prescription is  one week 
(see 4.4.  Special warnings and precautions for use). 

Children 3 to 6 years of age: 5 ml 3 times daily  
Children 6 to 12 years of age: 10 ml 3 times daily  
Adolescents over 12 years of age: 15 ml 3 times daily  
Adults: 15 ml 4 times daily  

Wash and dry the graduated cup after each use and between
different users. 

4.3 
CONTRA-INDICATIONS 
Hypersensitivity to butamirate citrate or to any of
the ingredients.  

4.4         SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
Due  to  inhibition  of  the  cough  reflex  by  butamirate,  the  simultaneous 
administration  of  expectorants  has  to  be  avoided,  because  it  may  lead  to  the 
stagnation  of  mucus  in  the  respiratory  tract,  which  increases  the  risk  of 
bronchospasm and airways infection. 

A doctor or pharmacist needs to be consulted if the cough persists for more than 7 
days. 

  PEDIATRIC POPULATION 
The pediatric drops may only be used with a doctor’s prescription in children aged 
less than 2 years. 
  INFORMATION CONCERNING EXCIPIENTS 
Sorbitol  (E  420):    Patients  with