MUCODYNE 250 MG/5ml Syrup

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CARBOCISTEINE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

R05CB03

INN (International Name):

CARBOCISTEINE

Dosage:

250 MG/5ml

Pharmaceutical form:

Syrup

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Mucolytics

Authorization status:

Transfer Pending

Authorization date:

1999-09-24

Patient Information leaflet

 
Reference:
4490 1.3.1.3 - Leaflet Text - PIL - 250mg/5ml - 2015-10-07 - 0000 - GLUv5
3.2 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
MUCODYNE SYRUP 250 MG/5 ML 
Carbocisteine 

IS THIS LEAFLET HARD TO SEE OR READ? 
PHONE [phone] FOR HELP 
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION. 

•  
Keep this leaflet. You may need to read it again 
•  
If you have any further questions, ask your doctor or pharmacist 
•  
This medicine has been prescribed for you. Do not pass it on to
others. It may harm 
them, even if their symptoms are the same as yours 
•  
If you get any side effects, talk to your doctor or pharmacist.
 This includes any 
possible side effects not listed in the leaflet. 

IN THIS LEAFLET: 
1.  
WHAT MUCODYNE SYRUP IS AND WHAT IT IS USED FOR 
2.  
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUCODYNE SYRUP 
3. 
 HOW TO TAKE MUCODYNE SYRUP 
4.  
POSSIBLE SIDE EFFECTS 
5.  
HOW TO STORE MUCODYNE SYRUP 
6.  
CONTENTS OF THE PACK AND OTHER INFORMATION 

1. 
WHAT MUCODYNE SYRUP IS AND WHAT IT IS USED FOR 

Mucodyne Syrup 250 mg/5 ml (called Mucodyne Syrup in this
leaflet) contains a medicine called 
carbocisteine. This belongs to a group of medicines
called ‘mucolytics’. It works by making mucus 
(phlegm) less sticky. This makes the mucus easier
to cough up. 

Mucodyne Syrup is used for problems with the
breathing passages (respiratory tract). These problems 
happen when too much mucus is made or the
mucus is too sticky. 

2.  
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUCODYNE SYRUP 

DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: 

  You are allergic (hypersensitive) to carbocisteine or any of
the other ingredients of Mucodyne 
Syrup (listed in Section 6
below). Signs of an allergic reaction include: a
rash, swallowing or 
breat

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mucodyne Syrup 250 mg/5 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 250 mg of Carbocisteine.
Each 5ml also contains sucrose 2g and Methyl Parahydroxybenzoate (E218) 7.5mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
An amber coloured syrup with an odour of cinnamon and rum.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive or
viscous mucus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
RECOMMENDED DOSAGE:
ADULTS:
The usual dose is 15ml three times daily initially, reducing to 10ml three times daily when a satisfactory response
has been obtained.
CHILDREN:
The usual daily dose is 20mg/kg in divided doses. The paediatric preparation should be used.
4.3 CONTRAINDICATIONS
1.
Use in patients with a known hypersensitivity to Carbocisteine.
2.
Use in patients with active peptic ulceration.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is recommended in the elderly, in those with a history of gastroduodenal ulcers, or those taking concomitant
medications known to cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, patients should discontinue
medication.
Because of the possible effect on the mucous glands of the stomach, this product should be used with caution in
patients with a history of peptic ulceration.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 11/02/2016_
_CRN 2169091_
_page number: 1_
Mucodyne Syrup is unsuitable for those patients who have inherited fructose intolerance, glucose-galactose
m