MUCODYNE PAEDIATRIC SYRUP 125 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:

125 MG/5ml

Pharmaceutical form:

Syrup

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Mucolytics

Authorization status:

Transfer Pending

Authorization date:

2002-06-11

Patient Information leaflet

Reference: 4474 1.3.1.3 - Leaflet
Text - PIL - 125mg/5ml - 2015-08-24 - 0000 - GLUv5 tracked
3.1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MUCODYNE PAEDIATRIC SYRUP 125MG/5ML
Carbocisteine
IS THIS LEAFLET HARD TO SEE OR READ?PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE GIVING YOUR CHILD 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 your child. Do not pass it on
to others. It may 
harm them, even if their symptoms are the same as your childs.
• 
If your child gets any side effects, talk to your doctor or
pharmacist.  This includes 
any possible side effects not listed in the leaflet.
WHAT IS IN THIS LEAFLET:
1. 
WHAT MUCODYNE PAEDIATRIC IS AND WHAT IT IS USED FOR
2. 
WHAT YOU NEED TO KNOW BEFORE YOU GIVE MUCODYNE PAEDIATRIC TO YOUR
CHILD
3.
HOW TO GIVE MUCODYNE PAEDIATRIC TO YOUR CHILD
4. 
POSSIBLE SIDE EFFECTS
5. 
HOW TO STORE MUCODYNE PAEDIATRIC
6. 
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT MUCODYNE PAEDIATRIC
1.
WHAT MUCODYNE PAEDIATRIC IS AND WHAT IT IS USED FOR
Mucodyne Paediatric Syrup 125mg/5ml (called Mucodyne Paediatric 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 Paediatric 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.
Mucodyne Paediatric is specially made for children.
2. BEFORE YOU GIVE MUCODYNE
PAEDIATRIC TO YOUR CHILD
2. 
WHAT YOU NEED TO KNOW BEFORE YOU GIVE MUCODYNE PAEDIATRIC TO YOUR
CHILD
DO NOT GIVE THIS MEDICINE TO YOUR CHILD AND TELL YOUR DOCTOR IF:
 Your child is allergic (hypersensitive) to carbocisteine or any
of the other ingredients of 
Mucodyne Paediatric (li

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mucodyne Paediatric Syrup 125 mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each of 5 ml of syrup contains 125 mg of Carbocisteine.
Excipients:
Also includes Sucrose 3.25g/5ml
Sodium Methylhydroxybenzoate (E219) 7.5mg/5ml
Red Ponceau 4R (E124) 0.25 mg/5ml
Ethanol 32mg/5ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
A red colour syrup with an odour and taste of raspberry and cherry.
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:
Children:
Children 2-5 years:
2.5 - 5ml four times daily
Children 5-12 years:
10ml - three times daily
4.3 CONTRAINDICATIONS
Use in patients with a known hypersensitivity to Carbocisteine.
Use in patients with active peptic ulceration.
Use in patients below 2 years of age.
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_
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase
insufficiency