MUCODYNE 375 Milligram Capsules Hard

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:

375 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Mucolytics

Authorization status:

Authorised

Authorization date:

2002-11-30

Patient Information leaflet

11502008-06

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 FOR YOU.
•  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 Capsules are and what they are 
used for
2. What  you  need  to  know  before  you  take 
Mucodyne Capsules
3. How to take Mucodyne Capsules
4. Possible side effects
5. How to store Mucodyne Capsules
6. Contents of the pack and other information
1. WHAT MUCODYNE CAPSULES ARE AND 
WHAT THEY ARE USED FOR
Mucodyne 375mg Capsules, Hard (called Mucodyne 
Capsules  in  this  leaflet)  contain  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 Capsules are 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 CAPSULES

DO NOT TAKE THIS MEDICINE AND TELL YOUR 
DOCTOR IF:

  You are allergic (hypersensitive) to carbocisteine 
or  any  of  the  other  ingredients  of  Mucodyne 
Capsules (listed in Section 6 below) Signs of an 
allergic reaction include: a rash, swallowing or 
breathing  problems,  swelling  of  the  lips,  face, 
throat or tongue

  Yo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mucodyne 375 mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 375 mg of Carbocisteine.
Excipients: Each capsule contains sunset yellow (E110) and 22mg of lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, Hard (capsule).
Size No. 1 opaque, yellow, capsule, hard having an identification mark printed “mucodyne 375” in black ink and
containing a white to almost white powder.
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:
2 capsules three times a day initially, reduced to 1 capsule 4 times a day when a satisfactory response has
been attained.
Children:
It is not recommended that this formulation be used for children.
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
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_Date Printed 18/07/2016_
_CRN 2179473_
_page number: 1_
4.5 INTERACTIO