Mucodyne 250mg/5ml syrup

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carbocisteine

Available from:

Sanofi

ATC code:

R05CB03

INN (International Name):

Carbocisteine

Dosage:

50mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03070000; GTIN: 5012877345158

Patient Information leaflet

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
MUCODYNE 250MG/5 ML PAEDIATRIC
SYRUP
Carbocisteine
Is this leafl et hard
to see or read?
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help
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE
• Keep this leafl et. 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 any of the side eff ects gets serious, or if you notice
any side eff ects not listed in this leafl et, please tell
your doctor or pharmacist.
IN THIS LEAFL ET:
1. What Mucodyne Paediatric Syrup is and what it is
used for
2. Before you take Mucodyne Paediatric Syrup
3. How to take Mucodyne Paediatric Syrup
4. Possible side eff ects
5. How to store Mucodyne Paediatric Syrup
6. Further information
1. WHAT MUCODYNE PAEDIATRIC SYRUP IS
AND WHAT IT IS USED FOR
Mucodyne 250 mg/5 ml Paediatric Syrup (called
Mucodyne Paediatric Syrup in this leafl et) 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 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. BEFORE YOU TAKE MUCODYNE PAEDIATRIC SYRUP
DO NOT TAKE THIS MEDICINE AND TELL YOUR
DOCTOR IF:
✕ Your child is under 2 years of age.
✕ You are allergic (hypersensitive) to carbocisteine
or any of the other ingredients of Mucodyne
Paediatric Syrup (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.
✕ You have an ulcer in your stomach or gut (small
intestine)
Do not take this medicine if any of the above apply
to you. If you are not sure, ta

Summary of Product characteristics

OBJECT 1
MUCODYNE SYRUP
Summary of Product Characteristics Updated 14-Oct-2016 | SANOFI
1. Name of the medicinal product
Mucodyne 250 mg/5 ml Syrup
Mucodyne 250 mg/5 ml Paediatric Syrup
2. Qualitative and quantitative composition
Each 5 ml of oral solution contains 250 mg of Carbocisteine. Also
contains 2 g of sucrose, 70 mg of
ethanol (1.6% v/v), 7.5 mg of methyl parahydroxybenzoate (E218) and 33
mg of sodium (1.4 mmol).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Syrup
A clear amber coloured syrupy liquid
4. Clinical particulars
4.1 Therapeutic indications
Carbocisteine is a mucolytic agent for the adjunctive therapy of
respiratory tract disorders characterised
by excessive, viscous mucus, including chronic obstructive airways
disease.
4.2 Posology and method of administration
_ADULTS INCLUDING THE ELDERLY (300 ML PRESENTATION ONLY):_
Dosage is based upon an initial daily dosage of 2250 mg Carbocisteine
in divided doses, reducing to 1500
mg daily in divided doses when a satisfactory response is obtained
e.g. for normal syrup 15ml tds
reducing to 10ml tds.
_CHILDREN (125 ML PRESENTATION ONLY):_
Children 2 – 5 years: The usual dose is 1.25 – 2.5 ml four times
daily
Children 5 – 12 years: The usual dose is 5 ml three times daily
Mucodyne Syrup and Mucodyne Paediatric Syrup are for oral use.
_USE OF SYRINGE FOR DOSING (125 ML PRESENTATION ONLY) _
An oral dosing syringe is provided for use for dosing children.
_HOW TO USE THE ORAL DOSING SYRINGE FOR CHILDREN _
The syringe end should be placed into the neck of the bottle below the
liquid fill line. To fill the syringe
whilst holding the syringe in place, gently pull the plunger down
drawing the medicine to the correct
mark on the syringe. The dose for children is given above based on
age. Remove the syringe from the
bottle neck carefully. Place the end of the syringe into the child's
mouth against the cheek and gently
press the plunger down slowly to gently release the medicine. After
use replace the bottle cap. Wash the
syringe in wa