Mucodyne 375mg capsules

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:

375mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03070000; GTIN: 5013011006843

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MUCODYNE
® 375MG CAPSULES
(CARBOCISTEINE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
•
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 any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist
IN THIS LEAFLET:
1) What Mucodyne Capsules are and what they are used for
2) Before you take Mucodyne Capsules
3) How to take Mucodyne Capsules
4) Possible side effects
5) How to store Mucodyne Capsules
6) Further information
1) WHAT MUCODYNE CAPSULES ARE AND WHAT THEY ARE
USED FOR
Mucodyne 375mg Capsules (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) 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
✖ You have an ulcer in your stomach or gut
Do not take this medicine if any of the above apply to you. If you are
not
sure, talk to your doctor or pharmacist before taking Mucodyne
Capsules.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking this medicine if:
•
You are elderly.
•
Have had an ulcer in your stomach or gut.
•
You are taking other medicines known to cause bleeding in the
stomach.
PREGNANCY AND

Summary of Product characteristics

OBJECT 1
Mucodyne 375mg Capsules
Summary of Product Characteristics Updated 21-Sep-2021 | SANOFI
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
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8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Mucodyne 375 mg Capsules, Hard
2. Qualitative and quantitative composition
Carbocisteine 375 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard
Yellow, size 1 capsules, hard marked “MUCODYNE 375” in black and
containing a white to off-white
powder or friable plug.
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
Posology
Adults (including the elderly)
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. two capsules three times a day
reducin