Carbocisteine 375mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carbocisteine

Available from:

Teva UK Ltd

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: 5017007012856

Patient Information leaflet

MUCODYNE 375MG CAPSULES
(carbocisteine)
PATIENT INFORMATION LEAFLET
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 get serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Mucodyne 375mg Capsules but will be called
Mucodyne Capsules throughout this leaflet.
IN THIS LEAFLET:
What Mucodyne Capsules are and what they are used for
Before you take Mucodyne Capsules
How to take Mucodyne Capsules
Possible side effects
How to store Mucodyne Capsules
Further information
WHAT MUCODYNE CAPSULES ARE AND WHAT THEY ARE
USED FOR
Mucodyne 375mg Capsules (called Mucodyne Capsules in this lea flet)
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.
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 medicine

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbocisteine 375mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains carbocisteine 375mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Size 0 capsule with opaque blue cap and opaque yellow body, containing
white to
off-white odourless powder.
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
(6 capsules) in
divided doses, reducing to 1500 mg (4 capsules) daily in divided doses
when a
satisfactory response is obtained. For example, two capsules three
times a day
reducing to one capsule four times a day.
_Paediatric population _
This formulation is not recommended for use in children.
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
•
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.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
There are no known interactions with other medicinal products or other
forms of
interaction.
4.6
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
Although tests in mammalian species have revealed no teratogenic
effects,
carbocisteine is not recommended during the first trimester of
pregnancy.
Breastfeeding
It is unknown whether carbocisteine and / or its metabolites are
excreted in
human milk. A risk to the ne