Carbocisteine 375mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carbocisteine

Available from:

A A H Pharmaceuticals 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: 5025903015949

Patient Information leaflet

BBBA3995
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CARBOCISTEINE 375MG CAPSULES
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
only. 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 this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1 WHAT CARBOCISTEINE 375MG CAPSULES
ARE AND WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CARBOCISTEINE 375MG CAPSULES
3 HOW TO TAKE CARBOCISTEINE 375MG
CAPSULES
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE CARBOCISTEINE 375MG
CAPSULES
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT CARBOCISTEINE 375MG CAPSULES
ARE AND WHAT THEY ARE USED FOR
Carbocisteine 375mg Capsules are used to
help treat respiratory tract problems (problems
with the breathing passages) characterised
by too much sticky mucus, including chronic
obstructive airways disease (lung damage with
restricted airways).
Carbocisteine 375mg Capsules contain
carbocisteine which belongs to a group of
medicines called mucolytics which cause the
mucus to be less sticky and easier to cough up.
2 WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CARBOCISTEINE 375MG CAPSULES
DO NOT TAKE CARBOCISTEINE 375MG
CAPSULES IF YOU:
• are ALLERGIC to carbocisteine or any of the
other ingredients of this medicine (listed in
section 6)
• have an ACTIVE PEPTIC (STOMACH) ULCER.
WARNINGS AND PRECAUTIONS
Talk to your doctor if you:
• are ELDERLY
• have a history of STOMACH ULCERS
• are taking medicines that may cause
INTESTINAL BLEEDING
• are PREGNANT or planning to become
pregnant
• are BREAST FEEDING.
OTHER MEDICINES AND CARBOCISTEINE
375MG CAPSULES
Tell your doctor or pharmacist if you are taking,
have recently taken

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