Carbocisteine 375mg capsules

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

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资料单张 资料单张 (PIL)
01-03-2019
产品特点 产品特点 (SPC)
29-06-2017
公众评估报告 公众评估报告 (PAR)
28-04-2011

有效成分:

Carbocisteine

可用日期:

DE Pharmaceuticals

ATC代码:

R05CB03

INN(国际名称):

Carbocisteine

剂量:

375mg

药物剂型:

Oral capsule

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 03070000

资料单张

                                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 
                                
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产品特点

                                OBJECT 1
CARBOCISTEINE 375MG CAPSULES
Summary of Product Characteristics Updated 11-Jul-2017 | Accord-UK Ltd
•
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
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
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
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
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
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. 
                                
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