Carbocisteine 375mg Hard Capsules

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

CARBOCISTEINE

可用日期:

Zista Pharma Limited Suite G19, The Business & Technology Centre (btc), Bessemer Drive, Stevenage, Herts SG1 2DX, United Kingdom

ATC代码:

R05CB03

INN（国际名称）:

CARBOCISTEINE 375 mg

药物剂型:

HARD CAPSULE

组成:

CARBOCISTEINE 375 mg

处方类型:

POM

治疗领域:

COUGH AND COLD PREPARATIONS

授权状态:

Withdrawn

授权日期:

2019-03-05

资料单张

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4 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARBOCISTEINE 375 MG HARD CAPSULES
Carbocisteine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 signs of illness 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 Hard Capsules is and what it is used for
2.
What you need to know before you take Carbocisteine 375mg Hard
Capsules
3.
How to take Carbocisteine 375mg Hard Capsules
4.
Possible side effects
5.
How to store Carbocisteine 375mg Hard Capsules
6.
Contents of the pack and other information
1.
WHAT
Carbocisteine
375mg Hard Capsules
IS AND WHAT IT IS USED FOR
Carbocisteine 375 mg Hard Capsulescontain 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. The 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
Carbocisteine 375mg Hard Capsules
DO NOT TAKE CARBOCISTEINE 375MG HARD CAPSULES IF :
•
you are allergic to the active substance or any of the other
ingredients of this medicine
(listed in section 6).
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
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking this medicine if:
•
you are elderly.
•
have had an ulcer in your stomach or gut.
•
you are taking other medicin

产品特点

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbocisteine 375 mg Hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Carbocisteine 375 mg.
Excipient with known effect: Also contains 8.50 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
Yellow coloured size ‘1’ capsule printed ‘375’ in black
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 2250mg Carbocisteine
in
divided doses, reducing to 1500mg daily in divided doses when a
satisfactory
response is obtained e.g. two capsules three times a day reducing to
one
capsule four times a day.
_CHILDREN:_
This formulation is not recommended for children.
METHOD OF ADMINISTRATION
Carbocisteine capsules are for oral use.
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6
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.
Important information regarding the ingredients of this medicine
This product contains Lactose. Patients with rare hereditary problems
of
galactose intolerance, total lactase deficiency or glucose-galactose
malabsorption should not take this medicine.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None stated
4.6
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
Although tests in mammalian species hav