Carbocisteine Capsules Hard 375mg

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

CARBOCISTEINE

Sẵn có từ:

Bristol Laboratories Limited

Mã ATC:

R05CB03

INN (Tên quốc tế):

CARBOCISTEINE

Dạng dược phẩm:

HARD CAPSULE

Thành phần:

CARBOCISTEINE 375 milligram(s)

Loại thuốc theo toa:

POM

Khu trị liệu:

COUGH AND COLD PREPARATIONS

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2019-01-30

Tờ rơi thông tin

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4 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARBOCISTEINE 375 MG CAPSULES, HARD
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 is and what it is used for
2.
What you need to know before you take Carbocisteine
3.
How to take Carbocisteine
4.
Possible side effects
5.
How to store Carbocisteine
6.
Contents of the pack and other information
1.
WHAT CARBOCISTEINE IS AND WHAT IT IS USED FOR
Carbocisteine 375mg Capsules, Hard (called Carbocisteine 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. Carbocisteine 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
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
You are allergic to 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.
If you are not sure, talk to your doctor or pharmacist before taking
Carbocisteine
Capsules.
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4
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking this medicine if:
•
You are elderly.
•
You have had an ulcer in your st

Đặc tính sản phẩm

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5
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbocisteine
375 mg Capsules, Hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 375mg of Carbocisteine.
Excipient(s) with known effect: Each capsule contains 8.5mg of lactose
monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, Hard (capsule)
Size “1” hard gelatin capsule having yellow cap & yellow body
printed with
“375” in black ink and containing a white to off white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carbocisteine is a mucolytic agent for the adjunctive therapy of
respiratory
tract disorders characterised by excessive or 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. The normal daily
dosage is
20mg/kg body weight in divided doses.
It is recommended that this is achieved with Paediatric Syrup.
_METHOD OF ADMINISTRATION _
Carbocisteine capsules are for oral use.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance(s) or to any of the
excipients
listed in section 6.1.
•
Use in patients with active peptic ulceration.
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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 _
Patients with rare hereditary problems of galactose intolerance, the
Lapp
lactase deficiency or glucose-galactose malabsorption should not tak