Carbocisteine 375mg Capsules, Hard

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

CARBOCISTEINE

Mevcut itibaren:

Brillpharma (Ireland) Limited Inniscarra, Main Street, Rathcoole, Co. Dublin, Ireland

ATC kodu:

R05CB03

INN (International Adı):

CARBOCISTEINE 375 mg

Farmasötik formu:

HARD CAPSULE

Kompozisyon:

CARBOCISTEINE 375 mg

Reçete türü:

POM

Terapötik alanı:

COUGH AND COLD PREPARATIONS

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2019-01-30

Bilgilendirme broşürü

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5 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.
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 Carbocisteine Capsules.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking this medicine if:
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Ürün özellikleri

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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 (6 Capsules)
Carbocisteine in divided doses, reducing to 1500mg (4 capsules) 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.
_ _
_PAEDIATRIC POPULATION: _
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.
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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.
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.
Because of the possible effect on the mucous glands of the stomach,
this
product should be used with caution in patients with a history of
peptic
ulceration.
IMPOR