Carbocisteine 375mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carbocisteine

Available from:

Flamingo Pharma (UK) 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: 5060464500404

Patient Information leaflet

160 mm
280 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBOCISTEINE 375 MG 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 Capsule is and what it is used for
2. What you need to know before you take Carbocisteine Capsule
3. How to take Carbocisteine Capsule
4. Possible side effects
5. How to store Carbocisteine Capsule
6. Contents of the pack and other information
1. WHAT CARBOCISTEINE CAPSULE IS AND WHAT IT IS USED FOR
Carbocisteine 375 mg Capsules 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 CAPSULE
DO NOT TAKE CARBOCISTEINE CAPSULES IF:
• You are allergic to carbocisteine or any of the
other ingredients of this medicine (listed in
Section 6)
•
S igns of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of the
lips, face, throat or tongue
•
Y ou 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.
•
LACTOSE: This medicine contains lactose. This is a
type of sugar. If you have been told by your doctor
that you can

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbocisteine 375 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbocisteine 375 mg
Excipient(s) with known effect:
Each capsule contains 22.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule
Yellow size ‘1’ hard gelatin capsules imprinted with ‘C’ on
cap and ‘375mg’ on body
with black ink containing white to off white granular powder or
friable plug.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carbocisteine is a mucolytic agent for the adjunctive therapy of
respiratory tract
disorders characterized by excessive, viscous mucus, including chronic
obstructive
airways disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS INCLUDING THE ELDERLY: _
Dosage is based upon an initial daily dosage of 2250 mg Carbocisteine
in divided
doses, reducing to 1500 mg 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.
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.
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.
Patients
with
rare
hereditary
problems
of
galactose
intolerance,
total
lactase
deficiency or glucose-galactose malabsoprtion 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
There are no available data on carbocisteine use in pregnant women. No
conclusions
can
be
drawn
regarding
whether
or
not
ca