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CARBOCISTEINE 375 MG CAPSULES HARD

Active substance(s): CARBOCISTEINE

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TEVA UK Ref:

Version:

231-30-22011-C LEA CARBOCISTEINE 375mg CAPS TUK
3

4 June 2015

breathing problems, swelling of the lips,
face, throat or tongue.
• you have an ulcer in your stomach or gut.

Carbocisteine 375 mg
Capsules, hard
PACKAGE LEAFLET:
INFORMATION FOR THE USER
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 375 mg Capsules,hard contain
the active substance 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 is 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 Carbocisteine if you
• are allergic (hypersensitive) to
carbocisteine or any of the other
ingredients of Carbocisteine (see list of
ingredients in section 6). An allergic
reaction may include rash, swallowing or

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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.

knows what you have taken. If you take too
many Carbocisteine capsules, it is likely that
you will get an upset stomach
(gastrointestinal disturbance).

Warnings and precautions
Talk to your doctor or pharmacist before
taking Carbocisteine. Caution is
recommended in patients with peptic ulcers.

If you forget to take Carbocisteine
If you forget a dose, do not worry. Just wait
until the next dose is due. Do not take a
double dose to make up for a forgotten dose.

Children and adolescents
Carbocisteine capsules should not be used
in children.

If you have any further questions on the use
of this medicine, ask your doctor or
pharmacist.

Pregnancy, breast-feeding and fertility
• If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby ask your doctor
or pharmacist for advice before taking this
medicine.
Carbocisteine contains lactose
Patients who are intolerant to lactose (milk
sugar) should note that Carbocisteine
contains a small amount of lactose. If you
have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicinal product.

3

How to take Carbocisteine

Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
The recommended dose is
Adults (including the elderly)
The usual dose is 2 capsules, 3 times a day.
If your symptoms improve, your dose should
be lowered to 1 capsule, 4 times a day
Use in children and adolescents
Carbocistine is not recommended for
children.
Route(s) and/or method of administration
Take this medicine by mouth.
If you feel that this medicine is too weak or
too strong, do not change the dose yourself,
but ask your doctor.
If you take more Carbocisteine than you
should
If you take more Carbocisteine than you
should, tell a doctor or go to a hospital
casualty department straight away. Take the
medicine pack with you. This is so the doctor

Version 2.6

Approved

4

Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Stop taking Carbocisteine and tell your
doctor immediately or go to the casualty
department at your nearest hospital if the
following happens:
• an allergic reaction causing swelling of
the lips, face or neck leading to severe
difficulty in breathing, severe skin rash or
hives
• blood in your vomit or black tarry stools.

How to store Carbocisteine

Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton and blister
or label after the abbreviation EXP. The
expiry date refers to the last day of that
month.
Do not store above 25°C.
Do not throw away any medicines via
wastewater or household waste . Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

6

Contents of the pack and other
information

What Carbocisteine contains
The active substance is carbocisteine. Each
capsule contains 375 mg carbocisteine.
The other ingredients are:
Lactose monohydrate
Sodium laurilsulphate
Silica, colloidal anhydrous
Magnesium stearate

These are very serious but rare side effects.
You may need urgent medical attention or
hospitalisation.

Capsule cap/body:
Gelatin
Sodium laurilsulphate
Iron oxide yellow (E172)
Titanium dioxide (E171)

The following side effects have also been
reported at the approximate frequencies
shown:

Printing ink:
Shellac, Black iron oxide (E172), Propylene
glycol, Potassium hydroxide

Rare: may affect up to 1 in 1,000 people
• nausea, diarrhoea.

What Carbocisteine looks like and contents
of the pack
Carbocisteine capsules are yellow, size 1
hard capsules, imprinted “6C1” on the cap
and “375” on the body, containing a white
or off-white granular powder. They are
available in tubs containing 100 capsules, or
in blister packs of 30, 100 & 120 capsules.

Very rare: may affect up to 1 in 10,000
people
• allergic skin reactions such as pruritus,
urticaria and rash
• abdominal pain.
• Severe illness with blistering of the skin,
mouth, eyes and genitals
• Inflamatory skin eruption.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.

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Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
TEVA UK Limited, Brampton Road,
Hampden Park, Eastbourne, BN22 9AG,
United Kingdom.
This leaflet was last revised in 04/2015
PL 00289/1500

22011-C

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 mockup-pil-uk-pl00289-1500-carbocisteine-caps-375mg

APPROVALS
Signed by
Hemal Joshi

REG0067695

Meaning of Signature
Regulatory Affairs Approval

Version 2.6

Approved

Server Date
16-Jun-2015 02:28:20 PM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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