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CARBOCISTEINE 375 MG CAPSULES HARD

Active substance(s): CARBOCISTEINE / CARBOCISTEINE / CARBOCISTEINE

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Package leaflet: Information for the user

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 375 mg Capsules, hard (called
Carbocisteine in this leaflet) contains 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 is used for respiratory tract
disorders 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 to carbocisteine 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.
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 medicines known to cause
bleeding in the stomach.
Pregnancy and breast-feeding
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.
This medicine should not be taken during the first
three months of your pregnancy.

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.
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.
Adults and elderly
The recommended dose is two capsules, 3 times
each day. If your symptoms improve, your dose
should be lowered to one capsule, 4 times, each
day.
Use in children
Carbocisteine is not recommended for children.
If you take more Carbocisteine than you
should
If you take more capsules 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 knows what
you have taken. If you take too many capsules,
it is likely that you will get an upset stomach
(gastrointestinal disturbance).

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

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Carbocisteine and see a doctor or
go to a hospital straight away if:
- You have an allergic reaction. The signs
may include: a rash, swallowing or breathing
problems, swelling of the lips, face, throat or
tongue.
- You have blistering or bleeding of the skin,
including around your lips, eyes, mouth,
nose and genitals. You may also have flu-like
symptoms and fever. This may be something
called ‘Stevens-Johnson syndrome’.
- You have blood in your vomit or black tarry stools.
Tell your doctor or pharmacist if any of the
following side effects get serious or lasts
longer than a few days:
- Vomiting.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme, website www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Carbocisteine
Store below 30°C.
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 after
“EXP”. The expiry date refers to the last day of
that month.
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 of carbocisteine.
- The other ingredients are:
Capsule Contents: mannitol; maize starch;
croscarmellose sodium; sodium laurilsulfate,
grade K12; colloidal anhydrous silica and
magnesium stearate.
Capsule Shell: gelatine; red iron oxide E172;
titanium dioxide E171 and yellow iron oxide
E172.
What Carbocisteine looks like and contents
of the pack
The Carbocisteine capsules are hard gelatine
capsules, filled with homogenous white
powder. The colour of the capsule body and
of the capsule cap is dull-yellow opaque. The
dimension of each capsule is approximately
19.4 ± 0.3 mm.
The capsules are blister-packed in transparent
PVC/PVDC/aluminium hard foil. Each blister
strip contains 10 capsules.
Pack sizes: 20, 30, 50 or 120 capsules.
Not all pack sizes may be marketed.
Marketing
Authorisation
Holder
Manufacturer
ALKALOID-INT d.o.o.,
Šlandrova ulica 4,
Ljubljana-Črnuče, 1231, Slovenia
PL 34088/0044
Distibuted by
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park
Croxley Green, Hertfordshire, WD18 8YA
United Kingdom
This leaflet was last revised in 11/2016

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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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