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Carbocisteine 375mg Capsules

Document: leaflet ACTAVIS_PL 30306-0646 change

Read all of this leaflet carefully before you start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What is in this leaflet: j What Carbocisteine 375mg Capsules are and what they are used for

^ Before you take Carbocisteine 375mg Capsules

^ How to take Carbocisteine 375mg Capsules

4| Possible side effects a How to store Carbocisteine 375mg Capsules q Further information

J What Carbocisteine 375mg Capsules are and what they are used for

Carbocisteine 375mg Capsules are used to help treat respiratory tract problems (problems with the breathing passages) characterised by too much sticky mucus, including chronic obstructive airways disease (lung damage with restricted airways).

Carbocisteine 375mg Capsules contain carbocisteine which belongs to a group of medicines called mucolytics which cause the mucus to be less sticky and easier to cough up.

^ Before you take Carbocisteine 375mg Capsules

Do not take Carbocisteine 375mg Capsules:

•    If you are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Carbocisteine 375mg Capsules (ingredients are listed in Section 6)

•    If you have an active peptic (stomach) ulcer.

Before you take Carbocisteine 375mg Capsules you should tell your doctor:

•    If you are pregnant or planning to become pregnant

•    If you are breast feeding.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Currently carbocisteine is not known to effect or be affected by any other medicines you may be taking.

Pregnancy and breast-feeding

Carbocisteine 375mg Capsules are not recommended during the first three months of pregnancy.

If you are pregnant, think you are pregnant or are breast-feeding you must talk to your doctor before taking this medicine.

Driving and using machines

Carbocisteine 375mg Capsules are not known to affect the ability to drive or operate machinery.

a How to take Carbocisteine 375mg Capsules

Always take Carbocisteine 375mg Capsules exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

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The usual adult dose at the beginning of treatment is 2 capsules to be swallowed 3 times a day until a satisfactory improvement is seen. The dose is then reduced to 1 capsule 4 times a day.

If you take too many Carbocisteine 375mg Capsules:

If you take too many capsules contact your nearest hospital casualty department or tell your doctor IMMEDIATELY. Take the carton and this leaflet with you.

If you forget to take Carbocisteine 375mg Capsules, take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose but simply take your next dose at the normal time.

Do not take a double dose to make up for the one you missed.

If you have to go to the doctor, dentist or hospital for any reason, tell them you are taking Carbocisteine 375mg Capsules.

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

4 Possible side effects

Like all medicines, Carbocisteine 375mg Capsules can cause side effects, although not everybody gets them.

A few people can be allergic (hypersensitive) to some medicines: Contact your doctor or go to the nearest hospital casualty department IMMEDIATELY if any of the following happen after taking your medicine:

•    Wheezing, difficulty breathing or swallowing, dizziness

•    Swelling of the eyelids, face, lips, tongue or throat

•    Itchy skin rash affecting the whole body

Tell your doctor if you experience any of the following:

•    Skin rashes

•    Bleeding from the stomach or intestine (which may be seen as black, tar-like stools).

These are rare side effects (occurring in less than 1 person in 1000)

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

By reporting side affects you can help provide more information on the safety of this medicine.

^ How to store Carbocisteine 375mg Capsules

Keep out of the reach and sight of children. Store below 25°C.

Do not use Carbocisteine 375mg Capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

Each Carbocisteine 375mg Capsule contains:

•    The active substance: carbocisteine 375mg

•    Other ingredients: microcrystalline cellulose, macrogol, magnesium stearate

•    The capsules are made from gelatin, iron yellow oxide (E172), brilliant blue FCF (E133) and titanium dioxide (E171).

What Carbocisteine 375mg Capsules look like and contents of the pack

Carbocisteine 375mg Capsules are yellow and blue containing white to off-white odourless powder.

The capsules are packed in blisters, in cartons containing 120 capsules.

Marketing Authorisation Holder

Arrow Generics Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS,

United Kingdom

Manufacturer

Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8nS,

United Kingdom

This leaflet was last revised in July 2014.

Actavis, Barnstaple, EX32 8NS, UK

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