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Carbocisteine 250mg/5ml Syrup

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Document: leaflet MAH BRAND_PLPI 18799-2592 change

5. How to store Mucodyne

syrup

5. How to store Mucodyne

syrup

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

•    Do not use Mucodyne syrup after the expiry date which is stated on the label and carton after EXP.

The expiry date refers to the last day of that month.

•    After use, wipe the neck of the bottle with a clean, damp cloth. This will remove any medicine left on the bottle, so you can put the cap back on tight. If you use the measuring beaker to take this medicine, make sure the beaker is clean and dry before you use it.

•    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.


6. Further information


What Mucodyne Syrup contains

Each 5ml of syrup contains 250mg of the active substance, carbocisteine. The other ingredients are methyl parahydroxybenzoate (E218), caramel colour, cinnamon oil, Aromatic Elixir (containing ethyl alcohol, rum and aromatic rum flavour), sodium hydroxide, purified water and sucrose.


What Mucodyne syrup looks like and contents of the pack

Mucodyne syrup is clear, amber coloured syrup with an odour of cinnamon and rum.

Mucodyne syrup is available in 250ml and 300ml bottles and comes with a measuring beaker.

Manufactured by:

Sanofi Winthrop Industrie, 1-3 allee de la Neste - Z.I. d'en Sigal, 31770, Colomiers, France.    OR

A. NATTERMANN & Cie GmbH, Cologne, Germany.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, UK.

Mucodyne® 250mg/5ml syrup PL 18799/2592

Leaflet date: 19.08.2015

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mucodyne®

250mg/5ml syrup

(carbocisteine)

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

The name your medicine is Mucodyne® syrup 250mg/5ml but will be referred as Mucodyne syrup throughout this leaflet.

In this leaflet:

1.    What Mucodyne Syrup is and what it is used for

2.    Before you take Mucodyne Syrup

3.    How to take Mucodyne Syrup

4.    Possible side effects

5.    How to store Mucodyne Syrup

6.    Further information

1. What Mucodyne syrup is and what it is used


M ucodyne Syrup 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.

Mucodyne syrup 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. Before you take Mucodyne syrup


ng Do not take this medicine and tell your doctor if:

x You are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Mucodyne syrup (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue x You have an ulcer in your stomach or gut (small intestine)

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 Mucodyne syrup.


Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if:

•    You are pregnant, might become pregnant or think you may be pregnant. This medicine should not be taken during the first three months of your pregnancy

•    You are breast-feeding or planning to breast-feed

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Important information about some of the ingredients of Mucodyne syrup.

Mucodyne syrup contains:

•    Sucrose: If you have been told by the doctor that you cannot tolerate some sugars, talk to your doctor before taking Mucodyne syrup.

•    Ethanol: Mucodyne syrup contains 1-34% ethanol (alcohol). A 15ml dose of this medicine contains up to 200mg of ethanol; this is about the same amount of alcohol as 4ml of beer or 1.67ml of wine per dose. This can be harmful for those suffering from alcoholism. It should also be taken into account in pregnant or breast-feeding women and high risk groups such as patients with liver disease or fits (epilepsy).


•    Sodium: This medicine contains 97mg of sodium in each 15ml dose. Take this into consideration if you are on a controlled sodium diet

*    Methyl parahydroxybenzoate:

May cause allergic reactions (these may not happen straight away). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.

3. How to take Mucodyne syrup

Always take Mucodyne syrup exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

•    Take this medicine by mouth

•    Mucodyne syrup comes with a measuring beaker

•    If you feel that this medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

How much to take

Adults (including the elderly)

•    Usual dose is 15ml three times each day

•    If your symptoms improve, your dose may be lowered to 10ml, three times, each day

Children

• Mucodyne syrup is not

recommended for children. A lower strength syrup called 'Mucodyne Paediatric 125mg/5ml Syrup' is available for use in children

If you take more Mucodyne syrup than you should

If you take more Mucodyne syrup 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 much Mucodyne syrup, it is likely that you will get an upset stomach (gastrointestinal disturbance).

If you forget to take Mucodyne syrup

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, Mucodyne syrup can cause side effects, although not everybody gets them.

Stop taking Mucodyne syrup 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 flulike symptoms and fever. This may be something called 'Stevens-Johnson syndrome'

Tell a doctor straight away if you notice any of the following serious side effects:

•    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, 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/ye llowcard.

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


•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

•    Do not use Carbocisteine syrup after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

•    After use, wipe the neck of the bottle with a clean, damp cloth. This will remove any medicine left on the bottle, so you can put the cap back on tight. If you use the measuring beaker to take this medicine, make sure the beaker is clean and dry before you use it.

•    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.


6. Further information


What Carbocisteine Syrup contains

Each 5ml of syrup contains 250mg of the active substance, carbocisteine. The other ingredients are methyl parahydroxybenzoate (E218), caramel colour, cinnamon oil, Aromatic Elixir (containing ethyl alcohol, rum and aromatic rum flavour), sodium hydroxide, purified water and sucrose.


What Carbocisteine syrup looks like and contents of the pack

Carbocisteine syrup is clear, amber coloured syrup with an odour of cinnamon and rum.

Carbocisteine syrup is available in 250ml and 300ml bottles and comes with a measuring beaker.

Manufactured by:

Sanofi Winthrop Industrie, 1-3 allee de la Neste - Z.I. d'en Sigal, 31770, Colomiers, France.    OR

A. NATTERMANN & Cie GmbH, Cologne, Germany.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, UK.

Carbocisteine 250mg/5ml syrup PL 18799/2592

Leaflet date: 19.08.2015

PACKAGE LEAFLET: INFORMATION FOR THE USER

Carbocisteine 250mg/5ml syrup

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

The name your medicine is Carbocisteine syrup 250mg/5ml but will be referred as Carbocisteine syrup throughout this leaflet.

In this leaflet:

1.    What Carbocisteine Syrup is and what it is used for

2.    Before you take Carbocisteine Syrup

3.    How to take Carbocisteine Syrup

4.    Possible side effects

5.    How to store Carbocisteine Syrup

6.    Further information

1. What Carbocisteine syrup is an d what it is


Carbocisteine Syrup 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 syrup 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. Before you take Carbocisteine syrup


ng Do not take this medicine and tell your doctor if:

x You are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Carbocisteine syrup (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue x You have an ulcer in your stomach or gut (small intestine)

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 syrup.


Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if:

•    You are pregnant, might become pregnant or think you may be pregnant. This medicine should not be taken during the first three months of your pregnancy

•    You are breast-feeding or planning to breast-feed

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Important information about some of the ingredients of Carbocisteine syrup.

Carbocisteine syrup contains:

•    Sucrose: If you have been told by the doctor that you cannot tolerate some sugars, talk to your doctor before taking Carbocisteine syrup.

•    Ethanol: Carbocisteine syrup contains 1-34% ethanol (alcohol). A 15ml dose of this medicine contains up to 200mg of ethanol; this is about the same amount of alcohol as 4ml of beer or 1.67ml of wine per dose. This can be harmful for those suffering from alcoholism. It should also be taken into account in pregnant or breast-feeding women and high risk groups such as patients with liver disease or fits (epilepsy).


•    Sodium: This medicine contains 97mg of sodium in each 15ml dose. Take this into consideration if you are on a controlled sodium diet

*    Methyl parahydroxybenzoate:

May cause allergic reactions (these may not happen straight away). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.

3. How to take Carbocisteine

Always take Carbocisteine syrup

exactly as your doctor has to ld you.

You should check with your doctor or

pharmacist if you are not sure.

Taking this medicine

•    Take this medicine by mouth

•    Carbocisteine syrup comes with a measuring beaker

•    If you feel that this medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

How much to take

Adults (including the elderly)

•    Usual dose is 15ml three times each day

•    If your symptoms improve, your dose may be lowered to 10ml, three times, each day

Children

• Carbocisteine syrup is not recommended for children. A lower strength syrup called 'Carbocisteine Paediatric 125mg/5ml Syrup' is available for use in children

If you take more Carbocisteine syrup than you should

If you take more Carbocisteine syrup 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 much Carbocisteine syrup, it is likely that you will get an upset stomach (gastrointestinal disturbance).

If you forget to take Carbocisteine syrup

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, Carbocisteine syrup can cause side effects, although not everybody gets them.

Stop taking Carbocisteine syrup 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 flulike symptoms and fever. This may be something called 'Stevens-Johnson syndrome'

Tell a doctor straight away if you notice any of the following serious side effects:

•    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, 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/ye llowcard.

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