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Carbocisteine Syrup 250mg/5ml

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Mucodyne Syrup 250mg/5ml Ref: 1171/130513/01/F

(carbocisteine)

Patient Information Leaflet

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.

Your medicine is called Mucodyne Syrup 250mg/5ml but will be referred to as Mucodyne Syrup throughout the leaflet.

In this leaflet:

,1^ What Mucodyne Syrup is and what it is used for Before you take Mucodyne Syrup ,3^ How to take Mucodyne Syrup Possible side effects How to store Mucodyne Syrup Further information

^ What Mucodyne Syrup is and what it is used for

Mucodyne Syrup 250 mg/5 ml (called Mucodyne Syrup 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.

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.

l2) Before you take Mucodyne Syrup

Do not take this medicine and tell your doctor if:

*    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

*    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 125mg/5ml paediatric 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.

Mucodyne Syrup 250mg/5ml

(carbocisteine)

Ref: 1171/130513/01/B

Possible side effects

Like all medicines, Mucodyne Syrup can cause side effects, although not everybody gets them.

Manufacturer and Licence Holder

This medicine is manufactured by A. NATTERMANN & Cie GmbH, Cologne, Germany. and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

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 flu-like 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

Talk to your doctor or a pharmacist if you notice any side effects not listed in this leaflet.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 15184/1171 Mucodyne Syrup 250mg/5ml Mucodyne is a registered trademark of Aventis Pharma B.V.

Revision date: 13/05/13

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

How to store Mucodyne Syrup

Keep out of the sight and reach of children.

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.

Do not store above 25°C.

When diluted Mucodyne Syrup should not be kept for more than 14 days 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

What Mucodyne Syrup contains

*    Each 5ml of syrup contains 250mg of the active substance, carbocisteine

*    The other ingredients are caramel (E150), methyl parahydroxybenzoate (E218), cinnamon oil, sodium hydroxide, water purified, sucrose, aromatic elixir

What Mucodyne Syrup looks like and contents of the pack

Mucodyne syrup is a clear amber syrup smelling of rum and slightly of cinnamon.

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

(carbocisteine)

Patient Information Leaflet

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.

Your medicine is called Rhinathiol Syrup 250mg/5ml but will be referred to as Rhinathiol Syrup throughout the leaflet.

In this leaflet:

[ft What Rhinathiol Syrup is and what it is used for ^ Before you take Rhinathiol Syrup 3 How to take Rhinathiol Syrup Possible side effects How to store Rhinathiol Syrup Further information

^ What Rhinathiol Syrup is and what it is used for

Rhinathiol Syrup 250 mg/5 ml (called Rhinathiol Syrup 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.

Rhinathiol 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.

[p Before you take Rhinathiol Syrup

Do not take this medicine and tell your doctor if:

*    You are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Rhinathiol 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

*    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 Rhinathiol 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 Rhinathiol Syrup

Rhinathiol Syrup contains:

*    Sucrose: If you have been told by the doctor that you cannot tolerate some sugars, talk to your doctor before taking Rhinathiol Syrup

*    Ethanol: Rhinathiol 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.

How to take Rhinathiol Syrup

Always take Rhinathiol 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

*    Rhinathiol 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

*    Rhinathiol Syrup is not recommended for children. A lower strength 125mg/5ml paediatric syrup is available for use in children

If you take more Rhinathiol Syrup than you should

If you take more Rhinathiol 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 Rhinathiol Syrup, it is likely that you will get an upset stomach (gastrointestinal disturbance).

If you forget to take Rhinathiol 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.

Rhinathiol Syrup 250mg/5ml

(carbocisteine)

Ref: 1171/130513/02/B

Patient Information Leaflet

Manufacturer and Licence Holder

This medicine is manufactured by A.NATTERMANN & Cie GmbH, Cologne, Germany. and is procured from within the EU and repackaged by the

Possible side effects

Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

Like all medicines, Rhinathiol Syrup can cause side effects, although not everybody gets them.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

Stop taking Rhinathiol 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

POM PL 15184/1171 Rhinathiol Syrup 250mg/5ml

or breathing problems, swelling of the lips, face, throat or tongue * You have blistering or bleeding of the skin, including around your lips,

Rhinathiol is a registered trademark of Sanofi-Aventis.

eyes, mouth, nose and genitals. You may also have flu-like symptoms and fever. This may be something called ‘Stevens-Johnson synddrome'.

Revision date: 13/05/13

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

* Blood in your vomit or black tarry stools

Talk to your doctor or a pharmacist if you notice any side effects not listed in this leaflet.

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

How to store Rhinathiol Syrup

Keep out of the sight and reach of children.

Do not use Rhinathiol 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.

Do not store above 25°C.

When diluted Rhinathiol Syrup should not be kept for more than 14 days 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

What Rhinathiol Syrup contains

* Each 5ml of syrup contains 250mg of the active substance, carbocisteine

* The other ingredients are caramel (E150), methyl parahydroxybenzoate

(E218), cinnamon oil, sodium hydroxide, water purified, sucrose, aromatic elixir

What Rhinathiol Syrup looks like and contents of the pack

Rhinathiol Syrup is a clear amber syrup smelling of rum and slightly of

cinnamon.

Rhinathiol Syrup is available in 250ml bottles and comes with a measuring beaker.

Patient Information Leaflet

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.

Your medicine is called Carbocisteine Syrup 250mg/5ml but will be referred to as Carbocisteine Syrup throughout the leaflet.

In this leaflet:

[ft What Carbocisteine Syrup is and what it is used for ^ Before you take Carbocisteine Syrup 3 How to take Carbocisteine Syrup Possible side effects How to store Carbocisteine Syrup Further information

^ What Carbocisteine Syrup is and what it is used for

Carbocisteine Syrup 250 mg/5 ml (called Carbocisteine Syrup 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 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.

[p Before you take Carbocisteine Syrup

Do not take this medicine and tell your doctor if:

*    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

*    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.

How to take Carbocisteine Syrup

Always take Carbocisteine 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

*    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 125mg/5ml paediatric 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.

Patient Information Leaflet 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 flu-like 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

Talk to your doctor or a pharmacist if you notice any side effects not listed in this leaflet.

Manufacturer and Licence Holder

This medicine is manufactured by A.NATTERMANN & Cie GmbH, Cologne, Germany. and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

[POMl PL 15184/1171 Carbocisteine Syrup 250mg/5ml

Revision date: 13/05/13

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

^ How to store Carbocisteine Syrup

Keep out of the sight and reach of children.

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.

Do not store above 25°C.

When diluted Carbocisteine Syrup should not be kept for more than 14 days 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 caramel (E150), methyl parahydroxybenzoate

(E218), cinnamon oil, sodium hydroxide, water purified, sucrose, aromatic elixir

What Carbocisteine Syrup looks like and contents of the pack

Carbocisteine Syrup is a clear amber syrup smelling of rum and slightly of cinnamon.

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