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Stop taking Soluble Paracetamol and Codeine Tablets and see a doctor or go to a hospital straight away if:

•    You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swatlowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Soluble Paracetamol and Codeine Tablets

•    You get serious skin reactions. Very rare cases have been reported.

Talk to your doctor straight away if you notice any of the following serious side effects:

•    Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This is a very rare side effect

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

•    Constipation • Feeling sick (nausea), being sick (vomiting)

•    Dizziness, light-headedness, drowsiness, confusion • Difficulty in passing water

•    You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia)

•    Becoming addicted to codeine 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 at: www.mhra.aov.uk/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

How do I know if I am addicted?

If you take this medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

•    You need to take the medicine for longer periods of time

•    You need to take more than the recommended dose

•    When you stop taking this medicine you feel very unwell but you feel better if you start taking the medicine again

5.    HOW TO STORE SOLUBLE PARACETAMOL AND CODEINE TABLETS

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date shown on the pack. The expiry date refers to the last day of that month.

Store your medicine in the original packaging in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist howto throw away medicines you no longer use. This will help protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Soluble Paracetamol and Codeine Tablets contain

•    The active substances are codeine phosphate and paracetamol. Each tablet contains 8mg of codeine phosphate and 500mg of paracetamol

•    The other ingredients are sorbitol, saccharin sodium, sodium lauryl sulphate, citric acid, sodium carbonate, sodium bicarbonate, povidone and dimeticone.

What Soluble Paracetamol and Codeine Tablets look like and contents of the pack

Flat white tablets with bevelled edges. They come in cartons of 24 and 32 tablets. Not all pack sizes may be marketed.

The Marketing Authorisation Holder is Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.

The Manufacturer is Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon, Newcastle upon Tyne, NE3 3TT, UK

This leaflet was last updated in April 2014

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PACKAGE LEAFLET - INFORMATION FOR THE USER

SOLUBLE PARACETAMOL AND CODEINE TABLETS

Codeine Phosphate and Paracetamol

0 Important things you should know about Soluble Paracetamol and Codeine Tablets

• This medicine can only be used for the short term treatment of acute moderate pain when other painkillers have not worked • You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it • If you take this medicine for headaches for more than 3 days it can make them worse

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.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Soluble Paracetamol and Codeine Tablets are and what they are used for

2.    What you need to know before you take Soluble Paracetamol and Codeine Tablets

3.    Howto take Soluble Paracetamol and Codeine Tablets

4.    Possible side effects

5.    Howto store Soluble Paracetamol and Codeine Tablets

6.    Contents of the pack and other information

•    You are breastfeeding or planning to breastfeed

•    The person going to take the tablets is under 12 years of age. Soluble Paracetamol and Codeine Tablets must not be given to children under 12 years of age.

•    You are under 18 years of age and have had your tonsils or adenoids removed due to obstructive sleep apnoea syndrome

•    You know that you metabolise very rapidly codeine into morphine

Do not take Soluble Paracetamol and Codeine Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Soluble Paracetamol and Codeine Tablets.

Warnings and precautions

Take special care and check with your doctor before taking Soluble Paracetamol and Codeine Tablets if:

•    You have severe kidney or liver problems

•    You have a liver problem caused by alcohol

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Children and adolescents

Use in children and adolescents after surgery

Soluble Paracetamol and Codeine Tablets should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.

Use in children with breathing problems

Soluble Paracetamol and Codeine Tablets is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Other medicines and Soluble Paracetamol and Codeine Tablets

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Soluble Paracetamol and Codeine Tablets and other medicines can affect the way each other work.

While taking Soluble Paracetamol and Codeine Tablets you should not take any other medicines which contain paracetamol.

This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.

Do not take this medicine and tell your doctor or pharmacist if you are taking any of the following:

•    Medicines used to thin the blood such as warfarin

•    Metoclopramide or domperidone - used to stop you feeling sick (nausea) or being sick (vomiting)

•    Colestyramine - for lowering blood cholesterol levels

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Soluble Paracetamol and Codeine Tablets.

Pregnancy and breast-feeding

Talk to your doctor before taking these tablets if:

•    You are pregnant, think you may be pregnant or plan to get pregnant,

•    You are planning to breastfeed

•    Do not take Soluble Paracetamol and Codeine Tablets while you are breastfeeding. Codeine and morphine passes into breast milk.

Driving and using machines

Soluble Paracetamol and Codeine Tablets can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive whilst taking this medicine until you know how it affects you

•    It is an offence to drive if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

-    The medicine has been prescribed to treat a medical or dental problem and

-    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive whilst taking this medicine.

Soluble Paracetamol and Codeine Tablets contains sodium and sorbitol

•    Sodium: There is 388mg of sodium per effervescent tablet. This may be harmful to people on a low sodium or low salt diet.

•    Sorbitol: This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.

3.    HOW TO TAKE SOLUBLE PARACETAMOL AND CODEINE TABLETS

Always take Soluble Paracetamol and Codeine Tablets exactly as instructed on this leaflet. Check with your doctor or pharmacist if you are not sure.

Adults and children over 12

•    Do not take more than the recommended dose.

•    Do not take for more than 3 days. If the pain does not improve after 3 days you must speak to your doctor or pharmacist

•    The usual dose of Soluble Paracetamol and Codeine Tablets is 2 effervescent tablets, taken together

•    Dissolve the effervescent tablets in a glass of water before taking

•    Adults should wait at least 4 hours before taking another dose

•    Children aged 12 years and over should wait at least 6 hours before taking another dose

•    Do not take more than 8 tablets in any 24-hour period

This medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, talk to your doctor for advice.

Use in children

Soluble Paracetamol and Codeine Tablets should not be given to children under 12 years of age due to the risk of severe breathing problems.

If you take more Soluble Paracetamol and Codeine Tablets than you should

•    Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

•    Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken

If you forget to take Soluble Paracetamol and Codeine Tablets If you forget to take a dose at the right time, take it as soon as you remember. However do not take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours between doses.

If you stop taking Soluble Paracetamol and Codeine Tablets This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Important side-effects you should know about Soluble Paracetamol and Codeine Tablets

•    Taking a painkiller for headaches too often or for too long can make them worse.

•    Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets

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PACKAGE LEAFLET - INFORMATION FOR THE USER

SOLUBLE PARACETAMOL AND CODEINE TABLETS

Codeine Phosphate and Paracetamol

Q Important things you should know about Soluble Paracetamol and Codeine Tablets

• This medicine can only be used for the short term treatment of acute moderate pain when other painkillers have not worked • You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it • If you take this medicine for headaches for more than 3 days it can make them worse

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.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1. What Soluble Paracetamol and Codeine Tablets are and what they are used for

2. What you need to know before you take Soluble Paracetamol and Codeine Tablets

3. How to take Soluble Paracetamol and Codeine Tablets

4. Possible side effects

5. How to store Soluble Paracetamol and Codeine Tablets

6. Contents of the pack and other information

1. WHAT SOLUBLE PARACETAMOL AND CODEINE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Soluble Paracetamol and Codeine Tablets. Soluble Paracetamol and Codeine Tablets contains two different medicines called codeine phosphate and paracetamol. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paracetamol. It is for the short term treatment of acute moderate pain caused by headaches, migraine, toothache, neuralgia, period pain and rheumatic pains when other painkillers have not worked. Wait at least 4 hours after you last took other painkillers before taking this medicine.

Soluble Paracetamol and Codeine Tablets can be used in children over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLUBLE PARACETAMOL AND CODEINE TABLETS

This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it If you take a painkiller for headaches for more than 3 days it can make them worse

Do not take Soluble Paracetamol and Codeine Tablets and tell your doctor if:

• You are allergic to the active substances or any of the other ingredients in your medicine (listed in Section 6)

Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue

•    You are breastfeeding or planning to breastfeed

•    The person going to take the tablets is under 12 years of age. Soluble Paracetamor ana Codeine Tablets must not be given to children under 12 years of age.

•    You are under 18 years of age and have had your tonsils or adenoids removed due to obstructive sleep apnoea syndrome

•    You know that you metabolise very rapidly codeine into morphine

Do not take Soluble Paracetamol and Codeine Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Soluble Paracetamol and Codeine Tablets.

Warnings and precautions

Take special care and check with your doctor before taking Soluble Paracetamol and Codeine Tablets if:

•    You have severe kidney or liver problems

•    You have a liver problem caused by alcohol

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Children and adolescents

Use in children and adolescents after surgery

Soluble Paracetamol and Codeine Tablets should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.

Use in children with breathing problems

Soluble Paracetamol and Codeine Tablets is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Other medicines and Soluble Paracetamol and Codeine Tablets

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Soluble Paracetamol and Codeine Tablets and other medicines can affect the way each other work.

While taking Soluble Paracetamol and Codeine Tablets you should not take any other medicines which contain paracetamol.

This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.

Do not take this medicine and tell your doctor or pharmacist if you are taking any of the following:

•    Medicines used to thin the blood such as warfarin

•    Metoclopramide or domperidone - used to stop you feeling sick (nausea) or being sick (vomiting)

•    Colestyramine - for lowering blood cholesterol levels

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Soluble Paracetamol and Codeine Tablets.

Pregnancy and breast-feeding

Talk to your doctor before taking these tablets if:

•    You are pregnant, think you may be pregnant or plan to get pregnant,

•    You are planning to breastfeed

•    Do not take Soluble Paracetamol and Codeine Tablets while you are breastfeeding. Codeine and morphine passes into breast milk.

Stop taking Soluble Paracetamol and Codeine Tablets and see a doctor or go to a hospital straight away if:

•    You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may meanyou are having an allergic reaction to Soluble Paracetamol and Codeine Tablets

•    You get serious skin reactions. Very rare cases have been reported.

Talk to your doctor straight away if you notice any of the following serious side effects:

•    Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This is a very rare side effect

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 at: www.mhra.gov.uk/ye1lowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

^3 How do I know if I am addicted?

If you take this medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

•    You need to take the medicine for longer periods of time

•    You need to take more than the recommended dose

•    When you stop taking this medicine you feel very unwell but you feel better if you start taking the medicine again

5. HOW TO STORE SOLUBLE PARACETAMOL AND CODEINE TABLETS

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date shown on the pack. The expiry date refers to the last day of that month.

Store your medicine in the original packaging in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What Soluble Paracetamol and Codeine Tablets contain

•    The active substances are codeine phosphate and paracetamol. Each tablet contains 8mg of codeine phosphate and 500mg of paracetamol

•    The other ingredients are sorbitol, saccharin sodium, sodium lauryl sulphate, citric acid, sodium carbonate, sodium bicarbonate, povidone and dimeticone.

What Soluble Paracetamol and Codeine Tablets look like and contents of the pack

Flat white tablets with bevelled edges. They come in cartons of 24 and 32 tablets.

Not all pack sizes may be marketed.

The Marketing Authorisation Holder is Zentiva, One Onslow Street, Guildford,

Surrey GU1 4YS, UK

The Manufacturer is A. Nattermann & Cie. GmbH, Nattermannallee 1,50829 Cologne, Germany

This leaflet was last updated in September 2014

418591-09.14-GB

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