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Document: leaflet LLOYDS_PL 00142-0197 change

• leaflet LLOYDS_PL 00142-0197
• leaflet MAH GENERIC_PL 00142-0197
• leaflet MAH GENERIC_PL 28444-0147
• leaflet MAH GENERIC_PL 41318-0040

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

This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by

paracetamol, ibuprofen or aspirin alone. Do not take less than four hours after taking other painkillers.

You should only take this product for a maximum of three 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 three 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 three days it can make them worse.

•    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.

Index

T| What Co-codamol tablets are and what they are used for

2    Before you take

3    How to take

4    Possible side effects ~5| How to store

"6| Further information

_1 What Co-codamol tablets are and what they are used for

Co-codamol tablets belong to a group of medicines called analgesics and are used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.

Do not take less than four hours after taking other painkillers.

J Before you take

•    This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it (see 'If you stop taking the tablets').

•    If you take a painkiller for headaches for more than three days it can make them worse.

Do not take Co-codamol tablets and tell your doctor if you:

•    are allergic (hypersensitive) to paracetamol, codeine phosphate or other opioids, or any of the ingredients in the tablet (see section 6)

•    have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis)

•    have difficulty breathing, or other chronic lung disease

•    are having an asthma attack.

Check with your doctor or pharmacist before taking Co-codamol tablets if you have:

•    liver or kidney problems

•    diseased adrenal glands (Addison's disease) or high blood pressure caused by a tumour near a kidney (phaeochromocytoma)

•    inflammatory bowel disease

•    gall bladder disease or gall stones

•    recently had surgery on your gastro-intestinal tract or urinary system

•    an enlarged prostate gland and have difficulty urinating and are male

•    epilepsy or suffered head injury or raised pressure in the

skull (may cause painful eyes, changes in vision or headache behind the eyes)

•    an underactive thyroid gland

•    muscle weakness (myasthenia gravis)

•    low blood pressure or are in shock

•    suffered from alcoholism, drug abuse or dependence or mental illness.

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. Especially:

•    ciprofloxacin (antibacterial medicine)

•    Monoamine Oxidase Inhibitors (MAOIs, eg. moclobemide)

•    oral contraceptives (the "pill")

•    medicines to prevent blood clotting such as warfarin

•    cyclizine, metoclopramide or domperidone (to prevent sickness)

•    guanethidine or diuretics ("water tablets") e.g. spironolactone, furosemide (to treat high blood pressure)

•    mexiletine (to treat irregular heartbeats)

•    loperamide or kaolin (to treat diarrhoea)

•    selegiline (for Parkinson's disease)

•    phenytoin (to treat epilepsy)

•    cimetidine (to treat stomach ulcers)

•    atropine or hyoscine (anticholinergic medicines)

•    cisapride (to treat gastro-oesophageal reflux disease)

•    medicines which affect the nervous system such as sleeping tablets, diazepam, hydroxyzine and medicines to treat mental illness

•    medicines to treat depression {eg. tranylcypromine, amitriptyline)

•    medicines which affect the liver (e.g. primidone and rifampicin)

•    colestyramine (to treat high cholesterol levels)

•    muscle relaxants

•    barbiturates (e.g. phenobarbital)

•    anaesthetics

•    opioid antagonists (buprenorphine, naltrexone, naloxone)

Diet

If your diet is poor or you have a low protein intake, you may be at a higher risk of serious paracetamol poisoning when taking Co-codamol tablets.

Driving and using machines

Co-codamol tablets may cause dizziness, blurred vision or the inability to think clearly. Make sure you are not affected before you drive or operate machinery.

Continued over page

Pregnancy and breast-feeding

Do not take Co-codamol tablets during pregnancy or whilst breast-feeding, unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn. Usually it is safe to take Co-codamol tablets while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.

_3| How to take

Always take Co-codamol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Do not drink alcohol whilst taking Co-codamol tablets. Swallow the tablets with water.

Take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice.

Doses:

Do not take for more than three days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist.

•    Adults and children over 12 years: 1 to 2 tablets every 4 to 6 hours up to a maximum of 8 tablets in a day

•    Children aged 6 to 12 years: half to 1 tablet every 4 to 6 hours up to a maximum of 4 tablets in a day

•    Children under 6 years: not recommended

•    Elderly: Dosage is usually reduced in the elderly with liver damage.

If you take more than you should Seek immediate medical advice in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick, loss of appetite, stomach pain or liver damage, coma, clammy skin, fits, confusion, drowsiness, tiredness, low blood pressure, pinpoint pupils, slow heart beat or breathing rate.

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking the tablets

This medicine contains codeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms such as tremor, difficulty sleeping, feeling or being sick, sweating and increased heart rate, breathing or blood pressure. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

_4 Possible side effects

Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard. gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday - Friday) or fill in a paper form available from your local pharmacy.

Contact your doctor immediately if you notice any of the

following side effects:

•    Allergic Reactions - skin rash or itchy skin, difficulty breathing, increased sweating, redness or flushed face, mucosal lesions (such as mouth ulcers), drug fever.

Tell your doctor if you notice any of the following side effects

or notice any other effects not listed:

•    Gastrointestinal system - stomach irritation (mild stomach pain, heartburn and feeling sick), constipation, feeling or being sick, loss of appetite, dry mouth, difficulty in the passage of food through guts, abdominal pain (may be caused by spasm of the bile ducts) and inflammation of the liver or pancreas

•    Heart - slow heart rate, palpitations, low blood pressure, inflammation of the heart muscle

•    Blood - anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor

•    Urinary system - pain and difficulty in passing urine and a less frequent need to do so, kidney problems.

•    Nervous system - confusion, drowsiness, dizziness, 'spinning' sensation, mood changes, depression, hallucinations (seeing or hearing things that are not real), restlessness, excitation, fits, increased pressure in the skull (painful eyes, changes in vision or headache behind the eyes), headache, difficulty sleeping, nightmares, reduced alertness, tolerance (medicine has less effect)

or dependence (suffer from withdrawal symptoms e.g. tremor, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly)

•    Eyes - blurred or double vision, extremely small pupils

•    Others - trembling, unusual tiredness or weakness, malaise, low body temperature

How do I know if I am addicted?

If you take the 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 the medicine you feel very unwell but you feel better if you start taking the medicine again.

5 How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place, protected from light.

Do not use Co-codamol tablets after the expiry date stated on the label/carton/bottle. 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.

6| Further information

What Co-codamol tablets contain

•    The active substances (the ingredients that makes the tablets work) are 8mg of codeine phosphate and 500mg paracetamol.

•    The other ingredients are colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid.

What Co-codamol tablets look like and contents of the pack

Co-codamol are white, uncoated tablets.

Pack sizes are 30 and 32.

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in January 2011

Actavis, Barnstaple, EX32 8NS, UK

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

•    This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by

paracetamol, ibuprofen or aspirin alone. Do not take less than four hours after taking other painkillers.

•    You should only take this product for a maximum of three 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 three 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 three days it can make them worse.

•    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.

Index

T| What Co-codamol tablets are and what they are used for

2    Before you take

3    How to take

4    Possible side effects T| How to store

_6| Further information

T| What Co-codamol tablets are and what they are used for

Co-codamol tablets belong to a group of medicines called analgesics and are used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.

Do not take less than four hours after taking other painkillers.

Before you take

•    This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it (see 'If you stop taking the tablets').

•    If you take a painkiller for headaches for more than three days it can make them worse.

Do not take Co-codamol tablets and tell your doctor if you:

•    are allergic (hypersensitive) to paracetamol, codeine phosphate or other opioids, or any of the ingredients in the tablet (see section 6)

•    have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis)

•    have difficulty breathing, or other chronic lung disease

•    are having an asthma attack.

Check with your doctor or pharmacist before taking Co-codamol tablets if you have:

•    liver or kidney problems

•    diseased adrenal glands (Addison's disease) or high blood pressure caused by a tumour near a kidney (phaeochromocytoma)

Continued top of next column

50441058    Continued over page

•    Gastrointestinal system - stomach irritation (mild stomach pain, heartburn and feeling sick), constipation, feeling or being sick, loss of appetite, dry mouth, difficulty in the passage of food through guts, abdominal pain (may be caused by spasm of the bile ducts) and inflammation of the liver or pancreas

•    Heart - slow heart rate, palpitations, low blood pressure, inflammation of the heart muscle

•    Blood - anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor

•    Urinary system - pain and difficulty in passing urine and a less frequent need to do so, kidney problems.

•    Nervous system - confusion, drowsiness, dizziness, 'spinning' sensation, mood changes, depression, hallucinations (seeing or hearing things that are not real), restlessness, excitation, fits, increased pressure in the skull (painful eyes, changes in vision or headache behind the eyes), headache, difficulty sleeping, nightmares, reduced alertness, tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms e.g. tremor, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly)

•    Eyes - blurred or double vision, extremely small pupils

•    Others - trembling, unusual tiredness or weakness, malaise, low body temperature

How do I know if I am addicted?

If you take the 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 the medicine you feel very unwell but you feel better if you start taking the medicine again.

5| How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place, protected from light.

Do not use Co-codamol tablets after the expiry date stated on the label/carton/bottle. 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.

6| Further information

What Co-codamol tablets contain

•    The active substances (the ingredients that makes the tablets work) are 8mg of codeine phosphate and 500mg paracetamol.

•    The other ingredients are colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid.

What Co-codamol tablets look like and contents of the pack

Co-codamol are white, uncoated tablets.

Pack sizes are 30 and 32.

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

This leaflet was last revised ^{in January} 2011

Actavis, Barnstaple, EX32 8NS, UK