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Document: leaflet MAH GENERIC_PL 00142-0197 change

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• leaflet MAH GENERIC_PL 00142-0197
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• leaflet MAH GENERIC_PL 41318-0040

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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, difficulty sleeping, 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

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: Continued top of next column 50827452 AAAH3400

www.mhra.gov.uk/yellowcard. 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 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.

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.

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, pregelatinsed 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 September 2014

actavis

Actavis, Barnstaple, EX32 8NS, UK

, Read all of this leaflet carefully before j 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

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

0 Before you take

0 How to take

0 Possible side effects

0 How to store

0 Further information

Continued top of next column

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

Co-codamol contains two different medicines called codeine phosphate and paracetamol. Co-codamol tablets belong to a group of medicines called analgesics, which act to relieve pain. Co-codamol 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.

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

0 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:

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

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

•    if you have difficulty breathing, or other chronic lung disease

•    if you are having an asthma attack.

•    for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome

•    if you know that you metabolise very rapidly codeine into morphine

•    if you are breastfeeding

Continued over page

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 gastrointestinal 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.

Warnings and precautions

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

Co-codamol 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

Co-codamol is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

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, e.g. 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 (e.g. 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.

Do not drink alcohol whilst taking Co-codamol tablets.

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Co-Codamol Tablets 8/500mg x 30 & 32's (UK)

50827452

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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.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while 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 while taking this medicine.

Pregnancy and breast-feeding Pregnancy

Do not take Co-codamol tablets during pregnancy, unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn.

Breastfeeding

Do not take Co-codamol while you are breastfeeding. Codeine and morphine passes into breast milk.

Q 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:

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.

•    Adults and children over 12 years: 1 to 2 tablets every 6 hours, as needed. Do not take more than 8 tablets in 24 hours

•    Children under 12 years: should not be taken due to the risk of severe breathing problems

•    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, pale or 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.

Q 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.

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Paracetamol/Codeine 500mg/8mg tablet leaflet - UK			colours/plates:
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