Co-codamol 8/500mg tablets are a combination of two active ingredients commonly known as Paracetamol and Codeine.

Paracetamol, is an analgesic (painkiller) It is a medication for the relief of mild pain and fever.

Codeine is a stronger painkiller than Paracetamol known as an opioid. Opioid painkillers are easily and rapidly absorbed by the body and attach themselves to one or more of 4 opioid receptors in the brain. When these receptors are stimulated, they reduce pain without eliminating its cause.

This combination of painkillers can relieve moderate to acute pain associated with headaches, sore throats, migraines, toothache, period pains, neuralgia, colds and flu. Co-codamol may also help relieve mild pain associated with Rheumatism and Arthritis.

It is especially important with this item that you read and fully understand the Patient Information Leaflet before purchasing.

Symptoms, Treatment and advice

This medicine is an Analgaesic that is used as a painkiller to reduce or eliminate mild, moderate or acute pain. It is not a treatment so will not cure or resolve the underlying cause of the pain e.g. back pain or toothache.
It is important that you seek your doctor or pharmacist’s advice if you are unsure about the cause of the pain and in any event this medicine should not be used for more than 3 days without seeking professional medical advice.

Before you take this medicine

Check the foil is not broken before use. If it is, do not take that tablet.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not drink alcohol whilst taking Co-codamol tablets. Swallow the tablets with
water. Do not take Co-codamol 8/500mg tablets less than 4 hours after you have taken any other painkiller.

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

The recommended dose is:

• Adults and children 16 to 18 years: 1 to 2 tablets every 6 hours, as needed. Do not take more than 8 tablets in 24 hours
• Children 12 to 15 years: 1 tablet every 6 hours as needed. Do not give your child more than 4 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.

This medicine can be taken by adults and children aged 12 years and over. However, some
people should not take this medicine or should seek the advice of their pharmacist or doctor
first. Please view the section on Ingredients and Precautions.

Ingredients

Paracetamol 500 mg and Codeine Phosphate 8mg are the active ingredients. As well as the active ingredients, the tablets also contain colloidal anhydrous silica, maize starch, pregelatinsed maize starch, stearic acid.

Precautions

• 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 a painkiller for headaches for more than three days it can make them worse.
• Do not take Co-codamol tablets if you are allergic to paracetamol, codeine phosphate or other opioids, or any of the other ingredients of this medicine (listed above).
• 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

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

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

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

Keep the tablets stored below 25°C in a dry place, protected from light. If symptoms persist or worsen after 3 days, you should consult your doctor for further advice.

Talk to 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.

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.

Other medicines and Co-codamol tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• 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.

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.

Possible Side Effects and Reporting of 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.

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

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed here You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

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

Other Information

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.

If you need more advice consult your doctor or pharmacist.

Keep all medicines out of the sight and reach of children.