Co-codamol 8/500mg Tablets – patient leaflet, side effects, dosage

1. What Co-codamol tablets are and what they are used for

This medicine has been prescribed for you for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. This medicine can be used to reduce body temperature. Co-codamol can be used in adults and children over 12 years of age. It contains codeine which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed for you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your doctor or pharmacist should have explained how long you will be taking it for, when it is appropriate to stop and how to do this safely.

2. What you need to know before you take Co-codamol tablets

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 in section 6)

  • if you are a child under 12 years of age
  • 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 codeine very rapidly into morphine
  • if you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you have:

• ever been or are currently addicted to opioids, alcohol, prescription medicines, or illegal drugs

• previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
• 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
  • low blood pressure or are in shock
  • a condition called myasthenia gravis which weakens the muscles.

During treatment with Co-codamol tablets, tell your doctor straight away if you:

• have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

• experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine.

  • experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

Tolerance, dependence, and addiction

This medicine contains codeine which is an opioid medicine.

It can cause dependence and/or addiction.

Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Co-codamol can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use. Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Co-codamol if you:

• or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”)

• are a smoker

  • have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Co-codamol, it could be a sign that you have become dependent or addicted:

• you need to take the medicine for longer than advised by your doctor
• you need to take more than the recommended dose
• you might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain
• you are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• you have made repeated, unsuccessful attempts to quit or control the use of the medicine
• when you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Co-codamol tablets).

Do not take for longer than your doctor tells you to

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

  • 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.

Sleep-related breathing disorders

Co-codamol can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.

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. This is especially important if you are taking or have taken within the last two weeks:

• monoamine oxidase inhibitors (MAOIs) such as moclobemide and phenelzine used in the treatment of depression
• medicines which make you drowsy or sleepy (CNS depressants and benzodiazepines) such as medicines used to treat anxiety or anaesthetics
• medicines for depression such as dosulepin, mirtazapine (Tricyclic) or chlorpromazine (phenothiazines)
• medicines known as tranquillisers, or hypnotics
• sleeping tablets, sedatives and some antihistamines.

You may experience more drowsiness if you take these medicines with co-codamol.

Concomitant use of Co-codamol tablets and sedative medicines such as benzodiazepines or related drugs also increases the risk of difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Co-codamol tablets together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms. Tell your doctor or pharmacist if you are taking, have recently taken or might take:

• ciprofloxacin (antibacterial medicine)
• 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 to treat mental illness
  • medicines which affect the liver (e.g. primidone and rifampicin)
  • colestyramine (to treat high cholesterol levels)
  • muscle relaxants
  • barbiturates (e.g. phenobarbital)
  • opioid antagonists (buprenorphine, naltrexone, naloxone)
  • flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2)
  • gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain). Co-codamol with food and alcohol

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.

Drinking alcohol whilst taking Co-codamol tablets may result in drowsiness, difficulties in breathing, coma and may be life-threatening. It is recommended not to take alcohol while you are taking

Co-codamol tablets.

Pregnancy and breast-feeding

Pregnancy

Do not take Co-codamol tablets if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby. If you take Co-codamol tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated. Breast-feeding

Do not take Co-codamol tablets while you are breast-feeding as codeine and morphine pass into breast milk and will affect your baby.

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.

3. How to take Co-codamol tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Co-codamol tablets, when and how long you need to take them, when to contact your doctor, and when you need to stop them (see also, If you stop taking Co-codamol tablets). Swallow the tablets with water.

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

The recommended dose is:

• Adults: 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours

  • 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 should not be taken for more than 3 days.

Co-codamol tablets should be used for the shortest duration necessary to relieve symptoms. If no effective pain relief is achieved while taking the medicine, you should seek the advice of a physician. If you take more Co-codamol tablets than you should

Talk to your 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.

If you (or someone else) take more tablets than you should, 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 heartbeat or breathing rate.

If you forget to take Co-codamol 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. Remember to leave at least 4 to 6 hours between doses for adults and 6 hours for children aged 12 to 18 years.

If you stop taking Co-codamol tablets

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

Contact your doctor for advice on how to stop taking Co-Codamol tablets gradually to avoid withdrawal symptoms.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking co-codamol and see a doctor or go to a hospital straight away if you have: Very rare (may affect up to 1 in 10,000 people):

• a severe skin reaction, such as reddening of the skin with blisters or peeling and may be associated with a high fever and joint pain. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome or toxic epidermal necrolysis), or if you experience a red, scaly rash with bumps under the skin and blisters (acute generalised

  exanthematous pustulosis or fixed drug eruption).

Not known (frequency cannot be estimated from the available data):

• swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing, increased sweating, redness or flushed face, mucosal lesions (such as mouth ulcers), drug fever. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to co-codamol
• a fit (seizure)
• difficulty breathing and you feel dizzy
• severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis)

• A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).

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

  Uncommon (may affect up to 1 in 100 people):

  • kidney failure (fluid retention, shortness of breath, tiredness, confusion).

Not known (frequency cannot be estimated from the available data):

• dependence and addiction (see section “How do I know if I am addicted?”)
• constipation, feeling sick (nausea), being sick (vomiting), dry mouth
• dizziness, spinning sensation, light-headedness, drowsiness, confusion
• feeling overly happy (euphoria)
• a feeling of unease or dissatisfaction
• pain and difficulty passing urine
• you get infections or bruise more easily than usual. This could be because of a blood problem
• stomach irritation (mild stomach pain, heartburn and feeling sick), loss of appetite, difficulty in the passage of food through guts, abdominal pain and swelling (may be signs of liver damage, biliary spasm or a swollen intestine)
• slow heart rate, palpitations, low blood pressure, inflammation of the heart muscle
• a less frequent or difficulty in needing to pass urine, kidney problems

• mood changes, depression, hallucinations (seeing or hearing things that are not real), restlessness,

  excitation, 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)

  • blurred or double vision, excessive constriction (shrinking) of the pupil of your eye
  • lower abdominal pain (may be caused by spasms of the uterus)
  • trembling, unusual tiredness or weakness, general discomfort and illness, low body temperature
  • problem affecting a valve in the intestines (sphincter of Oddi dysfunction).

Drug Withdrawal

When you stop taking Co-codamol tablets, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating. How do I know if I am addicted?

If you notice any of the following signs whilst taking Co-codamol tablets, it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your doctor

  • You feel you need to use more than the recommended dose
  • You are using the medicine for reasons other than prescribed
  • When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.

If you notice any of these signs, it is important you talk to your doctor.

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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Co-codamol tablets

Keep this medicine out of the sight and reach of children. Store this medicine in a safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been intended for them. Store below 25°C in a dry place, protected from light. Do not take this medicine after the expiry date which is stated on the label/carton/bottle. The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information What Co-codamol tablets contain

• The active substances are codeine phosphate and paracetamol. Each tablet contains 8mg of codeine phosphate and 500mg paracetamol.
• The other ingredients are colloidal anhydrous silica, maize starch, stearic acid.

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

Co-codamol are white, circular, flat bevelled-edge uncoated tablets impressed ‘C’ and the identifying letters ‘CH’ on either side of a central division line on one face. Pack sizes are 100.

Marketing Authorisation Holder

Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

Manufacturer

Accord, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in April 2026.

100 tablets

For oral use Co-codamol

8/500mg Tablets

(Codeine Phosphate and Paracetamol)

Each tablet contains 8mg Codeine Phosphate and 500mg Paracetamol. Use as directed by physician. FOR DISPENSING PURPOSES ONLY. Do not exceed the stated dose. If symptoms persist consult your doctor. This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel. See the leaflet inside for more information. Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction. Keep out of the sight and reach of children. Read the package leaflet before use. Contains paracetamol. Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.

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

Accord Healthcare Ltd,

North Harrow, HA1 4HF, UK Can cause addiction

Contains opioid

_mg5008

PL 20075/0702

BBBC5040 51038607

Each tablet contains 8mg Codeine Phosphate and 500mg Paracetamol. Use as directed by physician. FOR DISPENSING PURPOSES ONLY. Do not exceed the stated dose. If symptoms persist consult your doctor. This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel. See the leaflet inside for more information. Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction. Keep out of the sight and reach of children. Read the package leaflet before use. Contains paracetamol. Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.

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

Accord Healthcare Ltd,

North Harrow, HA1 4HF, UK Can cause addiction

Contains opioid

PL 20075/0702

BBBC5040 51038607

Area

co-codamol #8/500 mg tablets

braille reads:-co-codamol 8/500 mg

tablets

co-codamol #8/500 mg tablets