Patient leaflet - Co-codamol 8 mg / 500 mg tablets
1. What Co-codamol is and what it is used for
The name of your medicine is Co-codamol tablets (called Co-codamol throughout this leaflet). Co-codamol contains two different medicines called codeine phosphate and paracetamol. Paracetamol is an analgesic (relieves pain) and an antipyretic (lowers raised temperatures). Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. Co-codamol is used for short-term treatment of acute moderate pain such as headaches, migraine, neuralgia, toothache, dysmenorrhoea and rheumatic pain. This medicine has been prescribed to 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 prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone). Wait at least 4 hours after you last took other painkillers before taking this medicine.
2. What you need to know before you take Co-codamol
This medicine contains paracetamol. Do not take
anything else containing paracetamol while taking this medicine
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 use Co-codamol for pain relief in children
and adolescents (0-18 years of age) after the removal of their tonsils or adenoids removed due to obstructive sleep apnoea syndrome (sleep disruption due to respiratory pauses). 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. Taking a painkiller for headaches too often or for too long can make them worse.
Addiction can cause withdrawal symptoms when
you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling of being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping this medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Rarely increasing the dose of this medicine can make you sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.
Opioids should only be used by those they are
prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent does of opioid, may increase the risk of addiction.
Overuse and misuse can lead to overdose and/or
death.
Warnings and precautions
Do not take Co-codamol 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 have severe asthma attacks or severe
breathing problems, for example chronic bronchitis or emphysema.
- You suffer from severe kidney or liver disease
- You have recently had a head injury.
You have been told by your doctor that you have
increased pressure in your head. Signs of this include: headaches, being sick (vomiting) and blurred vision.
You have recently had an operation on your liver,
gallbladder or bile duct.
You are taking medicine to treat depression called
MAOIs (monoamine oxidase inhibitors) or have taken them in the last 2 weeks. MAOIs are medicines such as moclobemide, phenelzine or Isocarboxazid, tranylcypramine (see 'Other medicines and Co-codamol').
You are an alcoholic.
The person going to take the tablets is under 12
years of age.
Co-codamol 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 you metabolise very rapidly codeine into
morphine
You are breastfeeding or planning to breastfeed
During treatment with Co-codamol Tablets, tell your doctor straight away if:
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).
Taking this medicine regularly, particularly for a
long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
Do not take Co-codamol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Co-codamol
Take special care and check with your doctor before taking Co-codamol if:
Are or have ever been addicted to opioids, alcohol,
prescription medicines, or illegal drugs.
Have previously suffered withdrawal symptoms
such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
Feel you need to take more Co-codamol to get the
same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to you prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.
You have severe kidney, liver or thyroid problems
because the dose might need to be lower
- You are prone to suffer from asthma
You have problems passing water or prostate
problems.
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this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.
If you use 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 breastfeeding as codeine passes into breast milk and will affect your baby.
Driving and using machines
Co-codamol Tablets may cause dizziness or drowsiness and you should not drive or operate machinery if you are affected this way.
Codeine may disturb your vision.
Co-codamol 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.
Changing or stopping treatment
Chronic usage of Co-codamol may lead to tolerance and dependence. If you have taken regular daily doses of Co-codamol for a long time, do not increase the dose or suddenly stop treatment without discussing this with your doctor.
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”).
- You are a smoker.
You 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).
3. How to take Co-codamol
Your prescriber should have discussed with you, how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine Always take this medicine exactly as described in this leaflet or 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, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also, If you stop taking Co-codamol).
Do not take for more than 3 days. If you need to
use this medicine for more than three days you should speak to your doctor or pharmacist
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. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms
The score line is not intended for breaking the tablet
- Swallow the tablets whole with a drink of water
Adults: The recommended dose is 1 or 2 tablets every 4 to 6 hours when needed, up to a maximum of 8 tablets in 24 hour period. If you feel the effect is too strong or too weak or your symptoms persist, speak to your doctor or pharmacist. 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. A lower dosage may be needed if you are elderly or have other medical problems.
Check with your doctor about this.
Do not take with any other paracetamol-containing products.
Use in children and adolescents
Use in children aged 16 to 18 years: The recommended dose is 1-2 tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Use in children aged 12 to 15 years: The recommended dose is 1 tablet every 6 hours when necessary to a maximum of 4 tablets in 24 hours.
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.
Co-codamol should not be given to children under 12 years of age due to the risk of severe breathing problems.
If you take more Co-codamol tablets 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. Bring the remaining tablets and this leaflet with you so that the medical staff knows what you have taken.
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, coma, pale skin, low blood pressure, pinpoint pupils, irregular, slow or fast heartbeat, difficulty breathing, liver or kidney damage.
If you forget to take Co-codamol
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 forget to take a dose then take your next dose at the usual time. Never take two doses at the same time.
If you stop taking Co-codamol
This medicine contains codeine and can cause addiction if you take it continuously for more than three days. Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber 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. When you stop taking it you may get withdrawal symptoms such as restlessness, tremor, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (Palpitations), diarrhoea, feeling or being sick, shaking, shivering or sweating and increased heart rate, breathing or increased blood pressure, fever, weakness and muscular pains may occur if you suddenly stop taking this medicine. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.
Co-codamol 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 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. All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2). Frequency “Not known” (frequency cannot be estimated from the available data).
Important side-effects you should know about Co-codamol
- 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 taking the tablets.
Stop taking Co-codamol 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 mean you are having an allergic reaction to Co-codamol
- You get serious skin reactions. Very rare cases have been reported.
Talk to your doctor straight away if you notice the following serious side effect:
- 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
The following side effects may happen with this medicine:
Common (the following may affect up to 1 in 10 people)
- Constipation
- Feeling sick (nausea), being sick (vomiting)
- Dizziness, light-headedness, sleepiness, drowsiness, confusion
- Shortness of breath
- Lying down may help these effects if they happen.
- Difficulty in passing water Becoming dependent on codeine
You get infections or bruise more easily than usual.
This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia)
Uncommon (may affect up to 1 in 100 people):
Drug Withdrawal
When you stop taking Co-codamol tablets, you may experience drug withdrawal symptoms, which include unintentional muscle movement, restlessness and difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), feeling depressed, loss of appetite, feeling or being sick, diarrhoea, shaking, shivering or sweating, excess tear production, runny nose, sneezing, yawning, goose bumps, larger pupils, weakness, muscle cramps, feeling thirsty, and increase in heart rate, temperature, breathing rate and blood pressure
Other possible side effects:
- Not known (frequency cannot be estimated from the available data):
- Symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system (a problem affecting a valve in the intestines known as sphincter of Oddi dysfunction), e.g. severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever.
- a feeling of extra well being, or of disorientation
- stomach pains, inflammation of pancreas
- small eye pupils, problems with vision, headaches
- slowing of the pulse
- difficulty in passing urine
- liver damage, especially in heavy drinkers
- changes in blood cells, such as low number of cells which fight infection and of cells which are involved in blood clotting.
- dependence and addiction (see section “How do I know if I am addicted?”).
If you notice any of these signs, it is important you talk to your prescriber.
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 than adviced by your prescriber.
- 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 very unwell but you feel better if you start taking the medicine again
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
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.
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. This medicine does not require any special storage conditions.
Do not throw away 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 contains
Co-codamol 8mg/500mg:
The active substances are Codeine Phosphate
Hemihydrate and Paracetamol. Each tablet contains 8mg of Codeine
Phosphate Hemihydrate and 500mg of Paracetamol.
- The score line is not intended for breaking the tablet
- The other ingredients are Pregelatinized maize starch, Stearic acid, Povidone K-30, Lactose monohydrate, Powdered cellulose, Talc, Magnesium stearate.
What Co-codamol looks like and contents of the pack
Co-codamol 8mg/500mg tablets are white to almost white, capsule-shaped, biconvex, bevelled edged tablets, with 'CC3' on one side and 'score line' on the other side.
The score line is not intended for breaking the tablet.
Co-codamol 8mg/500mg tablets are available in Blister pack of PVC and Aluminium foil. Such blisters are packaged into cardboard carton. Carton containing 10, 20, 30 or 32 tablets in blister.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Lyrus Life Sciences Limited
C/O Thakur-Chabert 7a Vine Street
Uxbridge
United Kingdom
UB8 1QE
The Manufacturer is:
Wave Pharma Limited
Ground Floor, Cavendish House,
369 Burnt Oak Broadway,
Edgware, HA8 5AW
United Kingdom
For any information about this product, please contact the local representative of the Marketing Authorisation Holder: United Kingdom
24 Hour Helpline +447816 860 664
This leaflet was last revised in 07/2026.
Size: 130x640 mm
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