Co-codamol 15 mg/500 mg effervescent tablets – patient leaflet, side effects, dosage

1. What Co-codamol is and what it is used for

This medicine has been prescribed for you for the relief of mild to severe short term pain. Co-codamol contains codeine phosphate and paracetamol. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It also contains paracetamol, an analgesic (relieves pain) and an antipyretic (lowers raised temperatures). Co-codamol can be used in adults and children over 12 years of age for the short term treatment of moderate pain which is not relieved by other painkillers such as paracetamol or ibuprofen alone. 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 doctor or pharmacist should have explained how long you will be taking it for, and when it is appropriate to stop, how to do this safely.

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

Important things you should know about Co-codamol

• Do not take for longer than directed by your doctor or pharmacist
• This medicine contains paracetamol. Do not take anything else containing paracetamol whilst taking this medicine
• 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.

Do not take Co-codamol if:

• you are allergic to paracetamol, codeine phosphate or any of the other ingredients of this medicine

  (listed in section 6)

  • you suffer from breathing problems, for example chronic bronchitis or emphysema or are suffering an asthma attack
  • you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them within the last two weeks. MAOIs, such as phenelzine, moclobemide or isocarboxazid, are medicines used to treat depression (see ‘Other medicines and Co-codamol’)
  • you have just had a head injury or suffer from increased pressure on the brain
  • you know that you metabolise codeine very rapidly into morphine
  • you are breast-feeding
  • you drink a lot of alcohol
  • you are under 18 years of age and have had your tonsils or adenoids removed as Codeine in Co-codamol may cause Obstructive Sleep Apnoea Syndrome (sleep disruption due to respiratory pauses)
  • you have recently had an operation to your liver, gallbladder or bile duct (biliary tract)
  • the person going to take the tablets is under 12 years of age. Co-codamol should not be taken by children under 12 years of age.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Co-codamol if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
• have a bowel problem such as colitis or Crohn’s disease or a blockage of your bowel
• are elderly
• have severe liver or kidney problems, because the dose might need to be lower
• have an enlarged prostate or narrowing of your urethra (tube through which urine is passed)
• have a condition called myasthenia gravis which weakens the muscles
• have an underactive thyroid gland (hypothyroidism)
• have Addison’s disease (where the adrenal glands do not produce enough hormones)
• are sensitive to aspirin or other medicines used for the treatment of inflammation (Non-Steroidal Anti-inflammatory Drugs, or NSAIDs) such as ibuprofen
• know you are a slow or intermediate metaboliser of an enzyme called CYP2D6, because a different dose may be applicable to you
• are taking a benzodiazepine or a medicine that induces CYP3A4 enzyme activity such as rifampicin.

During treatment with Co-codamol, 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 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
• experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine.

Stop taking Co-codamol and see a doctor or go to a hospital straight away if:

Very rare (may affect up to 1 in 10,000 people):

• you get serious skin reactions.
• you get severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis).

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

• you have difficulty in breathing, wheezing, tightness in the chest or you feel dizzy (bronchospasm)
• 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
• you have 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 last longer than a few days:

Frequency and severity are determined by dosage, duration of treatment and individual sensitivity:

• constipation
• feeling sick (nausea), being sick (vomiting)
• dizziness, light-headedness, drowsiness, confusion
• difficulty in passing water (urine), inability to empty the bladder.

Very rare (may affect up to 1 in 10,000 people):

• you get infections or bruise more easily than usual. This could be because of a blood problem (such as neutropenia, leucopenia or thrombocytopenia).

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

• you get infections more easily than usual. This could be because of a blood problem called agranulocytosis
• problem affecting a valve in the intestines (sphincter of Oddi dysfunction).

The following side effects have also been reported:

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

• hives affecting deeper skin layers (angioedema)
• low blood pressure (hypotension) with high doses

If any of the side effects become serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

Drug Withdrawal

When you stop taking Co-codamol, 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, it could be a sign that you have become addicted.

• you need to take the medicine for longer than advised by your doctor or pharmacist
• 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 or pharmacist.

  Co-codamol with alcohol

  You should not drink alcohol while you are taking this medicine. This is because Co-codamol can change the way alcohol affects you.

  Pregnancy, fertility and breast-feeding

  If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

  Pregnancy

  Do not take Co-codamol if you are pregnant or think you might be pregnant unless you have discussed this with your doctor or pharmacist and the benefits of treatment are considered to outweigh the potential harm to the baby.

  If you take Co-codamol 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 while you are breast-feeding as codeine passes into breast milk and will affect your baby.

  Fertility

  There is no data on the effects of this medicine on human fertility.

  Driving and using machines

  This 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 and 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.

Co-codamol contains sodium

The maximum recommended daily dose of this medicinal product contains 3348.8 mg sodium (found in table salt). This is equivalent to 167.44 % of the adult recommended maximum daily dietary intake for sodium. Talk to your pharmacist or doctor if you need co-codamol on a daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet.

Co-codamol contains sorbitol

This medicine contains 100 mg sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

3. How to take Co-codamol

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

• Do not take more than the recommended dose
• Do not take for longer than your doctor tells you to

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’).

Method of administration

Dissolve the effervescent tablets in a glass of water before taking. Do not chew your tablets.

Dose:

Adults aged 18 years and over: the usual dosage is 2 tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours. If you feel the effect of Co-codamol is too strong or too weak, talk to your doctor or pharmacist.

Elderly: A lower dosage may be needed if you are elderly or have other medical problems. Check with your doctor about this.

Children aged 16 to 18 years: 2 tablets every 6 hours when necessary up to a maximum of 4 doses in 24 hours.

Children aged 12 to 15 years: 1 tablet every 6 hours when necessary to a maximum of 4 doses in 24 hours.

Children under 12 years: Co-codamol should not be given to children under 12 years of age, due to the risk of severe breathing problems.

Do not take with any other paracetamol-containing products. Do not exceed the stated dose.

This medicine should not be taken for more than 3 days. 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 take more Co-codamol than you should

• talk to a doctor or go to your nearest hospital casualty department straight away even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage
• remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken.

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, if it is almost time for your next dose, skip the missed dose. Do not take two doses at or near the same time. Remember to leave at least 6 hours between doses.

If you stop taking Co-codamol

Do not suddenly stop taking this medicine. If you want to stop taking your tablets, discuss this with your doctor or pharmacist 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.

4. Possible side effects

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

Important side effects you should know about Co-codamol

• taking a painkiller for headaches too often or for too long can make them worse
• dependence and addiction (see section ‘How do I know if I am addicted?’) (not known: frequency cannot be estimated from the available data).

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 Website: 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

• Keep this medicine out of the sight and reach of children.
• Do not take this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.
• 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.
• Do not store above 25°C.
• Store in the original package in order to protect from moisture.
• 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 contains

The active substances of Co-codamol 15 mg/500 mg effervescent tablets are codeine phosphate hemihydrate and paracetamol. Each tablet contains 15 mg of codeine phosphate hemihydrate and 500 mg paracetamol.

The other ingredients are citric acid, sorbitol (E420), sodium hydrogen carbonate, povidone, simeticone, sodium carbonate, saccharin sodium, macrogol 6000.

What Co-codamol 15 mg/500 mg effervescent tablets look like and contents of pack

Co-codamol 15 mg/500 mg effervescent tablets are white to off-white, round, flat, bevelled edge tablets, plain on both sides. The diameter of tablet is approximately 25.4 mm.

They come in surlyn strip packs containing 100 tablets.

Marketing Authorisation Holder

Accord, Barnstaple, EX32 8NS, UK

Manufacturer

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

Harrow, HA1 4HF,

United Kingdom

This leaflet was last revised in March 2026.

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BBBC5002 UKP002 GB00 0000 0 00000000 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’).

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.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Children and adolescents over 12 years of age

Use in children and adolescents after surgery Codeine must not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome (sleep disruption due to respiratory pauses).

Use in children with breathing problems Codeine 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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

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

• monoamine oxidase inhibitors (MAOIs) such as moclobemide and phenelzine used in the treatment of depression, or have taken them within the last 2 weeks.

Tell your doctor or pharmacist if you are taking or have taken within the last two weeks:

• 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 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 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 the following medicines:

• chloramphenicol – an antibiotic used for infections
• mexiletine (medicine for irregular heartbeats)
• medicines to treat sickness (metoclopramide, domperidone)
• medicines to treat epilepsy (e.g. phenytoin and carbamazepine)
• colestyramine, used to treat high levels of lipids in your blood, or for problems related to your bile duct
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2)
• other strong painkillers called opioids
• medicines which prevent blood clotting (anticoagulants such as warfarin)
• the oral contraceptive pill
• medicines such as quinidine, fluoxetine, paroxetine, bupropion, cinacalcet, methadone or rifampicin, as these may alter the effect of Co-codamol
• gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

Some products which can be bought without a prescription may contain paracetamol or codeine, so always check the labels for ingredients.