CO-CODAMOL 8mg/500mg EFFERVESCENT TABLETS – patient leaflet, side effects, dosage

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

The name of your medicine is Co-codamol 8mg/500mg Effervescent Tablets. Co-codamol Effervescent Tablets contain two different medicines called codeine phosphate hemihydrate and paracetamol. Co-codamol Effervescent Tablets belong to a group of medicines called analgesics, which act to relieve pain. Co-codamol Effervescent 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. Co-codamol Effervescent Tablets can be used to reduce body temperature.

This medicine contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It also contains paracetamol, another analgesic to relieve pain.

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.

It contains the Codeine phosphate hemihydrate and Paracetamol which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been provided 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 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 Effervescent Tablets

Do not take Co-codamol Effervescent Tablets and tell your doctor if you:

• are allergic to paracetamol, codeine phosphate hemihydrate or other opioids, or any of the other ingredients of this medicine (listed in section 6)

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

  • have difficulty breathing, or other chronic lung disease
  • are having an asthma attack
  • are under 12 years of age
  • are under 18 years of age and have had your tonsils or adenoids removed due to obstructive sleep apnoea syndrome
  • know that you metabolise codeine into morphine very rapidly
  • are breastfeeding or are planning to breastfeed.

Do not take Co-codamol Effervescent Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Co-codamol Effervescent Tablets.

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

Warnings and precautions

Talk to a doctor or pharmacist before taking Co-Codamol Effervescent 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 (pheochromocytoma)
• 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
• 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

• suffered from alcoholism, drug abuse or dependence or mental illness.

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

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 Effervescent Tablets 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 Effervescent Tablets 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 Effervescent Tablets, 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

Important side effects you should know about

• 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 the capsules.

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

• Urinary system - kidney problems.
• Drug withdrawal

When you stop taking co-codamol 8mg/500mg Effervescent 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.

Rare (may affect up to 1 in 1,000 people):

• Allergic Reactions - skin rash or itchy skin, mucosal lesions (such as mouth ulcers), drug fever

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

• Allergic Reactions - difficulty breathing, increased sweating, redness or flushed face
• 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. A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).
• Immune system – anaphylactic shock, angioedema
• Urinary system - pain and difficulty in passing urine and a less frequent need to do so
• Nervous system - confusion, drowsiness, dizziness, light-headedness, ‘spinning’ sensation, mood changes, depression, hallucinations (seeing or hearing things that are not real), restlessness, excitation, fits (seizure), 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), trembling, unusual tiredness or weakness
• Eyes - blurred or double vision, extremely small pupils
• Others - malaise, low body temperature
• Problem affecting a valve in the intestines (sphincter of Oddi dysfunction)
• Dependence and addiction (see section “How do I know if I am addicted?”).

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
• 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.

  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 Effervescent Tablets.

  Do not drink alcohol whilst taking Co-codamol Effervescent Tablets.

  Driving and using machines

  Co-codamol Effervescent 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.

Details regarding a new UK driving offence, concerning driving after drugs have been taken, may be found at: www.gov.uk/drug-driving-law.

Pregnancy and breast-feeding

Pregnancy

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

Do not take Co-codamol Effervescent Tablets 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 Effervescent Tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Breastfeeding

Do not take Co-codamol Effervescent Tablets while you are breastfeeding. Codeine and morphine pass into breast milk and will affect your baby.

Co-codamol Effervescent Tablets contains sodium and sorbitol

Sodium: This medicine contains 418.5 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 20.92 % of the recommended maximum daily dietary intake of sodium for an adult. Talk to your pharmacist or doctor if you need Co-codamol Effervescent Tablets on a daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet.

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 Effervescent Tablets

Always take this medicine exactly as your doctor 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 Effervescent Tablets, 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 Effervescent Tablets).

Do not drink alcohol whilst taking Co-codamol Effervescent Tablets. Dissolve the effervescent tablets in half a glass of water before taking.

Take this medicine for as long as your doctor tells you to, as it may be dangerous to stop without their advice. Co-codamol Effervescent 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 healthcare professional.

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.

If you take more Co-codamol Effervescent 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) 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 heartbeat or breathing rate.

If you forget to take Co-codamol Effervescent Tablets

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 6 hours between doses.

If you stop taking Co-codamol Effervescent Tablets

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, 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.

If you stop taking the tablets you may develop the following withdrawal symptoms: tremor, difficulty sleeping, feeling or being sick, sweating and increased heart rate, breathing or blood pressure. Contact your doctor for advice on how to stop taking Co-codamol Effervescent 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 Effervescent

Tablets and seek medical attention if you notice any of the symptoms listed.

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 Effervescent Tablets

• Keep this medicine out of the sight and reach of children.
• Do not take this medicine after expiry date which is stated on the label and carton after EXP. The expiry date refers to last day of that month.
• In-use shelf life (polypropylene tube): Use within 1 month of first opening the tube.
• Store your medicine in the original packaging in order to protect from moisture.
• 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.
• 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 Effervescent Tablets contain

• The active substances are codeine phosphate hemihydrate and paracetamol. Each effervescent tablet contains 8mg of codeine phosphate hemihydrate and 500mg of paracetamol.
• The other ingredients are Sodium hydrogen carbonate, Sodium carbonate, Sorbitol, Saccharin sodium, Citric Acid, Polyethylene glycol 6000, Povidone K25, Simethicone.

What Co-codamol Effervescent Tablets look like and contents of the pack

Co-codamol Effervescent Tablets are white to off white, round, flat, bevelled edge tablets, plain on both sides.

Strip packs:

The Effervescent Tablets are available in Paper/PE/ Aluminium/Surlyn Strip in following pack sizes. Pack sizes per carton: 10, 12, 16, 24, 30, 50, 56, 60, 100 or 112 tablets.

Pack sizes per strip: 4 or 10 tablets.

Polypropylene tube pack:

The Effervescent Tablets are packed in white opaque plain polypropylene tube and white opaque tamper evident polyethylene cap with inbuilt desiccant. Pack size: 10 (1 x 10) tablets per carton, 16 (2 x 8) tablets per carton, 20 (1 x 20) tablets per carton, 24 (3 x 8) tablets per carton, 24 (1 x 24) tablets per carton, 30 (3 x 10) tablets per carton, 50 (5 x 10) tablets per carton, 56 (7 x 8) tablets per carton, 60 (3 x 20) tablets per carton, 100 (5 x 20) tablets per carton and 112 (14 x 8) tablets per carton.

Pack sizes per tube: 8, 10, 20 or 24 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

The leaflet was last revised in April 2026.

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• 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 Effervescent Tablets).

During treatment with Paracetamol 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).

Do not take for longer than directed by your doctor or pharmacist.

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 or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your doctor or pharmacist will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else.

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.

Contact your doctor if you 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.

Sleep-related breathing disorders

Co-codamol Effervescent Tablets 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.

Children and adolescents

Use in children and adolescents after surgery Co-codamol Effervescent Tablets 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 Effervescent Tablets 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 Effervescent Tablets

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

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

Concomitant use of Co-codamol Effervescent Tablets and sedative medicines such as benzodiazepines or related drugs 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 Effervescent 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.