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

1. WHAT CO-CODAMOL 8/500 IS AND WHAT IT IS USED FOR

Co-codamol is an analgesic (painkiller), used for the short-term treatment of acute moderate pain caused by headaches, migraine, toothache, neuralgia, period pain and rheumatic pains when other painkillers have not worked. Wait at least 4 hours after you last took other painkillers before taking this medicine. Co-codamol tablets can be used in adults and 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. 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. Co-codamol 8/500 is used to relieve pain, including muscular and rheumatic pains, headache, migraine, neuralgia (severe burning or stabbing pain following the line of a nerve), toothache, sore throat, period pains, aches and pains, discomfort associated with influenza (flu), feverishness and feverish colds.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL 8/500

• 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 (see ‘If you stop taking Co-codamol tablets’).

  • If you take a painkiller for headaches for more than three days it can make them worse.

Do not take Co-codamol 8/500 if you:

• are allergic to paracetamol, codeine phosphate or other opioids, or any of the other ingredients of this medicine (these are listed in section 6)
• are a child under 12 years of age
• have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis)
• have difficulty breathing, obstructive airways disease, respiratory depression or other chronic lung disease
• are having an asthma attack
• are a child or adolescent for pain relief (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome
• know that you metabolise codeine very rapidly into morphine
• are breast feeding
• are already taking other medicines containing paracetamol
• have a dependency to alcohol
• have recently had a head injury or 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 eyesight
• are receiving monoamine oxidase inhibitor (MAOI) therapy or have taken them in the last 2 weeks. MAOIs are medicines such as moclobemide, phenelzine or tranylcypromine (see ‘Other medicines and Co-codamol 8/500’).

Warnings and Precautions

Tolerance, dependance, 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 8/500 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 8/500 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 8/500, 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’)

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  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 8/500).

  Talk to your doctor before taking this medicine if you:

  • are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
  • have liver or kidney problems.
  • suffer from seizures.
  • have a condition called myasthenia gravis which weakens the muscles.
  • have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
  • feel you need to take more of Co-codamol 8/500 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 your doctor who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Taking this medicine regularly, particularly for a long time, can lead to addiction. 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.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor about your treatment.

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 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. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Also talk to your doctor or pharmacist before taking Co-codamol 8/500 if you have:

• diseased adrenal gland (Addison's disease) or high blood pressure caused by a tumour near a kidney (phaeochromocytoma)
• gall bladder disease or gall stones
• inflammatory bowel disease
• 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
• are on a low sodium diet

Do not take for longer than directed by your prescriber.

• Taking codeine regularly for a long time can lead to addiction
• 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.

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

During treatment with Co-Codamol 8/500, 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).

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.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Co-codamol 8/500

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

Sleep-related breathing disorders: Co-codamol 8/500 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 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 (may be seen in children with neuromuscular disorders, severe heart or lung conditions, upper respiratory or lung infections, multiple trauma or after extensive surgical procedures), since the symptoms of morphine toxicity may be worse in these children.

Other medicines and Co-codamol 8/500

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
• 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 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. Page 2

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

• 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)
• hydroxyzine and 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).

Co-codamol 8/500 with food, drink 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, breast-feeding and fertility: 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. Do not take Co-codamol 8/500 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 use Co-codamol 8/500 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 8/500 while you are breastfeeding as codeine and morphine passes into breast milk and will affect your baby.

Driving and using machinery

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 doctor 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.

Co-codamol 8/500 contains sodium and aspartame

The maximum recommended daily dose of this medicinal product contains 3504mg sodium (found in table salt). This is equivalent to 175% of the adult recommended maximum daily dietary intake for sodium.

Talk to your pharmacist or doctor if you need Co-codamol 8/500 on a daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet. This medicine contains 5 mg aspartame in each effervescent tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

3. HOW TO TAKE CO-CODAMOL 8/500

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 8/500, 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 8/500).

Do not exceed the recommended doses. Co-codamol 8/500 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.

Dosage: 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 usual doses for Co-codamol 8/500 are as follows:

Adults: Should take one or two tablets dissolved in water every 4 to 6 hours, as needed. Do not take more than 8 tablets in 24 hours.

Children 16-18 years: One or two tablets dissolved in water every 6 hours when necessary to a maximum of 8 tablets in 24 hours.

Children 12-15 years: Children aged 12 years and above should take one tablet dissolved in water every 6 hours when necessary. Do not take more than 4 tablets in 24 hours. Co-codamol 8/500 should not be taken by children below the age of 12 years, due to the risk of severe breathing problems.

Elderly: Dosage is usually reduced in the elderly with liver damage.

Method of Administration: For oral administration only. These tablets should be dissolved in at least half a glass of water before taking them and can be taken with or without a meal. The solution should be drunk immediately after preparation. These tablets are meant to be dissolved first so do not try to swallow them whole.

If you take more Co-codamol 8/500 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. Remember to take the pack and any remaining tablets with you.

If you stop taking Co-codamol 8/500: 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 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 forget to take Co-codamol 8/500: If you forget to take one or more doses, take your next dose when you remember and then go on as prescribed. Do not take a double dose to make up for a forgotten dose. 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 have any further questions on the use of this medicine, ask your doctor or pharmacist. _{Page 3}

Customer: Kent Originated by: DOB (AWG)

Colours: Black

Product: Co-Codamol Effervescent 8/500mg Tablets (PL 51463/0018)

Dimensions: 500 x 210mm

4. POSSIBLE SIDE EFFECTS

Like all medicines, Co-codamol 8/500 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 get:

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).
• 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):

• 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.
• Fits (seizures).
• Difficulty breathing and dizziness.

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

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

• Drug withdrawal (see section “Drug withdrawal”)
• Kidney failure (fluid retention, shortness of breath, tiredness, confusion)

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

• Severe stomach pains (pancreatitis)
• Stomach pains, (mild stomach pain, heartburn and feeling sick), loss of appetite, dry mouth, difficulty in the passage of food through guts, abdominal pain and swelling (may be signs of liver damage, biliary spasm or a swollen intestine)
• Problems with the blood (thrombocytopenia and agranulocytosis). This is usually shown by tiredness, weakness, or unexplained bruising or bleeding.
• Skin rashes, hives, itching or lesions
• Increased sweating
• Red or flushed face
• Constipation
• Nausea, vomiting, feeling sick
• Dizziness or vertigo
• Confusion
• Blurred or double vision
• Mental depression or irritability
• Drowsiness
• Slow heart rate, palpitations, low blood pressure, inflammation of the heart muscle
• Fever
• Chest pain or tightness or abnormal heartbeat
• Lower abdominal pain (may be caused by spasms of the uterus)
• Trembling, unusual tiredness or weakness, general discomfort and illness, low body temperature
• Excessive constriction (shrinking) of the pupil of your eye and drooping eyelid

• 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)

  • Dependence and addiction (see section “How do I know if I am addicted?”)
  • Pain and difficult passing urine

There have been very rare reports of blood problems, so if you notice unusual bleeding or you bruise easily, tell your doctor as soon as possible.

An adverse reaction with an unknown frequency may also occur:

• A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).
• Problem affecting a valve in the intestines (sphincter of Oddi dysfunction)

Drug Withdrawal: When you stop taking Co-codamol 8/500 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 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 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 or pharmacist. 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 8/500

Do not store your tablets above 25°C. Store in a dry place and protect from light. Do not take this medicine after the expiry date stated on the carton. 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. Keep all medicines out of the sight and reach of children. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Co-codamol Effervescent Tablets 8/500mg contain:

The active ingredients are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg paracetamol and 8 mg codeine phosphate hemihydrate. The other ingredients are sodium hydrogen carbonate, citric acid anhydrous, sodium carbonate, povidone, simeticone, sodium saccharin, aspartame (E951) and polysorbate 80.

What Co-codamol Effervescent Tablets 8/500mg look like and the contents of the pack: Co-codamol Effervescent Tablets 8/500mg are white, circular, with a flat bevelled edge and plain on both sides. Your medicine is available in blister packs of 100 tablets.

Marketing Authorisation Holder: Kent Pharma UK Limited, 2nd Floor, Connect 38, 1 Dover Place, Ashford, Kent, England, TN23 1FB.

Manufacturer responsible for batch release:

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

This leaflet was last revised in February 2026.

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