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

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

The name of your medicine is Co-codamol 8/500 mg Effervescent Tablets (called Cocodamol throughout this leaflet).

This medicine has been prescribed for you for the relief of severe pain. Co-codamol can be used in children over 12 years of age for the short-term relief of moderate pain is not relieved by other painkillers such as paracetamol or ibuprofen alone.

Co-codamol contains codeine which belongs to a class of medicines called opioids, which are ‘pain relievers’. It also contains paracetamol, another analgesic to relieve 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.

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 your doctor tells you to.

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

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

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

• You are allergic (hypersensitive) to codeine, paracetamol, or any of the other ingredients of this 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
• 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 eyesight
• You have recently had an operation on your liver, gall bladder or bile duct (biliary tract)
• 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 tranylcypromine (see ‘Taking other medicines and Cocodamol’)
• You are an alcoholic
• The person going to take the tablets is 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 that you metabolise very rapidly codeine into morphine
• You are breastfeeding

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.

Warnings and precautions

Tolerance, dependence, and 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. This medicine contains codeine which is an opioid medicine. It can cause dependence and/or addiction.

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
• 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).

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.

Talk to your doctor or pharmacist or nurse if you experience any of the following symptoms while taking Co-codamol Effervescent tablets

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

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 before taking Co-codamol if:

• You have a condition called myasthenia gravis which weakens the muscles.
• You are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• You have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• You feel you need to take more of 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 your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.
• You have severe kidney or liver problems
• You have problems passing water or prostate problems
• You have a bowel problem such as colitis or Crohn’s disease or a blockage of your bowel
• You are elderly

• You are sensitive to aspirin or other medicines used for the treatment of inflammation

  (Non-Steroidal Anti-Inflammatory Drugs) such as ibuprofen

• You are taking a benzodiazepine.
• You know you are a slow or intermediate metaboliser of an enzyme called CYP2D6, because a different dose may be applicable to you.
• You are taking a medicine that induces CYP3A4 enzyme activity such as rifampicin

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.

During treatment with Co-codamol, 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).

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

Other medicines and Co-codamol

Tell your doctor or pharmacist if you are taking or have recently taken or might be take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Co-codamol can affect the way some other medicines work. Also, some other medicines can affect the way Co-codamol works.

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

Concomitant use with sedative medicines

Concomitant use of Co-codamol and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, 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.

Co-codamol contains paracetamol. Do not take anything else contain paracetamol while taking this medicine.

This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your pharmacist and more widely in shops.

Do not take this medicine and tell your doctor or pharmacist if you are taking any of the following:

Medicines to treat depression called MAOIs (monoamine oxidase inhibitors) or have taken them in the last 2 weeks. MAOIs are medicines such as moclobemide, phenelzine, tranylcypromine

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) 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
• medicines to thin the blood such as warfarin
• chloramphenicol – an antibiotic used for infections

• metoclopramide or domperidone – used to stop you feeling sick (nausea) or being sick

  (vomiting)

• colestyramine – for lowering blood cholesterol levels
• 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).

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

If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Co-codamol.

Co-codamol with food, drink and alcohol

You should not drink alcohol while you are taking these tablets. This is because Co-codamol can change the way alcohol affect you.

Children and adolescents

Use in children and adolescents after surgery

Codeine 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

Codeine is not recommended in children with breathing problems since the symptoms of morphine toxicity may be worse in these children.

Pregnancy, breast-feeding

Do not take co-codamol, 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 and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Co-codamol during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take codeine while you are breastfeeding as Codeine and morphine passes into breast milk and will affect your baby.

Driving and using machines

Co-codamol 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 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 and sorbitol

• Sodium: The maximum recommended daily dose of this medicinal product contains 868 mg sodium (found in table salt). This is equivalent to 43.4% 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.

• Sorbitol: This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.

Changing or stopping treatment

Long term 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 with your doctor.

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.

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).

Always take this medicine exactly as your doctor 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
• Dissolve the effervescent tablets in a glass of water before taking

Adults: 2 tablets every 4 to 6 hours when necessary up to a maximum of 8 tablets in 24 hours Children aged 16 to 18 years: 1 to 2 tablets every 6 hours when necessary up to a maximum of four doses in 24 hours

Children aged 12 to 15 years: 1 tablet every 6 hours when necessary to a maximum of four doses 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 Effervescent tablets should be used for 3 days only to relieve symptoms. If no effective pain relief is achieved while taking the medicine, you should seek the advice of a healthcare professional.

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

If you take more Co-codamol than you should

• Tell your doctor or go to your nearest hospital casualty department straight away even if you feel well. This is because of the risk of 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 4 hours between doses.

If you stop taking Co-codamol

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. Withdrawal symptoms such as restlessness, difficultly 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
• Unknown frequency: dependence and addiction (see section “How do I know if I am addicted?”).

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

• You have difficulty breathing or you feel dizzy
• 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.
• 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

Other side effect has been reported:

Codeine-related side effects:

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

• Constipation
• Feeling sick (nausea) or being sick (vomiting)
• Dizzyness, drowsiness, light-headed, confused
• Difficulty in passing water (urine)
• Becoming dependent on codeine

Paracetamol-related side effects:

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 or thrombocytopenia)

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

• Difficulty breathing, wheezing, tightness in the chest (bronchospasm)
• Low blood pressure (hypotension) with high doses.
• You get infections more easily than usual. This could be because of a blood problem called agranulocytosis.
• 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, 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 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 unwell, and you feel better once taking the medicine again.

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

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

Keep this medicine out of the sight and reach of children.

Do not use Co-codamol after the expiry date stated on label. The expiry date refers to the last day of the month.

Store in a cool dry place at or below 25°C. 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 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 to protect the environment.

6. Contents of the pack and other information What Co-codamol 8/500 mg Effervescent Tablets contain:

• The active ingredients are codeine phosphate and paracetamol. Each tablet contains 8 mg of codeine phosphate and 500 mg of paracetamol
• The other ingredients are citric acid, povidone, sodium saccharin, sodium cyclamate, sodium bicarbonate, polyethylene glycol and sodium carbonate (anhydrous)

What Co-codamol 8/500 mg Effervescent Tablets look like and the contents of the pack:

Co-codamol 8/500 mg Effervescent Tablets are white, round, flat, bevelled-edged tablets with a rough surface. They are available in carton strip packs of 10, 12, 16, 24, 30, 36, 50, 56, 100 or 112 tablets.

Not all pack sizes or pack types may be marketed.

Marketing Authorisation Holder:

Activase Pharmaceuticals Limited

11 Boumpoulinas, 3rd Floor

P.C. 1060 Nicosia,

Cyprus

Manufacturer:

Cupal Limited

King Street, Blackburn, Lancashire, BB2 2DX. United Kingdom

For more information about this product, please contact the Marketing Authorisation Holder This leaflet was last revised in 02/2026