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

1. What Co-Codamol Capsules are and what they are used for

The name of your medicine is Co-Codamol 8/500 mg Capsules (called Co-Codamol Capsules throughout this leaflet).

This medicine has been prescribed for you for pain relief (analgesia). It contains codeine which belongs to a class of medicines called opioids, which are ‘pain relievers’. 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.

Co-Codamol Capsules also contain paracetamol, another analgesic to relieve pain. Co-Codamol Capsules are used to treat pain from headaches, muscular and rheumatic pain, back pain, nerve pain, period pain and dental pain. Co-Codamol Capsules can also be used to relieve the symptoms of cold, flu and sore throats.

Co-Codamol Capsules can be used in adults and children aged 12 years and over for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.

2. What you need to know before you

take Co-Codamol Capsules Important things you should know about Co-Codamol Capsules

• Do not take for longer than directed by your prescriber
• Taking a painkiller for headaches too often or for too long can make them worse - This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.

Warnings and precautions

Do not take Co-Codamol Capsules and tell your doctor if:

• You are allergic to the active substances or any 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 are taking 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.
• You are 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 are breast-feeding or planning to breast-feed. • You know that you metabolise codeine very rapidly into morphine.

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

Talk to your doctor, pharmacist or nurse before taking Co-Codamol Capsules if:

• You have kidney problems
• You have liver problems, including non-cirrhotic alcoholic liver disease, as the hazard of overdose is higher
• You have a condition called myasthenia gravis which weakens the muscles
• 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 suffer from hypothyroidism
• You have a disease of the adrenal gland called Addison’s disease
• You are taking benzodiazepine
• You are elderly
• You suffer from seizures.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Co-Codamol • 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.

Tolerance, dependence, and addiction

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

Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Co-Codamol can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Co-Codamol if: • You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).

• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Co-Codamol, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose • You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Co-Codamol). Codeine is transformed into 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. During treatment with Co-codamol Capsules, 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).

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 and adolescents with breathing problems

Co-codamol is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Co-codamol is not recommended in adolescents over 12 years of age with breathing problems for the treatment of cold.

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 Capsules

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

Tell your doctor, pharmacist or nurse 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, mirtazipine (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. C8WC1LUJ3

  V4

JOB INFORMA

Product Nam

Bottle Size: Strength:

Design Icon:

100 90 80 70

60

50

40

30

20

10

0

SBL

Co-Coda

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.

While taking Co-Codamol you should not take any other medicines which contain paracetamol.

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

Please inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2). Tell your doctor or pharmacist if you are taking any other medicines:
• Metoclopramide or domperidone – used for nausea (feeling sick), vomiting (being sick) and other stomach problems. These medicines may increase the speed at which paracetamol is absorbed by the body. • Cholestyramine – used for high cholesterol and other fats in the blood. This medicine may reduce the absorption of Co-Codamol Capsules.
• Anticoagulants – used to thin the blood (such as warfarin). You can take occasional doses of Co-Codamol Capsules. However if you need to take painkillers every day, talk to your doctor. • Muscle relaxants.
• Medicines to treat Parkinson’s disease. • Colestyramine – for lowering blood cholesterol levels. • The oral contraceptive pill.
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain). If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co- Codamol Capsules.

Co-Codamol with alcohol

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

Pregnancy and breast-feeding

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

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

Do not take Co-Codamol Capsules while you are breast-feeding as codeine passes into breast milk and will affect your baby.

Driving and using machines

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 taken 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.

3. How to take Co-Codamol Capsules

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, 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).

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.

The recommended dose is:

Adults: 1–2 capsules, repeated if necessary every 4–6 hours with a maximum of 8 capsules a day. Children aged 12 years to 18 years: Co-Codamol Capsules should not be taken to treat cough and cold by children aged 12 to 18 years who have breathing problems.

Children aged 12 years to 15 years: 1 capsule every 6 hours when necessary, up to 4 times a day. Children aged 16 years to 18 years: 1 - 2 capsules every 6 hours when necessary, up to a maximum of 8 capsules in 24 hours.

This medicine should not be used in children aged under 12 years

Co-Codamol Capsules should be taken orally. If you take more Co-Codamol Capsules than you should

• Talk to a 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.
• Remember to take any remaining capsules and the pack with you. This is so the doctor knows what you have taken.

If you forget to take Co-Codamol Capsules

If you forget to take a dose at the right time, take it as soon as you remember. However do not take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours between doses.

If you stop taking Co-Codamol Capsules

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, 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. The following side effects may happen with this medicine:

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.

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

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Co-Codamol Capsules.
• You get serious skin reactions. Very rare cases have been reported.
• You have a fit (seizure).
• You have difficulty breathing and you feel dizzy. Talk to your doctor straight away if you notice any of the following serious side effects:
• 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. Tell your doctors or pharmacist if any of the following gets serious or lasts longer than a few days:
• Constipation
• Feeling sick (nausea), being sick (vomiting), dry mouth • Dizziness, light-headedness, drowsiness, confusion • Feeling overly happy (euphoria)
• A feeling of unease or dissatisfaction
• Excessive constriction (shrinking) of the pupil of your eye
• Difficulty in passing water
• You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytosis). Not known (frequency cannot be estimated from the available data):
• Dependence and addiction (see section “How do I know if I am addicted?”)
• 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 Capsules, 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 Capsules, 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 Capsules

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 out of the sight and reach of children. Do not use after the expiry date (EXP) which is stated on the carton and blister. Do not store above 25°C, i.e. this medicine may be stored at room temperature. Do not throw away any medicines via wastewater. 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 Capsules contain

• Each capsule contains: Active ingredients: Paracetamol 500mg and Codeine Phosphate 8mg. • The other ingredients are maize starch, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, shellac, iron oxide, propylene glycol. What Co-Codamol Capsules look like and contents of the pack

Hard, white opaque capsules with “Co-Codamol” in red along the cap and body. Available in packs of 32 and 100 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder

Lucis Pharma Limited,

Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

Manufacturer

Surepharm Services Limited

Bretby Business Park, Ashby Road East, Bretby, Burton-on-Trent, DE15 0YZ, UK

This leaflet was last revised in March 2026.

C8WC1LUJ3

V4

JOB INFORMA

Product Nam

Bottle Size: Strength:

Design Icon:

100 90 80 70

60

50

40

30

20

10

0

SBL

Co-Coda