Patient leaflet - Co-codamol 30/500 mg tablets BP
1. WHAT CO-CODAMOL 30/500 mg TABLETS ARE AND WHAT THEY ARE USED FOR
Co-codamol 30/500mg Tablets contain paracetamol and codeine (painkillers), which are used to relieve severe pain.
Codeine 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 30/500mg 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL 30/500 mg TABLETS Important things you should know about Co-codamol Tablets
Do not take for longer than your doctor tells you to. • Taking a painkiller for headaches too often or for too long can
make them worse.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescri-ber 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 heart-beat (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 experien-ce 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. Overu-se and misuse can lead to overdose and/or death.
Warnings and precautions
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 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 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 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 Tablets).
Do NOT take this medicine if you:
are allergic (hypersensitive) to paracetamol, codeine phosphate,
other opioid painkillers or any of the other ingredients of this medicine (listed in section 6)
have moderate or severe kidney failure or liver disease • have asthma or another lung disease which makes breathing
difficult
have increased pressure in the brain, e.g. following a head injury
- have diarrhoea associated with inflammation of the bowel or following poisoning
- have recently had gall bladder surgery
- are an alcoholic
- are at risk of paralysis of the intestine (paralytic ileus) • are taking Monoamine Oxidase Inhibitors for depression or have taken them within the last 14 days
- know that you metabolise very rapidly codeine into morphine • are breastfeeding
- Do not use for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome.
Sleep-related breathing disorders
Co-codamol 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 conside-red by your doctor.
During treatment with Co-codamol 30/500mg 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 malnu-trition, 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 situ-ations 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 (nau-sea) and being sick (vomiting).
DO NOT TAKE WITH ANY OTHER PARACETAMOL OR CODEINE CONTAINING PRODUCTS.
Children and adolescents
Use in children and adolescents after surgery:
Codeine should not be used for pain relief in children and adole-scents 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.
Tell your doctor before you start to take this medicine if you:
- suffer from myasthenia gravis (muscle weakness and fatigue) • have low blood pressure or are suffering from shock • have a history of cardiac arrhythmias (erratic heartbeat) • have thyroid or adrenal disease
- have prostate or urinary problems e.g. difficulty passing water • have mild kidney or liver disease
- suffer from convulsions
- have a history of drug abuse or emotional instability • suffer from bowel disease
- have recently had gastro-intestinal surgery
- have gall stones
- are elderly or infirm
- have asthma, bronchitis or emphysema
Talk to your doctor if you experience any of the following symptoms while taking Co-codamol 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.
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 diffe-rent 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.
Other medicines and Co-codamol Tablets
Talk to your doctor or pharmacist before you take this medicine if you are taking any of the following:
- sedatives, tranquillisers, antidepressants, sleeping tablets, or alcohol
- medicines used to treat water retention or high blood pressure • medicines to treat mental illness (anti-psychotics) • medicines to prevent blood clotting, such as warfarin • medicines to treat diarrhoea, such as loperamide and kaolin • muscle relaxants, such as atropine
anaesthetics or other drugs used in surgery (such as
neuromuscular blocking agents)
medicines that affect the liver e.g. carbamazepine,
phenobarbital, phenytoin (antiepileptics) or rifampicin (antibiotic)
- antihistamines
- gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain)
- naloxone or naltrexone (used to treat drug abuse or overdose) • colestyramine (used to reduce cholesterol in the blood) • quinidine flecainide or mexiletine (used to treat certain heart conditions)
- metoclopramide or domperidone (used to treat nausea and vomiting)
- cimetidine (used to treat stomach ulcers)
- cisapride (used to treat heart burn)
- chloramphenicol (an antibiotic)
- oral contraceptives (the “pill”)
- hydroxyzine (an anti-histamine)
- probenecid (used to treat gout)
PROOF- SHEET
REPLACES NUMBER/VERSION:
9526I
CODE
9537A
BOOKLET/LEAFLET DIMENSIONS
206x418/206x42 mm
PROOF VERSION
Endret format på PV pga. økt tekstmengde. Opprettet nytt artikkelnummer.
9537A
2026-03-06
4
CLA
Customer
Description
Product Reference No
Date / Operator
Palla Pharma AS
PAL PV CO-COD 30/500 RUND
9537A
06.03.2026 Larsen Carsten
206.00 x 418.00 mm
Black Cutting DImensions
prepress.esonpac@mm.group
4PROOF
Eson Pac Itemnumber
1041515
YOUR OVERPRINT SETTINGS ARE CORRECT
206.00 mm
- isoniazid (used to treat tuberculosis)
- anxiolytics (to help with anxiety)
- sodium oxybate (used to treat narcolepsy)
intravenous busulfan (used in chemotherapy to treat cancer) • flucloxacillin (antibiotic), due to a serious risk of blood and fluid
abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
Please tell your doctor or pharmacist if you are taking or have re-cently taken any other medicines, including those obtained without a prescription.
Pregnancy and breastfeeding
Do not take Co-codamol Tablets 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 Tablets 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 Tablets while you are breastfeeding as
codeine passes into breast milk and will affect your baby. Driving and using machines
If these tablets make you feel drowsy, or cause changes in your vision, including blurred or double vision, do not 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.
Tell the hospital staff, your doctor or dentist that you are taking the-se tablets before you have any treatment or operation, or before the appointment date if you are to have a blood or urine test.
3. HOW TO TAKE CO-CODAMOL 30/500 mg TABLETS
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.
Always take this medicine exactly as your doctor has told you. You should 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 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 Tablets).
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 Tablets should be used for the shortest duration neces-sary to relieve symptoms. If no effective pain relief is achieved while taking the medicine, you should seek the advice of a physician. Adults and the Elderly: Take one or two tablets every 4-6 hours. Do not take more than 8 tablets in any 24 hour period. A lower dosage may be needed if you are elderly or have other medical problems. Check with your doctor about this.
Children aged 16-18 years: Take one or two tablets every 6 hours when required. Do not take more than 8 tablets in any 24 hour period.
Children aged 12-15 years: Take one tablet every 6 hours when required. Do not take more than 4 tablets in any 24 hour period. Children aged less than 12 years: Co-codamol Tablets should not be used in children under the age of 12 years, due to the risk of seve-re breathing problems.
DO NOT EXCEED THE STATED DOSE
If you take more Co-codamol Tablets 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.
If the doctor is not there, go to your local hospital casualty depart-ment. Take this leaflet and any remaining tablets with you. The hazard of overdose with paracetamol is greater in those with alcoholic liver disease.
If you forget to take Co-codamol 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 4 hours between doses. If you stop taking Co-codamol Tablets
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, Co-codamol Tablets can cause side effects, alt-hough not everybody gets them.
Important side effects you should know about Co-codamol Tablets
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 the tablets and tell your doctor immediately or go to the nearest hospital casualty department if you have any of the following:
Blood disorders such as thrombocytopenia (reduction in
blood platelets, which increases risk of bleeding or bruising), neutropenia and leucopenia (reduction in white blood cells, which may make infection more likely) and pancytopenia (severe reduction in blood cells which can cause weakness, bruising or make infections more likely).
Symptoms of an allergic reaction (rare side effect), such as
swelling of the lips, face or neck leading to severe difficulty breathing, skin rash or hives.
Very rare cases of serious skin reactions have been reported.
- Serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).
A serious blistering condition of the skin, mouth, eyes and
genitals (Stevens-Johnson syndrome).
- Problem affecting a valve in the intestines (sphincter of Oddi dysfunction). The frequency is not known, as it cannot be estimated from the available data.
Tell your doctor or pharmacist if any of the following side effects gets worse or lasts longer than a few days:
- constipation
- drowsiness
- nausea, vomiting, anorexia, diarrhoea, incontinence • abdominal pain (may be caused by spasm of the bile or urinary ducts)
- skin rash, itching, sweating, facial flushing, low body temperature • dry mouth, blurred or double vision, pin-point pupils or other changes in vision
- malaise, tiredness, headache, fever
- dizziness, vertigo, light-headedness
- slow or rapid heartbeat, palpitations, breathing difficulties • low blood pressure, feeling faint on standing from a seated or lying position
- decreased libido or potency, weak erection in men • confusion, anxiety, mood changes (including depression, sadness, euphoria)
- convulsions, hallucinations, nightmares, depression • stomach cramps, enlargement of the spleen
- uncontrolled muscle movement or rigidity
- pain or difficulty in passing urine, increased or decreased frequency
- restlessness
- high blood glucose levels
- swelling of the lymph nodes
- kidney damage
A serious condition that can make blood more acidic (called meta-bolic acidosis) can occur in patients with severe illness using para-cetamol (see section 2). The frequency is not known, as it cannot be estimated from the available data.
Drug Withdrawal
When you stop taking Co-codamol Tablets, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpi-tations), 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 Tablets, 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 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 THIS MEDICINE Keep out of the sight and reach of children
Store this medicine in a safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been intended for them.
Do not store above 25 °C. Store in the original package. Do not use after the expiry date printed on the pack. The expiry date refers to the last day of that month.
Do not throw away any medicines via waste water 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 this medicine contains:
The active ingredients in each tablet are paracetamol 500mg and codeine phosphate 30mg.
The other ingredients are maize starch, povidone, colloidal silica, magnesium stearate and potassium sorbate (E202). What this medicine looks like and contents of the pack:
Co-codamol 30/500mg Tablets are off-white, round, flat bevel-ed-ged tablets, plain on one side and embossed with “30” and ”C/COD” on either side of the break line on reverse, available in packs of 10, 20, 30, 50 and 100 tablets.
Marketing Authorisation Holder:
Palla Pharma (UK) Holding Limited, 10 Norwich Street, London, EC4A 1BD, UK
Manufacturers:
Palla Pharma Norway AS, Gruveveien 1, Kragerø, NO-3770, Norway
Date of revision: February 2026
Customer
Description
Product Reference No
Date / Operator
Palla Pharma AS
PAL PV CO-COD 30/500 RUND
9537A
06.03.2026 Larsen Carsten
206.00 x 418.00 mm
Black Cutting DImensions
prepress.esonpac@mm.group
4PROOF
Eson Pac Itemnumber
1041515
YOUR OVERPRINT SETTINGS ARE CORRECT
206.00 mm