CO-CODAMOL 30/500mg EFFERVESCENT TABLETS – patient leaflet, side effects, dosage

1. WHAT CO-CODAMOL 30/500 ARE AND WHAT THEY ARE USED FOR

The active ingredients in Co-codamol 30/500 are paracetamol and codeine phosphate hemihydrate.

Paracetamol and codeine belong to a group of medicines called analgesics (pain killers). Co-codamol 30/500 are used for the relief of severe pain.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL 30/500

Important things you should know about Co-codamol 30/500

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 30/500 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 30/500 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 30/500, 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’)

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 30/500).

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

Do not take Co-codamol 30/500 if you

• are allergic (hypersensitive) to paracetamol, codeine or any of the other ingredients in the tablets (these are listed in Section 6, Further Information) Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue
• are already taking other medicines containing paracetamol
• have a dependency to alcohol, or are an alcoholic
• have severe asthma attacks or severe breathing problems
• have liver or kidney problems
• are on a low sodium diet
• have bowel or prostate problems
• are receiving monoamine oxidase inhibitor (MAOI) therapy. Co- codamol 30/500 should not be taken concurrently or within 14 days of MAOI’s
• 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
• have recently had an operation on your liver, gallbladder or bile duct (biliary tract)
• are under 12 years of age
• know that you metabolise very rapidly codeine into morphine (this is more common in Afro-Caribbean patients)
• are breast-feeding
• are under 18 years of age and have had your tonsils or adenoids removed due to obstructive sleep apnoea syndrome

Do not take Co-codamol 30/500 if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Co-codamol 30/500.

Talk to your doctor or pharmacist before taking Co-Codamol Tablets:

• If you have a condition called myasthenia gravis which weakens the muscles.
• have severe kidney or liver problems.
• have problems passing water or prostate problems.
• have a bowel problem such as colitis or Crohn’s disease or a blockage of your bowel.
• are elderly.
• are sensitive to aspirin or other medicines used for the treatment of inflammation (Non-Steroidal Anti-inflammatory Drugs) such as Ibuprofen.
• are taking a benzodiazepine.
• know you are a slow or intermediate metaboliser of an enzyme called CYP2D6, because a different dose may be applicable to you.
• are taking a medicine that induces CYP3A4 enzyme activity such as rifampicin.
• are or have ever been addicted to opioids, alcohol, prescription medicines or illegal drugs.
• 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 Co-codamol 30/500 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 prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.
• are on a low sodium diet.

During treatment with Co-Codamol 30/500, 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), or if you experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine. 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).

Warnings and Precautions

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

Sleep-related breathing disorders

Co-codamol 30/500 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.

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

Take special care with Co-codamol 30/500:

• Do not take for longer than directed by your doctor or pharmacist.
• Taking codeine regularly for a long period of time can lead to addiction, which might cause you to feel restless and irritable when you stop taking the tablets.
• Taking a painkiller for headaches too often or for too long can make them worse.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Co-codamol 30/500 can affect the way some other medicines work. Also, some other medicines can affect the way Co-codamol 30/500 works.

Concomitant use of Co-codamol 30/500 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 30/500 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.

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

Do not take these tablets if you are already taking other medicines containing paracetamol. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as they may decrease or increase the effect of Co-codamol 30/500:

• metoclopramide or domperidone (often taken for sickness or stomach problems)
• colestyramine (for high blood lipid levels)
• anticoagulants to reduce blood clotting (e.g. warfarin)
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain)

It may still be all right for you to take Co-codamol 30/500 and your doctor will be able to decide what is suitable for you.

Co-codamol 30/500 with food, drink and alcohol

Co-codamol 30/500 should be dissolved in at least half a glass of water and can be taken with or without a meal. You should not drink alcohol while you are taking Co-codamol 30/500. This is because Co-codamol 30/500 can change the way alcohol affects you.

Taking your medicine with food and drink

Co-codamol 30/500 should be dissolved in at least half a glass of water and can be taken with or without a meal.

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 and breast-feeding

Do not take Co-codamol 30/500 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 30/500 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 30/500 while you are breast-feeding as codeine and morphine passes into breast milk and will affect your baby.

Ask your doctor or pharmacist for advice before taking any medicines. Driving and using machinery

Co-codamol 30/500 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.

The maximum recommended daily dose of this medicinal product contains about 3504mg of 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 30/500 on a daily basis for a prolonged period of time, especially if you have been advised to have a low sodium diet.

This medicine contains 5mg of 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 30/500

Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Co-codamol 30/500, 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 30/500).

Do not exceed the recommended doses. If painful symptoms are not relieved in a few days, consult your doctor. Co-codamol 30/500mg 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

The usual doses for Co-codamol 30/500 are as follows:

Adults and children over 15 years:

1 or 2 tablets dissolved in water at 4 hourly intervals up to a maximum of 8 tablets in any 24 hour period. Do not continue to take these tablets for more than 3 days unless instructed by your doctor.

Children 12 to 15 years:

1 tablet dissolved in water every 4 - 6 hours when necessary, do not take more than 4 tablets in any 24 hours. Do not continue to take these tablets for more than 3 days unless instructed by your doctor. Do not exceed the recommended dose

Not recommended for use in children under 12 years of age.

Method of Administration

For oral administration only. These tablets should be dissolved in at least half a glass of water before taking them. The solution should be drunk immediately after preparation. These tablets are meant to be dissolved first so don’t try to swallow them whole.

If you take more Co-codamol 30/500 than you should

If you have accidentally taken more than your prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. An overdose of paracetamol can cause serious liver damage, which may not show any signs for a day or two, by which time treatment may not be successful.

If you forget to take Co-codamol 30/500

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.

If you have any further questions about this product ask your doctor or pharmacist.

If you stop taking Co-codamol 30/500

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 30/500:

• 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?”), a serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).

Stop taking Co-codamol 30/500 and see a doctor or go to a hospital straight away if you:

• have difficulty in breathing or you feel dizzy.
• 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 effects have been reported: Codeine-related side effects: Frequency and severity are determined by dosage, duration of treatment and individual sensitivity:

• Skin rashes
• Constipation
• Nausea, vomiting
• Light-headedness, dizziness
• Confusion
• Drowsiness
• Urinary retention
• 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:

• 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.
• problem affecting a valve in the intestines (sphincter of Oddi dysfunction)

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).If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Drug Withdrawal

When you stop taking Co-codamol 30/500, 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 notice any of the following signs whilst taking Co-codamol 30/500, 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 30/500

Do not store your tablets above 25°C. Store in a dry place and protect from light.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Keep this medicine 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 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 30/500mg Effervescent Tablets contains

• The active ingredients are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500mg paracetamol and 30mg 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 30/500mg Effervescent Tablets look like and the contents of the pack

Co-codamol 30/500 mg Effervescent Tablets are white, circular, with a flat bevelled edge and plain on both sides.

Your medicine is available in blister packs of 30, 32, 56, 60, 84, 90 and 100 tablets (not all pack sizes may be marketed).

Marketing Authorisation Holder

Kent Pharma UK Limited,

2^nd 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.