Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
• do not take for longer than directed by your prescriber • taking codeine regularly for a long time can lead to addiction, which might make you feel restless and irritable when you stop the tablets • taking a painkiller for headaches too often or for too long can make them worse Codeine Phosphate Tablets should not be given if you: • have ever had a reaction to or been told that you are allergic to codeine phosphate, any other opioid analgesic or any of the other ingredients in the tablets (see section 6) • have been told you have a tumour of the adrenal gland near your kidney called phaeochromocytoma • have severe problems with breathing • are pregnant or breast-feeding • have increased pressure on the brain, have just had a head injury or if you are unconscious • are suffering from acute alcoholism • are at risk from a blocked intestine • have severe stomach cramps caused by a condition known as biliary colic • are suffering from severe diarrhoea • 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 • know that you metabolise very rapidly codeine into morphine
Tolerance, dependence, and addiction
This medicine contains codeine which is an opioid medicine. It can cause dependence and/or addiction.
Sleep-related breathing disorders Codeine Phosphate 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. 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.
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.
Other Medicines and Codeine Phosphate Tablets It is very important that you inform your doctor if you are taking or have taken any other medicines, as some medicines may affect the way Codeine Phosphate Tablets work. In particular, tell your doctor if you are taking any of the following: • monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine used in the treatment of depression. You must also tell your doctor if you have stopped taking any of these or related medicines in the last two weeks • tricyclic antidepressants, which are used in the treatment of depression • tranquillising drugs or sleeping tablets such as diazepam, nitrazepamand temazepam • medicines used to treat mental illnesses, including schizophrenia (e.g. chlorpromazine, haloperidol) • medicines used for diarrhoea (e.g. loperamide, kaolin) • medicines which are used as premedication before operations and after heart attacks such as atropine • anaesthetics, particularly general anaesthetics (used in surgery to numb pain) • antihistamines such as benadryl (used to treat allergies e.g. hayfever) • sodium oxybate (used to treat narcolepsy) • medicines used to treat nausea and vomiting, such as metoclopramide or Domperidone • mexiletine or quinidine, used to control heart rhythm • cimetidine, used to treat stomach ulcers and indigestion • ritonavir, used to treat HIV (a viral infection) • gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain) However if your doctor does prescribe Codeine Phosphate 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.
Codeine Phosphate Tablets with food, drink and alcohol You should not drink alcohol whilst you are taking Codeine Phosphate Tablets, as they will increase its effects. Alcohol may increase the sedative effects of codeine phosphate and make you very sleepy.
Pregnancy, breast-feeding and fertility Do not take Codeine Phosphate 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 Codeine Phosphate during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Codeine Phosphate 15mg Tablets BP Codeine Phosphate 30mg Tablets BP Codeine Phosphate 60mg Tablets BP
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
This medicine has been prescribed for you to relieve pain, suppress coughs and treat diarrhoea. It contains the Codeine Phosphate 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. Codeine 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.
Speak to your doctor before you take Codeine Phosphate Tablets if you: • 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 of Codeine Phosphate Tablets 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 using drugs or have used drugs in the past as taking codeine phosphate for a long time can lead to addiction • are taking or have taken within the last two weeks, monoamine oxadise inhibitors (MAOIs) such as moclobemide, or phenelzine used in the treatment of depression • suffer from asthma (your doctor may decide to administer Codeine Phosphate Tablets if your asthma is controlled. However, you should not be given this medicine if you are having an acute asthma attack) • suffer from bronchitis (an inflammation of the lining of the tubes in the lungs, resulting in coughing spells accompanied by thick phlegm and breathlessness) or emphysema (a lung condition which leaves you struggling for breath) • suffer from cor-pulmonale (a type of heart failure) • are severely obese • have a severely deformed spine • are suffering from mental illness brought on by an • have liver problems infection • have problems with your bile duct • have kidney problems • have an under-active thyroid or adrenal gland • suffer from an enlarged prostate gland (in men) or have • are in a state of severe shock difficulty passing urine • have inflammatory bowel disease, such as • have low blood pressure Crohn's disease or ulcerative colitis or a • are very run down blockage in the bowel muscles • suffer from convulsions (fits) • are a child or elderly • are feeling weak and feeble • have 'myasthenia gravis' (tiredness and weakness of some of your muscles e.g. eyes, mouth and throat muscles) • are a poor metaboliser of codeine • you experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine. If any of the above apply to you, speak to your doctor, nurse or pharmacist before you take Codeine Phosphate Tablets. 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.
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.
Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Codeine Phosphate can also lead to dependence, abuse and addiction, which may result in lifethreatening 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 Codeine Phosphate 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 Codeine Phosphate, 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 or cough. - 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 Codeine Phosphate).
Do not take Codeine Phosphate while you are breastfeeding as Codeine Phosphate passes into breast milk and will affect your baby.
Driving and using machines You may feel drowsy and confused and you may develop blurred or double vision when you are taking Codeine Phosphate Tablets, so you should not drive or operate machinery. This medicine can affect your ability to drive. Do not drive whilst taking this medicine until you know how this medicine affects you. It may be an offence to drive if your ability to drive safely is affected. There is further information for patients who are intending to drive in Great Britain - go to https://www.gov.uk/drug
Important information about some of the ingredients of Codeine Phosphate Tablets: These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars then do not take these tablets until you have consulted your doctor.
Adults For relief of mild to moderate pain, 30mg to 60mg every six hours as needed.. For diarrhoea, 30mg three or four times daily. For a dry and painful cough, 15 to 30mg three or four times a day. No more than 240mg should be taken in 24 hours. You may need a reduced dose if you have kidney or liver problems. You may also be given a reduced dose if you suffer from any of the conditions listed above in the section headed 'Speak to your doctor before you take Codeine Phosphate Tablets if you:' Your doctor will decide the dose that is best for you. Always follow your doctor's instructions completely. Also, follow any special instructions or warnings that appear on the label that the pharmacist has put on the package. If you do not understand or are in any doubt, ask your pharmacist.
If you think that you or someone else has taken too much of their opioid medicine, dial 999 immediately. If you forget to take Codeine Phosphate Tablets You should continue to take your medicine for as long as your doctor tells you to. If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER double the next dose to make up for the one missed. Do not take a double dose to make up for a forgotten dose.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or nurse immediately if you experience the following serious side effect: • a severe allergic reaction (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing). If you suffer such a reaction, you should not be given any more codeine. Your doctor will decide on the appropriate treatment for allergic reactions. Difficulty in breathing and physical and psychological dependence are possible serious side effects. It is possible that you could become dependent on codeine.
Side effects that are common include: • drowsiness • feeling sick or being sick • constipation • sweating Apart from constipation, these side effects tend to disappear with time. Side effects that are less common include: • dizziness • feeling faint on standing up • small pupils (in the eye) • blurred vision • double vision or other changes in vision • mental clouding or confusion • mood changes such as depression and sadness • feeling extremely happy for no particular reason • imagining things (hallucinations) • nightmares • headache • vertigo (a feeling of dizziness or being lightheaded) • facial flushing • difficulty breathing • stomach cramps • sweating • dry mouth • difficulty or pain in passing urine • passing less urine than usual • biliary spasm (causing pain in the right side of your • palpitations (trembling, shaking, irregular heart beats) abdomen, particularly after eating a meal, which may • hyperglycaemia (abnormally high levels of spread towards your right shoulder) glucose in the blood) • increased pressure within your head (raised intracranial • feeling unwell pressure) • hypothermia • pancreatitis (inflammation of the pancreas) • an enlarged spleen or swollen/enlarged lymph nodes • feeling tired • uncontrolled muscle movements • fever • muscle rigidity • anorexia • skin rash • restlessness • reduced sexual drive or impotence after long • slower or faster pulse term use. • wheals or itching
Unknown frequency: dependence and addiction (see section "How do I know if I am addicted?"), Symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system (a problem affecting a valve in the intestines known as sphincter of Oddi dysfunction), e.g. severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever.
Drug Withdrawal When you stop taking Codeine Phosphate Tablets, 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.
If you notice any of the above, talk to your doctor or a pharmacist. 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.
What Codeine Phosphate Tablets contains The active substance is Codeine Phosphate. The other ingredients are lactose monohydrate, acacia, maize starch, magnesium stearate and stearic acid. (see Section 2 'Important information about some of the ingredients of Codeine Phosphate Tablets').
What Codeine Phosphate Tablets looks like and contents of the pack Codeine Phosphate Tablets 15mg are white, circular tablets marked C15 on one face. Codeine Phosphate Tablets 30mg are white, circular biconvex tablets Codeine Phosphate Tablets 60mg are white, circular tablets marked C60 on one face. Codeine Phosphate Tablets are available in container packs of 28,30,56,60,84,90,100, 250 and 500 tablets. They are also available in blister packs of 28, 30, 56, 60, 84,90 and 100 tablets (Not all pack sizes may be marketed).
Marketing Authorisation Holder Milpharm Limited, 1 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF United Kingdom
Manufacturer Generis Farmaceutica S.A. Rua Joao De Deus, N° 19, Venda Nova, 2700-487 Amadora
This leaflet was last revised in 01/2026. Ref: Ver 1.0
Always take this medicine exactly as your doctor or pharmacist 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 Codeine Phosphate, 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 Codeine Phosphate). 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. Unless instructed differently, take your tablet(s) with a glass of water. If you have been given a blister pack, to obtain a tablet, press on the tablet from the blister (or bubble) pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it. The recommended oral dose is:
Adolescents older than 12 years of age The recommended starting dose for children aged 12 years or above for relief of mild to moderate pain is 30mg to 60mg every six hours, as needed. Codeine Phosphate tablets should not be taken by children below the age of 12 years due to the risk of severe breathing problems. Codeine Phosphate Tablets are not recommended for the treatment of diarrhoea in children. The Elderly: in all cases the dosage should be reduced. 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. Codeine Phosphate should be used for the shortest duration necessary to relieve symptoms. If you take more Codeine Phosphate Tablets than you should If you or someone else swallow several of these tablets together, contact your doctor or nearest hospital emergency department immediately. Always take any tablets left over with you, this leaflet and also the box, as this will allow easier identification of the tablets. Taking too much medicines is called an overdose, whether it's internal or not. This can be very serious and may cause death. Some of the signs of an overdose include • Confusion or hallucinations • Slurred speech • Lips or fingernails are blue or purple • Poor coordination or balance • Unresponsive or unconscious • Heavy or unusual snoring • Difficulty breathing or no breathing • Very small pupils in the eyes Your family, friends, and carers should know these signs so they can take immediate action.
If you stop taking Codeine Phosphate 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. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
How do I know if I am addicted? Addiction can happen gradually, It 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. You might feel that you need to carry on taking your medicine, even when it doesn't help to relieve your pain. If your pain is becoming difficult to manage, talk to your doctor. Your body may have stopped sensing the pain-relieving effect of your opioid. This is called 'opioid tolerance'. It could be an early warning sign that you are at risk of becoming addicted. Signs that you may be addicted to opioids include: • Craving of the medicine • Feeling that you need to take more medicine than prescribed or as instructed on the pack, even though the medicine is causing unwanted effects on your overall health (for example, some of the withdrawal side effects in the next section) • Feeling that you need to take additional medicines containing opioids or other pain relief medicines to achieve the same relief • Taking opioid medicines for reasons other than pain relief; for instance, to 'stay calm' or 'help you sleep' • Experiencing withdrawal side effects when you stop taking the medicine suddenly (see below).
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package and keep containers tightly closed. Do not use Codeine Phosphate Tablets after the expiry date, which is stated on the carton. The expiry date refers to the last day of that month. REMEMBER this medicine is for YOU only. Never give it to anyone else. It may harm them, even if the symptoms are the same as yours. Unless your doctor tells you to, do not keep tablets that you no longer need. Give them back to the pharmacist. 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. 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.
Codeine phosphate 15mg Tablets comes as tablet containing 15mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Codeine phosphate 15mg Tablets is codeine phosphate.
Medicines with the same active substance, strength and form include: Codeine Phosphate 15mg Tablets, Codeine Phosphate Tablets BP 15mg. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Codeine phosphate 15mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone)
Dry or painful cough
Diarrhoea
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with Codeine Phosphate in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).
Posology
For Mild to Moderate Pain
Adults:
Codeine should be used at the lowest effective dose for the shortest period of time. The dose may be taken, up to 4 times a day at intervals of not less than 6 hours. Maximum daily dose of codeine should not exceed 240mg.
The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.
Elderly
Dosage should be reduced in elderly patients.
Paediatric population
Children aged 12 years to 18 years:
The recommended codeine dose for children 12 years and older should be 30-60mg every 6 hours when necessary up to a maximum dose of codeine of 240mg daily. The dose is based on the body weight (0.5-1mg/kg).
Children aged less than 12 years:
Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see section 4.3 and 4.4).
For dry or painful cough
Adults:
15-30mg 3-4 times daily.
Elderly
Dosage should be reduced in elderly patients
Paediatric Population
Children aged less than 12 years:
Codeine is contraindicated in children below the age of 12 years for the symptomatic treatment of cough see section 4.3.
Children aged 12 years to 18 years
Codeine is not recommended for use in children aged 12 years to 18 years with compromised respiratory function for the symptomatic treatment of cough (see section 4.4).
Diarrhoea
Adults:
30mg three to four times daily (range 15-60mg)
Elderly
Dosage should be reduced in elderly patients
Paediatric Population
Not recommended.
Method of administration
Oral route
Acute respiratory depression, hypersensitivity to codeine or other opioid analgesics or to any of the excipients, obstructive airways disease, liver disease, severe hepatic dysfunction, acute alcoholism.
Use should be avoided in patients with raised intracranial pressure or head injury (in addition to the risk of respiratory depression and increased intracranial pressure, may affect pupillary and other responses vital for neurological assessment).
Codeine should not be given to comatose patients.
Codeine is also contraindicated in conditions where inhibition of peristalsis is to be avoided, where there is a risk of paralytic ileus, where abdominal distension develops, or in acute diarrhoeal conditions such as acute ulcerative colitis or antibiotic associated colitis (e.g. pseudomembranous colitis) or diarrhoea caused by poisoning.
Codeine is also contraindicated in the following:
• In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life-threatening adverse reactions (see section 4.4)
• In women during breastfeeding (see section 4.6).
• In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.
Use with caution or in reduced doses in asthma and decreased respiratory reserve; avoid use during an acute asthma attack (see 4.3 Contraindications). It should only be used with caution or in reduced dose in elderly patients or debilitated patients, or in patients with hypotension, hypothyroidism, prostatic hypertrophy, adrenocortical insufficiency, inflammatory or obstructive bowel disorders, urethral stricture, shock, convulsive disorders, myasthenia gravis. It should be avoided or the dose reduced in patients with renal or hepatic impairment (see 4.3 Contraindications, liver disease). Use with caution in those with a history of drug abuse.
CYP2D6 metabolism
Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.
General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal.
Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:
Population
Prevalence %
African/Ethiopian
29%
African American
3.4% to 6.5%
Asian
1.2% to 2%
Caucasian
3.6% to 6.5%
Greek
6.0%
Hungarian
1.9%
Northern European
1%-2%
Post-operative use in children
There have been reports in the published literature that codeine given post-operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, led to rare, but life-threatening adverse events including death (see also section 4.3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.
Children with compromised respiratory function
Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. These factors may worsen symptoms of morphine toxicity.
Opioid analgesics should be avoided in patients with biliary tract disorders or used in conjunction with an antispasmodic.
Administration of pethidine and possibly other opioid analgesics to patients taking a monoamine oxidase inhibitor (MAOI) has been associated with very severe and sometimes fatal reactions. If the use of codeine is considered essential then great care should be taken in patients taking MAOIs or within 14 days of stopping MAOIs (see section 4.5).
The risk-benefit of continued use should be assessed regularly by the prescriber.
Drug dependence, tolerance and potential for abuse
For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with current or past history of substance misuse disorder (including alcohol misuse) or mental health disorder (e.g., major depression).
Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse.
A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance.
The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for analgesic treatment should be reviewed regularly.
Discontinuation should be carried out gradually in patients who may have developed physical dependence, to avoid precipitating withdrawal symptoms.
Drug withdrawal syndrome
Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with Codeine Phosphate.
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.
The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.
Hyperalgesia
Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality. Symptoms of hyperalgesia may resolve with a reduction of opioid dose.
Codeine contains lactose monohydrate
Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Alcohol: the hypotensive, sedative and respiratory depressive effects of alcohol may be enhanced.
Anaesthetics: concomitant administration of codeine and anaesthetics may cause increased CNS depression and/or respiratory depression and/or hypotension.
Anti-arrhythmics: codeine delays the absorption of mexiletine. The analgesic activity of codeine is likely to be significantly impaired by quinidine which impairs codeine metabolism.
Antidepressants: The depressant effects of opioid analgesics may be enhanced by tricyclic antidepressants.
MAOIs taken with pethidine have been associated with severe CNS excitation or depression (including hypertension or hypotension). Although this has not been documented with codeine, it is possible that a similar interaction may occur and therefore the use of codeine should be avoided while the patient is taking MAOIs and for 2 weeks after MAOI discontinuation.
Antihistamines: concomitant administration of codeine and antihistamines with sedative properties may cause increased CNS depression and/or respiratory depression and/or hypotension.
Antipsychotics: enhanced sedative and hypotensive effect.
Anxiolytics and hypnotics: enhanced sedative effect.
Domperidone and metoclopramide: codeine antagonises the effect of cisapride, metoclopramide and domperidone on gastrointestinal activity.
Sodium oxybate: concomitant administration of codeine and sodium oxybate may cause increased CNS depression and/or respiratory depression and/or hypotension.
Ulcer-healing drugs: Cimetidine may inhibit the metabolism of codeine resulting in increased plasma concentrations.
Interference with laboratory tests: Opioids may interfere with gastric emptying studies as they delay gastric emptying and with hepatobiliary imaging using technetium Tc 99m disofenin as opioid treatment may cause constriction of the sphincter of Oddi and increase biliary tract pressure.
Pregnancy
As with all medications caution should be exercised during pregnancy, especially in the first trimester. A possible association with respiratory and cardiac malformations has been reported following first trimester exposure to codeine.
Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate.
If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.
Opioid analgesics may cause gastric stasis during labour, increasing the risk of inhalation pneumonia in the mother.
Breast feeding
Administration to nursing women is not recommended as Codeine Phosphate may be secreted in breast milk and may cause respiratory depression in the infant.
If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.
Codeine produces sedation and may also cause changes in vision, including blurred or double vision therefore treatment may impair ability to drive and use machines. If affected, patients should not drive or operate machinery.
The effects of alcohol are enhanced by opioid analgesics.
This medicine can impair cognitive function and can effect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road of Traffic Act 1988. When prescribing this medicine patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicines affect you
• It is offence to drive while under the influence of this medicine.
• However, you would not be committing an offence (called 'statutory defence') if:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
o It was not affecting your ability to drive safely
Regular prolonged use of codeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped.
Prolonged use of a painkiller for headaches can make them worse.
Tolerance and some of the most common side effects – drowsiness, nausea, and vomiting, and confusion – generally develops with long term use.
Immune system disorders: maculopapular rash has been seen as part of a hypersensitivity syndrome associated with oral codeine phosphate; fever, splenomegaly and lymphadenopathy also occurred.
Endocrine disorders: hyperglycaemia.
Metabolism and nutrition disorders: anorexia.
Psychiatric disorders: mental depression, hallucinations and nightmares, restlessness, confusion, mood changes, euphoria and dysphoria.
Frequency unknown: drug dependence (see section 4.4).
Nervous system disorders: convulsions (especially in infants and children), dizziness, drowsiness, headache (prolonged use of a painkiller for headaches can make them worse). Raised intracranial pressure may occur in some patients.
Eye disorders: blurred or double vision or other changes in vision. Miosis.
Ear and labyrinth disorders: vertigo.
Cardiac disorders: tachycardia, palpitations and bradycardia.
Vascular disorders: postural hypotension, facial flushing. Large doses produce hypotension.
Respiratory, thoracic and mediastinal disorders: Dyspnoea. Large doses produce respiratory depression.
Gastrointestinal disorders: nausea, vomiting, constipation, dry mouth, stomach cramps, pancreatitis.
Hepatobiliary disorders: Biliary spasm (may be associated with altered liver enzyme values).
Skin and subcutaneous tissue disorders: allergic reactions such as skin rashes, urticaria, pruritus, sweating and facial oedema.
Musculoskeletal and connective tissue disorders: Uncontrolled muscle movements. Muscle rigidity may occur after high doses.
Renal and urinary disorders: difficulty with micturation, urinary retention, ureteric spasm, dysuria. An antidiuretic effect may also occur with codeine.
Reproductive system and breast disorders: sexual dysfunction, erectile dysfunction, decreased potency. Decreased libido.
General disorders and administration site conditions: malaise, tiredness, hypothermia.
Uncommon: drug withdrawal syndrome.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms
Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The triad of coma, pinpoint pupils and respiratory depression is considered indicative of opioid over dosage with dilation of the pupils occurring as hypoxia develops. Nausea and vomiting are common. Other opiod overdose symptoms include hypothermia, confusion, convulsions, severe dizziness, severe drowsiness, hypotension and tachycardia (possible but unlikely), nervousness or restlessness, excitement, hallucinations, bradycardia, circulatory failure, slow or troubled breathing, severe weakness, convulsions, especially in infants and children. Rhabdomyolysis, progressing to renal failure, has been reported in over dosage with opioids.
Management
This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg. In acute overdosage with respiratory depression or coma, the specific opioid antagonist naloxone is indicated using one of the recommended dose regimens– repeated doses may be required in a seriously poisoned patient as naloxone is a competitive antagonist with a short half life.
Patients should be observed closely for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.
Ask anything about Codeine phosphate 15mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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