The facts about over-the-counter medicines containing codeine

Codeine - the facts

Codeine and addiction

How codeine works

Pack instructions

Pack size

Indications

Advertising

Codeine - the facts

  • What is Codeine?
    Codeine is an effective painkiller and at low doses it is used in combination with paracetamol or ibuprofen for the relief of pain such as migraine, muscular and joint pains, back ache, toothache and other dental pain and period pain.

    Codeine belongs to a group of medicines called opioids. Opioids mimic the effects of naturally occurring pain reducing chemicals (endorphins). They combine with the opioid receptors in the brain to block the transmission of pain signals.  Opioid medicines are classified as strong or weak. Strong opioids such as morphine are used to relieve severe pain, including cancer pain. Weak opioids, such as codeine, are available over-the-counter (OTC) in low doses to provide pain relief.

  • Is Codeine addictive?
    Codeine has a different molecular make up to morphine and heroin, which makes it much weaker.  As a result, it is far less addictive than its more potent counterparts.

    Some people do get addicted to over-the-counter (OTC) codeine products and take doses higher than recommended for long periods of time, but the scale of UK dependency from the misuse of OTC codeine products is still unknown, Figures of 30,000 people addicted have been quoted but these are based on guesses, not evidence.  Doctors and researchers are in agreement that it is a relatively small problem. 

  • Is Codeine safe for people to use without advice from a health professional?
    Codeine products are restricted to pharmacy sale and cannot be on self selection.  The pharmacist or trained assistant is legally required to supervise the sale and offer appropriate advice, particularly to customers who are using the products for the first time.  Used correctly, for a few days at a time, following the instructions on the pack, medicines containing codeine are generally safe and effective. 

    27.5 million packs of OTC codeine products are bought by people every year. The most popular pack size is 32 tablets. In addition over 20 million people are prescribed codeine/paracetamol products from their doctors to manage ongoing pain such as arthritis. The number of tablets per prescription varies from 50 to 500.  

    The safe use of codeine is of paramount importance to the pharmaceutical industry.  All licensed medicinal products placed on the market have been evaluated for safety and efficacy by the Medicines and Healthcare products Regulatory Agency (MHRA).  All medicines carry some risk of side effects, or the potential for overuse.  However, in assessing medicines it is essential to consider the risk/benefit profile.  The efficacy of codeine and the impact that would result from further restricting access to it confers a benfit which outweighs the risk.  The risk/benefit picture is continually reviewed.

  • What instructions are given on the packs to ensure safe use?
    Pack instructions explain who the product is or is not suitable for, what the products should be used for, how much to take, when and how long to take the medicines for.  They advise consulting a doctor or pharmacist after 3 days treatment.  They explain the possible side effects, such as drowsiness, nausea, dizziness, constipation or allergic reactions such as skin rashes, and advise patients to tell their pharmacist or doctor if they experience anything unusual or take the wrong dose.

    As part of its ongoing commitment to the safe use of OTC medicines containing codeine, industry manufacturers brought in voluntary guidelines in 2005 which added addiction warnings to packs and patient information leaflets citing that regular codeine use can lead to addiction and that users should consult their doctor if they need to continue taking codeine containing products after three consecutive days of use. In future, the front of the packs will say "Can cause addiction. For three days use only".

  • What control is there over the sale of codeine products?
    Products containing codeine are restricted to sale in pharmacies and cannot be sold without the supervision of a pharmacist or trained assistant. Pharmacists are vigilant in monitoring the sales of products containing codeine and can stop the sale of the medicine to anyone suspected of misusing the product, but are unable to prevent people from visiting alternative pharmacies.

  • Should the pack sizes of codeine products be reduced?
    Restriction of pack size is one way of discouraging people from using medicines for longer than recommended.  In 2005, manufacturers voluntarily agreed to reduce the pack size of over the counter codeine products to 32 tablets. In future, packs of 100 tablets will be available only on prescription.

  • What more is the industry doing to ensure the safe use of codeine products?
    In the past PAGB has sponsored research, funded a helpline manned by nurses to help people who have become addicted and provided leaflets and help to pharmacists who want tools to manage supply to their customers who they suspect are over using codeine medicines. 

    • PAGB and its members continue to work with regulators and addiction charities to discuss what additional steps can be taken to minimise the risk of codeine dependency without penalising the majority of consumers who use OTC codeine medicines safely and effectively. Consumers currently benefit from on pack information which provides the following support and advice:

    • Advice on how to use the product safely and effectively
    • Guidance on what type of pain to use the product for
    • Explicit warning signs on dosage and information on what to do in the event of an overdose
    • Information on when to consult a doctor
    • Detailed list of product ingredients

Codeine and addiction

  • What do we mean by addiction?
    Addiction is defined according to two types of product use:

    1. Misuse: when the product is used for proper reasons but at an inappropriate dose or for longer than recommended.

    2. Abuse: when the product is used for an inappropriate purpose or inconsistent with medical practice.

    In the case of codeine products we are mostly concerned with misuse.  People start by taking the product for treatment of a painful condition and continue to take it long beyond the recommended time frame, often increasing the dose as they do so.  If a product is taken for longer, or at a higher dose than recommended, it can result in an addiction that is one reason why the label instructions say that the products should only be used for 3 days.

  • Can people get addicted to codeine products that are prescribed to treat long term illnesses?
    Some people with long-term illnesses such as arthritis need pain relief every day and are prescribed codeine/paracetamol products by a doctor. This type of usage is appropriate pain management.  For the majority of people, occasional use of codeine products is sufficient to deal with a specific pain when it is troublesome.  If people have concerns about long term use of any analgesics they should speak to their doctor.

  • What makes codeine addictive?
    Codeine belongs to a group of medicines called opioids. They combine with the opioid receptors in the brain to block the transmission of pain signals.  Opioid medicines are classified as strong or weak. Strong opioids such as morphine are used to relieve severe pain, including cancer pain. Weak opioids, such as codeine, are available over-the-counter (OTC) in low doses to provide pain relief.   Opioids mimic the effects of naturally occurring pain reducing chemicals (endorphins).  Endorphins are the feel good chemicals of the brain.

    Codeine has a different molecular make up to morphine and heroin, which makes it much weaker.  As a result, it is less addictive than its more potent counterparts that is why in OTC medicines codeine is always combined with paracetamol or ibuprofen.  Combining codeine with these medicines creates a more effective pain relief product than the analgesics on their own. 

  • How many people are addicted to codeine medicines? 
    While there is increasing awareness of the potential for some people to become addicted, the scale of UK dependency from the misuse of OTC codeine products is still unknown, Figures of 30,000 have been quoted but these are based on guesses not evidence. Researchers are in agreement that it is a relatively small problem. 

    27 million packs of codeine containing medicines are sold over-the-counter in the UK every year.  The vast majority are used appropriately. There is no evidence to indicate that the number of people addicted to OTC codeine products is increasing.

  • If codeine can be addictive why is it available without a prescription?
    Used correctly, for a few days at a time, following the instructions on the pack, medicines containing codeine are safe and effective. 

    Codeine is an effective painkiller in combination with paracetamol or ibuprofen for the relief of pain such as migraine, muscular and joint pains, back ache, toothache and other dental pain and period pain.  It offers pain relief when a single ingredient product is not effective.

    It is important for people to take the correct dose of codeine and to not under dose or miss doses for fear of addiction.  There is no support for restricting the supply of codeine to prescription only. 

  • Do people treat medicines less carefully because they can buy them over the counter?
    Recent research carried out by IPSOS/MORI1 on behalf of the MHRA explored perception of risk associated with medicines. It tested the theory that people might think that they need not worry about the safety of a medicine that they bought over–the-counter.  33% of those who responded tended to agree with that suggestion but 44% had the same attitude to the supply of medicines on prescription and overall the majority of people (69%) feel that the benefits of medicines outweigh the risks.

  • Should people be warned that codeine can be addictive?
    As part of its ongoing commitment to the safe use of OTC medicines containing codeine, manufacturers voluntarily brought in warnings in 2005 which:

    • Added addiction warnings to packs and patient information leaflets citing that regular codeine use can lead to addiction and that users should consult their doctor if they need to use codeine products after three consecutive days of use.

    • Now, a front of pack warning will be added to say "Can cause addiction. For three days use only".

  • What controls are there over the sale of codeine containing medicines?
    Products containing codeine are restricted to sale in pharmacies and cannot be sold without the supervision of a pharmacist or trained assistant. Pharmacists are vigilant in monitoring the sales of products containing codeine and can stop the sale of the medicine to anyone suspected of misusing the product, but are unable to prevent people from visiting alternative pharmacies.

  • How can people avoid becoming addicted to codeine medicines?
    Codeine products should be taken only to relieve symptoms of pain and only for short periods, unless a doctor has advised otherwise. A doctor should be consulted after 3 days of continuous use.

    Headaches and migraine headaches which go on for more than 3 days should be investigated by a doctor as should tension headaches which occur frequently.  Dental pain and muscular or joint pains can last for longer than 3 days but people who experience these are generally being treated by a health professional who can advise about the management of pain.

  • What should people do if they think they are addicted?
    Anyone who believes they, or someone they know, is taking too much of any over-the-counter (OTC) product should contact a health care practitioner.

How codeine works

  • What is Codeine?
    Codeine is an effective painkiller and at low doses it is used in combination with paracetamol or ibuprofen for the relief of pain such as migraine, muscular and joint pains, back ache, toothache and other dental pain and period pain.

    Codeine belongs to a group of medicines called opioids. Opioids mimic the effects of naturally occurring pain reducing chemicals (endorphins). They combine with the opioid receptors in the brain to block the transmission of pain signals.

    Opioid medicines are classified as strong or weak. Strong opioids such as morphine are used to relieve severe pain, including cancer pain. Weak opioids, such as codeine, are available over-the-counter (OTC) in low doses to provide pain relief.  At higher doses codeine is only available as a prescription product.

    In OTC medicines, codeine is always combined with either paracetamol or ibuprofen.  Combining codeine with these medicines creates a more effective pain relief product than analgesics on their own.

  • How long should people use codeine medicines without medical advice?
    People are advised to use codeine containing products for only 3 days.  In general, this length of time is considered appropriate for self treatment for pain which is strong enough to need a codeine containing product instead of a single ingredient pain relief medicine.

    Over the counter codeine containing products are mainly intended for the treatment of acute pain.  Most period pain lasts for less than 72 hours.  Headaches and migraine headaches which go on for more than 3 days should be investigated by a doctor as should tension headaches which occur frequently. 

    Dental pain and muscular or joint pains can last for longer than 3 days but people who experience these are generally being treated by a health professional who can advise about the management of pain.

  • What are the side effects of codeine medicines?
    The most common side effects are drowsiness, nausea, dizziness, constipation or allergic reactions. 

    The products with paracetamol can cause liver damage if taken in excess or for a long period of time.  People report gastric upsets caused by the ibuprofen or by the ingredients in the effervescent paracetamol versions.

    Regular use for long periods of time can lead to addiction and coming off the medicine can result in symptoms such as restlessness and irritability.

Pack instructions

  • What is the new information?
    Warnings will be added to the front of packs saying "Can cause addiction. For three days use only." All the existing warnings and advice about dosage will reamin on packs. Patient Information Leaflets will also include more information about the potential for addiction and the risks of over use.

  • What information is already given to people to ensure safe use of codeine products?
    Used correctly, for a few days at a time, following the instructions on the pack, medicines containing codeine are generally safe and effective.  All products carry instructions on the label advising on correct use.  The instructions cover:
    • What the product is for  - relief of pain such as migraine, muscular and joint pains, back ache, toothache and other dental pain and period pain. 
    • How much to take and how often to take it – one to two tablets at a time. 
      No more than 8 tablets a day in the case of paracetamol/codeine combinations. 
      No more than 6 tablets a day in the case of ibuprofen/codeine combinations

    • People are also told:
      • Not to exceed the stated dose
      • Do not take for more than 3 days without medical advice
      • Consult a doctor or pharmacist if the symptoms persist
      • Consult a doctor or other health professional for advice if more than the recommended dose is taken accidentally.

    • In order to deter people from taking the products for long periods or too frequently the following additional statements are included
      • Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.
      • Taking a painkiller for headaches too often or for too long can make them worse.

  • Do people read the package instructions?
    Independent research has shown that most people do follow the instructions and use medicines responsibly2. In a study carried out in 2005:

    • 74.5% of people reported that they always followed the directions on the OTC drug package, while 11.9% said they often followed the directions.
    • 40.8% reported that they would stop and go to their GP if their OTC medicine did not work within the recommended period of time.

      • Almost a quarter (24.3%) said they would stop using the product and return to the pharmacy
      • 22.1% said they would decrease the dose or stop the medication.
      • Less than 9% indicated that they would increase the dose
      • Only 2.3% and 2.2% respectively would use the product more often or for a longer time than recommended.

  • Does the pack size have anything to do with safe use?
    Reducing pack sizes is one way to deal with the over use of medicines.  The manufacturers of codeine containing over the counter medicines voluntarily limited the pack size to 32 tablets.  This is 4 days treatment for the paracetamol/codeine combinations and just over 5 days treatment for ibuprofen/codeine combinations.

  • What information is available when the products are purchased?
    Products containing codeine are restricted to sale in pharmacies and cannot be sold without the supervision of a pharmacist or trained assistant who will ask a number of questions to establish who the product is for, whether the person has used it before, if they know how to take it and whether they are taking other medicines.  On the basis of the answers to these questions, the pharmacist may be involved in the sale personally and give advice on a more appropriate product or refuse the sale.

Pack size

  • What is the new pack size limitation?
    Manufacturers of branded codeine products have already voluntarily limited their pack sizes to 32 tablets. This will become a legal limit and pharmacists will be asked to supply only one pack per customer. Packs of 100 tablets will become prescription only.

  • What is the current pack size for codeine products?
    Codeine containing products are available in a variety of pack sizes.  Over 84% of purchases are for packs of 32 or less. Packs of 100 tablets are classified as pharmacy sale and can only legally be sold under pharmacy supervision.

  • The dosage instructions say use for three days, so why are the pack sizes larger?
    While some of the conditions like headache, dental pain or period pain are short term, all of the products can be used for longer if a doctor or other health professional advises you to do so.  Some of the painful conditions that codeine products are used for, like backache, muscular or arthritic/rheumatic pain or joint pain can last for longer than 3 days. 

  • Would reducing the pack size further help ensure safe use?
    The maximum pack size of 32 tablets for over the counter medicines was introduced by the manufacturers voluntarily in 2005.  This is the same maximum pack size for products containing paracetamol alone.  Used correctly, following the instructions on the pack, medicines containing codeine are generally safe and effective.

  • Would pharmacists find it easier to spot people who are misusing codeine products if they had to visit more often to buy small packs?
    Products containing codeine are restricted to sale in pharmacies and cannot be sold without the supervision of a pharmacist or trained assistant. Pharmacists are vigilant in monitoring the sales of products containing codeine and can advise people who have been using it for the correct indications but for longer than advisable.  They can direct customers to more appropriate treatment or advise seeing a doctor.  They do stop the sale of the medicine to anyone suspected of buying excessive amounts but are unable to control sales if people attempt to deceive them to obtain excessive product because they are dependent on codeine, nor can they prevent people from visiting alternative pharmacies.

Indications

  • What kind of pain can codeine containing products treat?
    Currently most of the codeine containing pain relief products can be used to treat mild to moderate pain. In future, the indications will change to make it clear the products should be used for no more than three days to treat moderate, acute pain which is not relieved by paracetamol, ibuprofen or aspirin alone. This includes indications such as period pain, migraine and dental pain.

  • What is the current medical advice on the use of codeine containing pain relief products?
    The World Health Organisation recommends that for mild pain people should use a pain relief product with paracetamol or a non steroidal anti-inflammatory (NSAID) such as ibuprofen or aspirin. If the pain persists or increases or is more than a mild pain then a product containing codeine is appropriate. NICE recommends the use of codeine containing pain relief products as a first line treatment for back pain.

Advertising

  • What warnings will be in advertisements?
    Warnings in all medicines advertisements already advise people to read the leflet and label, where detailed information is available to ensure safe use. In addition advertisements will include the same warning as the front of packs "Can cause addiction. For three days use only."

  • How will this be enforced?
    All advertising for non prescription medicines is controlled by law and in addition the Proprietary Association of Great Britain has a code of practice which checks all advertisements issued by its member companies for compliance before they are published.

  • What other restrictions will be placed on advertisements?
    In the future, the advertising will be limited to moderate acute pain. References and imagery which indicate mild pain or very secere pain will be removed.

1 Risks and benefits of medicines and medical devices – Perceptions, Communication & Regulation. Ipsos MORI research     conducted for the Medicines and Healthcare products Regulatory Agency research study for MHRA March 2006.
URL: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=1017

2 Wazaify M, Shields E, Hughes CM and McElnay JC. Societal perspectives on over-the-counter (OTC) medicines. Family Practice 2005; 22: 170–176. URL: http://fampra.oxfordjournals.org/cgi/reprint/22/2/170