Information on over-the-counter medicines containing codeine

Fact sheets

Codeine - the facts

Codeine and addiction

Pack instructions

Resources for healthcare professionals

In development.

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Fact sheets:

Codeine - the facts

Codeine and addiction

Pack instructions

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 benefit which outweighs the risk.  The risk/benefit picture is continually reviewed, most recently in 2009.  The MHRA, the medicines regulatory body, concluded that the benefits of OTC codeine products outweighed any potential risks but asked manufacturers to include additional information on the potential for addiction if the product is used for long periods.

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 and they warn about the possibility of addiction.  They also 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.  The packaging now includes this information prominently on the front of the packs.

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.  This is now a legal requirement.  Pharmacists cannot sell packs larger than 32 tablets.

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.

PAGB has worked with the British Pain Society, the MHRA, the Royal Pharmaceutical Society and the National Pharmacy Association to produce a leaflet about addiction and the management of pain with over the counter medicines.  This will be used by pharmacists to advise customers that they suspect are over using codeine products.  The information in the leaflet will help people recognise the signs that they are have become addicted and will provide information about alternative treatment for pain.

Codeine and addiction

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

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

How do people know that they are addicted?
The self help group CodeineFree have a check list to help people understand if they have a dependency.  The questions to ask are:

  • Do you take pain killers for more than 3 days?
  • Do you take more than 8 a day?
  • Do you watch the clock till its time to take your next dose?
  • Do you need them to help keep you calm?
  • Do you use two or more pharmacies for your purchases?
  • Do you mix the types of painkillers you take?
  • Do you suffer from aches and pains, shivers and flu-like symptoms if you don’t take any?
  • Do you feel like you are the only person with this problem?

If the answer to any of these questions is yes then people should be speaking to a health professional

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 other 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. 

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 have voluntarily:

  • Added addiction warnings to packs and patient information leaflets informing people 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
  • Added warnings prominently to the front of packs “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.

The pack size for over the counter packs of codeine is now legally limited to 32 tablets.  Pharmacists are not allowed to sell larger packs.

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.

Pack instructions

What information is given to people to ensure safe use of codeine products?
Medicines containing codeine are generally safe and effective.  Like all medicines, codeine containing remedies must be used correctly, for a few days at a time, and pack instructions must be followed and adhered to.  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
    • If you need to take the medicine for more than three days you should see your doctor or pharmacist
  • In order to deter people from taking the products for long periods or too frequently the following additional statements are included
    • This medicine contains codeine which can cause addiction if you take it continuously for more than three days.  This can give you withdrawal symptoms from the medicine when you stop taking it
    • If you take a painkiller for headaches for more than three days it can make them worse.

Information about Addiction
In addition to the information above all packs will soon carry two prominent statements on the front of the pack

  • Can cause addiction
  • Use for three days only

Do people read the package instructions?
Independent research has shown that most people do follow the instructions and use medicines responsibly.2 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 misuse of medicines.  The pack size for over the counter sale of medicines containing codeine is now legally limited to a maximum of 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.

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