- codeine phosphate hemihydrate
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00014/0865 .
Paracetamol and Codeine 500 mg/ 12.8 mg Tablets
Information for the user
Boots Paracetamol and Codeine 500mg/12.8ml Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
What this medicine is for
This medicine can be used for in adults and children aged 12 years and over for the short term treatment of acute moderate pain that is not relieved by aspirin, ibuprofen or paracetamol alone.
It can be used for headache, migraine, period pain, backache, dental pain, sprains and strains, sciatica, arthritic and rheumatic pain.
This medicine contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain.
This medicine also contains paracetamol. Paracetamol, an analgesic, acts to relieve pain.
Before you take this medicine
Do not take:
Talk to your pharmacist or doctor:
Other important information
Do not drink alcohol (wine, beer, spirits) whilst taking this medicine. Alcohol increases the risk of side effects occurring and may make you feel more drowsy.
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.
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.
Breastfeeding: Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.
Driving and using machines: This medicine can affect your ability to drive or use machines as it may make you feel sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Information about some of the ingredients in this medicine: Sodium metabisulphite (E223) may rarely cause severe allergic reactions, tightness of the chest or difficulty in breathing.
If you take other medicines
Do not take anything else containing paracetamol or codeine while taking this medicine.
Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:
How to take this medicine
Check the foil is not broken before first use. If it is, do not take that tablet.
Adults: can take two tablets up to 4 times a day but not more often than every 4 hours. Don’t take more than 8 tablets in any 24 hours.
Children 16 years to 18 years of age: can take one to two tablets Up to 4 times a day but not more often than every 6 hours. Don’t take more than 8 tablets in any 24 hours.
Children 12 to 15 years of age: can take one tablet Up to 4 times a day but not more often than every 6 hours. Don’t take more than 4 tablets in any 24 hours.
Swallow each tablet whole with water.
Do not take for more than 3 days.
If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist for advice.
Do not give to children under 12 years, due to the risk of severe breathing problems.
Do not take more medicine than the table tells you to.
If you do not get better, talk to your doctor.
If you take too many tablets: Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.
Possible withdrawal effects when stopping treatment
This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.
Possible side effects
Most people will not have problems, but some people may have side effects when taking this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional.
If you get any of these serious side effects, stop taking the tablets. See a doctor at once:
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.
How do I know if I am addicted?
If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:
How to store this medicine
Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.
Store in the original package.
Use by the date on the end flap of the carton.
What is in this medicine
Each tablet contains Codeine Phosphate Hemihydrate 12.8 mg, Paracetamol 500 mg, which are the active ingredients.
As well as the active ingredients, the tablets also contain maize starch, microcrystalline cellulose, magnesium stearate, sodium metabisulphite (E223).
This pack contains 30 white, pillow shaped tablets, with the letter ‘M’on one side.
Who makes this medicine
Manufactured for the Marketing Authorisation holder
Leaflet prepared April 2019
If you would like any further information about this medicine, please contact
To request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Boots Paracetamol and Codeine 500mg/12.8mg Tablets
Reference number: 00014/0865
This is a service provided by the Royal National Institute of Blind people.
Artwork reference WBAG426302