Active ingredient
- codeine phosphate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
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: PL 31750/0111 .
Codeine Phosphate Tablets BP 15 mg and 30 mg
Package leaflet: Information for the user
Codeine Phosphate Tablets BP 15 mg
Codeine Phosphate Tablets BP 30 mg
Codeine phosphate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Codeine Phosphate Tablets are and what they are used for
2. What you need to know before you take Codeine Phosphate Tablets
3. How to take Codeine Phosphate Tablets
4. Possible side effects
5. How to store Codeine Phosphate Tablets
6. Contents of the pack and other information
1. What Codeine Phosphate Tablets are and what they are used for
Codeine Phosphate Tablets contain codeine phosphate. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paracetamol.
Codeine Phosphate Tablets are used in adults for:
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.
2. What you need to know before you take Codeine Phosphate Tablets
Do not take Codeine Phosphate Tablets if you:
Do not use Codeine Phosphate Tablets 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.
Adolescents older than 12 years of age
Codeine is not recommended in adolescents with compromised respiratory function for the treatment of cough and/or cold.
Warnings and precautions
Talk to your doctor or pharmacist before taking Codeine Phosphate Tablets if you:
Other important warnings:
Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces the effects of codeine and relieves pain and symptoms of cough. 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 or relieve their cough. 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.
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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Codeine is known to interfere with some medicines. It is particularly important to tell your doctor or pharmacist if you are taking the following medicines:
Laboratory test results may also be affected.
Codeine Phosphate Tablets with food, drink and alcohol
Do not drink alcohol whilst taking Codeine Phosphate Tablets. Alcohol may increase the sedative effects of Codeine Phosphate Tablets and make you very sleepy.
You can take the tablets regardless of food intake.
Pregnancy, breast-feeding and fertility
Do not use this medicine if you are pregnant. Do not take codeine while you are breastfeeding.
Codeine and morphine passes into breast milk.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or operate machinery because you may suffer from confusion, drowsiness, hallucinations (seeing, feeling or hearing things that are not there), blurred or double vision, fits or dizziness. This can affect driving or the operation of machinery.
The medicine can affect your ability to drive as it may make you 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.
Codeine Phosphate Tablets contain lactose and sodium
This medicine contains lactose monohydrate which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Codeine Phosphate Tablets contain less than 1 mmol sodium (23 mg) per maximum daily dose, that is to say ‘sodium- free’.
3. How to take Codeine Phosphate Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
For the relief of pain:
Adults and children over 12 years: 30-60 mg every four hours, when necessary to a maximum of 240 mg daily.
For the relief of coughing:
Adults: 15-30 mg three or four times daily.
For the treatment of prolonged diarrhoea:
Adults: 15-60 mg every four to six hours. Do not take more than 240 mg in 24 hours.
A lower dosage may be needed if you are an older person who may have liver or kidney problems.
The 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.
Use in children and adolescents
Children below the age of 12 years
Codeine Phosphate Tablets should not be taken by children below the age of 12 years due to the risk of severe breathing problems.
Children aged 12 years to 18 years
In children and adolescents between 12 years and 18 years who have problems with their breathing, codeine is not recommended as this population may be more susceptible to breathing problems due to codeine.
Swallow these tablets with water.
If you take more Codeine Phosphate Tablets than you should
If you take too many tablets, you may have symptoms such as feeling or being sick, depression, low blood pressure, pinpoint pupils, slow breathing rate, fast heart rate. Contact your doctor or pharmacist at once for advice.
If you forget to take Codeine Phosphate Tablets
If you forget to take a dose take it as soon as you remember and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Codeine Phosphate Tablets
If you stop taking the tablets you may develop the following withdrawal symptoms tremor, difficulty sleeping, feeling or being sick, sweating and increased heart rate, breathing or blood pressure, restlessness, irritability, anxiety, depression, loss of appetite, loose stool, excessive tears, runny nose, sneezing, yawning, hair standing on ends, widening of the pupil, weakness, fever, muscle cramps, dehydration.
Prolonged use can lead to tolerance and dependence on the medicine. Taking codeine regularly for a long time can be habit forming, which might cause you to feel restless and irritable when you stop the tablets. Your doctor will stop your tablets gradually to avoid you having withdrawal symptoms.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If the following happens, stop taking Codeine Phosphate Tablets and tell your doctor immediately or contact the casualty department at your nearest hospital:
Other side effects
Tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms e.g. tremor, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Codeine Phosphate Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, carton and blister after “EXP”. The expiry date refers to the last day of that month.
Store below 25°C. Store the tablets in the original packaging. Do not put them in another container. For container packaging replace the cap securely after use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Codeine Phosphate Tablets contains
What Codeine Phosphate Tablets look like and contents of the pack
Codeine Phosphate 15 mg tablets are white to off white, circular normal biconvex tablets embossed with R114
Codeine Phosphate 30 mg tablets are white to off white, circular normal biconvex tablets embossed with R115
The tablets are available in 15 mg and 30 mg strengths and in containers of 1000, 500, 100, 90, 80, 70, 60, 50, 40, 30, 20 and 10 tablets and in blister strips of 100, 90, 80, 70, 60, 50, 40, 30, 28, 20 and 10 tablets.
Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in February 2018
V005
5th Floor, Hyde Park, Hayes, 3, 11 Millington Road, Hayes, UB3 4AZ, UK
+44 (0) 208 848 8688
+44 (0) 208 848 5052