- 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: PL20417/0028 .
Co-codamol Effervescent Tablets 8/500mg - BXP
PATIENT INFORMATION LEAFLET
CO-CODAMOL EFFERVESCENT TABLETS 8/500 mg
The name of this medicine is Co-Codamol Effervescent Tablets 8/500 mg, which will be referred to as Co-Codamol 8/500 throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
1. What Co-codamol 8/500 are and what they are used for
2. Before you take Co-codamol 8/500
3. How to take Co-codamol 8/500
4. Possible side effects
5. How to store Co-codamol 8/500
6. Further information
1. WHAT CO-CODAMOL 8/500 ARE AND WHAT THEY ARE USED FOR
The active ingredients in Co-codamol 8/500 are paracetamol and codeine phosphate hemihydrate. Codeine can be used in children over 12 years of age for short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. It can be used on its own or in combination with other pain killers. It is used to relieve muscular and rheumatic pains, headache, migraine, neuralgia (severe burning or stabbing pain following the line of a nerve), toothache and period pains.
This medicine contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It also contains paracetamol, another analgesic to relieve pain.
2. BEFORE YOU TAKE CO-CODAMOL 8/500
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 this medicine for headaches for more than three days it can make them worse. This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.
Do not take Co-codamol 8/500 if you:
Warnings and Precautions
Take special care with Co-Codamol 8/500 if you:
The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
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.
Children and adolescents
Co-codamol must not be given to children under 12 years of age.
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.
Taking other medicines
Do not take these tablets if you are already taking other medicines containing paracetamol. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as they may decrease or increase the effect of Co-Codamol 8/500:
If your diet is poor or you have low protein intake, you may be at a higher risk of serious paracetamol poisoning when taking Co-codamol tablets. Do not drink alcohol whilst taking Co-codamol tablets. It may still be all right for you to take Co-codamol 8/500 and your doctor will be able to decide what is suitable for you.
Taking your medicine with food and drink
Co-codamol 8/500 should be dissolved in at least half a glass of water and can be taken with or without a meal.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Do not take codeine while you are breast feeding. Codeine and morphine passes into breast milk.
Driving and using machinery
Co-Codamol tablets may cause dizziness, blurred vision or the inability to think clearly. Make sure you are not affected before you drive or operate machinery. This 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.
Important information about some of the ingredients of Co-codamol 8/500
Each of these tablets contains about 438 mg of sodium and may interfere if you are on a low sodium diet. Talk to your doctor or pharmacist if you need one or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
This product also contains aspartame (a source of phenylalanine), which should not be given to anyone with phenylketonuria.
3. HOW TO TAKE CO-CODAMOL 8/500
Do not take for more than three days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist.
The usual doses for Co-codamol 8/500 are as follows:
Should take 1 or 2 tablets dissolved in water every 6 hours, as needed. Do not take more than 8 tablets in 24 hours.
Children 16-18 years:
One to two tablets dissolved in water every 6 hours when necessary to a maximum of 8 tablets in 24 hours.
Children 12-15 years:
One tablet dissolved in water every 6 hours when necessary. Do not take more than 4 tablets in 24 hours.
Dosage is usually reduced in the elderly with liver damage.
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. Do not exceed the recommended dose. Co-codamol 8/500 should not be taken by children below the age of 12 years, due to the risk of severe breathing problems.
Method of Administration
For oral administration only. These tablets should be dissolved in at least half a glass of water before taking them. The solution should be drunk immediately after preparation. These tablets are meant to be dissolved first so don’t try to swallow them whole.
If you take more Co-codamol 8/500 than you should
Talk to your 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. Remember to take the pack and any remaining tablets with you. If you are giving this medicine to a child, immediate medical advice should be sought in the event of overdose, even if the child seems well, because of the risk of delayed, serious liver damage. Symptoms of an overdose include feeling or being sick, loss of appetite, stomach pain, coma, pale skin, low blood pressure, pinpoint pupils, fast heartbeat or difficulty breathing.
If you forget to take Co-codamol 8/500
If you forget to take one or more doses, take your next dose when you remember and then go on as prescribed. Do not take a double dose to make up for a forgotten dose.
Withdrawal symptoms: This medicine contains codeine and can cause addiction if you take it continuously for more than three 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. If you have any further questions about this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
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.
Stop taking Co-Codamol and see a doctor or go to hospital straight away if:
If you get any of the following symptoms after taking these tablets, you should contact your doctor immediately:
The following effects have been reported:
Other side effects:
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:
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 CO-CODAMOL 8/500
Do not store your tablets above 25°C. Store in a dry place and protect from light. Do not take this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month. Keep this medicine out of the sight and reach of children. 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.
6. FURTHER INFORMATION
What Co-codamol 8/500 mg Effervescent Tablets contain:
The active ingredients are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500mg paracetamol and 8mg codeine phosphate hemihydrate. The other ingredients are sodium hydrogen carbonate, citric acid anhydrous, sodium carbonate, povidone, simeticone, sodium saccharin, aspartame (E951) and polysorbate 80.
What Co-codamol 8/500 look like and the contents of the pack:
Co-codamol 8/500 mg Effervescent Tablets are white, circular, with a flat bevelled edge and plain on both sides. Your medicine is available in blister packs of 7, 10, 14, 28, 30 and 32 tablets (not all pack sizes may be marketed).
Marketing Authorisation Holder:
Manufacturer responsible for batch release:
This leaflet was last revised in August 2019.