- codeine phosphate
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: PL04425/0635 .
Co-Codamol 30mg500mg Capsules (Zentiva OLS)
PACKAGE LEAFLET – INFORMATION FOR THE USER
Co-codamol 30mg/500mg CAPSULES
Codeine Phosphate and Paracetamol
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
1. What co-codamol is and what it is used for
2. Before you take co-codamol
3. How to take co-codamol
4. Possible side effects
5. How to store co-codamol
6. Further information
1. WHAT CO-CODAMOL IS AND WHAT IT IS USED FOR
The name of your medicine is Co-codamol 30mg/500mg Capsules (called co-codamol throughout this leaflet). Co-codamol is used to treat severe pain. Co-codamol 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. Co-codamol contains codeine. Codeine belongs to a group of medicines called opiod analgesics which act to relieve pain. It also contains paracetamol, another analgesic to relieve pain.
2. BEFORE YOU TAKE CO-CODAMOL
Important things you should know about co-codamol
Warnings and precautions
Do not take co-codamol and tell your doctor if:
Do not take co-codamol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking co-codamol.
Take special care and check with your doctor before taking co-codamol if:
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 is 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 sick or being sick, constipation, lack of appetite.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because co-codamol can affect the way some other medicines work. Also, some other medicines can affect the way co-codamol works.
Other medicines and co-codamol:
Concomitant use of co-codamol and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory despression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe co-codamol together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Co-codamol contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.
This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.
Do not take this medicine, and tell your doctor, if you are taking
Tell your doctor or pharmacist if you are taking any of the following medicines, or have taken them in the past two weeks:
Tell your doctor or pharmacist if you are taking any other medicines:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking co-codamol.
Taking co-codamol with food and drink
You should not drink alcohol while you are taking these capsules. This is because taking co-codamol can change the way alcohol affects you.
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.
Pregnancy and breast-feeding
Talk to your doctor before taking these capsules if:
Do not take co-codamol and speak to your doctor if:
Driving and using machines
Co-codamol 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 whilst taking this medicine.
Important information about some of the ingredients of your co-codamol capsules
Azorubine: This may cause allergic reactions.
Changing or stopping treatment
Chronic usage of co-codamol may lead to tolerance and dependence. If you have taken regular daily doses of co-codamol for a long time, do not increase the dose or suddenly stop treatment without discussing this with your doctor.
3. HOW TO TAKE CO-CODAMOL
Always take co-codamol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults: 2 capsules every 4 to 6 hours when necessary up to a maximum of 8 capsules in 24 hours. Elderly people may be prescribed a lower dose.
Children aged 16 to 18 years: 1-2 capsules every 6 hours when necessary up to a maximum of 8 capsules in 24 hours.
Children aged 12 to 15 years: 1 capsule every 6 hours when necessary to a maximum of 4 capsules in 24 hours.
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.
Children under 12 years:
Co-codamol should not be given to children under 12 years of age due to the risk of severe breathing problems.
If you take more co-codamol than you should
If you have forgotten to take co-codamol
If you forget to take a dose at the right time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take two doses at or near the same time. Remember to leave at least 4 hours between doses.
4. POSSIBLE SIDE EFFECTS
As with all medicines, co-codamol can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Important side-effects you should know about co-codamol
Stop taking co-codamol and see a doctor or go to a hospital straight away if:
Talk to your doctor straight away if you notice the following serious side effect:
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:
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.
5. HOW TO STORE CO-CODAMOL
Keep this medicine in a safe place out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the pack.
Store your medicine in the original packaging in order to protect from moisture.
Do not store above 25°C.
Ask your pharmacist how to dispose of medicines no longer required. Do not dispose of medicines by flushing down a toilet or sink or by throwing out with your normal household rubbish. This will help protect the environment.
6. FURTHER INFORMATION
What Co-codamol 30mg/500mg Capsules contain
What Co-codamol 30mg/500mg Capsules look like and contents of pack
Co-codamol 30/500 Capsules are grey and purple printed with the word ‘SOLPADOL’ in black ink.
They come in cartons of 100 capsules.
The Marketing Authorisation Holder is
The Manufacturer is
This leaflet was last updated in July 2019