Patient Leaflet Updated 23-Mar-2021 | Zentiva
Co-Codamol 15/500 Tablets
PACKAGE LEAFLET – INFORMATION FOR THE USER
CO-CODAMOL 15/500 TABLETS
Codeine Phosphate and Paracetamol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine contains codeine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
What is in this leaflet:
1. What co-codamol is and what it is used for
2. What you need to know before you take co-codamol
3. How to take co-codamol
4. Possible side effects
5. How to store co-codamol
6. Contents of the pack and other information
1. WHAT CO-CODAMOL IS AND WHAT IT IS USED FOR
The name of your medicine is Co-codamol 15/500 Tablets (called co-codamol throughout this leaflet).
This medicine has been prescribed for you for the relief of moderate pain. Co-codamol contains two different medicines called codeine and paracetamol. Codeine belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL
Important things you should know about co-codamol
Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.
Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.
Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
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.
Co-codamol must not be given to children under 12 years of age.
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 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
Use in children and adolescents after surgery
Co-codamol 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
Co-codamol is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.
If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking co-codamol.
Other medicines and co-codamol
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.
Concomitant use of co-codamol and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), 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.
While taking co-codamol you should not take any other medicines which contain paracetamol.
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 or pharmacist if you are taking the following:
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.
Co-codamol with alcohol
You should not drink alcohol while you are taking these tablets.
This is because taking co-codamol can change the way alcohol affects you.
Pregnancy and breast-feeding
Driving and using machines
Co-codamol may 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.
3. HOW TO TAKE CO-CODAMOL
Your prescriber should have discussed with you, how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Always take co-codamol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults: 2 tablets every 4 to 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Elderly people may be prescribed a lower dose.
Use in children and adolescents
Children aged 16 – 18 years: 1-2 tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Children aged 12 – 15 years: 1 tablet every 6 hours when necessary up to a maximum of 4 tablets in 24 hours.
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.
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.
If you take more co-codamol than you should
If you forget to take co-codamol
If you forget to take a dose at the right time, take it as soon as you remember. However do not take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours between doses.
If you stop taking co-codamol
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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:
When you stop taking co-codamol, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.
How do I know if I am addicted?
If you notice any of the following signs whilst taking co-codamol, it could be a sign that you have become addicted.
If you notice any of these signs, it is important you talk to your prescriber.
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
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date shown on the pack. The expiry date refers to the last day of that month. Store your medicine in the original packaging in order to protect from moisture. Do not store above 25°C.
Do not throw away 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 Co-codamol 15/500 Tablets contain
What Co-codamol 15/500 Tablets look like and contents of pack
White to off-white capsule-shaped tablets, marked PRO 15 and scored on one side with a plain reverse.
They come in cartons of 100 tablets.
The Marketing Authorisation Holder is:
The Manufacturer is:
This leaflet was last updated in December 2020