Patient Leaflet Updated 30-Dec-2019 | 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.
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). Co-codamol contains two different medicines called codeine phosphate and paracetamol. 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 painkillers such as paracetamol. Co-codamol is used to treat moderate 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.
2. WHAT YOU NEED TO KNOW 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.
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.
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, 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
Talk to your doctor before taking these tablets 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.
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. 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.
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:
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. 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 updated in June 2019