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CO-CODAMOL 8/500 TABLETS
Active substance(s): CODEINE PHOSPHATE / CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL / CODEINE PHOSPHATE / CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL / CODEINE PHOSPHATE / CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL
CO-CODAMOL 8/500 TABLETS
Codeine Phosphate and Paracetamol
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or
pharmacist. Do not pass this medicine on to others. It may harm them, even if their symptoms are the same as
yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
What is in this leaflet:
1. What co-codamol is and what it is used for
4. Possible side effects
5. How to store co-codamol
2. What you need to know before you take co-codamol
3. How to take 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 8/500 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 headache including
migraine, toothache, neuralgia, period pain, pain caused by rheumatism and arthritis and to relieve the
symptoms of colds, flu and sore throats.
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
• Do not take for longer than your doctor tells you to
• Taking codeine regularly for a long time can lead to addiction, which might cause you to feel
restless and irritable when you stop the tablets
• Taking a painkiller for headaches too often or for too long can make them worse
Warnings and precautions
Do not take co-codamol and tell your doctor if:
• You are allergic (hypersensitive) to codeine, paracetamol or any of the other ingredients in your medicine
(listed in Section 6: Further information)
Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs,
arms, face, throat or tongue
• The person going to take the tablets is under 12 years of age. Co-codamol must not be given to children
under 12 years of age
• You are under 18 years of age and have had your tonsils or adenoids removed due to obstructive sleep
• You know you metabolise very rapidly codeine into morphine
• You are breastfeeding or planning to breastfeed
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:
• You have severe kidney or liver problems
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 cold. 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 cold. 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 and adolescents 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.
Co-codamol is not recommended in adolescents over 12 years of age with breathing problems for the treatment
If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking co-codamol.
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.
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.
Tell your doctor if you are taking any of the following medicines:
• Medicines used to thin the blood such as warfarin
• Metoclopramide or domperidone - used to stop you feeling sick (nausea) or being sick (vomiting)
• Colestyramine - for lowering blood cholesterol levels
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking co-codamol.
Pregnancy and breast-feeding
Talk to your doctor before taking these tablets if:
• You are pregnant, think you may be pregnant or plan to get pregnant.
• You are planning to breastfeed
• Do not take co-codamol while you are breastfeeding. Codeine and morphine passes into breast milk.
Driving and using machines
Co-codamol can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive whilst taking this medicine until you know how it affects you
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided with
the medicine and
- It was not affecting your ability to drive safely
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
Taking co-codamol for a long time may lead to tolerance and dependence. 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.
• Do not take more than the recommended dose
• Do not take for longer than your doctor tells you to
Adults and children over 12
• Swallow the tablets whole with a drink of water
• The usual dose of co-codamol is 2 tablets, taken together
• Adults should wait at least 4 hours before taking another dose
• Children aged 12 years and over should wait at least 6 hours before taking another dose
• Do not take more than 8 tablets in any 24-hour period
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: Co-codamol should not be given to children under 12 years of age due to the risk of severe
If you take more co-codamol than you should
• Talk to a 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 any remaining tablets and the pack with you. This is so the doctor knows what you have
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:
Stop taking co-codamol and see a doctor or go to a hospital straight away if:
• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or
breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria)
This may mean you are having an allergic reaction to co-codamol
• You get serious skin reactions. Very rare cases have been reported.
Talk to your doctor straight away if you notice any of the following serious side effects:
• Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the
pancreas (pancreatitis). This is a very rare side effect
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few
• Constipation, feeling sick (nausea), being sick (vomiting)
• Dizziness, light-headedness, drowsiness, confusion
• Difficulty in passing water
• Becoming dependent on codeine
• You get infections or bruise more easily than usual. This could be because of a blood problem.
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 in a safe place out of the reach and sight 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Co-codamol 8/500 Tablets contain
• Each Co-codamol 8/500 Tablet contains 8mg of codeine phosphate and 500mg of paracetamol as the active
• The other ingredients are maize starch, povidone, potassium sorbate, microcrystalline cellulose, stearic acid,
magnesium stearate, talc, pregelatinised starch and purified water.
• Co-codamol 8/500 Tablets are flat white tablets, marked S/4 on one side. They come in cartons of 50 and
The Marketing Authorisation Holder and Manufacturer is Zentiva, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK.
Zentiva is a registered trademark © 2015 Zentiva
This leaflet was updated in September 2015
CO-CODAMOL 8/500 TABS
-50's & 100's pack-
PATIENT INFORMATION LEAFLET
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.