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CO-CODAMOL 8/500 MG EFFERVESCENT TABLETS

Active substance(s): CODEINE PHOSPHATE / PARACETAMOL

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Patient Information Leaflet



Co-codamol 8/500 mg Effervescent Tablets
(codeine phosphate and paracetamol)

Important information about Co-codamol
• If you need to use this medicine for more than three days at a time, see your doctor, pharmacist or healthcare
professional
• 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
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 any 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist
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 8/500 mg Effervescent Tablets (called Co-codamol throughout this leaflet).
Co-codamol contains two different medicines called:
• Codeine
• Paracetamol
These medicines both belong to a group of medicines called pain-killers (analgesics).
Co-codamol is used for the relief of mild to moderate pain including headache, migraine, neuralgia, toothache, sore
throat, muscular and period pains.
It is also used for the symptomatic relief of influenza, feverishness and colds.
2. Before you take Co-codamol
Do not take Co-codamol if:
• You are allergic (hypersensitive) to codeine, paracetamol or any of the other ingredients (listed in Section 6 below)
• You have problems with your kidneys or liver
Take special care with Co-codamol
Check with your doctor or pharmacist before taking Co-codamol if:
• You are pregnant or breast-feeding (see Pregnancy and breast-feeding section below)
If any of the above apply to you (or you are not sure), check with 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 or
codeine
This includes other pain-killers, and some cough and cold remedies. It also includes other medicines available from
your pharmacist and more widely in shops. Always check the name of the medicines inside anything you buy or are
prescribed, to see if they contain paracetamol or codeine.
Tell your doctor or pharmacist if you are taking any of the following medicines:
• Medicines used to thin the blood (such as warfarin)
• Metoclopramide or domperidone - used for feeling sick (nausea) or being sick (vomiting)
• Cholestyramine - used for high cholesterol and fat levels in the blood
• Chloramphenicol – an antibiotic
• Medicines to treat epilepsy
• Medicines to treat depression
• Medicines to help you relax or sleep
If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Co-codamol.
Taking Co-codamol with food and drink
Talk to your doctor or pharmacist before taking this medicine if you have been drinking alcohol.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant or are
breast-feeding.
Driving and using machines
You may feel sleepy or dizzy after taking Co-codamol. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of this medicine
• Sodium: This medicine contains 18.9 millimole of sodium in each Co-codamol 8/500 mg Effervescent tablet.
This is to be taken into consideration by patients on a controlled sodium diet.
Important information about Co-codamol
• If you need to use this medicine for more than three days at a time, see your doctor, pharmacist or healthcare
professional
• 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

3. How to take Co-codamol
How to take
• Dissolve the tablets in half a glass of water (100 ml). The tablets will dissolve more quickly in warm water or
when stirred
• Do not take this medicine for more than 3 days without consulting a doctor
How much to take
Adults and children over 12 years of age
• The usual dose is 1 or 2 tablets
• Leave at least 4 hours before each dose of Co-codamol
• Do not take more than 8 tablets in any 24 hour period
• Elderly people may be given a lower dose
Children
• Co-codamol is not recommended for use in children under 12 years of age.
If you think that the effect of Co-codamol is too strong or too weak, talk to your doctor or pharmacist.
Changing the dose after taking Co-codamol regularly for a long time
Taking Co-codamol regularly and for a long time can make you addicted to the medicine. If you have taken regular daily
doses of Co-codamol for a long time, talk to your doctor before increasing the dose or before suddenly stopping treatment.
If you take more Co-codamol than you should
• Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of
delayed, serious liver damage
• Remember to take this medicine pack and any remaining tablets with you, so the doctor knows what you have taken
If you forget to take Co-codamol
• If you forget a dose, do not worry, take it as soon as you remember. However, if it is nearly time for your next dose, skip
the missed dose
• Do not take a double dose to make up for a forgotten dose
• Remember to leave at least 4 hours between doses
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Co-codamol can cause side effects, although not everybody gets them.
Important side effects you should know about Co-codamol
• Taking codeine regularly for a long time can make you addicted to the medicine. This means that when you stop
taking the tablets, you might feel restless and irritable
• Taking a painkiller for headaches too often or for too long can make them worse
Stop taking Co-codamol and see a doctor straight away if:
• You develop an allergic reaction. Signs of an allergic reaction include a rash, swelling of your face, lips, mouth and
throat, difficulty swallowing or difficulty breathing
Other possible side effects may include:
• Constipation
• Feeling sick (nausea) or being sick (vomiting)
• Feeling dizzy, light-headed or sleepy
• Feeling confused
• Disorders of the blood (thrombocytopenia and agranulocytosis)
If any of the side effects get serious or lasts for longer than a few days or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Co-codamol
Keep out of the reach and sight of children.
Do not use Co-codamol after the expiry date stated on label. The expiry date refers to the last day of the month.
Store in a cool dry place at or below 25°C.
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 codeine phosphate and paracetamol. Each tablet contains 8 mg of codeine phosphate and
500 mg of paracetamol
• The other ingredients are citric acid, povidone, sodium saccharin, sodium cyclamate, sodium bicarbonate, polyethylene
glycol and sodium carbonate (anhydrous)
What Co-codamol 8/500 mg Effervescent Tablets look like and the contents of the pack:
Co-codamol 8/500 mg Effervescent Tablets are white, round, flat, bevelled-edged tablets with a rough surface. They are
available in carton strip packs of 10, 12, 16, 24, 30, 36, 50, 56, 100 or 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Consilient Health Ltd.
5th floor, Beaux Lane House,
Mercer Street Lower, Dublin 2,
Ireland





Manufacturer:
TBC

Date of leaflet revision: April 2009
P0063

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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.

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