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Active substance: PARACETAMOL

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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.
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



The name of your medicine is Co-codamol 8/500 Tablets (called co-codamol throughout this leaflet). Cocodamol contains two different medicines called codeine phosphate and paracetamol. It belongs to a group of
medicines called analgesics (painkillers) and 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.



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
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
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
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
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.

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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 cocodamol.
Pregnancy and breast-feeding
• If you are pregnant, think you may be pregnant or plan to get pregnant, talk to your doctor before taking
these tablets.
• Usually it is safe to take co-codamol while breast feeding as the levels of the active ingredients of this
medicine in breast milk are too low to cause your baby any problems. However, some women who are at
increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of
the following side effects develop in you or your baby, stop taking this medicine and seek immediate
medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping
for longer than normal, and shallow or slow breathing
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.



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
• Wait at least 4 hours before taking another dose
• Do not take more than 8 tablets in any 24-hour period
Children: Co-codamol should not be given to children under 12 years of age.
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 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.



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)

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This may mean you are having an allergic reaction to co-codamol
Talk to your doctor straight away if you notice the following serious side effect:
• 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.
If any of the side effects gets serious, lasts longer than a few days or you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.



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.



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 ingredient.
• The other ingredients are maize starch, povidone, potassium sorbate, microcrystalline celluslose, 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
100 tablets.
The Marketing Authorisation Holder is:
Winthrop Pharmaceuticals, PO Box 611, Guildford, Surrey, GU1 4YS, UK.
The Manufacturer is:
Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
''Zentiva'' is a registered trademard © 2010 Winthrop Pharmaceuticals.
Leaflet last updated on: 03 / 2011

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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.