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SOLUBLE PARACETAMOL AND CODEINE TABLETS

Active substance(s): CODEINE PHOSPHATE / PARACETAMOL / CODEINE PHOSPHATE / PARACETAMOL / CODEINE PHOSPHATE / PARACETAMOL

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419365 (alt 418558) GMID 657778 PB Cocodamol 500-8 8x4 GB Operator A.Schmitz 148 x 210 DC
- 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.
Co-codamol contains sodium and sorbitol
• Sodium: There is 388mg of sodium per effervescent tablet. This may be harmful
to people on a low sodium or low salt diet.
• Sorbitol: This is a type of sugar. If you have been told by your doctor that you
cannot tolerate some sugars, talk to your doctor before taking this medicine.
3. HOW TO TAKE CO-CODAMOL
Always take co-codamol exactly as instructed on this leaflet. Check with your doctor
or pharmacist if you are not sure.
• Do not take more than the recommended dose.
• Dissolve the effervescent tablets in a glass of water before taking
Adults and the elderly: 2 tablets every 4 hours when necessary up to a maximum of 8
tablets in 24 hours.
Children aged 16 to 18 years: 1 to 2 tablets every 6 hours when necessary up to a
maximum of four doses in 24 hours.
Children aged 12 to 15 years: 1 tablet every 6 hours when necessary to a maximum of
four doses in 24 hours.
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 under 12 years: Co-codamol should not be given to children under 12 years
of age due to the risk of severe breathing problems.
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 taken
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
This medicine contains codeine and can cause addiction if you take it continuously
for more than 3 days. When you stop taking it you may get withdrawal symptoms.
You should talk to your doctor or pharmacist if you think you are suffering from
withdrawal symptoms.
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
• Taking a painkiller for headaches too often or for too long can make them worse.
• 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.
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
• Serious skin reactions. Very rare cases have been reported.

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PACKAGE LEAFLET – INFORMATION FOR THE USER

CO-CODAMOL 8/500 EFFERVESCENT TABLETS
Codeine Phosphate and Paracetamol
Important things you should know about co-codamol
• This medicine can only be used for the short term treatment of acute moderate
pain when other painkillers have not worked
• You should only take this product for a maximum of 3 days at a time. If you
need to take it for longer than three days you should see your doctor or
pharmacist for advice
• This medicine contains codeine which can cause addiction if you take it
continuously for more than 3 days. This can give you withdrawal symptoms from
the medicine when you stop taking it
• If you take this medicine for headaches for more than 3 days it can make them
worse
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
What is in this leafet:
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
5. How to store co-codamol
4. Possible side effects
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 Effervescent Tablets (called
co-codamol throughout this leaflet). Co-codamol contains 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
pain killers such as paracetamol. Co-codamol is for the short term treatment of
acute moderate pain caused by headaches, migraine, toothache, neuralgia, period
pain and rheumatic pains when other painkillers have not worked. Wait at least 4
hours after you last took other painkillers before taking this medicine. 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
• This medicine contains codeine which can cause addiction if you take it
continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it
• If you take a painkiller for headaches for more than 3 days it can make
them worse
Warnings and precautions
Do not take co-codamol and tell your doctor if:
• You are allergic to the active substances or any of the other ingredients in your
medicine (listed in Section 6) 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 apnoea syndrome
• You know that you metabolise very rapidly codeine into morphine
• You are breastfeeding or planning to breastfeed
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Do not take co-codamol if any of the above applies 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
• You have a liver problem caused by alcohol
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking this medicine.
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.
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.
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:
• 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 applies 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

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 days:
• You get infections or bruise more
• Constipation
easily than usual. This could be
• Feeling sick (nausea), being sick
because of a blood problem (such
(vomiting)
as agranulocytosis, neutropenia
• Dizziness, light-headedness,
or thrombocytopenia)
drowsiness, confusion
• Becoming addicted to codeine
• Difficulty in passing water
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.
How do I know if I am addicted?
If you take this medicine according to the instructions on the pack it is
unlikely that you will become addicted to the medicine. However, if the following
apply to you it is important that you talk to your doctor:
• You need to take the medicine for longer periods of time
• You need to take more than the recommended dose
• When you stop taking this medicine you feel very unwell but you feel better if you
start taking the medicine again
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 throw away any 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 8/500 Effervescent Tablets contain
• The active substances are codeine phosphate and paracetamol. Each tablet
contains 8mg of codeine phosphate and 500mg of paracetamol.
• The other ingredients are sorbitol, saccharin sodium, sodium lauryl sulphate,
citric acid, sodium carbonate, sodium bicarbonate, povidone, and dimeticone.
Contents of pack
Co-codamol 8/500 Effervescent Tablets come in cartons of 24 and 32 tablets.
Not all pack sizes may be marketed.
The Marketing Authorisation Holder is Zentiva, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK.
The Manufacturer is A. Nattermann & Cie. GmbH, Nattermannallee 1, 50829
Cologne, Germany
This leaflet was last updated in December 2016

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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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