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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)

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, please ask your doctor or pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours
• 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 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 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.
Codeine can be used in children over 12 years of age for the short-term relief of moderate pain is not
relieved by other painkillers such as paracetamol or ibuprofen alone.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
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
• Taking codeine regularly for a long time can lead to addiction, which might cause you
to feel restless and irritable when you stop taking 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 (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

You have severe asthma attacks or severe breathing problems

You have recently had a head injury

You have been told by your doctor that you have increased pressure in your head. Signs of this
include: headaches, being sick (vomiting) and blurred eyesight

You have recently had an operation on your liver, gallbladder or bile duct (biliary tract)

You are taking medicine to treat depression called MAOIs (monoamine oxidase inhibitors) or
have taken them in the last 2 weeks. MAOIs are medicines such as moclobemide, phenelzine or
tranylcypromine (see ‘Taking other medicines’)

You are an alcoholic
• The person going to take the tablets is 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
• If you know that you metabolise very rapidly codeine into morphine
• If you are breastfeeding
Do not take Co-codamol if any of the above apply to you.
Take special care and check with your doctor before taking Co-codamol if:

You have severe kidney or liver problems

You have problems passing water or prostate problems

You have a bowel problem such as colitis or Crohn’s disease or a blockage of your bowel

You are elderly

You are sensitive to aspirin or other medicines used for the treatment of inflammation (NonSteroidal Anti-Inflammatory Drugs) such as ibuprofen
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.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking
this medicine.
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
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.
Do not take this medicine and tell your doctor or pharmacist if you are taking any of the
following:



Medicines to treat depression called MAOIs (monoamine oxidase inhibitors) or have taken them
in the last 2 weeks. MAOIs are medicines such as moclobemide, phenelzine, tranylcypromine

Tell your doctor if you are taking any of the following medicines:
• Medicines which make you drowsy or sleepy (CNS depressants)
• Medicines to thin the blood such as warfarin
• Chloramphenicol – an antibiotic used for infections
• Metoclopramide or domperidone – used to stop you feeling sick (nausea) or being sick
(vomiting)
• Colestyramine – for lowering blood cholesterol levels
• The oral contraceptive pill
If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Cocodamol.
Taking Co-codamol with food and drink
You should not drink alcohol while you are taking these tablets. This is because Co-codamol can
change the way alcohol affect you.
Children and adolescents
Use in children and adolescents after surgery
Codeine 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
Codeine is not recommended in children with breathing problems, since the symptoms of morphine
toxicity may be worse in these children.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before taking this medicine if:

You are pregnant, think you may be pregnant or plan to get pregnant.
Do not take Co-codamol and speak to your doctor if:

You are in the last three months of pregnancy

In labour
Do not take codeine 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
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.
Co-codamol contains sodium and sorbitol
• 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.



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.

Changing or stopping treatment
Long term usage if 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 with your doctor.
3. How to take Co-codamol
Always take this medicine as your doctor has told you. 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

Dissolve the effervescent tablets in a glass of water before taking
Adults: 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 below the age of 12 years,
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 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 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
Like all medicines, Co-codamol 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 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 or go to a hospital straight away if:

You have difficulty breathing or you feel dizzy
• 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 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 days:
• Constipation
• Feeling sick (nausea) or being sick (vomiting)
• Feeling dizzy, drowsiness, light-headed or sleepy
• Feeling confused
• Difficulty in passing water
• Becoming dependent on codeine
• You get infections or bruise more easily than usual. The could be because of a blood problem
(such as agranulocytosis, neutropenia or thrombocytopenia)
• Difficulty breathing, wheezing, tightness in the chest (bronchospasm)
Reporting 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:
ww.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 out of the sight and reach 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. Contents of the pack and other 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:
Activase Pharmaceuticals Limited

11 Boumpoulinas, 3rd Floor
P.C. 1060 Nicosia,
Cyprus
Manufacturer:
TBC
Date of leaflet revision: December 2017

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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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