CO-CODAMOL 8 MG/500 MG TABLETS

Active substance: PARACETAMOL

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CO-CODAMOL 8 mg/500 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects get 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
Your tablets are called Co-Codamol Tablets. They are a mixture of two drugs – paracetamol,
which relieves pain and fever and codeine phosphate, a pain killer belong to a group of
medicine called opoid analgesics.
Co-Codamol is used in children over 12 years of age to treat pain, including muscular and
rheumatic pains, headache, migraine, neuralgia, toothache, sore throat, period pains, aches
and pains, discomfort associated with flu, feverishness and feverish colds.

2.

BEFORE YOU TAKE CO-CODAMOL
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.

DO NOT take Co-Codamol if you:
are allergic (hypersensitive) to paracetamol, codeine or any other opioid analgesics, or any of
the other ingredients of this medicine listed in section 6, Further Information
are taking any other products containing paracetamol, such as over-the-counter cold remedies
have recently suffered a head injury or have suffered a serious illness or accident which
resulted in increased pressure in the brain

suffer from alcoholism
suffer from any disorder which may cause fits
have breathing problems that are caused by bronchitis or asthma.
are having an asthma attack
have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis)
are children and adolescents (0-18 years of age) and taking it for pain relief after removal of
tonsils or adenoids due to obstructive sleep apnoea syndrome children
know that you metabolise codeine very rapidly into morphine.
are breastfeeding.
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 with breathing problems
Codeine is not recommended in children with breathing problems, since the symptoms of
morphine toxicity may be worse in these children.
Take special care with Co-Codamol
Do not take for longer than directed by your prescriber.
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.
Your doctor will review your treatment with this medicine regularly to assess that the
benefits of continued treatment outweigh any risks to you.
Tell your doctor before you start to take this medicine if you:
have any problems with your kidneys or liver
suffer from an underactive thyroid gland, underactive adrenal glands or an enlarged prostate
gland and have difficulty urinating and are male
have low blood pressure
have bowel problems
have myasthenia gravis (muscle weakness)
are suffering from shock
suffer from allergies, for example to food, cosmetics, dust or drugs
diseased adrenal glands (Addison‟s disease) or high blood pressure caused by a tumour near
a kidney (phaeochromocytoma)
gall bladder disease or gall stones
recently had surgery on your gastro-intestinal tract or urinary system

epilepsy or suffered head injury or raised pressure in the skull (may cause painful eyes,
changes in vision or headache behind the eyes)
suffered from alcoholism, drug abuse or dependence or mental illness.

Taking other medicines
Talk to your doctor if you are taking any of the following:
other pain killers which contain codeine
monoamine oxidase inhibitors (e.g. phenelzine, moclobemide, for treatment of depression),
or if you have stopped taking these within the last two weeks
other medicines which depress the nervous system such as antidepressants (e.g. fluoxetine,
amitriptyline), phenothiazines (e.g. chlorpromazine), hypnotics (e.g. temazepam) or
sedatives (sleeping tablets, e.g. diazepam)
anticoagulants e.g. warfarin (to stop your blood clotting)
medicines for diarrhoea e.g. loperamide or kaolin
medicines for muscle spasm e.g. dicyclomine or propantheline
cholestyramine (to lower cholesterol)
metoclopramide, cisapride or domperidone, cyclizine,(to stop you feeling or being sick)
quinidine or mexiletine (for irregular heart rhythm)
cimetidine (to reduce stomach acid)
ciprofloxacin (antibacterial medicine)
oral contraceptives (the “pill”)
guanethidine or diuretics (“water tablets”) e.g. spironolactone, furosemide (to treat high
blood pressure)
selegiline (for Parkinson‟s disease)
phenytoin (to treat epilepsy)
atropine or hyoscine (anticholinergic medicines)
medicines which affect the liver (e.g. primidone and rifampicin)
muscle relaxants
barbiturates (e.g. phenobarbital)
anaesthetics
opioid antagonists (buprenorphine, naltrexone, naloxone)
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Tell your doctor you are taking Co-Codamol if you are due to have an operation or any treatment
which requires an anaesthetic.
Diet
If your diet is poor or you have a low protein intake, you may be at a higher risk of serious
paracetamol poisoning when taking Co-codamol.

Taking Co-Codamol with food and drink
Do not drink alcohol while you are taking Co-Codamol.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for
advice before taking this medicine.
Do not take Co-codamol during pregnancy, unless advised by your doctor. Do not take
codeine while breastfeeding. Codeine and morphine passes into breast milk. Regular use
during pregnancy may cause withdrawal symptoms in the newborn.
Driving and using machines
Co-Codamol may cause dizziness or drowsiness, blurred vision or the inability to think
clearly. If you are affected, do not drive or operate machinery.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Do not drive while 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 while taking this
medicine.

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.
The tablets should be swallowed with a drink of water.
You should leave at least four hours between doses and you should not take more than four
doses in 24 hours.
The usual dose is:
Adults
1-2 tablets taken with a drink of water. The dose may be repeated every 4 - 6 hours, with a
maximum of 8 tablets in 24 hours.
Elderly

Your doctor will probably tell you to take a lower dose than the one normally recommended
for adults
Children 12 to 18 years old
1 - 2 tablets should not be repeated more frequently than every 6 hours and not more than 4
doses should be taken in any 24-hour period.
Co-codamol should not be taken for more than 3 days. If pain does not improve after 3 days,
talk to your doctor for advise.
Children under 12 years old
Co-Codamol is not recommended for use in Children under 12 years old due to risk of severe
breathing problem.
You may become tolerant to the effects of Co-Codamol if you need to take it for a long period of
time. If you notice that the tablets are not working as well as they did when you first started taking
them, you should go and see your doctor as an adjustment to your dose may be necessary. Do not
take a higher dose or more often than the doctor has told you.
If you take more Co-Codamol than you should
If you (or someone else) take too many tablets all together, or if you think a child has
accidentally swallowed any of the tablets, contact your nearest hospital casualty department or
your doctor immediately, even if you feel well, because of the risk of delayed serious liver
damage.
An overdose is likely to cause feeling or being sick, loss of appetite, abdominal pain, irregular
heartbeat, or pin-point-pupils.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor
so that they know which tablets were consumed.
If you forget to take Co-Codamol
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take
the next one. Do not take a double dose to make up for a forgotten dose.
If you stop taking Co-Codamol
Do not stop taking your medicine without talking to your doctor first even if you feel better.
Symptoms of restlessness and irritability may result when treatment is stopped after regular use.
If you stop taking the tablets you may develop the following withdrawal symptoms tremor,
difficulty sleeping, feeling or being sick, sweating and increased heart rate, breathing or blood
pressure.
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.

Stop taking the tablets and tell your doctor immediately or go to the casualty department at
your nearest hospital if the following happens:
an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in
breathing, or severe skin rash or hives.
This is a very serious but rare side effect. You may need urgent medical attention or
hospitalisation.
Tell your doctor if you experience any of the following effects:
fever or chills, sore throat, ulcers in you mouth or throat, unusual tiredness or weakness,
unusual bleeding or unexplained bruising, if you have an increase in number of nose bleeds.
you seem to be getting more infections than usual
severe pain in the abdomen or back, usually accompanied by sickness, diarrhoea or fever .

Tell your doctor if you notice any of the following side effects or notice any other effects not
listed:
Allergic Reactions - increased sweating, mucosal lesions (such as mouth ulcers), drug fever
Gastrointestinal system - stomach irritation (mild stomach pain, heartburn and feeling sick),
constipation, feeling or being sick, loss of appetite, dry mouth, difficulty in the passage of food
through guts, abdominal pain (may be caused by spasm of the bile ducts) and inflammation of
the liver or pancreas
Heart - slow heart rate, palpitations, low blood pressure which causes light-headedness or
fainting, inflammation of the heart muscle
• Blood - anaemia, changes in numbers and types of blood cells.
• Urinary system - pain and difficulty in passing urine and a less frequent need to do so, kidney
problems.
• Nervous system - confusion, drowsiness, dizziness, „spinning‟ sensation, mood changes,
depression, hallucinations (seeing or hearing things that are not real), restlessness, excitation,
fits, increased pressure in the skull (painful eyes, changes in vision or headache behind the
eyes), headache, difficulty sleeping, nightmares, reduced alertness, tolerance (medicine has less
effect) or dependence (suffer from withdrawal symptoms e.g. tremor, sweating, increased heart
rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is
stopped too quickly)
• Eyes - blurred or double vision, extremely small pupils
• Others - trembling, unusual tiredness or weakness, malaise, low body temperature, facial
flushing, anxiety

If any of the side effects get serious, 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.
Store in a cool dry place.
Do not use Co-Codamol after the expiry date that is stated on the outer packaging. The expiry
date refers to the last day of that month.
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 Tablets contain:
The active ingredients are codeine phosphate 8 mg and paracetamol 500 mg
The other ingredients are maize starch, pregelatinised maize starch, povidone,
hydroxybenzoate esters, sodium starch glycolate and magnesium stearate.
What Co-Codamol Tablets look like and contents of the pack:
Co-Codamol Tablets are white, coded “CO-COD 8-500” with a breakline on one side and a
twin triangle logo on the reverse side.
Co-Codamol Tablets are available in packs of 100 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Ltd,
Eastbourne, BN22 9AG
This leaflet was last revised: September 2014
PL 00289/1426

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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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