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CO-CODAMOL 8/500 TABLETS BP

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

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Patient Information Leaflet for
Co-Codamol 8mg/500mg Tablets
(Codeine Phosphate and Paracetamol)
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
This medicine can only be used for the short term relief of moderate pain that is not
relieved by other painkillers such as paracetamol or ibuprofen alone.
Do not take for longer than directed by your prescriber
Taking codeine/dihydrocodeine (DHC) 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.

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What is in this leaflet
1.
What Co-Codamol 8mg/500mg Tablets are and what they are used for
2.
What you need to know before you take Co-Codamol 8mg/500 mg Tablets
3.
How to take Co-Codamol 8mg/500 mg Tablets
4.
Possible side effects
5.
How to store Co-Codamol 8mg/500 mg Tablets
6.
Contents of the pack and other information

1.

What Co-Codamol 8mg/500mg Tablets and what they are used for

Co-codamol is a type of painkiller that contains paracetamol and codeine. Co-codamol tablets
are used in adults and 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. For headache,
migraine, toothache, period pains, rheumatic pains, muscle pains and backache.
This product contains codeine. 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.

2.

What you need to know before you take Co-codamol 8mg/500mg Tablets

This medicine contains codeine which can cause addiction if you take it continuously for
more than three days. This can give you withdrawal symptoms (e.g. feeling restless and
irritable) from the medicine when you stop taking it.
 If you take a painkiller for headaches for more than three days it can make them worse.
Do not take Co-Codamol 8mg/500mg tablets:


If you are under 18 years old and have had your tonsils or adenoids due to obstructive
sleep apnoea syndrome.













If you know you may metabolise very rapidly codeine into morphine.
If you are breastfeeding or planning to breast feed.
If you are allergic to Paracetamol, to Codeine or any other similar painkillers such as
dihydrocodeine, or to any of the other ingredients of this 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.
If you have liver disease or kidney failure.
If you have asthma or other breathing difficulties.
If you suffer from heart failure due to lung disease.
If you have recently suffered a head or brain injury.
If you are suffering from diarrhoea associated with colitis or due to any type of
poisoning.
If you suffer from alcohol dependency.
The person going to take the tablet is under 12 years old. Co-codamol must not be
given to children under 12 years old.

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.
Warnings and Precautions
Take special care and check your doctor or pharmacist before taking Co-codamol if
you:
• Have kidney or liver problems or alcoholic liver disease or a history of drug abuse.
• Suffer from high blood pressure or have an irregular heartbeat (slow or rapid).
• Have an under active thyroid gland or adrenal gland.
• Have urinary or prostate problems.
• Have recently had surgery on your stomach, suffer from gallstones, bowel disorders
or abdominal pain or swelling.
• Have ever suffered from convulsions or emotional problems.
• Are suffering from any kind of shock.
• Suffer from muscle weakness (myasthenia gravis).
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 and adolescents 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, have recently taken or might take any other
medicines:
 Phenothiazines (to treat serious mental and emotional disorders)
 Metoclopramide or Domperidone (for sickness and digestive disorders).
• Colestyramine (to help control blood cholesterol levels).
• Cimetidine (to treat stomach ulcers).
• Cisapride (to treat heartburn).
• Quinidine or Mexiletine (to treat certain heart conditions).
• Naloxone or Naltrexone (to treat drug overdose or abuse).
• Chloramphenicol (to treat eye infections).
• Hydroxyzine (an antihistamine used for itching).
• Blood thinning medicines such as Warfarin.
• Medicines to treat diarrhoea.
• Diuretics or other drugs for high blood pressure.
• Antimuscarinics (used to treat Parkinson's disease).
• Antidepressants including those known as monoamine oxidase inhibitors, anti-anxiety
drugs, sedative or hypnotic drugs.
• Anaesthetics
• Barbiturates (e.g. Phenobarbital)
• Any other paracetamol containing products
Co-codamol tablets should not be taken by patients currently taking monoamine oxidase
inhibitors (MAOI’s, e.g. moclobemide) or within two weeks of stopping treatment.
Co-codamol tablets may interfere with laboratory tests and you should inform your doctor if
you have any tests scheduled.
Cocourrent use of Co-codamol tablets with alcohol and barbiturates may increase the
hepatotoxicity of parcetamol, particularly after overdosage.
Pregnancy, breastfeeding and fertility
Do not take Co-codamol tablets if you are pregnant or while breast-feeding. If you think you
may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Codeine and morphine passes into breast milk. Co-codamol should not be used during
breastfeeding
Driving and using machines
Co-codamol can affect your ability to drive as it can make you feel 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 been following the instructions on how to take the medicine given by
the prescriber and

 The medicine does not affect your ability to drive safely.
Talk to your doctor or pharmacist if you are not sure whether it safe for you to drive whilst
taking this medicine.

3.

How to take Co-Codamol 8mg/500 mg Tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not sure.
Adults: One or two tablets to be taken every four to six hours, when necessary up to four
times daily. Maximum dose of 8 tablets in 24 hours.
Elderly: As for adults, however a reduced dose may be required.
The dose should not be repeated more frequently than every four hours for adults. Not more
than 4 doses should be administered in any 24 hour period.
Children and Adolescents:
Children aged 16-18 years: Take one to two tablets every 6 hours when necessary up to a
maximum of 8 tablets in 24 hours.
Children aged 12 – 15 years: take one tablet every 6 hours when necessary up to a
maximum of 4 tablets in 24 hours.
The dose should not be repeated more frequently than every six hours. Not more than 4
doses should be administered in any 24 hour period.
Swallow the tablets with a glass of water.
Do not give the tablets to children under 12 years due to the risk of severe breathing
problems.
Do not give the tablets for more than 3 days at a time unless your doctor tells you to.
Do not drink alcohol or take other Paracetamol containing products whilst taking these
tablets.
If you take more Co-codamol Tablets than you should:
Talk to a doctor at once if you take too much of this medicine, even if you feel well because
of the risk of delayed, serious liver damage. Take the container and any remaining capsules
with you. Symptoms of overdose include loss of appetite (anorexia), nausea, diarrhoea,
vomiting and abdominal pain.
If you forget to take Co-codamol Tablets:
If you miss a dose, do not take a double dose to make up for the missed dose.
If you stop taking Co-codamol Tablets
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
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you experience any of these symptoms after taking this medicine go to the nearest hospital
immediately:






Allergic reactions which may be severe such as skin rashes and itching sometimes
with swelling of the mouth or face or shortness of breath
Skin rash or peeling, or mouth ulcers
Fits (convulsions)
Difficulty breathing. These are more likely if you have experienced them before when
taking other painkillers such as ibuprofen and aspirin.
Unexplained bruising or bleeding, throat and mouth ulcers or bleeding gums
accompanied by tiredness and flu like symptoms

Very rare cases of serious skin reactions have been reported.
Other side effects























Nausea and vomiting
Headache
Hallucinations
Sweating
Flushing
Loss of appetite
Nightmares
Dry mouth
Vertigo
Muscle twitches or stiffness
Blurred or double vision
Slow heart rate
A fall in blood pressure on standing up (causing dizziness, light headedness or
fainting)
Pounding heart
Dizziness
Depression
Generally feeling unwell
Problems in passing urine
Stomach cramps
Tiredness
Blood disorders (which increases the risk of bleeding and brusing and makes
infections more likely)
Codeine can affect your bowels and can cause incontinence, constipation, a watery
diarrhoea like leakage, stomach pains and rarely, blockage of the bowel.

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 this medicine. However, if the following apply to you, it is important that
you talk to your doctor:
- You need to take this medicine for longer periods of time.
- You need to take more than the recommended dose.
- When you stop taking the medicine you feel very unwell but you feel better if you start
taking the medicine again.

5.






6.

How to store Co-Codamol 8mg/500 mg Tablets
Keep medicines out of the sight and reach of children.
Do not store above 25°C. Store in a dry place. Store in the original packaging to
protect from light and moisture.
Do not use this medicine after the expiry date which is stated on the packaging. The
expiry date refers to the last date of that month.
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.

Contents of the pack and other information

The active ingredients in Co-codamol tablets are Paracetamol 500 mg and Codeine Phosphate
8 mg. The inactive ingredients are pregelatinised maize starch, magnesium stearate and
povidone K30.
What Co-codamol Tablets looks like and contents of the pack
They are white, circular tablets marked CDM with a breakline on one face and CP on the
reverse.
Marketing Authorisation Holder
Aspar pharmaceuticals Limited,
Capitol Way, Colindale,
London NW9 0EQ.
Manufacturer
CP Pharmaceuticals Ltd,
Ash Road North,
Wrexham LL13 9UF,
United Kingdom
PL 08977/0039
The tablets are available in blister strip packs of 100 tablets.
Text Revision: February 2017.

Expand Transcript

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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