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CO-CODAMOL 8/500MG TABLETS

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

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50x130mm 12pp label leaflet Profile (BST)

Co-codamol Tablets

8
500
mg

Braille reads:co-codamol
8/500 mg
tablets

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PL 20075/0702

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Co-Codamol
8/500mg x 100’s (UK)
JDE No.:

100 tablets

(Codeine Phosphate and Paracetamol)
For oral use
Each tablet contains 8mg Codeine Phosphate and 500mg Paracetamol. Use as directed by physician. FOR
DISPENSING PURPOSES ONLY. Do not exceed the stated dose. If symptoms persist consult your doctor. This
medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you
feel. See the leaflet inside for more information. Do not take for longer than directed by your prescriber as
taking codeine regularly for a long time can lead to addiction. Keep out of the sight and reach of children.
Contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.
Talk to a doctor at once if you take too much of this medicine, even if you feel well.
Store below 25°C in a dry place. Protect from light. Read the package leaflet before use.
50930599 BBBA1147

m

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FMD

Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

50930599

Dimensions: 50X130 (12 pg)
Component: Label Leaflet
Pharmacode: 2706
Date Sent:
07/04/17
Technologist: R.Wrey
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Paracetamol/Codeine 500mg 8mg 100 Tablets Label Leaflet - UK
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UK-Eire-Artwork-Support@Actavis.com

Item no: BBBA1147
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Origination Date:
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50 x 130
Min Body Text Size: 7pt
Supplier:
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S.Anson
15.08.17
23.08.17
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Package leaflet: Information for the patient

Co-codamol 8/500mg Tablets
(Codeine Phosphate and Paracetamol)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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. See
section 4.
What is in this leaflet
1. What Co-codamol tablets are and what they are used for
2. What you need to know before you take Co-codamol tablets
3. How to take Co-codamol tablets
4. Possible side effects
5. How to store Co-codamol tablets
6. Contents of the pack and other information

- 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.
Pregnancy and breast-feeding
Pregnancy
Do not take Co-codamol tablets during pregnancy, unless advised by your doctor. Regular use during pregnancy may cause
withdrawal symptoms in the newborn.
Breastfeeding
Do not take Co-codamol while you are breastfeeding. Codeine and morphine passes into breast milk.
3. How to take Co-codamol tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Do not drink alcohol whilst taking Co-codamol tablets. Swallow the tablets with water.
Take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice.

1. What Co-codamol tablets are and what they are used for
Co-codamol contains two different medicines called codeine phosphate and paracetamol. Co-codamol tablets belong to a
group of medicines called analgesics, which act to relieve pain. 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.
Co-codamol can be used to reduce body temperature.
2. What you need to know before you take Co-codamol tablets
Do not take Co-codamol tablets:
• if you are allergic to paracetamol, codeine phosphate or other opioids, or any of the other ingredients of this medicine (listed
in section 6)
• if you have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis)
• if you have difficulty breathing, or other chronic lung disease
• if you are having an asthma attack.
• for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive
sleep apnoea syndrome
• if you know that you metabolise very rapidly codeine into morphine
• if you are breastfeeding

The recommended dose is
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.
• Adults and children 16 to 18 years: 1 to 2 tablets every 6 hours, as needed. Do not take more than 8 tablets in 24 hours
• Children 12 to 15 years: 1 tablet every 6 hours as needed. Do not give your child more than 4 tablets in 24 hours.
• Children under 12 years: should not be taken due to the risk of severe breathing problems
• Elderly: Dosage is usually reduced in the elderly with liver damage.
If you take more Co-codamol tablets than you should
Talk to your 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.
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your
nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick,
loss of appetite, stomach pain or liver damage, coma, pale or clammy skin, fits, confusion, drowsiness, tiredness, low blood
pressure, pinpoint pupils, slow heart beat or breathing rate.
If you forget to take Co-codamol tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and
then take the next dose at the right time.

Warnings and precautions
Talk to your doctor or pharmacist before taking Co-codamol tablets if you have:
• liver or kidney problems
• diseased adrenal glands (Addison’s disease) or high blood pressure caused by a tumour near a kidney
(phaeochromocytoma)
• inflammatory bowel disease
• gall bladder disease or gall stones
• recently had surgery on your gastro-intestinal tract or urinary system
• an enlarged prostate gland and have difficulty urinating and are male
• epilepsy or suffered head injury or raised pressure in the skull (may cause painful eyes, changes in vision or headache
behind the eyes)
• an underactive thyroid gland
• muscle weakness (myasthenia gravis)
• low blood pressure or are in shock
• suffered from alcoholism, drug abuse or dependence or mental illness.

• Taking a painkiller for headaches too often or for too long can make them worse.
• 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.

• 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 the tablets

If you stop taking Co-codamol tablets
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.
Contact your doctor for advice on how to stop taking Co-Codamol tablets gradually to avoid withdrawal symptoms.
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.
Stop taking Co-Codamol tablets and seek medical attention if you notice any of the symptoms listed.
• Allergic Reactions - skin rash or itchy skin, difficulty breathing, increased sweating, redness or flushed face, mucosal lesions
(such as mouth ulcers), drug fever
Tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.
• 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, inflammation of the heart muscle
• Blood - anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice
that you bruise more easily or have more infections talk to your doctor

Other medicines and Co-codamol tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
• ciprofloxacin (antibacterial medicine)
• Monoamine Oxidase Inhibitors (MAOIs, e.g. moclobemide)
• oral contraceptives (the “pill”)
• medicines to prevent blood clotting such as warfarin
• cyclizine, metoclopramide or domperidone (to prevent sickness)
• guanethidine or diuretics (“water tablets”) e.g. spironolactone, furosemide (to treat high blood pressure)
• mexiletine (to treat irregular heartbeats)
• loperamide or kaolin (to treat diarrhoea)
• selegiline (for Parkinson’s disease)
• phenytoin (to treat epilepsy)
• cimetidine (to treat stomach ulcers)
• atropine or hyoscine (anticholinergic medicines)
• cisapride (to treat gastro-oesophageal reflux disease)
• medicines which affect the nervous system such as sleeping tablets, diazepam, hydroxyzine and medicines to treat mental
illness
• medicines to treat depression (e.g. tranylcypromine, amitriptyline)
• medicines which affect the liver (e.g. primidone and rifampicin)

• 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, difficulty sleeping, 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

Ask your pharmacist how to throw away medicines you no longer require. These measures will help protect the
environment.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

What Co-codamol tablets look like and contents of the pack
Co-codamol are white, uncoated tablets.
Pack sizes are 100.

5. How to store Co-codamol tablets
Keep this medicine out of the sight and reach of children. Store below 25°C in a dry place, protected from light.Do not use this
medicine after the expiry date which is stated on the label/carton/bottle.
The expiry date refers to the last day of that month.
Do not throw away any medicine via wastewater or household waste.

6. Contents of the pack and other information
What Co-codamol tablets contain
• The active substances (the ingredients that makes the tablets work) are 8mg of codeine phosphate and 500mg
paracetamol.
• The other ingredients are colloidal anhydrous silica, maize starch, stearic acid.

Marketing Authorisation Holder
Accord Healthcare Ltd, North Harrow, HA1 4HF, UK
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in August 2017

• colestyramine (to treat high cholesterol levels)
• muscle relaxants
• barbiturates (e.g. phenobarbital)
• anaesthetics
• opioid antagonists (buprenorphine, naltrexone, naloxone)
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 tablets.
Do not drink alcohol whilst taking Co-codamol tablets.
Driving and using machines
Co-codamol tablets may cause dizziness, blurred vision or the inability to think clearly. Make sure you are not affected before
you 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

Co-codamol Tablets
(Codeine Phosphate and Paracetamol)

8
500
mg

5 055565 741887

100 tablets

Each tablet contains 8mg Codeine Phosphate and 500mg Paracetamol. Use as directed by physician.
For oral use
FOR DISPENSING PURPOSES ONLY. Do not exceed the stated dose. If symptoms persist consult your doctor.
This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel.
See the leaflet inside for more information. Do not take for longer than directed by your prescriber as taking codeine
regularly for a long time can lead to addiction. Keep out of the sight and reach of children. Read the package leaflet before use.
Contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.
Talk to a doctor at once if you take too much of this medicine, even if you feel well.
Store below 25°C in a dry place. Protect from light.
Accord Healthcare Ltd, North Harrow, HA1 4HF, UK
50930599 BBBA1147

10mm

PL 20075/0702

10mm
text free
to left of
pharmacode

Pharmacode
Area
(12 x 20mm)

10mm
text free
to right of
pharmacode

Bleed off
by 2mm
at bottom
of page

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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