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CO-CODAMOL 8/500MG TABLETS

Active substance(s): CODEINE PHOSPHATE / PARACETAMOL

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50x130mm 12pp label leaflet Profile (BST)
TECHNICAL APPROVAL
Unless specified do not delete, or move profile and/or technical information in any way.
This will result in the voidence of the BST technical approval.

Braille reads:co-codamol
8/500 mg
tablets

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Co-Codamol Tablets
8/500 x 100’s (UK)

(Codeine Phosphate and Paracetamol)

New advice for drivers see leaflet inside

8
500
mg

JDE No.:

100 tablets
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 reach and sight 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.
Actavis, Barnstaple, EX32 8NS, UK
50822774 AAAH2186 PL 30306/0280

PEEL HERE DO NOT REMOVE LEAFLET

Co-codamol Tablets

50822774

Dimensions: 50X130 (12 pg)
Component: Label Leaflet
Pharmacode: 1843
Date Sent:
08/09/14
Technologist: R.Wrey
Technically Approved

Paracetamol Codeine 500 mg 8 mg Tablets 100 Label Leaflet UK

Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

item no:

AAAH2186

dimensions:

print proof no:

2

pharmacode:

origination date: 8.9.14

approved for print/date

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.

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.
Index
1. What Co-codamol tablets are and what they are used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information

2. Before you take
Do not take Co-codamol tablets:
• if you are allergic (hypersensitive) to paracetamol, codeine phosphate or other opioids, or any of the ingredients in the tablet
(see 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

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

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
Always take Co-codamol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or
pharmacist.
Do not drink alcohol whilst taking Co-codamol tablets. Swallow the tablets with water.

Check with 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)

• Adults and children over 12 years: 1 to 2 tablets every 6 hours, as needed. Do not take more than 8 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 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.

Take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice.

If you forget to take the 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.

Doses:
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.

If you stop taking the 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.

• 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.
Warnings and precautions:
• 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
• 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

Contact your doctor for advice on how to stop taking Co-Codamol tablets gradually to avoid withdrawal symptoms.
4. Possible side effects
Like all medicines, Co-codamol tablets can cause side effects, although not everybody gets them. Please tell your doctor or
pharmacist if you notice any of the following effects or any effects not listed.
• Allergic Reactions - skin rash or itchy skin, difficulty breathing, increased sweating, redness or flushed face, mucosal lesions
(such as mouth ulcers), drug fever. Stop taking Co-Codamol tablets and seek medical attention if you notice any of the
symptoms 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
• 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,

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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription. Especially:
• ciprofloxacin (antibacterial medicine)
• Monoamine Oxidase Inhibitors (MAOIs, e.g. moclobemide)
• oral contraceptives (the “pill”)

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
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.
5. How to store
Keep out of the reach and sight of children. Store below 25°C in a dry place, protected from light.
Do not use Co-codamol tablets after the expiry date stated on the label/carton/bottle.
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.

What Co-codamol tablets look like and contents of the pack
Co-codamol are white, uncoated tablets.
Pack sizes are 100.
Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland.
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in September 2014

2. pms 464
3. pms 877
4. pms 485

6 pt

5.

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revision date:

9.9.14

Technical Approval

revised by:

db

date sent:

n/a

2. varnish free

Actavis UK

technically app. date:

n/a

3. braille

• 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)
• colestyramine (to treat high cholesterol levels)
• muscle relaxants
• barbiturates (e.g. phenobarbital)
• anaesthetics
• opioid antagonists (buprenorphine, naltrexone, naloxone)

6. Further 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 anyhydrous silica, maize starch, stearic acid.

1. black

originated by:

supplier:

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

min pt size:

50 x 130

colours/plates

6.
Non Printing Colours
1. profile

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
- 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.

Co-codamol Tablets
(Codeine Phosphate and Paracetamol)

New advice for drivers see leaflet inside

8
500
mg

100 tablets
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 reach and sight 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.
Actavis, Barnstaple, EX32 8NS, UK
PL 30306/0280

50822774 AAAH2186

10mm
text free
to left of
pharmacode

Pharmacode
Area
(12 x 20mm)

10mm
text free
to right of
pharmacode

10mm

Bleed off
by 2mm
at bottom
of page

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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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