CO-CODAMOL TABLETS BP 8/500MG

Active substance: PARACETAMOL

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65mm

Co-codamol tablets 8/500mg

•  This medicine can only be used for the short term
treatment of acute moderate pain which is not relieved by
paracetamol, ibuprofen or aspirin alone. Do not take less than
four hours after taking other painkillers.
•  You should only take this product for a maximum of three
days at a time. If you need to take it for longer than three days
you should see your doctor or pharmacist for advice.
• This medicine contains codeine which can cause addiction
if you take it continuously for more than three days. This can
give you withdrawal symptoms from the medicine when you
stop taking it.
• If you take this medicine for headaches for more than three
days it can make them worse.
• 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

1 What Co-codamol tablets are and what they
are used for

Co-codamol tablets belong to a group of medicines called
analgesics and are used for the short term treatment of
acute moderate pain which is not relieved by paracetamol,
ibuprofen or aspirin alone.
Do not take less than four hours after taking other painkillers.

2 Before you take

• This medicine contains codeine which can cause addiction if
you take it continuously for more than three days. This can
give you withdrawal symptoms from the medicine when
you stop taking it (see ‘If you stop taking the tablets’).
• If you take a painkiller for headaches for more than three
days it can make them worse.

Do not take Co-codamol tablets and tell your doctor
if you:

• are allergic (hypersensitive) to paracetamol, codeine
phosphate or other opioids, or any of the ingredients in the
tablet (see section 6)
• have diarrhoea caused by poisoning or severe bloody
diarrhoea (pseudomembranous colitis)
• have difficulty breathing, or other chronic lung disease
• are having an asthma attack.
Continued top of next column
50441040

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)
• 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.

C
L

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”)
• 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)

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 Cocodamol 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.

Continued over page

210mm +/- 0.5mm to centre line of next eye mark

Pharmacode
Position

Read all of this leaflet carefully before you start taking
this medicine.

83.6mm

(paracetamol and codeine phosphate)

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.
Take this medicine for as long as your doctor tells you to, it
may be dangerous to stop without their advice.
Doses:
Do not take for more than three days. If you need to use
this medicine for more than three days you must speak to
your doctor or pharmacist.
• Adults and children over 12 years: 1 to 2 tablets every 4 to 6
hours up to a maximum of 8 tablets in a day
• Children aged 6 to 12 years: half to 1 tablet every 4 to 6
hours up to a maximum of 4 tablets in a day
• Children under 6 years: not recommended
• Elderly: Dosage is usually reduced in the elderly with liver
damage.

If you take more than you should

Seek immediate medical advice in the event of an
overdose, even if you feel well, because of the risk of
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, clammy skin, fits, confusion, drowsiness, tiredness, low
blood pressure, pinpoint pupils, slow heart beat or breathing
rate.

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.

If you stop taking the tablets

This medicine contains codeine and can cause addiction if
you take it continuously for more than three days. When you
stop taking it you may get withdrawal symptoms such as
tremor, difficulty sleeping, feeling or being sick, sweating and
increased heart rate, breathing or blood pressure. You should
talk to your doctor or pharmacist if you think you are suffering
from withdrawal symptoms.

4 Possible side effects

Some people may have side-effects when taking this
medicine. If you have any unwanted side-effects you
should seek advice from your doctor, pharmacist or other
healthcare professional. Also you can help to make sure
that medicines remain as safe as possible by reporting any
unwanted side-effects via the internet at www.yellowcard.
gov.uk; alternatively you can call Freephone 0808 100 3352
(available between 10am-2pm Monday - Friday) or fill in a
paper form available from your local pharmacy.
Contact your doctor immediately if you notice any of the
following side effects:
• Allergic Reactions - skin rash or itchy skin, difficulty
breathing, increased sweating, redness or flushed face,
mucosal lesions (such as mouth ulcers), drug fever.

Continued top of next column
50441040

Tell your doctor if you notice any of the following side effects
or notice any other 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
• 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

How do I know if I am addicted?

If you take the medicine according to the
instructions on the pack it is unlikely that you will
become addicted to the medicine. However, if the
following apply to you it is important that you talk
to your doctor:
•  You need to take the 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 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.

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 anhydrous silica, maize
starch, pregelatinised maize starch, stearic acid.

What Co-codamol tablets look like and contents of
the pack
Co-codamol are white, uncoated tablets.
Pack sizes are 30 and 32.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in January 2011

Actavis, Barnstaple, EX32 8NS, UK

65mm

Do not take Co-codamol tablets during pregnancy or whilst
breast-feeding, unless advised by your doctor. Regular use during
pregnancy may cause withdrawal symptoms in the newborn.
Usually it is safe to take Co-codamol tablets while breast feeding
as the levels of the active ingredients of this medicine in breast
milk are too low to cause your baby any problems. However, some
women who are at increased risk of developing side effects at
any dose may have higher levels in their breast milk. If any of the
following side effects develop in you or your baby, stop taking
this medicine and seek immediate medical advice; feeling sick,
vomiting, constipation, decreased or lack of appetite, feeling tired
or sleeping for longer than normal, and shallow or slow breathing.

Pharmacode
Position

Pregnancy and breast-feeding

Co-codamol tablets 8/500mg
Read all of this leaflet carefully before you start taking
this medicine.
T
 his medicine can only be used for the short term
treatment of acute moderate pain which is not relieved by
paracetamol, ibuprofen or aspirin alone. Do not take less than
four hours after taking other painkillers.
•  ou should only take this product for a maximum of three
Y
days at a time. If you need to take it for longer than three days
you should see your doctor or pharmacist for advice.
•  his medicine contains codeine which can cause addiction
T
if you take it continuously for more than three days. This can
give you withdrawal symptoms from the medicine when you
stop taking it.
•  f you take this medicine for headaches for more than
I
three days it can make them worse.
• Keep this leaflet. You may need to read it again.
•  f you have any further questions, ask your doctor or
I
pharmacist.
•  his medicine has been prescribed for you. Do not pass it on
T
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

1 What Co-codamol tablets are and what they
are used for

Co-codamol tablets belong to a group of medicines called
analgesics and are used for the short term treatment of
acute moderate pain which is not relieved by paracetamol,
ibuprofen or aspirin alone.
Do not take less than four hours after taking other painkillers.

2 Before you take

•  his medicine contains codeine which can cause addiction
T
if you take it continuously for more than three days. This
can give you withdrawal symptoms from the medicine
when you stop taking it (see ‘If you stop taking the tablets’).
•  f you take a painkiller for headaches for more than three
I
days it can make them worse.

Do not take Co-codamol tablets and tell your doctor
if you:

• are allergic (hypersensitive) to paracetamol, codeine
phosphate or other opioids, or any of the ingredients in the
tablet (see section 6)
• have diarrhoea caused by poisoning or severe bloody
diarrhoea (pseudomembranous colitis)
• have difficulty breathing, or other chronic lung disease
• are having an asthma attack.

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)
Continued top of next column
50441058

• 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 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”)
• 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)

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.

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.

Pregnancy and breast-feeding

Do not take Co-codamol tablets during pregnancy or
whilst breast-feeding, unless advised by your doctor.
Regular use during pregnancy may cause withdrawal
symptoms in the newborn.

Continued over page

Pharmacode
Position

(paracetamol and codeine phosphate)

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.
Take this medicine for as long as your doctor tells you to, it
may be dangerous to stop without their advice.
Doses:
Do not take for more than three days. If you need to use
this medicine for more than three days you must speak to
your doctor or pharmacist.
• Adults and children over 12 years: 1 to 2 tablets every 4 to 6
hours up to a maximum of 8 tablets in a day
• Children aged 6 to 12 years: half to 1 tablet every 4 to 6
hours up to a maximum of 4 tablets in a day
• Children under 6 years: not recommended
• Elderly: Dosage is usually reduced in the elderly with liver
damage.

If you take more than you should

Seek immediate medical advice in the event of an
overdose, even if you feel well, because of the risk of
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, clammy skin, fits, confusion, drowsiness, tiredness, low
blood pressure, pinpoint pupils, slow heart beat or breathing
rate.

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.

If you stop taking the tablets

This medicine contains codeine and can cause addiction if
you take it continuously for more than three days. When you
stop taking it you may get withdrawal symptoms such as
tremor, difficulty sleeping, feeling or being sick, sweating and
increased heart rate, breathing or blood pressure. You should
talk to your doctor or pharmacist if you think you are suffering
from withdrawal symptoms.

4 Possible side effects

Some people may have side-effects when taking this
medicine. If you have any unwanted side-effects you
should seek advice from your doctor, pharmacist or other
healthcare professional. Also you can help to make sure
that medicines remain as safe as possible by reporting any
unwanted side-effects via the internet at www.yellowcard.
gov.uk; alternatively you can call Freephone 0808 100 3352
(available between 10am-2pm Monday - Friday) or fill in a
paper form available from your local pharmacy.
Contact your doctor immediately if you notice any of the
following side effects:
•  llergic Reactions - skin rash or itchy skin, difficulty
A
breathing, increased sweating, redness or flushed face,
mucosal lesions (such as mouth ulcers), drug fever.
Tell your doctor if you notice any of the following side effects
or notice any other effects not listed:

Continued top of next column
50441058

• 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, 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

How do I know if I am addicted?

If you take the medicine according to the
instructions on the pack it is unlikely that you will
become addicted to the medicine. However, if the
following apply to you it is important that you talk
to your doctor:
•  You need to take the 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 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.

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 anhydrous
silica, maize starch, pregelatinised maize starch,
stearic acid.

What Co-codamol tablets look like and
contents of the pack

Co-codamol are white, uncoated tablets.
Pack sizes are 30 and 32.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised
in January 2011
Actavis, Barnstaple, EX32 8NS, UK

Pharmacode
Position

Usually it is safe to take Co-codamol tablets while breast feeding
as the levels of the active ingredients of this medicine in breast
milk are too low to cause your baby any problems. However, some
women who are at increased risk of developing side effects at
any dose may have higher levels in their breast milk. If any of the
following side effects develop in you or your baby, stop taking
this medicine and seek immediate medical advice; feeling sick,
vomiting, constipation, decreased or lack of appetite, feeling tired
or sleeping for longer than normal, and shallow or slow breathing.

Expand view ⇕

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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