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CO-CODAMOL 8MG/500MG TABLETS

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

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30 mm

130 mm

Package leaflet: Information for the user

(Codeine phosphate and Paracetamol)
Important things you should know about
Co-codamol
• This medicine can only be used for the
short term treatment of acute moderate
pain when other painkillers have not
worked. Do not take less than four hours
after taking other painkillers.
• You should only take this product for a
maximum of 3 days at a time. If you need
to take it for longer than 3 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 3 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 3 days it can make them worse.
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.
- You must talk to a doctor if you do not feel
better or if you feel worse after three days.
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

1. What Co-codamol Tablets are and
what they are used for
• Co-codamol tablets contain a combination of
two ingredients paracetamol and codeine
phosphate.
Paracetamol is a non-narcotic analgesic (pain
killer) This product contains codeine. Codeine
belongs to a group of medicines called opioid
analgesics which act to relieve pain. Codeine
can be used on its own or in combination with
other pain killers such as paracetamol.
• Codeine 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. It can be used
to relieve pain caused by headache, migraine,
toothache, period pain, muscular pains and
backache.

2. What you need to know before
you take Co-codamol Tablets
• This medicine contains codeine which can
cause addiction if you take it continuously for
more than 3 days. This can give you
withdrawal symptoms from the medicine when
you stop taking it.
• If you take a painkiller for headaches for
more than 3 days it can make them worse.
Do not take Co-codamol:
• if you are allergic to paracetamol or codeine
phosphate 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 breast-feeding.
Warnings and precautions
Take special care with this medicine and talk
to your pharmacist or doctor if you have:
• kidney or liver 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,

COCODAMOL Tablets INSERT
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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.
Other medicines and Co-codamol
! This medicine contains paracetamol.
Do not take with any other paracetamol-containing
products.
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
The following medicines can affect Co-codamol:
• ciprofloxacin, isoniazid (antibacterial medicine)
• diflunisal (pain killer)
• probenecid (used to treat gout)
• 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)
If you go into hospital for surgery or tests, tell
your doctor you are taking Co-codamol, as you
may interact with some anaesthetics and
influence the results of certain tests and diagnostic
procedures.
Co-codamol tablets with food, drink and
alcohol
• Do NOT drink alcohol whilst taking Co-codamol
Tablets.
Pregnancy, breast-feeding and fertility
• Do not take this medicine if you are pregnant,
think you have become pregnant or intend to
become pregnant whilst taking these tablets.
• Do not take Co-codamol while you are
breastfeeding. Codeine and morphine passes
into breast milk.
Driving and using machines
Co-codamol 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.
IXXXXX

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CO-CODAMOL 8MG/500MG TABLETS

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.

10 mm

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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 contain Benzoates
• This medicine contains ethyl hydroxybenzoate
(E214), methyl hydroxybenzoate (E218),
propyl hydroxybenzoate (E216), which may
cause allergic reactions.

3. How to take Co-codamol 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.
The recommended dose is:
Adults over 18 years:
• The usual dose is one or two tablets to be
swallowed with water.
• The dose should not be taken more frequently
than every 4-6 hours and not more than 4
times in any 24 hour period.
• The maximum daily dose is 8 tablets (4g of
paracetamol and 64mg of codeine phosphate)
in any 24 hour period in divided doses.
Children aged 12 years to 18 years:
Children aged 12 years or above should take one
or two tablets every 6 hours, as needed. Do not
take more than 8 tablets in 24 hours.

• 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
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.

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 to talk to
your doctor• You need to take the medicine for longer
periods of time.
• You need to take more than the recommended
amount.
• 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 Co-codamol Tablets

• Do not take for more than 3 days. If you need
to use this medicine for more than three days
you must speak to your doctor or pharmacist.
If you stop taking Co-codamol 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. You should
talk to your doctor or pharmacist if you think
you are suffering from withdrawal symptoms.
Do not exceed the stated dose. If symptoms
persist consult your doctor.
If you take more Co-codamol Tablets than
you should
Contact your nearest hospital A&E (casualty
department) or your doctor immediately. Talk to a
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.
Take your medicine in its original packaging with
you in order to enable the doctor to identify your
medication easily.
Signs of overdose include difficulty in breathing;
pupils may be pin-point in size, nausea, vomiting,
loss of appetite and abdominal pain.
If you forget to take Co-codamol Tablets
If you forget to take a dose, wait and take your
next dose as usual.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP
FOR THE FORGOTTEN DOSE.

4. Possible Side Effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
STOP taking and contact your doctor or go
to a hospital straight away if you suffer from
below conditions:
• Allergic Reactions – skin rash or itchy skin,
difficulty breathing, increased sweating,
redness or flushed face, mucosal lesions (such
as mouth ulcers), drug fever.
• Very rare cases of serious skin reactions have
been reported.
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.

COCODAMOL Tablets INSERT
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Front240608

• Keep this medicine out of the sight and reach of
children.
• Do not store above 250C. Store in the original
package.
• Do not use these tablets after expiry date
shown on the carton or label. The expiry date
refers to the last day 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.

6. Contents of the pack and other
information
What Co-codamol Tablets contain
• The active substance is codeine phosphate
and paracetamol
• The other ingredients are: maize starch, potato
starch, povidone, stearic acid, talc,
magnesium stearate, methyl-p-hydroxy
benzoate (E218), ethyl-p-hydroxy benzoate
(E214) and propyl-p-hydroxy benzoate (E216).
What Co-codamol Tablets look like and
contents of the pack
• The tablets are clean, white, bevelled edged,
debossed with ‘8’ and broken breakline on one
side and ‘BL’ on the other side.
• They are available in packs of 8, 10, 12, 16,
20, 24, 28, 30 and 32 tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire, HP4 1EG, United
Kingdom
Telephone: 0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
Co-codamol 8mg/500mg Tablets;
PL 17907/0162
This leaflet was last revised in November
2015
To request a copy of this leaflet in Braille, large
print or audio format then please contact the
licence holder at the address (or telephone, fax,
email) above.

V13 18-11-15 D1

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Children aged less than 12 years:
Co-codamol should not be given to children
below the age of 12 years, due to the risk of
severe breathing problems.

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• 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

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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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