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BOOTS PARACETAMOL AND CODEINE TABLETS

Active substance(s): CODEINE PHOSPHATE / PARACETAMOL

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CO-CODAMOL 8MG/500MG
TABLETS
Important things you should know about co-codamol
• For the short term treatment of acute moderate
pain which is not relieved by paracetamol,
ibuprofen or aspirin alone.
• 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)
• 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

COCODAMOL Tablets INSERT
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Front

Warnings and precautions
Take special care with this medicine and talk to your
pharmacist or doctor if you:
• suffer from kidney or liver problems
• have a liver problem caused by alcohol
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
Codeine 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
Codeine 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:
• Other pain killers such as diflunisal
• Medicines to treat irregular heartbeats (e.g. mexiletine,
quinidine)
• Medicines to prevent blood clotting (e.g. warfarin)
• Medicines to treat epilepsy (e.g. phenytoin,
phenobarbital, primidone, carbamazepine)
• Medicines to treat ulcers (e.g. cimetidine)
• Medicines to reduce cholesterol in the blood
(e.g. colestyramine)
• Antibacterial medicines (e.g. isoniazide)
• Oral contraceptives (the ‘pill’)
• Medicines to treat gout (e.g. probenecid)
• Medicines to treat depression - such as monoamine
oxidase inhibitors (MAOIs). Avoid Co-codamol tablets
for 2 weeks after stopping the MAOIs
• Medicines to treat diarrhoea (e.g. loperamide, kaolin)
• Medicines to treat nausea or vomiting (e.g.
metoclopramide or domperidone)
• Medicines to treat anxiety and insomnia (e.g. diazepam
and nitrazepam)
• Medicines to treat mental illnesses including
schizophrenia (e.g. chlorpromazine and haloperidol)
If you go into hospital for surgery or tests, tell your doctor
you are taking Co-Codamol Tablets, 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 codeine while you are breastfeeding.
Codeine and morphine passes into breast milk.
Driving and using machines
• 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

PACKAGE LEAFLET: INFORMATION FOR THE USER

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24 mm

130 mm

10 mm

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4. Possible Side Effects
Like all medicines, Co-Codamol Tablets 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:
• itchy skin rash
• swelling of the face, lips, tongue or throat
• breathing difficulty or swallowing
Talk to your doctor straight away if you notice any of
the following serious side effects:
• Severe stomach pain, which may reach through to
your back. This could be a sign of inflammation of the
pancreas (pancreatitis). This is a very rare side effect

COCODAMOL Tablets
INSERT
SAME SIZE ARTWORK
130 x 260 mm
Front
240608

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 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,
nipasept (nipasept contains: 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
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
info@bristol-labs.co.uk
Email:
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.
V10 13-11-15 D0

260 mm

3. How to take Co-Codamol Tablets
Always take co-codamol exactly as instructed on the
leaflet
• You should check with your doctor or pharmacist if you
are not sure.
The usual 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 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 of above should take one to two
tablets every 6 hours, as needed. Do not take more than
8 tablets in 24 hours.
Children aged less than 12 years:
Co-codamol should not be taken by children below the
age of 12 years, due to the risk of severe breathing
problems.
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.
This medicine contains codeine and can cause
addiction if you take it continuously for more than 3 days.
When you stop taking it you may get withdrawal symptoms.
You should talk to your pharmacist if 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

• Yellowing of your skin or eyes and your urine becomes
darker in colour. This could be a liver problem, such
as jaundice or hepatitis
• A severe blistering rash in which layers of the skin may
peel off to leave large areas of raw exposed skin over
the body or you develop skin blisters. You may also
feel generally unwell, have a fever, chills and aching
muscles.
Tell your doctor or pharmacist if any of the following
side effects gets serious or lasts longer than a few
days:
• Constipation, feeling sick (nausea), being sick
(vomiting)
• Dizziness, light-headedness, drowsiness, confusion
• Difficulty in passing water
• You get infections or bruise more easily than usual.
This could be because of a blood problem.
• Becoming addicted to codeine
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.

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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
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.

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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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