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CO-CODAMOL 30 MG/500 MG EFFERVESCENT TABLETS

Active substance(s): CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL

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PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

Co-codamol 30mg/500mg
Effervescent Tablets
(Codeine phosphate hemihydrate 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. Do not
pass it on to others. It may harm them, even if their
symptoms 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
You must contact a doctor if your symptoms
worsen or do not improve.
In this leaflet
1. What Co-codamol is and what it is used for
2. What you need to know before you take
Co-codamol
3. How to take Co-codamol
4. Possible side effects
5. How to store Co-codamol
6. Contents of the pack and other information

1. What Co-codamol is and what it is
used for
Co-codamol 30mg/500mg Effervescent Tablets
(hereinafter referred to as Co-codamol) are painkillers
(analgesics) containing two medicines, codeine and
paracetamol. They are recommended for the relief of
severe pain in adults.
They can be used in children older than 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.
This product contains codeine. Codeine belongs to a
group of medicines called opioid analgesics which act
to relieve pain. It can be used on its own or in
combination with other pain killers such as
paracetamol (which is in this medicine).

2. What you need to know before you take
Co-codamol
Important things you should know about
Co-codamol
Do not take for longer than your doctor tells you to
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.
Do not take Co-codamol if you:
are allergic to codeine, paracetamol or any of the
other ingredients in your medicine (listed in
Section 6: Further information)
know that you metabolise very rapidly codeine
into morphine
experience severe asthmatic attacks or severe
breathing problems
have recently had a head injury
have an obstruction of the intestines
have recently had an operation on your liver, gall
bladder or bile duct (biliary tract)
have raised pressure in the brain. Signs of this
include headaches, being sick (vomiting) and
blurred eyesight
take monoamine oxidase inhibitors - MAOIs (used to treat depression) or you have taken them
in the last 14 days. MAOIs are medicines such as
moclobemide, phenelzine or tranylcypromine
are an alcoholic
are breast feeding your baby.
Do not use 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.

Take special care with Co-codamol and tell your
doctor if you have or have had:
severe kidney or liver problems
prostate problems (e.g. difficulty passing water)
a bowel disorder
sensitivity to aspirin or other medicines used for
the treatment of inflammation (NSAIDs) eg
ibuprofen.
Co-codamol should not be given to children under 12
years of age and should be taken with care in the
elderly.
Codeine is transformed to morphine in the liver by an
enzyme. Morphine is the substance that produces pain
relief. Some people have a variation in this enzyme
and this can affect people in different ways. In some
people, morphine is not produced or is 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.
Other medicines and Co-codamol
Please tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines,
including medicines obtained without prescription.
Co-codamol may affect the way some medicines work.
You must tell your doctor or pharmacist if you are
taking any of the following medicines:
chloramphenicol (an antibiotic)
drugs which make you sleepy, including alcohol
drugs used to thin the blood (e.g. warfarin).
In addition the following medicines may change the
effectiveness of Co-codamol. However, this medicine
should not affect their action:
metoclopramide/domperidone (used to treat
nausea and vomiting)
cholestyramine (used to treat high blood
cholesterol (fat) levels)
oral contraceptives ("the pill")
sodium oxybate (helps in the management of
certain sleep disorders).
Pregnancy, breast feeding and fertility
Talk to your doctor before taking Co-codamol if you
are pregnant, think you may be pregnant or are
planning to have a baby.
Do not take this medicine and speak to your doctor if
you are in the last three months of pregnancy or in
labour.
Do not take this medicine if you are breast feeding
your baby.
Children and adolescents
Use in children and adolescents after surgery
This medicine 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.
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
However, you would not be committing an offence
if:
(continued overleaf)

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 pharrmacist if you are not sure
whether it is safe for you to drive while taking this
medicine.
Co-codamol tablets contain sodium and
paracetamol
Co-codamol contains paracetamol. Do not take any
other medicine containing paracetamol on the
same day that you take Co-codamol.
Each Co-codamol tablet contains 410mg of sodium
which amounts to 3.28g of sodium daily at a maximum
dose of 8 effervescent tablets per day.
If you are on a sodium controlled diet please tell your
doctor. The medicine also contains sorbitol and
saccharin. If you have been told by your doctor that
you have an intolerance to some sugars, contact your
doctor before taking this medicine.

3. How to take Co-codamol
Always take Co-codamol exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure. Do not take for longer
than directed by your prescriber.
Dissolve the effervescent tablets in at least half a
tumbler-full of water before taking.
Adults
The recommended dose of Co-codamol is 1 or 2
effervescent tablets. You must leave at least 6 hours in
between doses. Do not take more than 8 effervescent
tablets in any 24 hour period.
If you are elderly you may be prescribed a lower dose.
Use in children and adolescents
Children aged 12 years and older: Your doctor will tell
you what dose should be used. The recommended
dose is 1 or 2 effervescent tablets every 6 hours as
needed. Do not take more than 8 effervescent tablets
in any 24 hour period.
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.
Children under 12 years
Co-codamol should not be taken by children below
the age of 12 years, due to the risk of severe breathing
problems.
If you take more Co-codamol than you should:
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.
If you forget to take Co-codamol
If you forget to take a tablet, take one as soon as you
remember.
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Co-codamol
If you have taken regular daily doses of Co-codamol
over a long period of time, you should not increase
the dosage or suddenly stop your treatment without
discussing this with your doctor.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Important side effects you should know about
Co-codamol
Taking a painkiller for headaches too often or for
too long can make them worse
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.
Stop taking Co-codamol and see a doctor or go to
a hospital straight away if:
you get swelling of the hands, feet, ankles, face,
lips or throat which may cause difficulty in
swallowing or breathing. You could also notice

an itchy, lumpy rash (hives) or nettle rash
(urticaria). This may mean you are having an
allergic reaction to Co-codamol (frequency of
this effect cannot be estimated from the available
data)
you get serious skin reactions (very rare: may
affect up to 1 in 10,000 people)
you get severe stomach pain, which may reach
through to your back. This could be a sign of
inflammation of the pancreas (very rare: may
affect up to 1 in 10,000 people).
Tell your doctor or pharmacist if any of the
following side effects gets serious or lasts longer
than a few days:
Very rare: may affect up to 1 in 10,000 people
bruising or more infections than usual. This could
be because of a blood problem (such as
agranulocytosis, neutropenia or
thrombocytopenia), due to the effect of
paracetamol on blood cell counts.
Frequency not known: cannot be estimated from the
available data
constipation, nausea (feeling sick), vomiting, loss
of appetite
dizziness, light-headedness
drowsiness, confusion
difficulty in passing water
shallow breathing, wheezing, tightness in the
chest (bronchospasm)
pupils in eyes become small.
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 Co-codamol
Keep out of the sight and reach of children.
Do not use after expiry date stated on the pack.
Store your medicine in the original package in order
to protect from light and moisture.
Do not store above 25ºC.

6. Contents of the pack and other
information
What Co-codamol 30mg/500mg Effervescent
Tablets contain
Each tablet contains 30mg of the active ingredient
Codeine phosphate hemihydrate and 500mg of the
active ingredient Paracetamol. Other ingredients are
included to aid the manufacture of the tablets and to
make them soluble. These other ingredients are
sodium hydrogen carbonate, anhydrous sodium
carbonate, anhydrous citric acid, sodium docusate,
sorbitol (E420), saccharin sodium, dimeticone,
sodium benzoate and macrogol.
What Co-codamol 30mg/500mg Effervescent
Tablets look like and contents of the pack
Co-codamol 30mg/500mg Effervescent Tablets are
white, bevelled, flat, round tablets.
Co-codamol 30mg/500mg Effervescent Tablets are
available in blister packs of 28, 30, 50, 56 and 100 or
in tube packs of 10, 16, 32 and 96. Not all pack sizes
or types may be marketed.
Marketing Authorisation Holder
Manx Pharma Ltd, Taylor Group House
Wedgnock Lane, Warwick, CV34 5YA, United Kingdom.
Manufacturer
Manx Healthcare Ltd, Taylor Group House
Wedgnock Lane, Warwick, CV34 5YA, United Kingdom.
Other formats
To request a copy of this leaflet in Braille, large print or
audio please call 01926 482511.
This leaflet was last revised
in June 2016

URN: GC01-PIL-25-010616

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

GC01-PIL-25-010616
Co-codamol Tablets PIL
305 x 148mm
2 June 2016
13816/25 PIL.ai
1 Colour - Black

M1X

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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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