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CO-CODAMOL TABLETS 8/500MG

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

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Artwork No.

e-mail : artworkcd@gmail.com
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141216/13

Colours Used

Customer

MAPharmachem

Black

Description

Co-codamol Leaflet

Keyline

Market

UK

Language

English

Size

180 x 300 mm

Min. Font Size

Arial Narrow, 9 pt

Page No.

1 of 1

Version No.

4

Date

03-04-17

Software

Coreldraw 12

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Patient Information Leaflet

However, you would not be committing an offence
!
!
Serious, sudden allergic reaction with symptoms
if:
such as fever and blisters on the skin and peeling of
The medicine has been prescribed to treat a
the skin (toxic epidermal necrolysis).
!
CO-CODAMOL TABLETS 8/500 mg
medical or dental problem and
!
A serious blistering condition of the skin, mouth,
(Codeine Phosphate 8mg/Paracetamol 500mg)
You have taken it according to the instructions
eyes and genitals (Stevens-Johnson syndrome).
!
given by the prescriber or in the information
!
inflammation of the pancreas which causes severe
Read all of this leaflet carefully before you start
Codeine is not recommended in children with
provided with the medicine and
pain in the abdomen and back (very rare side
taking this medicine.
breathing problems, since the symptoms of morphine
It was not affecting your ability to drive safely
effect)
!
!
Keep this leaflet.You may need to read it again.
toxicity may be worse in these children.
!
If you have any further questions, ask your doctor
Talk to your doctor or pharmacist if you are not sure
Tell your doctor or pharmacist if any of the
or pharmacist.
Warnings and precautions
whether it is safe for you to drive while taking this
following gets worse or lasts longer than a few
!
This medicine can only be used for the short term
Tell your doctor before you start to take this
medicine.
days:
treatment of acute, moderate pain which is not
medicine if you:
!
relieved by paracetamol, ibuprofen or aspirin
suffer from myasthenia gravis (muscle weakness
Tell the hospital staff, your doctor or dentist that you are
Common side effects
alone.
and fatigue)
taking these tablets before you have any treatment or
!
constipation
!
!
You should only take this product for a maximum of
have low blood pressure or are suffering from
operation, or before the appointment date if you are to
!
confusion and drowsiness
three days at a time. If you need to take it for longer
shock
have a blood or urine test.
!
than three days you should see your doctor or
have a history of cardiac arrhythmias (erratic
Uncommon side effects
pharmacist for advice.
heartbeat)
3. HOW TO TAKE CO-CODAMOL 8/500 mg
!
nausea, vomiting, stomach cramps, anorexia
!
!
This medicine contains codeine which can cause
have thyroid or adrenal disease
TABLETS
!
diarrhoea, incontinence
!
addiction if you take it continuously for more than
have mild kidney or liver disease
!
abdominal pain (may be caused by spasm of the
!
three days. This can give you withdrawal
have prostate or urinary problems e.g. difficulty
Always take this medicine exactly as your doctor has
bile or urinary ducts)
symptoms from the medicine when you stop taking
passing water
told you. You should check with your doctor or
!
skin rash, itching, sweating, facial flushing, low
!
it.
suffer from convulsions
pharmacist if you are not sure.
body temperature
!
!
If you take this medicine for headaches for more
have a history of drug abuse or emotional instability
!
dry mouth, blurred or double vision, pin-point pupils
!
than three days it can make them worse.
suffer from bowel disease
Adults, and the Elderly: Take one or two tablets every
!
malaise, tiredness, headache
!
have recently had gastro-intestinal surgery
4-6 hours. Do not take more than 8 tablets in any 24
!
dizziness, vertigo, light-headedness
!
1. WHAT CO-CODAMOL 8/500 mg TABLETS ARE
are elderly or infirm
hour period. A lower dosage may be needed if you are
!
slow or rapid heartbeat, palpitations, breathing
!
AND WHAT THEY ARE USED FOR
have gall stones.
elderly or have other medical problems. Check with
difficulties, problems in passing urine
your doctor about this.
!
low blood pressure, feeling faint on standing from a
Codeine is transformed to morphine in the liver by an
Co-codamol 8/500mg Tablets contain paracetamol
Children aged 16-18 years: Take one or two tablets
seated or lying position
enzyme. Morphine is the substance that produces pain
and codeine (painkillers), and are used for the short
every 6 hours when required. Do not take more than 8
!
decreased libido or potency
relief. Some people have a variation of this enzyme
term treatment of acute moderate pain which is not
tablets in any 24 hour period.
!
convulsions, hallucinations, nightmares,
and this can affect people in different ways. In some
relieved by paracetamol, ibuprofen or aspirin alone.
Children aged 12-15 years: Take one tablet every 6
depression, anxiety, mood changes
people, morphine is not produced or produced in very
For headache, toothache, period pain, arthritic and
hours when required. Do not take more than 4 tablets in
!
uncontrolled muscle movement or rigidity.
small quantities, and it will not provide enough pain
rheumatic pain when other painkillers have not

worked. Wait at least 4 hours after you last took other
painkillers before taking this medicine. Codeine
belongs to a group of medicines called opioid
analgesics which act to relieve pain. Co-codamol
tablets 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.

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.

any 24 hour period.
Children aged less than 12 years: Co-codamol
tablets should not be used in children under the age of
12 years, due to the risk of severe breathing problems.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
Swallow the tablets with a glass of water.
!
www.mhra.gov.uk/yellowcard.
Do not take for more than 3 days. If the pain does
!
By reporting side effects you can help provide more
not improve after 3 days, talk to your doctor for
information on the safety of this medicine.
advice.

Other medicines and Co-codamol
Talk to your doctor or pharmacist before you take this
How do I know if I am addicted?
DO NOT EXCEED THE STATED DOSE
medicine if you are taking any of the following:
If you take this medicine according to the instructions
!
sedatives, tranquillisers, antidepressants, sleeping
on the pack it is unlikely that you will become addicted
If you take more Co-codamol Tablets than you
!
tablets, or alcohol
This medicine contains codeine which can cause
to this medicine. However, if the following apply to you
should:
!
medicines used to treat water retention or high
addiction if you take it continuously for more than
it is important that you talk to your doctor.
If an overdose has been taken telephone your doctor
blood pressure
three days. This can give you withdrawal
immediately. If the doctor is not there, go to your local
!
medicines to treat mental illness (anti-psychotics)
symptoms from the medicine when you stop taking
!
You need to take the medicine for longer periods of
hospital casualty department. Take this leaflet and any
!
medicines to prevent blood clotting, such as
it.
time.
remaining tablets with you.
!
warfarin
If you take a painkiller for headaches for more than
!
You need to take more than the recommended
!
medicines to treat diarrhoea, such as loperamide
three days it can make them worse.
dose.
and kaolin
Talk to a doctor at once if you take too much of this
!
When you stop taking this medicine you feel very
!
muscle relaxants, such as atropine
medicine even if you feel well.
Do NOT take this medicine if you:
unwell but you feel better if you start taking the
!
anaesthetics or other drugs used in surgery (such
!
are allergic (hypersensitive) to paracetamol,
medicine again.
as neuromuscular blocking agents)
This is because too much paracetamol can cause
codeine phosphate, other opioid painkillers or any
!
medicines
that
affect
the
liver
e.g.
carbamazepine,
delayed, serious liver damage.
of the other ingredients of this medicine (listed in
5. HOW TO STORE THIS MEDICINE
phenobarbital, phenytoin (anti-epileptics) or
The hazard of overdose with paracetamol is greater in
section 6)
rifampicin (antibiotic).
those with alcoholic liver disease.
!
have moderate or severe kidney failure or liver
Keep out of the sight and reach of children
!
naloxone or naltrexone (used to treat drug abuse or
disease
Do not store above 25 °C. Store in a well-dosed
overdose)
Risk of addiction
!
have asthma or another lung disease which makes
container in a dry place, protected from light.
!
colestyramine (used to reduce cholesterol in the
This medicine contains codeine and can cause
breathing difficult
Do not use after the expiry date printed on the pack.
blood)
addiction if you take it continuously for more than 3
!
have increased pressure in the brain, e.g. following
Do not throw away any medidnes via waste water or
!
quinidine or mexiletine (used to treat certain heart
days. When you stop taking it you may get withdrawal
a head injury
household waste. Ask your pharmadst how to throw
conditions)
symptoms. You should talk to your doctor or
!
have diarrhoea associated with inflammation of the
away medidnes you no longer use. These measures
!
metoclopramide or domperidone (used to treat
pharmacist if you think you are suffering from
bowel or following poisoning
will help protect the environment.
nausea and vomiting)
withdrawal symptoms.
!
are an alcoholic
!
cimetidine (used to treat stomach ulcers)
!
are at risk of paralysis of the intestine (paralytic
6. CONTENTS OF THE PACK AND OTHER
!
cisapride (used to treat heart burn)
4. POSSIBLE SIDE EFFECTS
ileus)
INFORMATION
!
hydroxyzine (an anti-histamine)
!
are taking Monoamine Oxidase Inhibitors for
!
probenecid (used to treat gout)
Like all medicines, Co-codamol can cause side effects,
depression or have taken them within the last 14
What this medicine contains:
!
isoniazid (used to treat tuberculosis).
although not everybody gets them.
days
The active ingredients in each tablet are paracetamol
Please tell your doctor or pharmacist if you are taking
!
know that you metabolise very rapidly codeine into
500mg and codeine phosphate hemihydrate 8mg.
or have recently taken any other medicines, including
Stop taking the tablets and tell your doctor
morphine
The other ingredients are maize starch, povidone,
those obtained without a prescription.
immediately or go to the nearest hospital casualty
!
are breastfeeding.
colloidal silica, magnesium stearate and potassium
department if you have any of the following:
!
Do not use for pain relief in children and
sorbate (E202).
Pregnancy and breast-feeding
blood disorders such as thrombocytopenia
!
adolescents (0-18 years of age) after removal of
Do not take Co-codamol during pregnancy unless
(reduction in blood platelets, which increases risk
their tonsils or adenoids due to obstructive sleep
What this medicine looks like and contents of the
advised by your doctor.
of bleeding or bruising), neutropenia and
apnoea syndrome.
pack:
Do not take Co-codamol while you are breast-feeding.
leucopenia (reduction in white blood cells, which
Co-codamol 8/500mg Tablets are white, flat, round
Codeine and morphine passes into breast milk.
may make infection more likely) and
DO NOT TAKE WITH ANY OTHER PARACETAMOL
tablets with 'CO' and 'COD' on either side of a breakline
pancytopenia (severe reduction in blood cells
OR CODEINE CONTAINING PRODUCTS.
on one side and plain on the other.
Driving and using machines
which can cause weakness, bruising or make
They are available in packs of 30 and 32 tablets.
If these tablets make you feel drowsy, do not drive or
infections more likely)
Children and adolescents
operate machinery.The medicine can affect your ability
symptoms of an allergic reaction (rare side
!
Use in children and adolescents after surgery:
Marketing Authorisation Holder and Manufacturer:
to drive as it may make you sleepy or dizzy.
effect), such as skin rash or hives, swelling of the
Codeine should not be used for pain relief in children
M & A Pharmachem Ltd, Bolton BL5 2AL, UK
!
Do
not
drive
while
taking
this
medicine
until
you
lips,
face
or
neck
leading
to
severe
difficulty
and adolescents after removal of their tonsils or
know how it affects you.
breathing.
adenoids due to Obstructive Sleep Apnoea Syndrome.
Date of revision: April 2017
!
It is an offence to drive if this medicine affects your
!
Very rare cases of serious skin reactions have been
Use in children with breathing problems:
ability to drive.
reported.
PP2507
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CO-CODAMOL 8/500 mg TABLETS

Expand Transcript

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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