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CO-CODAMOL TABLETS BP 8/500MG

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

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•N
 ervous 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)
•E
 yes - blurred or double vision, extremely
small pupils
•O
 thers - 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.

6 Contents of the pack and other
information
What Co-codamol tablets contain
• T he active substances (the ingredients that
makes the tablets work) are 8mg of codeine
phosphate and 500mg paracetamol.
• T he other ingredients are colloidal
anhydrous silica, maize starch,
pregelatinsed maize starch, stearic acid.

Package leaflet: Information for the patient

Co-codamol tablets 8/500mg
(codeine phosphate and paracetamol)
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• 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.
• Y
 ou 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.
• T
 his 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.
• I f you take this medicine for
headaches for more than three days it
can make them worse.
• K
 eep this leaflet. You may need to read it
again.
• If you have any further questions, ask
your doctor or pharmacist.
• T his medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness 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.

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 December 2016

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:
•Y
 ou need to take the medicine for longer
periods of time.
•Y
 ou need to take more than the
recommended dose.
•W
 hen 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

Keep this medicine out of the sight and reach
of children.
Store below 25°C in a dry place, protected
from light
Do not use this medicine after the expiry date
which is stated on the label/carton/bottle.
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 require. These measures will help
protect the environment.

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BBBA0153 50912681

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Co-Dydramol Tablets
8/500mg x 30’s (UK)
JDE No.:

Actavis, Barnstaple, EX32 8NS, UK

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Do not take less than four hours after taking
other painkillers.

2 What you need to know before

you take Co-codamol tablets

• T his 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:
• if you are allergic to paracetamol, codeine
phosphate or other opioids, 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 breastfeeding

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page 4

page 1

Paracetamol Codeine 500mg/8mg 30 & 32 Tablets PIL - UK
approved for print/date

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
18/10/16
Technologist: R.Wrey

and what they are used for

Co-codamol contains two different medicines
called codeine phosphate and paracetamol.
Co-codamol tablets belong to a group of
medicines called 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.

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 C
 ontents of the pack and other
information

50912681

Pharmacode: 7178

1 What Co-codamol tablets are

Proof Round

05

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0153

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

C.Grant
20/10/16
19.12.16
S.Anson

Date sent:
N/A
Date received: N/A

Dimensions:
296 x 210
Min Body Text Size: 8pts
Supplier:
Actavis UK

Colours

Non Printing Colours

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1. Profile

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2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Warnings and precautions
Talk to your doctor or pharmacist before
taking Co-codamol tablets if you have:
• liver or kidney problems
•d
 iseased adrenal glands (Addison’s
disease) or high blood pressure
caused by a tumour near a kidney
(phaeochromocytoma)
• inflammatory bowel disease
•g
 all bladder disease or gall stones
• r ecently had surgery on your gastrointestinal tract or urinary system
• a n enlarged prostate gland and have
difficulty urinating and are male
•e
 pilepsy or suffered head injury or raised
pressure in the skull (may cause painful
eyes, changes in vision or headache behind
the eyes)
• a n underactive thyroid gland
•m
 uscle weakness (myasthenia gravis)
• low blood pressure or are in shock
• s uffered from alcoholism, drug abuse or
dependence or mental illness.
Warnings and precautions
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 tablets
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
• c iprofloxacin (antibacterial medicine)
•M
 onoamine Oxidase Inhibitors (MAOIs, e.g.
moclobemide)
Continued top of next column

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Co-Dydramol Tablets
8/500mg x 30’s (UK)
JDE No.:

•o
 ral contraceptives (the “pill”)
•m
 edicines to prevent blood clotting such as
warfarin
• c yclizine, metoclopramide or domperidone
(to prevent sickness)
•g
 uanethidine or diuretics (“water tablets”)
e.g. spironolactone, furosemide (to treat
high blood pressure)
•m
 exiletine (to treat irregular heartbeats)
• loperamide or kaolin (to treat diarrhoea)
• s elegiline (for Parkinson’s disease)
•p
 henytoin (to treat epilepsy)
• c imetidine (to treat stomach ulcers)
• a tropine or hyoscine (anticholinergic
medicines)
• c isapride (to treat gastro-oesophageal
reflux disease)
•m
 edicines which affect the nervous
system such as sleeping tablets, diazepam,
hydroxyzine and medicines to treat mental
illness
•m
 edicines to treat depression (e.g.
tranylcypromine, amitriptyline)
•m
 edicines which affect the liver (e.g.
primidone and rifampicin)
• c olestyramine (to treat high cholesterol
levels)
•m
 uscle relaxants
•b
 arbiturates (e.g. phenobarbital)
• a naesthetics
•o
 pioid antagonists (buprenorphine,
naltrexone, naloxone)

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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
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.

Breastfeeding
Do not take Co-codamol while you are
breastfeeding. Codeine and morphine passes
into breast milk.

3 How to take Co-codamol tablets

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.

Do not drink alcohol whilst taking Cocodamol 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.

4 Possible side effects

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.
The recommended dose is
•A
 dults and children 16 to 18 years: 1 to 2
tablets every 6 hours, as needed. Do not
take more than 8 tablets in 24 hours
•C
 hildren 12 to 15 years: 1 tablet every 6
hours as needed. Do not give your child
more than 4 tablets in 24 hours.
•C
 hildren under 12 years: should not be
taken due to the risk of severe breathing
problems
• E lderly: Dosage is usually reduced in the
elderly with liver damage.

Do not drink alcohol whilst 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.
The medicine can affect your ability to drive
as it may make you sleepy or dizzy.
•D
 o 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.
•H
 owever, 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
Continued over page

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.
Contact your doctor immediately if you
notice any of the following side effects:
•A
 llergic Reactions – skin rash or itchy skin,
difficulty breathing, increased sweating,
redness or flushed face, mucosal lesions
(such as mouth ulcers), drug fever.

If you take more Co-codamol tablets 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, pale or clammy skin, fits, confusion,
drowsiness, tiredness, low blood pressure,
pinpoint pupils, slow heart beat or breathing
rate.

Tell your doctor if you notice any of the
following side effects or notice any other
effects not listed:
•G
 astrointestinal 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
•H
 eart - slow heart rate, palpitations, low
blood pressure, inflammation of the heart
muscle
•B
 lood - 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
•U
 rinary system - pain and difficulty in
passing urine and a less frequent need to do
so, kidney problems.

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page 3

Paracetamol Codeine 500mg/8mg 30 & 32 Tablets PIL - UK
approved for print/date

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
18/10/16
Technologist: R.Wrey

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

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.

50912681

Pharmacode: 7178

If you forget to take Co-codamol 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.

Talk to your doctor or pharmacist if you are
not sure whether it is safe for you to drive
while taking this medicine.

Proof Round

05

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0153

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

C.Grant
20/10/16
19.12.16
S.Anson

Date sent:
N/A
Date received: N/A

Dimensions:
296 x 210
Min Body Text Size: 8pts
Supplier:
Actavis UK

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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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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