CO-CODAMOL 8/500 MG CAPSULES
Active substance(s): CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL
LUCIS Co-Codamol 8/500 mg Capsules PIL
Version 1 Created 10.02.17
Font: VAG Rounded Light & Bold 8pt (leading auto and as shown)
Now Version 6 - created 27.04.17
Profile size shown is 150 x 280 [8 folds @ 35mm] (profile advised 10.02.17)
PACKAGE LEAFLET – INFORMATION FOR THE USER
8 / 500mg CAPSULES
Codeine Phosphate 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, pharmacist or nurse.
• This 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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Co-Codamol Capsules are and what they
are used for
2. What you need to know before you take
3. How to take Co-Codamol Capsules
4. Possible side effects
5. How to store Co-Codamol Capsules
6. Contents of the pack and other information
1. What Co-Codamol Capsules are
and what they are used for
The name of your medicine is Co-Codamol 8/500
mg Capsules (called Co-Codamol Capsules
throughout this leaflet). Co-Codamol Capsules contain
two different medicines called codeine phosphate
and paracetamol. 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 painkillers such as
paracetamol. Co-Codamol Capsules are used to
treat pain from headaches, muscular and rheumatic
pain, back pain, nerve pain, period pain and dental
pain. Co-Codamol Capsules can also be used to
relieve the symptoms of cold, flu and sore throats.
Co-Codamol Capsules can be used in children aged
12 years and over for the short-term relief of
moderate pain that is not relieved by other
painkillers such as paracetamol or ibuprofen alone.
2. What you need to know before you
take Co-Codamol Capsules
Important things you should know about
- Do not take for longer than directed by your
- Taking codeine regularly for a long time can
lead to addiction, which might cause you to
feel restless and irritable when you stop taking
- Taking a painkiller for headaches too often or
for too long can make them worse
Do not take Co-Codamol Capsules if:
• You are allergic to the active substances or any
other ingredients of this medicine (listed in section
6). Signs of an allergic reaction include a rash and
breathing problems. There can also be swelling
of the legs, arms, face, throat or tongue.
• You are under 12 years of age.
• You are under 18 years of age and have had your
tonsils or adenoids removed due to obstructive
sleep apnoea syndrome
• You are breast-feeding or planning to breast-feed
• You know that you metabolise codeine very
rapidly into morphine
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Co-Codamol Capsules
• If you have kidney problems.
• If you have liver problems, including non-cirrhotic
alcoholic liver disease, as the hazard of overdose
• If you metabolise codeine in to morphine very
rapidly. (CYP2D6 ultra rapid metabolizer)
• The product is not recommended in children with
breathing problems, since the symptoms of
morphine toxicity may be worse in these children.
• Do not use in children and adolescents after
removal of their tonsils or adenoids due to
Obstructive Sleep Apnoea Syndrome.
Codeine is transformed into 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.
Other medicines and Co-Codamol Capsules
Tell your doctor, pharmacist or nurse if you are
taking, have recently taken or might take any other
medicines. This includes medicines obtained without
a prescription, including herbal medicines. This is
because Co-Codamol Capsules and some
medicines can affect the way each other work.
Tell your doctor if you are taking any of the following:
• Metoclopramide or domperidone – used for
nausea (feeling sick), vomiting (being sick) and
other stomach problems. These medicines may
increase the speed at which paracetamol is
absorbed by the body.
• Cholestyramine – used for high cholesterol and
other fats in the blood. This medicine may reduce
the absorption of Co-Codamol Capsules.
• Anticoagulants – used to thin the blood (such as
warfarin). You can take occasional doses of
Co-Codamol Capsules. However if you need to
take painkillers every day, talk to your doctor.
Pregnancy and breast-feeding
Talk to your doctor before taking these capsules if:
• You are pregnant, think you may be pregnant or
plan to get pregnant
• You are planning to breast-feed
• Do not take Co-Codamol Capsules while you are
breast-feeding. Codeine and morphine pass into
the 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.
• However, you would not be committing an
• The medicine has been taken to treat a
medical or dental problem and
• You have taken it according to 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
Details regarding a new UK driving offence,
concerning driving after drugs have been taken,
may be found at: www.gov.uk/drug-driving-law.
3. How to take Co-Codamol Capsules
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist if
you are not sure.
The recommended dose is:
Adults: 1–2 capsules, repeated if necessary every
4–6 hours with a maximum of 8 capsules a day.
Children aged 12 years to 18 years: Co-Codamol
Capsules should not be taken to treat cough and
cold by children aged 12 to 18 years who have
Children aged 12 years to 15 years: 1 capsule every
6 hours when necessary, up to 4 times a day
Children aged 16 years to 18 years: 1 - 2 capsules
every 6 hours when necessary, up to a maximum of
8 capsules in 24 hours.
This medicine should not be used in children aged
under 12 years
Co-Codamol Capsules should be taken orally.
If you take more Co-Codamol Capsules than you
• 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.
• Remember to take any remaining capsules and
the pack with you. This is so the doctor knows
what you have taken.
If you forget to take Co-Codamol Capsules
If you forget to take a dose at the right time, take it
as soon as you remember. However do not take a
double dose to make up for a forgotten dose.
Remember to leave at least 4 hours between doses.
Changing and stopping treatment
Chronic usage of co-codamol may lead to tolerance
and dependence. If you have taken regular daily
doses of co-codamol for a long time, do not
increase the dose or suddenly stop 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. The
following side effects may happen with this medicine:
Important side effects you should know about
• 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 these capsules.
Stop taking Co-Codamol Capsules and see a
doctor or go to 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 Capsules.
• You get serious skin reactions. Very rare cases
have been reported.
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
Tell your doctors or pharmacist if any of the
following gets serious or lasts longer than a few
• Feeling sick (nausea), being sick (vomiting)
• Dizziness, light-headedness, drowsiness,
• Difficulty in passing water
• Becoming dependent on codeine
• You get infections or bruise more easily than
usual. This could be because of a blood problem
(such as agranulocytosis, neutropenia or
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 Capsules
Keep out of the sight and reach of children.
Do not use after the expiry date (EXP) which is stated
on the carton and blister. Do not store above 25°C,
i.e. this medicine may be stored at room temperature.
Do not throw away any medicines via wastewater.
Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect
6. Contents of the pack and other
What Co-Codamol Capsules contain
• Each capsule contains: Active ingredients:
Paracetamol 500mg and Codeine Phosphate 8mg.
• The other ingredients are maize starch, colloidal
silicon dioxide, magnesium stearate, titanium
dioxide, gelatin, shellac, iron oxide, propylene glycol.
What Co-Codamol Capsules look like and
contents of the pack
Hard, white opaque capsules with “Co-Codamol” in
red along the cap and body. Available in packs of 32
and 100 capsules. Not all pack sizes may be
Marketing Authorisation Holder
Lucis Pharma Limited,
14 Aston Magna,
Moreton-in-Marsh, GL56 9QQ, UK
Surepharm Services Limited
Bretby Business Park,
Ashby Road East,
DE15 0YZ, UK
Leaflet last revised: May 2017