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BOOTS PARACETAMOL AND CODEINE EXTRA CAPSULES

Active substance: PARACETAMOL

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148 mm

How to take this medicine C How do I know if I am
addicted?

Paracetamol & Codeine Extra Capsules

430 mm

(Caffeine, Codeine Phosphate, Paracetamol)

Read all of this leaflet carefully because it contains important informa
This medicine is available without
C Talk to your pharmacist or
prescription to treat minor conditions.
doctor:
However, you still need to take it carefully • If you have severe kidney problems
to get the best results from it.
• If you have other liver problems (including a
• This medicine can only be used for the
disease caused by drinking alcohol)
short term treatment of acute moderate
• If you are taking monoamine oxidase
pain such as headache, migraine,
inhibitors (for depression), or have taken
rheumatic pain, muscular pain, backache,
them in the last 14 days
neuralgia, toothache and period pain that is
not relieved by aspirin, ibuprofen or
Other important information
paracetamol alone
Do not drink alcohol (wine, beer, spirits)
• You should only take this product for a whilst taking this medicine. Alcohol
maximum of 3 days at a time. If you need increases the risk of side effects occurring
to take it for longer than 3 days you should and may make you feel more drowsy.
see your doctor or pharmacist for advice
Codeine is transformed to morphine in the
• This medicine contains codeine which liver by an enzyme. Morphine is the
can cause addiction if you take it
substance that produces pain relief. Some
continuously for more than 3 days. This can people have a variation of this enzyme and
give you withdrawal symptoms from the
this can affect people in different ways. In
medicine when you stop taking it
some people, morphine is not produced or
• If you take this medicine for headaches produced in very small quantities, and it will
for more than 3 days it can make them
not provide enough pain relief. Other
worse
people are more likely to get serious side
• Keep this leaflet, you may need to read it
effects because a very high amount of
again
morphine is produced. If you notice any of
• Ask your pharmacist if you need more
the following side effects, you must stop
information or advice
taking this medicine and seek immediate
medical advice: slow or shallow breathing,
What this medicine is for
confusion, sleepiness, small pupils, feeling
This medicine can be used for the short
or being sick, constipation, lack of appetite.
term treatment of acute moderate pain
Use in children and adolescents after
such as headache, rheumatic and
muscular pain, backache, migraine, period surgery: Codeine should not be used for
pain relief in children and adolescents after
pain, dental pain and neuralgia that is not
removal of their tonsils or adenoids due to
relieved by aspirin, ibuprofen or
obstructive sleep apnoea syndrome.
paracetamol alone.
Use in children with breathing
This medicine contains Codeine. Codeine
problems: Codeine is not recommended
belongs to a group of medicines called
opioid analgesics which act to relieve pain. in children with breathing problems, since
the symptoms of morphine toxicity may be
This codeine-containing medicine can be
worse in these children.
used in adults and children aged 12 years
Breastfeeding: Do not take codeine while
and over.
you are breastfeeding. Codeine and
This medicine also contains Paracetamol
morphine passes into breast milk.
and Caffeine. Paracetamol, an analgesic,
Driving and using machines: This
acts to relieve pain. Caffeine helps to
medicine can affect your ability to drive or
increase the pain relief.
use machines as it may make you feel
sleepy or dizzy.
Before you take this
• Do not drive or use machines while taking
medicine
this medicine until you are sure you are not
• This medicine contains codeine which affected
can cause addiction if you take it
• It is an offence to drive if this medicine
continuously for more than 3 days. This can affects your ability to drive
give you withdrawal symptoms from the
• However, you would not be committing an
medicine when you stop taking it
offence if:
• If you take a painkiller for headaches
- The medicine has been prescribed to
for more than 3 days it can make them
treat a medical or dental problem and
worse
- You have taken it according to the
This medicine can be taken by adults and
instructions given by the prescriber or in
children aged 12 years and over. However,
the information provided with the
some people should not take this medicine
medicine and
or should seek the advice of their
- It was not affecting your ability to drive
pharmacist or doctor first.
safely
Do not take:
Talk to your doctor or pharmacist if you are
• For pain relief in children and
not sure whether it is safe for you to drive
adolescents (0-18 years of age) after
while taking this medicine.
removal of their tonsils or adenoids due to
Important information about some of
obstructive sleep apnoea syndrome
the ingredients in this medicine: The
• If you know that you metabolise very
colour ponceau 4R (E124) in this medicine
rapidly codeine into morphine
• If you are allergic to any of the ingredients may cause allergic reactions.
• If you have severe liver problems
If you take other medicines
• If you are pregnant, unless your doctor
C This medicine contains paracetamol.
tells you to
Do not take anything else containing
• If you are breastfeeding (see "Other
paracetamol while taking this medicine.
important information")
Before you take these capsules, make sure
that you tell your pharmacist about ANY
other medicines you might be using at the
same time, particularly the following:
• Domperidone or metoclopramide for feeling
sick or being sick (may increase the pain
relief effect of paracetamol)
• Colestyramine for reducing blood fat levels
(may reduce the pain relief effect of
paracetamol)
• Warfarin or other blood thinners - if you
take warfarin you can take occasional
amounts of this medicine, but talk to your
doctor first before you take it on a regular
basis
If you are unsure about interactions with
any other medicines, talk to your
pharmacist. This includes medicines
prescribed by your doctor and medicine
you have bought for yourself, including
herbal and homeopathic remedies.

Check the foil is not broken before use.
If it is, do not take that capsule.
Age
How many How often
to take
to take
Adults
Two
Every 4 hours, if
over 18
you need to, up to
years
4 times in 24
hours.
Don’t take more
than 8 capsules in
24 hours.
Children
aged 12
years to
18 years

Two

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:
• 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

Every 6 hours, if
you need to.
Don’t take more How to store this medicine
than 8 capsules in Do not store above 30°C. Store in the
24 hours.
original package.
Keep this medicine in a safe place out of
Swallow each capsule whole with water.
the sight and reach of children, preferably
Do not take for more than 3 days. If
in a locked cupboard.
you need to use this medicine for more
Use by the date on the end flap of the
than 3 days you must speak to your
carton.
doctor or pharmacist for advice.
Do not give to children under 12 years,
What is in this medicine
due to the risk of severe breathing
Each capsule contains Caffeine 30 mg,
problems.
Codeine Phosphate Hemihydrate 8 mg,
Do not take more medicine than the table Paracetamol 500 mg which are the active
ingredients.
above tells you to.
If you do not get better, talk to your doctor. As well as the active ingredients, the
C If you take too many capsules: Talk to capsules also contain sodium starch
glycolate, magnesium stearate, sodium
a doctor at once if you take too much of
laurilsulfate. The capsule shell contains
this medicine even if you feel well. This is
gelatin, quinoline yellow (E104), ponceau
because too much paracetamol can
4R (E124), titanium dioxide (E171), yellow
cause delayed, serious liver damage. Go
iron oxide (E172), printing ink contains
to your nearest hospital casualty
propylene glycol, shellac, black iron oxide
department. Take your medicine and this
(E172).
leaflet with you.
This pack contains 32 capsules.

Possible withdrawal effects
when stopping treatment

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 doctor
or pharmacist if you think you are suffering
from withdrawal symptoms.

Possible side effects

Most people will not have problems, but
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.
C If you get any of these serious side
effects, stop taking the capsules. See
a doctor at once:
• Difficulty in breathing, swelling of the face,
neck, tongue or throat (severe allergic
reactions)
• Very rare cases of serious skin reactions
have been reported. This may include
peeling, blistering and lesions of the skin.
If you get any of the following side
effects see your pharmacist or
doctor:
• Constipation, feeling sick
• Drowsiness or dizziness – do not drive or
use machines if you feel drowsy or dizzy
• Confusion, restlessness, changes in
mood, hallucinations, headaches
• Other allergic reactions (e.g. skin rash)
• Unusual bruising, or infections such as
sore throats - this may be a sign of very
rare changes in the blood
If any side effect becomes severe, or
you notice any side effect not listed
here, please tell your pharmacist or
doctor.

Who makes this medicine

Manufactured for the Marketing
Authorisation holder The Boots Company
PLC Nottingham NG2 3AA by Bristol
Laboratories Ltd Northbridge Road
Berkhamsted Herts HP4 1EG
Leaflet prepared May 2015.
If you would like any further information
about this medicine, please contact
The Boots Company PLC Nottingham
NG2 3AA

Other formats

To request a copy of this leaflet in Braille,
large print or audio please call, free of
charge:
0800 198 5000 (UK only)
Please be ready to give the following
information:
Product name: Boots Paracetamol and
Codeine Extra Capsules
Reference number: 00014/0613
This is a service provided by the Royal
National Institute of Blind People.

32 capsules.
Version No.
1

Date Issued
19/05/15

Reason For Change
Add PRAC paracetamol side effect
warning

ARTWORK ONLY
Category:
Sub-Category:
Brand:
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Healthcare
Analgesics
Core
Leaflet
Paracetamol & Codeine Extra Capsules
x32/Bristol

A

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148 mm width x 430 mm height

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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.

PIL601
26-00-951

CAD Ref No:
Printer:
Substrate:

Reporting of side effects

01/06/15
UK

N/A
N/A
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N/A

White Paper

N/A
0010000001(1152)

Technical & Non Printing Items
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PANTONE 280 C
1

PIL601

STUDIO USE ONLY

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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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