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CODEINE PHOSPHATE SYRUP BPC 1973

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Dimensions

297 x 210mm

Proof No.

11

Date

23.05.2014

PCP Header Box
Operator

Approved by
Date

gill.kennedy/louise.heel

Artwork No 520186
Suf fix

CRN

10996 & 9590

Reason for
Change

Addition of PRAC and Driving
warnings at the request of the
MHRA & Safety updates

B

Issued by
Date

MHRA/IMB
submission Yes
required

Data Matrix: 23295303 VERIFIED

This medicine may affect your ability to drive or operate machinery.
If you are feeling dizzy or drowsy, do not drive or operate machinery.
The medicine can affect your ability to drive as it may make you sleepy
or dizzy.
•  o not drive while taking this medicine until you know how it affects
D
you.
•  t is an offence to drive if this medicine affects your ability to drive.
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•  owever, you would not be committing an offence if:
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◦  he medicine has been prescribed to treat a medical or dental
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problem and
◦  ou have taken it according to the instructions given by the
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prescriber or in the information provided with the medicine and
Fonts Used
◦  t was not affecting your ability to drive safely.
I
Data Matrix: 23295303 VERIFIED
Times New Roman

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

Turn over

23295303

Date

23.05.2014
11

Driving and using machinery

Proof No.

Codeine Phosphate Syrup should not be used in pregnancy unless the
doctor has told you to do so.
Use in late pregnancy may cause shallow breathing in the newborn
baby and problems for the mother during labour.
Do not take codeine while you are breast feeding. Codeine and
morphine passes into breast milk.

297 x 210mm

•  s allergic to codeine or any of the ingredients listed.
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•  as liver disease, severe kidney problems, a head injury,
H
persistent headache, or raised head pressure.
•  s having an asthma attack or has general shortage of breath.
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• Is under Box
MHRA Header 12 years.
•  as problems emptying the bowel or has other problems associated
H
with
Colours Used
Codeine Phosphate
Product the bowel or intestine. Syrup BPC 1973
• 
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Title uffers from alcoholism.
Process Black
•  o not take the medicine for pain relief in children and adolescents
D
Component
(0-18 yearsLeaflet after removal of their tonsils or adenoids due to
of age)
Keyline (Does not print)
obstructive sleep apnoea syndrome.
Pack Size
500ml
•  f you know that you metabolise very rapidly codeine into
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IG Code
morphine. 23295303
•  f you are breastfeeding.
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Pregnancy and breast feeding

Dimensions

Do not take the medicine if the patient:

•  etoclopramide or domperidone (anti-nausea and vomiting
M
medicines).
•  lecainide or mexiletine (for the treatment of irregular heartbeat).
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•  ny tranquillisers, antidepressants, sedatives or sleeping tablets.
A
•  ny medicine used in the treatment of severe mental illness.
A

23295303

•  o not take for longer than directed by your doctor.
D
•  n rare cases people can be at increased risk of developing
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overdose symptoms from codeine even when they have taken the
recommended dose (people who are “ultra-rapid metabolisers” of
codeine). If you experience severe effects including feeling sick,
being sick, constipation, lack of appetite, feeling tired, sleeping
longer than normal, shallow or slow breathing, then stop taking this
medicine and seek immediate medical advice.
•  aking codeine regularly for a long time can lead to addiction, which
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might cause you to feel restless and irritable when you stop.
•  aking a painkiller for headaches too often or for too long can make
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them worse.
•  f you are elderly use with caution as the medicine can cause
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incontinence, diarrhoea, stomach pain and occasionally a blocked
bowel.

Talk to your doctor or pharmacist if the patient is already
taking any of the following:

IG Code

Take special care with codeine

Codeine is not recommended in children with breathing problems, since
the symptoms of morphine toxicity may be worse in these children.

500ml

2. Before you take the medicine

Use in children with breathing problems

Pack Size

Codeine Phosphate Syrup can be used in two ways:
•  n adults and children over 12 years of age for the short-term relief
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of moderate pain that is not relieved by other painkillers such as
paracetamol or ibuprofen alone.
•  or the relief of the symptoms of diarrhoea in adults and children
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over 12 years.

Codeine should not be used for pain relief in children and adolescents
after removal of their tonsils or adenoids due to Obstructive Sleep
Apnoea Syndrome.

Keyline (Does not print)

What is it for?

Use in children and adolescents after surgery

Leaflet

The name of your medicine is Codeine Phosphate Syrup B.P.C. 1973.
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 painkillers such as
paracetamol.

Component

1.  hat is the medicine and
W
what does it do?

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1. What is the medicine and what does it do?
2. Before you take the medicine.
3. How to take the medicine
4. Possible side effects
5. How to store the medicine
6. Further information

Process Black

In this leaflet

Fonts Used

•  his medicine has been prescribed for you personally and you should
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not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
•  eep this leaflet. You may need to read it again.
K
•  f you have further questions, please ask your doctor or pharmacist.
I
•  f any of the side effects become serious, or if you notice any side
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effects not listed in this leaflet, please tell your doctor or pharmacist.

Colours Used

Read all this leaflet carefully before you
start taking this medicine.

•  ntolerance to some sugars.
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•  idney or liver problems (a reduced dose may be recommended by
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your doctor).
•  history of asthma or other breathing problems, including bronchitis.
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•  ow blood pressure.
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•  rritable bowel syndrome (IBS) or other bowel problems.
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•  bdominal pain.
A
•  yasthenia gravis (a disease of the muscles).
M
•  nderactive thyroid or adrenal gland problems (a reduced dose may
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be recommended by your doctor).
•  allstones or bile duct problems.
G
•  rostate problems.
P
•  roblems passing urine.
P
•  rregular heartbeat.
I
•  history of epilepsy or fits.
A
•  r is suffering from shock.
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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.

Codeine Phosphate Syrup BPC 1973

(Codeine Phosphate 25mg per 5ml)

Talk to your doctor or pharmacist if the patient has any of
the following:

Product
Title

Codeine Phosphate Syrup
B.P.C. 1973

•  as previously had an addiction to medicines containing codeine or
H
morphine.

MHRA Header Box

PATIENT INFORMATION LEAFLET

Data Matrix: 23295303 VERIFIED

What the medicine looks like

The medicine is an almost colourless syrupy liquid.

4. Possible side effects
MHRA Header Box

Like all medicines, Codeine Phosphate Syrup can cause side effects,
although not everybody gets them.

Important side effects

If you think that you have any of the following side effects or
symptoms, stop using this medicine immediately and see a doctor as
soon as possible.
•  llergic reactions including skin rashes, itching and blistering.
A

Other possible side effects are:
•  Header Box
H
MHRA allucinations, mood changes, feeling restless or confused.

•  izziness or vertigo, feeling unwell, drowsiness, disturbed sleep,
D

Codeine Phosphate Syrup BPC 1973
Product
headache or seizures.
Title inpoint pupils or other problems with eyesight.
• P

Colours Used

Process Black

•  bnormal heartbeat.
A
Component faint when standing up, low body heat, facial Keyline (Does not print)
Leaflet
•  eeling
F
flushing or fluid
retention (e.g. swollen ankles and feet).
Pack Size
500ml
•  low, shallow breathing.
S
IG Code

23295303

Dimensions

297 x 210mm

Proof No.

11

Date

23.05.2014

Approved by
Date

gill.kennedy/louise.heel

Artwork No 520186
Suf fix

CRN

10996 & 9590

Reason for
Change

Addition of PRAC and Driving
warnings at the request of the
MHRA & Safety updates

B

Issued by
Date

MHRA/IMB
submission Yes
required

Times New Roman

Data Matrix: 23295303 VERIFIED

23295303

PCP Header Box
Operator

Fonts Used

23.05.2014
Date

PL 00240/6213R

11

May 2014

Proof No.

This leaflet was revised in

297 x 210mm

Thornton and Ross Ltd., Huddersfield,
HD7 5QH, England.

Dimensions

Marketing Authorisation Holder and Manufacturer

23295303

If you accidentally miss a dose, take the normal dose as soon as you
remember and then continue to take the medicine in the way you have
been told. Do not double up on the dose to make up for missed
doses.

The active substance is codeine phosphate 25mg per 5ml.
The other ingredients are chloroform, ethanol, purified water and syrup
(contains sucrose).

IG Code

If you take too much see a doctor straight away.

What the medicine contains

500ml

Elderly, frail, weak or infirm: The doctor will prescribe the correct dose
for you.

6. Further information

Pack Size

Adults and children over 12 years: 1 or 2 x 5ml spoonfuls by mouth
every 6 hours as needed. Do not take more than 8 x 5ml spoonfuls in
any 24 hours.
This medicine should not be taken for more than 3 days. If the diarrhoea
does not improve after 3 days, talk to your doctor for advice.
Codeine Phosphate Syrup should not be taken by children below the age
of 12 years, due to the risk of severe breathing problems.

Keep out of the sight and reach of children.
Do not use the medicine after any expiry date, which may appear on the
label.
Medicines should not be disposed of via wastewater or household
waste. Return any unused medicine to your pharmacist. These measures
will help protect the environment.

Keyline (Does not print)

The usual dose for diarrhoea is:

5. How to store the medicine

Leaflet

Adults and Children over 12 years: 1 or 2 x 5ml spoonfuls by mouth
every 6 hours as needed. Do not take more than 8 x 5ml spoonfuls in
any 24 hours.
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.
Codeine Phosphate Syrup should not be taken by children below the age
of 12 years, due to the risk of severe breathing problems.
Elderly, frail, weak or infirm: The doctor will prescribe the correct
dose for you.

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.

Component

The usual dose for the relief of pain is:

Reporting of side effects

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Dose: Always take your medicine as prescribed by your
doctor. The doctor may sometimes prescribe different doses to those
listed below. Always follow the doctor’s instructions carefully.

If any of the side effects become serious or if you notice any other
effects not mentioned here, tell your doctor or pharmacist straight away.
They will advise you what to do.

Process Black

This medicine has been prescribed for you personally.
Do not pass it on to others as it may harm them.

•  ead to addiction, or dependence, which might cause you to feel
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restless and irritable when you stop taking the syrup, or tolerance
(the medicine loses its effect).
• Make Irritable Bowel Syndrome worse.

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3. How to take the medicine

Taking codeine regularly for a long time can:

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To be taken into account in pregnant or breast feeding women,
children and high-risk groups such as patients with liver disease, or
epilepsy.
•  o not take this medicine if suffering from alcoholism or
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dependence on other opiates.

Codeine Phosphate Syrup BPC 1973

•  his medicine contains sucrose and ethanol (alcohol) as ingredients.
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If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product.
•  t contains 4.25g sucrose per 5ml spoonful. This should be taken into
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account in patients with diabetes mellitus.
•  his medicinal product contains 2.1 vol% ethanol (alcohol), i.e. up
T
to 166mg per dose, equivalent to 4.2ml beer, 1.75ml wine per dose.
Harmful for those suffering from alcoholism.

•  eeling or being sick, constipation, abdominal pain (including pain
F
caused by inflammation of the pancreas (pancreatitis) or bile duct
problems (biliary spasm)), loss of appetite or dry mouth.
•  weating, muscle twitching or muscle stiffness.
S
•  reteric spasm (urine tube problem causing abdominal or lower back
U
pain), difficulty in passing urine).
•  ow sexual urge.
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•  aking a painkiller for headaches too often or for too long can make
T
them worse.

Product
Title

Important information about some of the ingredients of this
medicine.

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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