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THORNTON & ROSS CODEINE PHOSPHATE 25MG/5ML ORAL SOLUTION

Active substance(s): CODEINE PHOSPHATE

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Dimensions

297 x 210mm

Proof No.

2

Date

22.04.2015

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 570144
Suf fix

CRN

12035

Reason for
Change

Removal or chloroform and
change to product title

B

Issued by
Date

MHRA/IMB
submission N/A
required

Data Matrix: 23295304 VERIFIED

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 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
Fonts Usedor in the information provided with the medicine and
◦ It was not affecting your ability to drive safely.
Data Matrix: 23295304 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

23295304

Date

22.04.2015
2

This medicine may affect your ability to drive or operate machinery.
If you are feeling dizzy or drowsy, do not drive or operate machinery.

Proof No.

Driving and using machinery

297 x 210mm

• Is allergic to codeine or any of the ingredients listed.
• Has liver disease, severe kidney problems, a head injury,
persistent headache, or raised head pressure.
• Is having an asthma attack or has general shortage of breath.
• Is under 12 years.
• Has
problems
MHRA
Header
Box emptying the bowel or has other problems associated
with the bowel or intestine.
Colours Used
Thornton
& Ross Codeine Phosphate
Product
• Suffers from
alcoholism.
Title
25mg/5ml
Oral
Solution
• Do not take the medicine for pain relief in children and
adolescents
Process
Black
(0-18 years of age) after removal of their tonsils or adenoids due to
Component
Keyline (Does not print)
obstructive Leaflet
sleep apnoea syndrome.
• IfSize
you know500ml
that you metabolise very rapidly codeine into
Pack
morphine.
IG Code
23295304
• If you are breastfeeding.

Codeine Phosphate Oral Solution 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.

Dimensions

Do not take the medicine if the patient:

Pregnancy and breast feeding

23295304

• Do not take for longer than directed by your doctor.
• In rare cases people can be at increased risk of developing
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.
• Taking codeine regularly for a long time can lead to addiction, which
might cause you to feel restless and irritable when you stop.
• Taking a painkiller for headaches too often or for too long can make
them worse.
• If you are elderly use with caution as the medicine can cause
incontinence, diarrhoea, stomach pain and occasionally a blocked
bowel.

• Metoclopramide or domperidone (anti-nausea and vomiting
medicines).
• Flecainide or mexiletine (for the treatment of irregular heartbeat).
• Any tranquillisers, antidepressants, sedatives or sleeping tablets.
• Any medicine used in the treatment of severe mental illness.

IG Code

Take special care with codeine

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

500ml

2. Before you take the medicine

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

Pack Size



Use in children with breathing problems

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Codeine Phosphate Oral Solution can be used in two ways:
• In adults and 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.
• For the relief of the symptoms of diarrhoea in adults and children
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.

Leaflet

What is it for?

Use in children and adolescents after surgery

Component

The name of your medicine is Thornton & Ross Codeine Phosphate
25mg/5ml Oral Solution, which will be referred to as ‘Codeine
Phosphate Oral Solution’ throughout this leaflet. 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.

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1. What is the medicine and
what does it do?

Process Black

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


Fonts Used

In this leaflet

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

• Intolerance to some sugars.
• Kidney or liver problems (a reduced dose may be recommended by
your doctor).
• A history of asthma or other breathing problems, including bronchitis.
• Low blood pressure.
• Irritable bowel syndrome (IBS) or other bowel problems.
• Abdominal pain.
• Myasthenia gravis (a disease of the muscles).
• Underactive thyroid or adrenal gland problems (a reduced dose may
be recommended by your doctor).
• Gallstones or bile duct problems.
• Prostate problems.
• Problems passing urine.
• Irregular heartbeat.
• A history of epilepsy or fits.
• Or is suffering from shock.
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.

Thornton & Ross Codeine Phosphate
25mg/5ml Oral Solution

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

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

Product
Title

Thornton & Ross Codeine Phosphate
25mg/5ml Oral Solution

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

MHRA Header Box

PATIENT INFORMATION LEAFLET

What the medicine contains

The active substance is codeine phosphate 25mg per 5ml.
The other ingredients are sodium methyl hydroxybenzoate (E219),
ethanol, purified water and syrup (contains sucrose).

What the medicine looks like

The medicine is an almost colourless syrupy liquid.


Like all medicines, Codeine Phosphate Oral Solution 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.
• Allergic reactions including skin rashes, itching and blistering.

side effects are:

• Hallucinations,
mood& Ross
changes,
feeling
restless or confused.
Colours Used
Thornton
Codeine
Phosphate
Product
• Dizziness or25mg/5ml
vertigo, Oral
feeling
unwell, drowsiness, disturbed sleep,
Title
Solution
Process Black
headache or seizures.
Component
• Pinpoint pupils
or other problems with eyesight.
Leaflet
Keyline (Does not print)
• Abnormal heartbeat.
Pack Size
500ml
• Feeling faint when standing up, low body heat, facial flushing or fluid
IG Code
23295304
retention (e.g.
swollen ankles and feet).
• Slow, shallow breathing.
Dimensions

297 x 210mm

Proof No.

2

Date

22.04.2015

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 570144
Suf fix

CRN

12035

Reason for
Change

Removal or chloroform and
change to product title

B

Issued by
Date

MHRA/IMB
submission N/A
required

Fonts Used

Times New Roman

Data Matrix: 23295304 VERIFIED

23295304

Date

22.04.2015
2

MHRA Header Box

4. Possible side effects

Proof No.

PL 00240/6213R

297 x 210mm

June 2015

Dimensions

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.

23295304

This leaflet was last revised in

IG Code

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

500ml

Marketing Authorisation Holder and Manufacturer

If you take too much see a doctor straight away.

MHRA
Header
Box
Other
possible

Data Matrix: 23295304 VERIFIED

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 Oral Solution 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.

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 Oral Solution 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.

• Lead to addiction, or dependence, which might cause you to feel
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.
• Do not take this medicine if suffering from alcoholism or
dependence on other opiates.
• It also contains sodium hydroxybenzoates which may cause allergic
reactions (possibly delayed).

Thornton & Ross Codeine Phosphate
25mg/5ml Oral Solution

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

• Feeling or being sick, constipation, abdominal pain (including pain
caused by inflammation of the pancreas (pancreatitis) or bile duct
problems (biliary spasm)), loss of appetite or dry mouth.
• Sweating, muscle twitching or muscle stiffness.
• Ureteric spasm (urine tube problem causing abdominal or lower back
pain), difficulty in passing urine.
• Low sexual urge.
• Taking a painkiller for headaches too often or for too long can make
them worse.

Product
Title

Important information about some of the ingredients of this
medicine.

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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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