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SYNDOL HEADACHE RELIEF TABLETS

Active substance: CODEINE PHOSPHATE

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Other nervous system problems which can
cause:
• dizziness, light-headedness, disorientation
and drowsiness
• headache, tremor, nervousness, confusion,
irritability, restlessness, anxiety and mood
changes
• vertigo.

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.

Heart and circulation effects which can
cause:
• an increased awareness of your heart beat
• a head rush or dizzy spells
• an increase in your heart rate or sweating.

5. How to store your medicine
Keep all medicines out of the sight and
reach of children.
Do not use this medicine after the expiry date
printed on the pack.
Do not store above 25°C. Store in the original
packaging.

Other less serious side effects which can
cause:
• difficulty in passing water, needing to pass
urine more often, or passing less urine
than usual
• decreased libido or potency
• muscle rigidity
• a dry mouth
• your eye’s pupil may become smaller
• blurred or double vision
• nightmares.

6. What is in this medicine?
Each film-coated white capsule-shaped
tablet, debossed on one side with 'PCC',
contains the active ingredients: paracetamol
500 mg, caffeine 30 mg and codeine
phosphate 8 mg.
They also contain: povidone, maize starch,
methylcellulose, talc, purified water, calcium
stearate, methylhydroxypropylcellulose and
polyethylene glycol.
This product is available in pack sizes of
30 and 10 tablets.

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:
• You need to take the medicine for longer
periods of time.
• You need to take more than the
recommended dose.
• When you stop taking the medicine you
feel very unwell but you feel better if you
start taking the medicine again.

7. Who makes this medicine?
The Marketing Authorisation holder and
manufacturer is Wrafton Laboratories Limited,
Braunton, Devon, EX33 2DL, UK.
Distributor: Sanofi, One Onslow Street,
Guildford, Surrey GU1 4YS
This leaflet was last revised in June 2014
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Package leaflet: Information for the user

Syndol Headache
Relief Tablets
Paracetamol, Codeine, Caffeine
Read all of this leaflet carefully before you
take this medicine because it contains
important information you need to know.
• For the short term treatment of acute
moderate pain, which is not relieved by
paracetamol, ibuprofen or aspirin alone.
• You 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.
• This 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.
• If you take this medicine for
headaches for more than three days it
can make them worse.
This medicine is available without prescription,
however, you still need to use this product
carefully to get the best results from it. Keep
this leaflet as you may need to read it again.
Ask your pharmacist if you need more
information or advice.
1. What is this medicine and what is it
used for?
This medicine contains:
• paracetamol which is a pain reliever
(analgesic) and helps reduce your
temperature when you have a fever
• codeine phosphate which is a pain reliever
(analgesic)
• caffeine which helps to increase the pain
relief from paracetamol and makes you
more alert.
1

These tablets are for the short term treatment
of acute moderate pain which is not relieved by
paracetamol, ibuprofen or aspirin alone. This
medicine is for the relief of migraine, headache,
rheumatic pain, period pain, toothache and
nerve pain.
2. Is this medicine suitable for you?
This 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.
If you take a painkiller for headaches for more
than three days it can make them worse.
Do not take this medicine if you:
• are allergic to paracetamol, codeine
phosphate, caffeine or any of the other
ingredients
• have acute asthma
• have severe respiratory disease
• suffer from alcoholism
• have had recent bile duct surgery (e.g. gall
stones)
• suffer from paralytic ileus, where your
bowel has ceased to function
• have recently had a head injury or raised
pressure in the skull.
Please see your doctor or pharmacist
before taking this medicine if you:
• suffer from kidney or liver problems,
including alcoholic liver disease
• have an enlarged prostate gland
• suffer from low blood pressure
• suffer from inflammatory or obstructive
bowel disorders such as constipation,
diarrhoea or bloating
• suffer from an underactive thyroid gland
• are elderly or debilitated.

Brand:

SYNDOL HEADACHE RELIEF LEAFLET 2746953

Category:
Argus Code:
Spec No:
Supersedes:

LEAFLET
314
2746953
00000

Ticket No:
Date:
Issue No:
Operator:
Page:

414870
17-JUN-14
10
KY

Size:

150x 280mm

FOR SCHAWK
USE ONLY
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If you are taking any of the following
medicines please see your doctor:
• medicines to treat high cholesterol levels
which reduce the amount of fat in the blood
such as colestyramine
• medicines to control feeling sick or being sick
such as metoclopramide or domperidone
• medicines called anti-coagulants, which are
used to thin the blood such as warfarin or
other coumarins - you may take occasional
doses of paracetamol but should consult your
doctor if you need to take it on a regular basis
• cimetidine, a medicine to treat heartburn or
peptic ulcers
• tricyclic antidepressants, which are medicines
used to treat depression e.g. amitriptyline and
imipramine
• antipsychotic medicines used to treat mental
illness e.g. chlorpromazine and risperidone
• quinidine or mexiletine, used to treat heart
problems
• antidepressant drugs called monoamine oxidase
inhibitors (MAOI’s) - these are medicines such as
phenelzine and moclobemide
• the antibiotic chloramphenicol
• other CNS depressant drugs such as sodium
oxybate
• barbiturates and benzodiazepines which are
medicines to calm you down or to help you
sleep (e.g. mephobarbital, pentobarbital,
diazepam and alprazolam).
• medicines for diarrhoea and tummy cramps as
taking these at the same time as Syndol
Headache Relief Tablets may make you
constipated.
• medicines such as atropine, procyclidene, or
hyoscine which are used to treat problems
with gut movement. Taking these at the same
time as Syndol Headache Relief Tablets may
make you severely constipated and may make
it difficult for you to pass urine.

• some antihistamines which may be used in
cough/cold remedies and anti-allergy
products. Taking these at the same time as
Syndol Headache Relief Tablets may make
you severely constipated and may make it
difficult for you to pass urine.
• naltrexone – used in the treatment of drug
dependence.
• Contains paracetamol.
• Do not take anything else containing
paracetamol while taking this medicine.
Pregnancy and breast-feeding
Please see your doctor or pharmacist before
taking this medicine if you are pregnant.

2

Usually it is safe to take Syndol Headache
Relief Tablets while breast-feeding as the levels
of the active ingredients of this medicine in
breast milk are too low to cause your baby any
problems. However, some women who are at
increased risk of developing side effects at any
dose may have higher levels in their breast milk.
If any of the following side effects develop in you
or your baby, stop taking this medicine and seek
immediate medical advice; feeling sick, vomiting,
constipation, decreased or lack of appetite,
feeling tired or sleeping for longer than normal,
and shallow or slow breathing.
Other important information:
Do not drink alcohol (beer, wine, spirits etc)
while taking this product.
Driving and using machines:
These tablets might cause drowsiness. If you are
affected, do not drive or operate machinery.
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 may be an offence to drive when taking
this medicine.

This is because too much paracetamol can
cause delayed, serious liver damage. Go to
your nearest hospital casualty department. Take
your medicine and this leaflet with you.

• However, you would not be committing an
offence if:
o The medicine has been taken to treat a
medical or dental problem and
o You have taken it according to the
information provided with the medicine
and
o 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 medicine.

SYNDOL HEADACHE RELIEF LEAFLET 2746953

Category:
Argus Code:
Spec No:
Supersedes:

LEAFLET
314
2746953
00000

STOP TAKING these tablets and contact your
doctor immediately if you develop any of the
following serious side effects at any time
while taking your medicine:

Details regarding a new driving offence concerning
driving after drugs have been taken in the UK may
be found here: https://www.gov.uk/drug-driving-law

Brand:

4. Possible side effects
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.

Ticket No:
Date:
Issue No:
Operator:
Page:

414870
17-JUN-14
10
KY

Size:

150x 280mm

Allergic reactions:
The following symptoms may mean you are
having an allergic reaction to this medicine:
• rash, itching or swollen red areas of the skin or
swelling of the face.

3. How to take this medicine
Swallow the tablets whole with water. Do not chew.
Adults, the elderly and children over 12 years:
2 tablets every 4 hours as required. Do not take
more than 4 doses (8 tablets) in any 24 hour
period.

Blood disorders which can cause:
• unexplained or unusual bruising or bleeding
• fever and infections.

Do not give to children under 12 years.

Heart and circulation effects which can cause:
• an unusually low heart rate
• low blood pressure
• hypothermia.

Do not take more medicine than the label tells you
to. If you do not get better, talk to your doctor.
Do not use for more than 3 days. If you need to
use this medicine for more than three days you
must speak to your doctor or pharmacist.

Nervous system problems which can cause:
• hallucinations.

Codeine addiction:
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. You should talk
to your doctor or pharmacist if you think you are
suffering from withdrawal symptoms.

FOR SCHAWK
USE ONLY
2 of 2

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Barcode:
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Product Logo Version: 000
Minimum Point Size of Text: 8pt
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Other serious side effects which can cause:
• restricted breathing
• abdominal or back pain.
Less serious side effects, that may occur
include those listed below:

Talk to a doctor at once if you take too
much of this medicine even if you feel well.
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Stomach and intestine effects including:
• constipation, stomach cramps, feeling sick
and vomiting.

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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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