Patient leaflet - Syndol Headache Relief tablets, Co-codamol Plus Caffeine tablets
1. What this medicine is and what it is used for
which can cause:
patient
difficulty in passing water, needing
This medicine contains:
Syndol® Headache
to pass urine more often, or passing less urine than usual
methylhydroxypropylcellulose and polyethylene glycol.
codeine phosphate. Codeine
belongs to a group of medicines called opioid analgesics which act to relieve pain.
Relief Tablets
decreased libido or potency
This product is available in pack sizes of 30 and 10 tablets.
muscle rigidity
Paracetamol, Codeine, Caffeine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
a dry mouth
- paracetamol, another analgesic to
The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK. Distributor: Sanofi, One Onslow Street, Guildford, Surrey GU1 4YS
your eye’s pupil may become
relieve pain.
smaller
- caffeine which helps to increase
blurred or double vision
the pain relief from paracetamol and makes you more alert.
nightmares.
- For the short term treatment of acute moderate pain, which is not relieved by paracetamol, ibuprofen or aspirin alone.
How do I know if I am addicted?
These tablets are for the short term
This leaflet was last revised in May 2019
If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine.
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.
- 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.
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.
2. What you need to know before you take this medicine
- 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.
You need to take more than the
recommended dose.
This medicine contains codeine
When you stop taking the medicine
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. This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.
you feel very unwell but you feel better if you start taking the medicine again.
Reporting of side effects
- If you take this medicine for headaches for more than three days it can make them worse.
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.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
If you take a painkiller for headaches
for more than three days it can make them worse.
Keep this leaflet. You may need to
read it again.
Ask your pharmacist if you need
Do not take this medicine if you:
more information or advice.
- are allergic to paracetamol, codeine,
- How to store your medicine Keep this medicine out of the sight and reach of children.
If you get any side effects, talk to your
caffeine or any of the other ingredients of this medicine (listed in section 6)
doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- have acute asthma
Do not use this medicine after the expiry date printed on the pack. Do not store above 25°C. Store in the original packaging.
- have severe respiratory disease
- You must talk to a doctor if you do
suffer from alcoholism
not feel better or if you feel worse. What is in this leaflet
have had recent bile duct surgery
(e.g. gall stones)
- Contents of the pack and other information
- suffer from paralytic ileus, where
What this medicine is and what it is
your bowel has ceased to function
used for
What this medicine contains
- have recently had a head injury or
- What you need to know before you
Each film-coated white capsule-shaped tablet, debossed on one side with 'PCC', contains the active ingredients: paracetamol 500 mg,
raised pressure in the skull
take this medicine
are breastfeeding
3. How to take this medicine
- have been told by your doctor that
4. Possible side effects
you are a CYP2D6 ultra metaboliser
5. How to store this medicine
caffeine 30 mg and codeine phosphate 8 mg.
- are under 18 years and have had
6. Contents of the pack and other
information
E2P00U4J3 1 4
Sanofi
SYNDOL HEADACHE RELIEF TABLETS LEAFLET
LEAFLET
E2P00U4J3
N/A
102391154/401454160 0020
05-Jun-19
3
210 x 280mm
N/A
N/A
1
Black Cutter
FOR
SANOFI ONLY
Regulatory
Approved: Yes No N/A
THESE
SIGNATURES ARE FOR HEAD OFFICE USE
Head of Regulatory
Approved: Yes No N/A
Other - as required
ONLY
Approved: Yes No
E2P00U4J3
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Warnings and precautions
Talk to 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.
Other medicines and Syndol®
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, like
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, Aspirin 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.
2
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 paracetamol, caffeine and codeine tablets may make you severely constipated and may make it difficult for you to pass urine.
naltrexone – used in the treatment of
drug dependence.
Taking this medicine with food, drink and alcohol
Do not drink alcohol (beer, wine, spirits etc) while taking this product.
Pregnancy and breastfeeding
Do not take this medicine if you are breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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
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.
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
- 3. How to take this medicine
Swallow the tablets whole with water. Do not chew.
Adults
Take 2 tablets every 4-6 hours as required. Do not take more than 8 tablets in 24 hours.
Children aged 16-18 years
Take 1-2 tablets every 6 hours as required. Do not take more than 8 tablets in 24 hours.
Children aged 12-15 years
Take 1 tablet every 6 hours, as required. Do not take more than 4 tablets in 24 hours. Do not take more frequently than every 6 hours.
Do not give to children under 12 years.
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.
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.
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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.
- 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.
3
STOP TAKING the tablets and contact your doctor immediately if you develop any of the following serious side effects at any time while taking your medicine:
Allergic reactions:
The following symptoms may mean you are having an allergic reaction to this medicine:
rash, itching, swollen red areas of the
skin or swelling of the face
very rare cases of serious skin
reactions have been reported Blood disorders which can cause:
unexplained or unusual bruising or
bleeding
- fever and infections.
Heart and circulation effects which can cause:
- an unusually low heart rate
- low blood pressure
- hypothermia
Nervous system problems which can cause:
- hallucinations.
Other serious side effects which can cause:
- restricted breathing
- abdominal or back pain.
Less serious side effects, that may occur include those listed below: Stomach and intestine effects
including:
constipation, stomach cramps, feeling
sick and vomiting.
Other nervous system problems which can cause:
dizziness, light headedness,
disorientation and drowsiness
headache, tremor, nervousness,
confusion, irritability, restlessness, anxiety and mood changes
- vertigo.
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.
Sanofi
SYNDOL HEADACHE RELIEF TABLETS LEAFLET
LEAFLET
E2P00U4J3
N/A
102391154/401454160 0020
05-Jun-19
3
210 x 280mm
N/A
N/A
1
Black Cutter
FOR
SANOFI ONLY
Regulatory
Approved: Yes No N/A
THESE
SIGNATURES ARE FOR HEAD OFFICE USE
Head of Regulatory
Approved: Yes No N/A
Other - as required
ONLY
Approved: Yes No
E2P00U4J3
Fonts used:
HelveticaNeue-Bold
HelveticaNeue-Light
9.0 pt
9.0 pt