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CO-CODAMOL CAPLETS

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Aspar Co-Codamol PIL N26.qxp

6/1/14

10:53

Page 1

ASPAR
Co-Codamol Caplets 8/500mg
Docment Information
File Prepared: 06.01.14
FILE VERSION : N26
Font used: HELVETICA Condensed (Med, Bold & Italic)
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Printed two sides in Back
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Aspar Co-Codamol PIL N26.qxp

6/1/14

Patient Information Leaflet for

Co-Codamol Caplets 8/500mg
(Codeine Phosphate and Paracetamol)
Read this leaflet carefully before taking these
caplets. It does not contain all the
information about your medicine that you
may need to know, so ask your doctor or
pharmacist if you have any questions. This
leaflet only applies to Co-Codamol Caplets.
• This medicine can only be used for the
short term relief of moderate pain that is
not relieved by other painkillers such as
paracetamol or ibuprofen 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.
1. WHAT THESE CAPLETS DO
Co-Codamol is a type of painkiller that contains
paracetamol and codeine. Co-Codamol can be used
in 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 headache, migraine, toothache, period pains,
rheumatic pains, muscle pains and backache.
2. CHECK BEFORE YOU TAKE
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.

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• If you take a painkiller for headaches for more
than three days it can make them worse.
Do not take Co-Codamol Caplets:
• For pain relief in children and adolescents
(0-18 years of age) after removal of their
tonsils or adenoids due to obstructive
sleep apnoea syndrome.
• If you know that you metabolise very
rapidly codeine into morphine.
• If you are breastfeeding.
• If you are allergic to Paracetamol, to
Codeine or any other similar painkillers
such as dihydrocodeine, or to any of the
other ingredients listed in section 6.
• If you have liver failure or kidney disease.
• If you have asthma or other breathing
difficulties.
• If you suffer from heart failure due to lung
disease.
• If you have recently suffered a head or
brain injury.
• If you are suffering from diarrhoea
associated with colitis or due to any type
of poisoning.
• If you suffer from alcohol dependency.

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Warnings and Precautions
Tell your doctor if you:
• Are pregnant or breast feeding.
• Have kidney or liver problems or alcoholic
liver disease.
• Suffer from high blood pressure or have
an irregular heartbeat (slow or rapid).
• Have an under active thyroid gland or
adrenal gland.
• Have urinary or prostate problems.
• Have recently had surgery on your
stomach, suffer from gallstones, bowel
disorders or abdominal pain or swelling.
• Have ever suffered from convulsions or
emotional problems.
• Are suffering from any kind of shock.
• Have a history of drug abuse.
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.
Children and adolescents
Use in children and adolescents after surgery
Co-Codamol should not be used for pain
relief in children and adolescents after
removal of their tonsils or adenoids due to
Obstructive Sleep Apnoea Syndrome.
Use in children with breathing problems
Co-Codamol is not recommended in children
with breathing problems, since the
symptoms of morphine toxicity may be
worse in these children.
Tell your doctor or pharmacist if you are
already taking any of the following
medicines:
• Metoclopramide or Domperidone (used to
treat nausea and vomiting).
• Colestyramine (used to lower cholesterol in
the blood).
• Cimetidine (to treat stomach ulcers).
• Cisapride (to treat heartburn).
• Quinidine or Mexiletine (to treat certain
heart conditions).
• Naloxone or Naltrexone (to treat drug
overdose or abuse).
• Chloramphenicol (to treat eye infections).
• Hydroxyzine (an antihistamine used for
itching).
• Blood thinning medicines such as Warfarin.
• Medicines to treat diarrhoea.
• Diuretics or other drugs for high blood
pressure.
• Antimuscarinics (used to treat Parkinson's
disease).
• Antidepressants including those known as
monoamine oxidase inhibitors, anti-anxiety
drugs, sedative or hypnotic drugs.

Aspar Co-Codamol PIL N26.qxp

6/1/14

Pregnancy, breastfeeding and fertility
Do not take Co-Codamol caplets during
pregnancy or while you are breastfeeding.
Codeine and Morphine passes into breast milk.
Important information about some of the
ingredients
This medicine contains methyl, ethyl and propyl
p-hydroxybenzoates (E218, E214 & E216)
which may cause allergic reactions (possibly
delayed).
3. HOW TO TAKE THESE CAPLETS
Dosage in adults, the elderly and children
aged 12 years to 18 years:
Take 1 to 2 caplets with water every 4 hours.
Do not take more than 8 caplets in 24 hours.
Children under 12 years
Not recommended due to the risk of severe
breathing problems.
When taking this medicine, it is important to
remember the following:
• Do not give these caplets to children under
12 years old unless told to by your doctor.
• Do not exceed the stated dose.
• Immediate medical advice should be
sought in the event of an overdose, even if
you feel well, because of the risk of
delayed, serious liver damage.
• If you miss a dose, do not take a double
dose to make up for the missed dose.
• Do not drink alcohol or take other
Paracetamol containing products whilst
taking these caplets.
• Do not take for more than 3 days. If the
pain does not improve after 3 days, you
must speak to your doctor or pharmacist
for advice.
• Risk of 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.
4. POSSIBLE SIDE EFFECTS
Some people may have side effects when taking
this medicine. If you have any unwanted sideeffects you should seek advice from your
doctor, pharmacist or other healthcare
professional. Also you can help to make sure
medicines remain as safe as possible by
reporting any unwanted side-effects via the
internet at www.yellowcard.gov.uk; alternatively
you can call Freephone 0808 100 3352
(available between 10am-2pm Monday-Friday)
or fill in a paper form available from your local
pharmacy.
Serious side effects
• Itching
• Skin rashes
• Facial swelling
• Convulsions
• Breathing difficulties
If you experience any of the above symptoms
after taking this medicine go to the nearest
hospital IMMEDIATELY.

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Other side effects
• Nausea and vomiting
• Headache
• Hallucinations
• Sweating
• Flushing
• Loss of appetite
• Nightmares
• Dry mouth
• Vertigo
• Muscle twitches or stiffness
• Blurred or double vision
• Slow or rapid heartbeat
• Dizziness
• Depression
• Generally feeling unwell
• Problems in passing urine
• Stomach cramps
• Tiredness
• Blood disorders which increases the risk of
bleeding and bruising and makes infections
more likely.
• Codeine can affect your bowels and can cause
incontinence, constipation, a watery diarrhoea
like leakage, stomach pains and rarely, blockage
of the bowel. If you experience any of these
or any other side effects and they get serious,
contact your doctor or pharmacist.
How do I know if I am addicted?
If you take this medicine according to the
instructions on the pack it is unlikely that you
will become addicted to this 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.
5. STORING YOUR MEDICINE
Keep your medicine in a safe place where
children cannot see or reach it.
Do not store above 25°C. Store in a dry place.
Protect from light.
Do not use this medicine after the expiry date
printed on the packaging.
6. MORE ABOUT YOUR MEDICINE
The active ingredients in Co-codamol Caplets
are Paracetamol 500mg and Codeine Phosphate
8 mg. They are white capsule shaped tablets,
broken breakline and embossed with ac 500/8
on one side. The other side is plain. The inactive
ingredients are starch (maize and potato),
povidone, talc, stearic acid, magnesium stearate,
methyl p-hydroxybenzoate (E218), ethyl
p-hydroxybenzoate (E214) and propyl
p-hydroxybenzoate (E216).
PL Holder and Manufacturer:
Aspar Pharmaceuticals Ltd,
Colindale, London, NW9 0EQ.
PL 08977/0012
Available in Pharmacy packs: 12, 16, 24, 25, 30
and 32 in blister, strip or bottles.
Text Revision: January 2014.

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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