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PARACODOL CAPSULES

Active substance(s): CODEINE PHOSPHATE / PARACETAMOL

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Patient Information Leaflet

 
PARACODOL® CAPSULES
Paracetamol (500mg) Codeine Phosphate Hemihydrate (8mg)

 
Please read this leaflet carefully because it contains important information for you.
Keep this leaflet, you may need to read it again.

 
• This medicine can only be used 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.

 
1. What are Paracodol Capsules for?
Paracodol Capsules are a combination of pain killers: codeine and paracetamol. Codeine
belongs to a group of medicines called opioid analgesics which act to relieve pain. This
medicine can only be used in patients aged 12 years and over for the short term treatment of
acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. This
includes muscular and rheumatic pains, headache, migraine, neuralgia, period pain,
toothache, aches and pains.

 
2. Before you take Paracodol Capsules

 
! 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:
 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 are taking anything else containing paracetamol.
 If you are allergic to any of the ingredients.
 If you know that you metabolise codeine very rapidly into morphine
 If you are breast-feeding

 
Consult your doctor before taking Paracodol Capsules if you:
• Are taking prescription medicines.
• Are taking medicines containing codeine, metoclopramide, domperidone, colestyramine,
warfarin or other coumarin anticoagulants.
• Are taking medicines which affect the liver.
• Have a liver or kidney condition.

Codeine is transformed into 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 (12-18 years old)
Do not use in children and adolescents after removal of their tonsils or adenoids due to
Obstructive Sleep Apnoea Syndrome.
The product is not recommended in children with breathing problems, since the symptoms of
morphine toxicity may be worse in these children.

 
Pregnancy and breast-feeding
Consult your doctor before taking the capsules if you are pregnant or think you may be
pregnant.
Do not take codeine while you are breast-feeding. Codeine and morphine passes into breast
milk.

 
Driving and using machines
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:
 The medicine has been taken to treat a medical or dental problem and
 You have taken it according to the information provided with the medicine and
 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 UK driving offence, concerning driving after drugs have been taken,
may be found at: www.gov.uk/drug-driving-law.
 
3. How should I take Paracodol Capsules?
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.

 
Adults aged 18 years and over: Take 1-2 capsules, repeated if necessary every 4-6 hours with
a maximum of 8 capsules a day.
Children aged 12 -18 years: Take 1 capsule, repeated if necessary every 4–6 hours with
a maximum of 4 capsules a day.
Paracodol Capsules should not be taken by children under 12 years due to the risk of severe
breathing problems.

 
Do not drink alcohol whilst taking this medicine.

 
Withdrawal – when you stop taking Paracodol Capsules:
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.

 

What if I take too many Paracodol Capsules?
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.
 

 
 

4. Do Paracodol Capsules cause any side effects?
Some people may have side-effects when taking this medicine.

 
Potential side-effects
Side effects are rare, but occasionally Paracodol Capsules can cause constipation and
hypersensitivity reactions such as skin rashes. Very rare cases of serious skin reactions have
been reported. If you notice that you bruise or bleed more easily than usual or if you are more
prone to infection, such as sore throats or mouth ulcers, you should speak to your doctor.

 
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.

 
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.

 
5. How should I store Paracodol Capsules?
Do not store above 25°C, i.e. this medicine may be stored at room temperature. Keep out of
the sight and of reach children. Do not use the capsules after the expiry date on the carton and
blister.

 
6. Further Information
What do Paracodol Capsules contain?
Paracodol Capsules contain the active ingredients: paracetamol 500 mg and codeine
phosphate 8 mg.
Inactive ingredients: pregelatinised maize starch, colloidal silicon dioxide, magnesium
stearate (E572), titanium dioxide, gelatin, shellac (E904), red iron oxide (E172) and
propylene glycol.
Available in packs of 10, 20 and 32 capsules. Not all pack sizes may be marketed.

 
Who makes Paracodol Capsules?
Manufactured by Wrafton Laboratories Ltd, Wrafton, Braunton, North Devon EX33 2DL for
the Product Licence holder, Bayer plc, Consumer Care Division, Newbury, Berkshire, RG14
1JA, UK.

Leaflet last revised: October 2016.
PARACODOL® is a registered trademark.
Bayer

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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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