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CO-DYDRAMOL 30/500 MG TABLETS

Active substance(s): DIHYDROCODEINE HYDROGEN TARTRATE / PARACETAMOL / DIHYDROCODEINE HYDROGEN TARTRATE / PARACETAMOL

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Patient Information Leaflet

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CO-DYDRAMOL 20/500 MG TABLETS & 30/500 MG TABLETS

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Children under 12 years:
Not recommended

(Dihydrocodeine Tartrate & Paracetamol)
Read all of this leaflet carefully before you start taking this
medicine.
!
Keep this leaflet. You may need to read it again.
!
If you have any further questions, ask your doctor or
pharmacist.
!
This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
!
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Co-dydramol Tablets are and what they are used
for
2. What you need to know before you take Co-dydramol
Tablets
3. How to take Co-dydramol Tablets
4. Possible side effects
5. How to store Co-dydramol Tablets
6. Contents of the pack and other information
1. WHAT CO-DYDRAMOL TABLETS ARE AND WHAT
THEY ARE USED FOR
Co-dydramol Tablets contain paracetamol and dihydrocodeine
which are analgesics (painkillers).
Co-dydramol Tablets are used to relieve severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CO-DYDRAMOL TABLETS
Do NOT take this medicine if you:
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are allergic (hypersensitive) to paracetamol, dihydrocodeine
or any of the other ingredients of this medicine (listed in
section 6)
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are having an asthma attack
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have other breathing problems or lung disease which makes
breathing difficult.
DO NOT TAKE WITH ANY OTHER PARACETAMOL
CONTAINING PRODUCTS.
Warnings and precautions
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Do not take for longer than directed by your doctor.
!
Taking dihydrocodeine regularly for a long time can lead to
addiction, which might cause you to feel restless and
irritable when you stop the tablets.
!
Taking a painkiller for headaches too often or for too long
can make them worse.
Tell your doctor before you start to take this medicine if
you:
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suffer from asthma or allergies
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have kidney disease or problems with kidney function
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have long term liver disease
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have increased pressure in the brain eg. following a brain or
head injury
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have prostate or urinary problems e.g. difficulty passing
water

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Swallow the tablets with a glass of water, preferably during
or after a meal.
Do not take more medicine than the label tells you to.

are an alcoholic
have an underactive thyroid gland (hypothyroidism)
are elderly.
Other medicines and Co-dydramol Tablets

Talk to your doctor or pharmacist before you take this
medicine if you are taking any of the following:
!
medicines to treat depression called MAOIs (monoamine
oxidase inhibitors) or have taken them in the last 14 days.
MAOIs are medicines such as moclobemide, phenelzine,
tranylcypromine
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medicines which make you drowsy or sleepy (CNS
depressants) such as anti-depressants, sleeping tablets,
tranquillisers or medicines for psychiatric or mental
disorders
!
medicines to prevent blood clotting, such as warfarin
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colestyramine (used to reduce cholesterol in the blood)
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metoclopramide or domperidone (used to treat nausea and
vomiting).
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including those obtained
without a prescription.

12-15 years age group:
1 tablet every four to six hours. Do not exceed six tablets in any
24 hour period.
Adults, aged 16 and over:
Take one or two tablets every four to six hours. Do not take more
than 2 tablets at once and do not take more than 8 tablets in 24
hours.
Elderly:
One tablet every 4 - 6 hours increasing to two tablets every 4 - 6
hours if required and tolerated. Do not exceed eight tablets in
any 24-hour period.
Caution should be taken when increasing the dose in the elderly.
If you take more Co-dydramol Tablets than you should:
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.
If the doctor is not there, go to your local hospital casualty
department. Take this leaflet and any remaining tablets with you.
The hazard of overdose with paracetamol is greater in those with
alcoholic liver disease.

Co-dydramol Tablets with alcohol
You should not drink alcohol while you are taking these tablets.
This is because Co-dydramol Tablets can change the way
alcohol affects you.

If you forget to take Co-dydramol Tablets
If you forget to take a dose, take it as soon as you remember,
unless it is almost time for your next dose. Do not take a double
dose to make up for a forgotten dose. Remember to leave at
least 4 hours between doses.

Pregnancy and breast feeding
Talk to your doctor before taking these tablets if you are
pregnant, think you may be pregnant or plan to get pregnant.
Driving and using machines
If these tablets make you feel drowsy, do not drive or operate
machinery. Co-dydramol Tablets can affect your ability to drive
as they 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 or in 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.

If you stop taking Co-dydramol Tablets
Long term usage of these tablets may lead to tolerance and
dependence. If you have taken regular daily doses for a long
time, do not suddenly stop treatment without discussing this with
your doctor as you may experience withdrawal effects.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-dydramol Tablets can cause side effects,
although not everybody gets them.
Stop taking the tablets and tell your doctor immediately or
go to the nearest hospital casualty department if you have
any of the following:
symptoms of an allergic reaction (rare side effect), such as
swelling of the lips, face or neck leading to severe difficulty
in breathing, skin rash or hives
!
you get serious skin reactions (red rash, blistering, skin
peeling or swelling/blistering of the mouth, throat or eyes).
Very rare cases have been reported.
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3. HOW TO TAKE CO-DYDRAMOL TABLETS
Two different strengths of tablets are available. Your doctor will
decide which strength of tablet will suit you best.
Always take this medicine exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
Continued overleaf

Tell your doctor straight away if you notice the following
serious side effect:
Severe stomach pain, which may reach through to your
back. This could be a sign of inflammation of the pancreas.
This is a very rare side effect.

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Tell your doctor or pharmacist if any of the following side
effects gets worse or lasts longer than a few days:
constipation
feeling sick (nausea), being sick (vomiting)
itching skin
headache
feeling of dizziness or spinning, light-headedness, giddiness
drowsiness
hallucinations
feeling in an unpleasant or uncomfortable mood
problems in passing urine
you get infections more often or bruise more easily than
usual. This could be because of a blood problem
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a need to take higher doses to obtain the same level of pain
relief (tolerance)
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becoming dependent on dihydrocodeine (which can lead to
restlessness and irritability when you stop taking the
tablets).
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Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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.
5. HOW TO STORE CO-DYDRAMOL TABLETS
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order
to protect from moisture.
Do not use this medicine after the expiry date printed on the
pack. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Co-dydramol Tablets contain:
The active ingredients in each tablet are paracetamol and
dihydrocodeine tartrate.
Co-dydramol 20/500 mg Tablets contain dihydrocodeine tartrate
20 mg and paracetamol 500 mg.
Co-dydramol 30/500 mg Tablets contain dihydrocodeine tartrate
30 mg and paracetamol 500 mg.
The other ingredients are maize starch, povidone, colloidal silica,
magnesium stearate and potassium sorbate (E202).
What Co-dydramol Tablets look like and contents of the
pack:
The tablets are white, capsule-shaped tablets, engraved on one
side with “CODYD20” or “CODYD30” and plain on the reverse.
They are available in packs of 56 and 112.
Marketing Authorisation Holder and Manufacturer:
M&A Pharmachem Ltd, Bolton BL5 2AL, UK.
For information in large print, on tape, on CD or in Braille,
phone 01942 852085.
This leaflet was last revised in 06/2016

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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