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CO-DYDRAMOL TABLETS 10/500MG

Active substance(s): DIHYDROCODEINE TARTRATE / PARACETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-dydramol Tablets 10/500mg
(Dihydrocodeine tartrate and paracetamol)
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you .
! Keep this leaflet. You may need to read it
again.
! If you have any further questions, ask your
doctor or pharmacist or nurse.
! This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
! If you get any side effects talk to your doctor or
pharmacist or nurse. 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 use Codydramol Tablets
3. How to use 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 the active ingredients
dihydrocodeine tartrate 10mg and paracetamol
500mg. Both of these are effective painkillers
(analgesics) and are used for pain relief and to
suppress a cough.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE CO-DYDRAMOL TABLETS
You should not be given Co-dydramol Tablets if
you:
! Are hypersensitive to paracetamol,
dihydrocodeine or other opioids, or any of the
ingredients in the product
! Have any allergies
! Have breathing difficulties
! Suffer with chronic bronchitis or emphysema
! Suffer with asthma
! Have liver disease
! Have diarrhoea caused by poisoning or severe
bloody diarrhoea (pseudomembranous colitis)
! Are having an asthma attack.
Warnings and precautions
Check with your doctor or pharmacist before taking
this medicine if you have:
! Liver problems
! Kidney disease
! Diseased adrenal glands (Addison's disease)
or high blood pressure caused by a tumour
near a kidney (phaeochromocytoma)
! Inflammatory bowel disease
! Gall bladder disease or gall stones
! Recently had surgery on your gastro-intestinal
tract or urinary system
! An enlarged prostate gland and have
difficulty urinating and are male
! Epilepsy or suffered head injury or raised
pressure in the skull (may cause painful eyes,
changes in vision or headache behind the
eyes)
! An underactive thyroid gland
! Muscle weakness (myasthenia gravis)
! Low blood pressure or are in shock

!

Suffered from alcoholism, drug abuse or
dependence or mental illness.
You should not take other medicines containing
paracetamol at the same time as Co-dydramol
Tablets (see section on Other medicines and Codydramol).
Do not take Co-dydramol Tablets for longer than
directed by your doctor. Taking dihydrocodeine
regularly for a long time can lead to addiction,
which may cause you to feel restless and irritable
when you stop taking the tablets.
Taking painkillers for headaches too often or for too
long can make them worse.
Other medicines and Co-dydramol Tablets
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including those obtained without a prescription.
In particular:
! Other products containing paracetamol
! Ciprofloxacin (antibacterial medicine)
! Monoamine Oxidase Inhibitors (MAOIs, e.g.
moclobemide), or have taken these within the
last 2 weeks
! Oral contraceptives (the "pill")
! Medicines to prevent blood clotting such as
warfarin
! Cyclizine, metoclopramide or domperidone (to
prevent sickness)
! Guanethidine or diuretics ("water tablets") e.g.
spironolactone, furosemide (to treat high blood
pressure)
! Mexiletine (to treat irregular heartbeats)
! Loperamide or kaolin (to treat diarrhoea)
! Selegiline (for Parkinson's disease)
! Phenytoin (to treat epilepsy)
! Cimetidine (to treat stomach ulcers)
! Atropine or hyoscine (anticholinergic
medicines)
! Cisapride (to treat gastro-oesophageal reflux
disease)
! Ritonavir (antiviral medicine)
! Medicines which affect the nervous system
such as sleeping tablets, diazepam,
hydroxyzine and medicines to treat mental
illness
! Medicines to treat depression (e.g.
tranylcypromine, amitriptyline)
! Medicines which affect the liver (e.g. primidone
and rifampicin)
! Colestyramine (to treat high cholesterol levels)
! Muscle relaxants
! Barbiturates (e.g. phenobarbital)
! Anaesthetics
! Opioid antagonists (buprenorphine, naltrexone,
naloxone)
! Imatinib (used to treat certain types of cancer).
If your diet is poor or you have a low protein intake,
you may be at a higher risk of serious paracetamol
poisoning when taking Co-dydramol Tablets.
Do not drink alcohol while you are taking these
tablets.
Pregnancy and breast-feeding
Do not take Co-dydramol Tablets during pregnancy
or while breast-feeding unless advised by your
doctor. Regular use during pregnancy may cause
withdrawal symptoms in the newborn.

Driving and using machines
These tablets may cause you to feel dizziness,
blurred vision or the inability to think clearly. If you
are affected you should not drive or operate
machinery until you feel better.
3. HOW TO USE CO-DYDRAMOL TABLETS
Always take Co-dydramol Tablets exactly as your
doctor has instructed you. You should check with
your doctor or pharmacist if you are unsure.

!

!
!

Co-dydramol Tablets should be swallowed with a
glass of water with or after a meal.
For pain relief:
Adults, the elderly and children over 12 years
of age:
One tablet every 4 hours.
If necessary, your doctor may tell you to take two
tablets, 4 times a day.
If you are elderly, you may be prescribed a lower
dose.
Children under 12 years of age:
These tablets should not be taken by children
under 12 years of age.
For coughing:
Adults, the elderly and children over 12 years
of age:
One tablet every 4 hours.
If you are elderly, you may be prescribed a lower
dose.
Children under 12 years of age:
These tablets should not be taken by children
under 12 years of age.
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 you forget to take Co-dydramol Tablets
If you have forgotten to take a dose, take the dose
as soon as you remember if needed for relief of
symptoms. If not needed, do not take the missed
dose, simply take your next dose at the scheduled
time.
If you stop taking Co-dydramol Tablets
Do not stop taking Co-dydramol Tablets without
consulting your doctor as your condition may
deteriorate.

!
!

Blood - anaemia, changes in
numbers and types of blood cells. If
you have an increase in number of
nose bleeds or notice that you bruise
more easily or have more infections
talk to your doctor
Urinary system - pain and difficulty in
passing urine and a less frequent
need to do so, kidney problems
Nervous system - confusion,
drowsiness, dizziness, 'spinning'
sensation, mood changes, depression,
hallucinations (seeing or hearing things that are
not real), restlessness, excitation, fits,
increased pressure in the skull (painful eyes,
changes in vision or headache behind the
eyes), headache, difficulty sleeping,
nightmares, reduced alertness, tolerance
(medicine has less effect) or dependence
(suffer from withdrawal symptoms e.g. tremor,
sweating, increased heart rate, increased
breathing rate, raised blood pressure and
feeling or being sick if the medicine is stopped
too quickly)
Eyes - blurred or double vision, extremely
small pupils
Others - trembling, unusual tiredness or
weakness, malaise, low body temperature,
breathing difficulties.

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.
5. HOW TO STORE CO-DYDRAMOL TABLETS
Check the expiry date printed on the label or side
of the box. Do not use after the expiry date stated
on the label.
Do not store above 25°C. Store in the original
package to protect from light.
In case of any visible signs of deterioration, you
should discard the package.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures help to protect the environment.
Keep out of the sight and reach of children
6. CONTENTS OF THE PACK AND OTHER
INFORMATION

4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-dydramol Tablets can cause
side effects, although not everyone gets them.
Contact your doctor at once if the following side
effects occur:
! Allergic Reactions - skin rash or itchy skin,
difficulty breathing, increased sweating,
redness or flushed face, mucosal lesions (such
as mouth ulcers), drug fever
! Very rare cases of serious skin reactions have
been reported
! Abdominal pain - may be caused by spasm of
the bile ducts and inflammation of the liver or
pancreas.
Tell your doctor if you notice any of the following
side effects or notice any other effects not listed:
! Gastrointestinal system - stomach irritation
(mild stomach pain, heartburn and feeling sick),
constipation, feeling or being sick, loss of
appetite, dry mouth, difficulty in the passage of
food through guts
! Heart - slow heart rate, palpitations, low blood
pressure especially on standing, inflammation
of the heart muscle

What Co-dydramol Tablets contain
Co-dydramol Tablets contain 10mg dihydrocodeine
tartrate and 500mg paracetamol per tablet.
The other ingredients are: maize starch, povidone,
stearic acid, sodium starch glycollate, colloidal
silicon dioxide and talc.
What Co-dydramol Tablets look like and
contents of the pack
Co-dydramol Tablets are white, round, biconvex
tablets with 15 marked on one side and L on the
reverse side.
Co-dydramol Tablets are available in packs of 25,
50,100, 250, 500 and 1,000 tablets.
Marketing Authorisation Holder
Ennogen Pharma Limited,
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS. UK.
Manufacturer
CLONMEL CHEMlCALS LTD
Clonmel, Ireland
This leaflet was last amended in December
2015

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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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