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CO-DYDRAMOL TABLETS 500/10MG.

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

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Artwork No.

020217/12

Colours Used

Customer

MAPharmachem

Black

Description

Eroset 500_10 mg Leaflet

Keyline

Market

UK

Language

English
170 x 298.45mm

Size

e-mail : artworkcd@gmail.com
Ph : +91-9845156610

Min. Font Size

Arial Narrow, 9 pt

Page No.

1 of 1

Version No.

1

Date

02-02-17

Software

Packaging Development

Coreldraw 12
Quality Assurance (QA)

Quality Control (QC)

Production

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Patient Information leaflet

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EROSET 500/10mg TABLETS

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(Paracetamol 500mg / Dihydrocodeine 10mg)

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Pregnancy and breast-feeding
Do not take Eroset tablets during pregnancy or whilst breast feeding, unless advised by your doctor.
Regular use during pregnancy may cause withdrawal symptoms in the newborn.

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.

1. WHAT EROSET IS AND WHAT IT IS USED FOR
Eroset tablets contain paracetamol and dihydrocodeine, which are used to relieve moderate pain and
reduce temperature.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EROSET
Do NOT take Eroset if:
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You are allergic (hypersensitive) to paracetamol, dihydrocodeine, other opioids or any of the other
ingredients of this medicine (listed in section 6)
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You have a medical condition where you find it difficult to breathe
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You are having an asthma attack
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You have liver disease
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You have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembraneous colitis).
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 or pharmacist or take more tablets than
recommended.
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Do not drink alcohol on the same day that you take these tablets.
!
Taking dihydrocodeine regularly for a long time can lead to addiction, which might cause you to feel
restless and irritable whenyou stop taking the tablets.
!
Taking a painkiller for headaches too often or for too long can make them worse.
Talk to your doctor or pharmacist before you take this medicine if you have:
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Kidney or liver problems, including alcohol liver disease
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Diseased adrenal glands (Addison's disease) or high blood pressure caused by a tumour near a
kidney (phaeochromocytoma)
!
Inflammatory bowel disease
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Gall bladder disease or gall stones
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Recently had surgery on your gastro-intestinal tract or urinary system
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An enlarged prostate gland
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Epilepsy or fits (may be made worse by Eroset)
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Suffered head injury or raised pressure in the skull (may cause painful eyes, changes in vision or
headache behind the eyes)
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An underactive thyroid gland
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Muscle weakness (myasthenia gravis)
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Low blood pressure or are in shock
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Suffered from alcoholism, drug abuse or dependence or mental illness
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You are elderly (you may need a lower dose)
Other medicines and Eroset
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without prescription. Especially:
Ciprofloxacin (antibacterial medicine)
Monoamine Oxidase Inhibitors (MAOIs for depression, e.g. moclobemide, or have taken these within
the last 2 weeks)
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Oral contraceptives (the “pill”)
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Medicines to prevent blood clotting such as warfarin
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Cyclizine, metoclopramide or domperidone (to prevent sickness)
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Guanethidine or diuretics (“water tablets”) e.g. spironolactone, furosemide (to treat high blood
pressure)
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Mexiletine (to treat irregular heartbeats)
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Loperamide or kaolin (to treat diarrhoea)
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Selegiline (for Parkinson's disease)
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Phenytoin (to treat epilepsy)
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Cimetidine (to treat stomach ulcers)
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Atropine or hyoscine (anticholinergic medicines)
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Cisapride (to treat gasto-oesophageal reflux disease)
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Medicines which affect the nervous system such as sleeping tablets, diazepam, hydroxyzine and
medicines to treat mental illness
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Medicines to treat depression (e.g. tranylcypromine, amitriptyline)
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Medicines which affect the liver (e.g. primidone and rifampicin)
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Colestyramine (to treat high cholesterol levels)
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Muscle relaxants
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Barbiturates (e.g. phenobarbital)
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Anaesthetics
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Opoid antagonists (buprenorphine, naltrexone, naloxone)

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Diet
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 Eroset tablets.
Driving and using machines
If these tablets make you feel drowsy, dizzy, or you experience blurred vision or vertigo (a type of
dizziness), or cannot think clearly, do not drive or operate machinery. The medicine can affect your ability
to drive as it may make you sleepy or dizzy.
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Do not drive while taking this medicine until you know how it affects you
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It is an offence to drive if this medicine affects your ability to drive
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However you would not be committing an offence if:
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The medicine has been prescribed to treat a medical or dental problem and
Continued overleaf

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.

3. HOW TO TAKE EROSET
Always take Eroset tablets exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure. These tablets are not recommended for children under 12 years of age.
Children aged 12-15 years:
1 whole tablet every 4-6 hours
Do not take more than 4 tablets in any 24-hour period

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!

Adults (including the elderly) and children over 16 years of age:
the tablets should be swallowed with or shortly after food.
take 1 tablet up to four times a day. Your doctor may increase this to 2 tablets 4 times a day if
necessary
the dose may be reduced if you are elderly or have under-active thyroid or severe kidney or liver
problems
!
do not take more often than every 4 hours
!
do not take more than 8 tablets in any 24-hour period
!
if symptoms persist consult your doctor.
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!
!

DO NOT EXCEED THE RECOMMENDED DOSE.
IF YOU OR ANYONE ELSE TAKES TOO MUCH EROSET: 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 an overdose has been taken contact your doctor immediately or go to your local hospital casualty
department. Please take this leaflet, any remaining tablets and the container with you.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. The
following side effects may happen with this medicine.
Important side-effects you should know about Eroset
Taking a painkiller for headache too often or too long can make them worse.
Taking Eroset regularly for a long time can lead to addiction,which might cause you to feel restless
and irritable when you stop the tablets.

!
!

Stop taking Eroset and see a doctor or go to a hospital straight away if:
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You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in
swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria)
This may mean you are having an allergic reaction to Eroset.
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You get serious skin reactions. Very rare cases have been reported.
!

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

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer
than a few days:
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Constipation, feeling sick (nausea), being sick (vomiting)
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Headache, dizziness, light-headedness, drowsiness, confusion
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Becoming dependent on dihydrocodeine
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You get infections or bruise more easily than usual. This could be because of a blood problem.
!
Redness or blood spots on the skin (purpura)
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 EROSET
Keep out of the sight and reach of children. Do not store above 25˚C. Store them in a cool dry place.
Protect from light. Keep the container well closed. Do not use 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 Eroset tablets contain:
The active ingredient in each tablet are paracetamol 500mg and dihydrocodeine tartrate 10mg.
The other ingredients are maize starch, povidone, colloidal silica, magnesium stearate and potassium
sorbate (E202).
What Eroset tablets look like and contents of the pack:
The tablets are white, round flat bevelled edged tablets plain on one side (or marked "M&A"). Engraved
on the other side with "CO" and "DYD" on either side of a breakline.
Marketing Authorisation Holder and Manufacturer:
M & A Pharmachem Ltd, Bolton, BL5 2AL, UK.
Date of last revision: February 2017
PP2486

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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