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CO-CODAMOL 8/500MG CAPSULES

Active substance(s): CODEINE PHOSPHATE / PARACETAMOL

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BRAILLE READS:

Co-codamol 8/500 mg
Capsules

PM/01/814

C

Healthcare Ltd.

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(No.) 8

Codeine and paracetamol. 100 Capsules.

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(No.) 5

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ARK 006
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g

Capsule contents: codeine phosphate 8 mg & paracetamol 500 mg.

healthcare ltd
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Contains paracetamol. Do not take with any other paracetamol-containing
products. Immediate medical advice should be sought in the event of an
overdose, even if you feel well.
For oral use.
Take as directed by your doctor.
If symptoms persist consult your doctor.
Do not take for longer than directed by your prescriber as taking codeine regularly for
a long time can lead to addiction.
For further information, please see the attached leaflet.

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BRAILLE SPECIFICATION: MARBURG MEDIUM

Flat size : 653 x 60mm
Flat size : 60 x 93/96mm
Fold Configuration : off centre to 282 then letter fold

Custom
healthcare ltd
Job No.:

UK 0000

Proof No.:

P4 / M4

Black

100%

95%

PMS
072U
+ 25%
Tint

50%

Product Name

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96mm
PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-codamol 8/500 mg Capsules
Codeine Phosphate, Paracetamol

In this leaflet
1. What Co-codamol is and what it is used for
2. Before you take Co-codamol
3. How to take Co-codamol
4. Possible side effects
5. How to store Co-codamol
6. Further information.

1. What Co-codamol is and what it is used for
Co-codamol is a combination of two pain killing drugs, Paracetamol and Codeine
Phosphate. It is used to relieve the symptoms of influenza and feverish colds
including a raised temperature. It is also used for the relief of mild to moderate
pain caused by headaches, sore throats, period pains, migraine, toothache,
neuralgia, muscular and rheumatic pains.

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2. Before you take Co-codamol
Do not take Co-codamol if you:
• Are allergic (hypersensitive) to Paracetamol, Codeine Phosphate or other
medicines known as opioids, e.g. Morphine, or any of the other ingredients of
Co-codamol (see section 6. Further Information)
• Have asthma or suffer from breathing difficulties which may be due to disease
or brought on by taking other painkilling drugs such as morphine, fentanyl or
pethidine
• Have diarrhoea caused by poisoning or have pseudomembranous colitis which
causes severe bloody diarrhoea.

Take special care
You should talk to your doctor or pharmacist before you take Co-codamol if any of
the following apply to you:
• You have kidney or liver problems

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• You drink excessively, are alcoholic or suffer from non cirrhotic alcoholic liver
disease
• You are suffering from, or have been treated in the past for, head injuries or
pressure inside your head
• You have an under-active thyroid gland (hypothyroidism) which can cause
tiredness or weight gain
• You have Addison’s disease which can lead to weight loss, low blood pressure
and bronzing of the skin
• You have phaeochromocytoma (a tumour near a kidney causing high blood
pressure)
• You have an enlarged prostate gland which causes difficulty passing urine in
men
• You have inflammatory bowel disease e.g. Crohn’s disease or ulcerative colitis
• You have recently had surgery on your digestive system or urinary tract
• You have gall bladder disease or gallstones
• You suffer from a disease called myasthenia gravis
• You have experienced convulsions

• You have low blood pressure or are in shock
• You have suffered from drug dependence or abuse, or mental illness.
– Do not take for longer than directed by your prescriber.
– Taking Codeine regularly for a long time can lead to addiction which
might cause you to feel restless and irritable when you stop taking the
capsules.
– Taking a painkiller for headaches too often or for too long can make
them worse.

You should not take Co-codamol if you are taking or have taken any medicines for
depression of the type known as Monoamine Oxidase Inhibitors (MAOIs) such as
Phenylzine, Tranylcypromine or Isocarboxazide within the last two weeks.
If you are taking any of the following drugs, you should talk to your doctor before
you first start taking Co-codamol as your doctor may need to alter the dosage of
your medication:
• Cimetidine (used to treat stomach ulcers)
• Cyclizine, Metaclopramide or Domperidone (used to prevent nausea or
vomiting)
• Colestyramine (used to treat high cholesterol in the blood)
• Ciprofloxacin (an antibacterial medicine)
• Mexiletine (use to treat an irregular heartbeat)
• Cisapride (used to treat gastro-oesophageal reflux disease)
• Selegiline (used to treat Parkinson’s disease)
• Hydroxyzine (an antihistamine, also used to treat anxiety)
• Oral contraceptives (“the pill”)
• Warfarin and other medicines to thin the blood

• Anticholinergic medicines e.g. Atropine, which affect the central nervous
system
• Any sedative or tranquiliser medicines, including phenothiazines e.g.
Chlorpromazine, barbiturates e.g. Phenobarbital, and tricyclic antidepressants
e.g. Amitriptyline
• Anaesthetics
• Medicines to treat high blood pressure such as Guanethidine or diuretics
(“water tablets”) e.g. Furosemide
• Medicines known as opioid antagonists e.g. Buprenorphine, Naltrexone,
Naloxone
• Muscle relaxants
• Medicines for diarrhoea.

Taking other medicines
Before taking Co-codamol, you should tell your doctor or pharmacist about all
medicines you are taking or plan to take, including those obtained without
prescription.
Whilst taking Co-codamol you should not take any other medicines
which contain Paracetamol. This includes some painkillers, cough and cold
remedies and a wide range of other medicines available from shops and
pharmacies.

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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 any of the side effects get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.

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Taking Co-codamol with food and drink

Market
Component
No. of Colours
Profiles
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Leaflet
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Pharmacode
SAP Code
Material No.
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• Do not drink alcohol whilst taking Co-codamol.
• If you have a poor diet with a low intake of protein your risk of serious
paracetamol poisoning when taking Co-codamol may be increased.

PMS
292U

5%

Cationic
Release
Varnish

Braille

Co-codamol
8/500 mg Capsules
Label/Leaflet
Three
As supplied
60 x 145mm
653 x 60mm
5060034833222
710
N/A
PM/01/814

09/12/2011
8 pt
8.75 pt
7 pt

Artwork Approval Signature Box

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Pregnancy and Breastfeeding

Driving and using machines
Co-codamol may cause dizziness or blurred vision, or impair your ability to think
clearly. Do not drive or use machinery if affected in this way.

3. How to take Co-codamol
Always take Co-codamol exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are unsure. You can swallow your capsules
with or without food. Most people take the capsules with a drink of water.
Adults and Children over 12 years of age:
• 1 or 2 capsules to be taken every 4 hours as required.
Do not exceed the stated dose:
– Do not take more frequently than – every 4 hours
– Do not take more than 2 capsules at a time
– Do not take more than 8 capsules in 24 hours.
If you think you have taken too many capsules go to your doctor or nearest
casualty department, taking your medicine with you.
Contains Paracetamol. Do not take with any other Paracetamol
containing products. 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.

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Like all medicines Co-codamol may occasionally cause side effects in some
patients.
Stop taking the medicine and see a doctor or go to a hospital straight away if you
develop a rash, start to itch, get short of breath or wheezy, develop swelling of
the mouth, throat, face or eyes, have increased sweating, a red or flushed face.
This may mean you are having an allergic reaction to Co-codamol.
Below is a list of other side effects which have occurred whilst taking
Co-codamol:
• Drowsiness, reduced mental alertness
• Nausea, vomiting, constipation
• Heartburn, abdominal pain or bloating
• Loss of appetite, dry mouth
• Liver and kidney problems
• Pancreatitis (inflammation of the pancreas which causes severe pain in the
abdomen and back)

• Vertigo, lightheadedness, dizziness or fainting
• Confusion, mood changes, restlessness, excitation
• Difficulty sleeping, nightmares
• Tolerance (your medicine has less effect)
• Raised pressure in the skull which causes headache and eye problems
• Blurred or double vision, very small pupils of the eyes
• Slow or irregular heartbeat, inflammation of the heart muscle
• Tiredness, sweating
• Feeling unwell, trembling, hypothermia
• Pain and difficulty in urinating
• Fits
• Hallucinations
• Mental depression
• Unexplained bruising and bleeding, sore throat and fever. This could be
because of a blood problem which may require diagnosis by a blood test.

Important side effects you should know about Co-codamol:
• Taking a painkiller for headaches too often or for too long can make them
worse.
• Taking Codeine regularly for a long time can lead to addiction, which might
cause you to feel restless and irritable when you stop taking the capsules.
If you experience these or any other side effects, stop taking the capsules and
talk to your doctor.

4. Possible Side Effects

5. Storing your medicine
Keep your capsules out of the reach and sight of children. Do not store above
25 °C.
Keep them in the pack in which they were supplied so they do not get mixed up
with other medicines.
Return any unused capsules to your pharmacist. Do not use after the expiry date
printed on the label.

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6. Further Information
The active substances in these capsules are Codeine Phosphate 8 mg and
Paracetamol 500 mg.
The other ingredients are Light Kaolin and Magnesium Stearate.
The capsule shells contain Gelatin and the colourant, Erythrosine.
The capsule ink contains Shellac and Black Iron Oxide E172.
Co-codamol 8/500 mg Capsules are pink, translucent, hard gelatine capsules,
printed CO COD 8.
They are available in packs of 32 and 100 capsules.
Remember, this medicine is for you. Do not share it with anyone else. It may not
suit them.
The MA holder and Manufacturer is:
Custom Healthcare Limited
Conway Street, Hove
East Sussex, BN3 3LW
This leaflet was last revised in November 2011.

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Co-codamol
8/500 mg
Capsules
Codeine and
paracetamol.
100 Capsules.

Capsule contents: codeine phosphate 8 mg &
paracetamol 500 mg.

Regulatory

Market Affiliate

Contains paracetamol. Do not take with any other
paracetamol-containing products. Immediate medical
advice should be sought in the event of an overdose,
even if you feel well.

POM

Healthcare Ltd.

Site Packaging

For oral use.
Take as directed by your doctor.
If symptoms persist consult your doctor.
Do not take for longer than directed by your prescriber as
taking codeine regularly for a long time can lead to addiction.
For further information, please see the attached leaflet.

60mm

• Taking Co-codamol is not recommended during pregnancy, unless advised by
your doctor.
• Usually it is safe to take Co-codamol Capsules while breast feeding as the level
of codeine in breast milk is too low to cause your baby any problems. However,
some women who are at increased risk of developing side effects at any dose
may have higher levels of codeine in their breast milk. If any of the following
side effects develop in you or your baby stop taking this medicine and seek
immediate medical advice; feeling sick, vomiting, constipation, decreased or
lack of appetite, feeling tired or sleeping for longer than normal, and shallow or
slow breathing.

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Proofreader

ARK Pharma Graphics Ltd
Crown House Business Centre
Home Gardens, Dartford, Kent
DA1 1DZ
Tel +44(0)1322 424656

V2.05.2008

Bar prints 100mm @ 100%

MAH: Custom Healthcare Ltd.
Conway Street, Hove, BN3 3LW
PL 33446/0001

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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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