CO-CODAMOL 30/500 TABLETS

Active substance: PARACETAMOL

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Zentiva
LLET COCOD TABS 30 500 UT Z

Store your medicine in the original packaging in order to protect from moisture.

PACKAGE LEAFLET – INFORMATION FOR THE USER

Do not store above 25°C.
Do not throw away 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

LEAFLET
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30305009
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30305009

CO-CODAMOL 30/500 TABLETS
Codeine Phosphate and Paracetamol

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Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

What Co-codamol 30/500 Tablets contain
• The active substances are codeine phosphate and paracetamol. Each tablet contains
30mg of codeine phosphate and 500mg of paracetamol.
• The other ingredients are, pregelatinised starch, maize starch, povidone, potassium
sorbate, microcrystalline cellulose, stearic acid, talc, magnesium stearate, and
croscarmellose sodium (type A).





What Co-codamol 30/500 Tablets look like and contents of pack
White capsule-shaped tablets, marked with the word SOLPADOL on one side.
They come in cartons of 100 tablets.

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What is in this leaflet:
1. What co-codamol is and what it is used for
2. What you need to know before you take co-codamol
3. How to take co-codamol
4. Possible side effects
5. How to store co-codamol
6. Contents of the pack and other information

The Marketing Authorisation Holder is
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
The Manufacturer is
Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon, Newcastle upon Tyne, NE3 3TT,
UK



Keep this leaflet. You may need to read it again
If you have any questions, ask your doctor or pharmacist
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. This includes any possible
side effects not listed in this leaflet.

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1. WHAT CO-CODAMOL IS AND WHAT IT IS USED FOR
The name of your medicine is Co-codamol 30/500 Tablets (called co-codamol throughout
this leaflet). Co-codamol contains two different medicines called codeine phosphate and
paracetamol. It belongs to a group of medicines called analgesics (painkillers) and is used to
treat severe pain.

This leaflet was last updated in October 2012.
‘Zentiva’ is a registered trademark © 2012 Zentiva.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL

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Important things you should know about co-codamol
• Do not take for longer than your doctor tells you to.
• Taking codeine 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.
Do not take co-codamol and tell your doctor if:
• You are allergic to the active substances or any of the other ingredients in your medicine
(listed in Section 6).
Signs of an allergic reaction include a rash and breathing problems. There can also be
swelling of the legs, arms, face, throat or tongue.
• You have severe asthma attacks or severe breathing problems.
• You have recently had a head injury.
• You have been told by your doctor that you have increased pressure in your head. Signs
of this include: headaches, being sick (vomiting) and blurred vision.
• You have recently had an operation on your liver, gallbladder or bile duct.
• You are taking medicine to treat depression called MAOIs (monoamine oxidase
inhibitors) or have taken them in the last 2 weeks. MAOIs are medicines such as
moclobemide, phenelzine or tranylcypramine (see ‘Other medicines and co-codamol’).
• You are an alcoholic.
• You are breastfeeding.
Do not take co-codamol if any of the above apply to you. If you are not sure, talk to your
doctor or pharmacist before taking co-codamol.

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Children
Co-codamol must not be given to children under 12 years of age.
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FOR
ZENTIVA USE
ONLY
Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

N/A

THESE
SIGNATURES
Zentiva - Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD OFFICE USE
Other - as required
Approved: Yes
No
ONLY
Date:
Signature:

30305009
60101300

Zentiva
LLET COCOD TABS 30 500 UT Z

Warnings and precautions
Take special care and check with your doctor before taking co-codamol if:
• You have severe kidney or liver problems.
• You have a liver problem caused by alcohol.
• You have problems passing water or prostate problems.
• You have a bowel problem such as colitis or Crohn’s disease or a blockage of your bowel.
• You are elderly.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking this medicine.
Other medicines and co-codamol
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes medicines obtained without a prescription, including herbal medicines. This is
because co-codamol can affect the way some other medicines work. Also, some other
medicines can affect the way co-codamol works.
While taking co-codamol you should not take any other medicines which contain
paracetamol
This includes some painkillers, cough and cold remedies. It also includes a wide range of
other medicines available from your doctor and more widely in shops.
Do not take this medicine, and tell your doctor, if you are taking:
• Medicines to treat depression called MAOIs (monoamine oxidase inhibitors) or have
taken them in the last 2 weeks. MAOIs are medicines such as moclobemide, phenelzine,
tranylcypramine
Tell your doctor if you are taking any of the following medicines:
• Medicines which make you drowsy or sleepy (CNS depressants)
• Medicines used to thin the blood such as warfarin
• Chloramphenicol - an antibiotic used for infections
• Metoclopramide or domperidone - used to stop you feeling sick (nausea) or being sick
(vomiting)
• Colestyramine - for lowering blood cholesterol levels
• The oral contraceptive pill
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking co-codamol.
Taking co-codamol with alcohol
You should not drink alcohol while you are taking these tablets. This is because taking
co-codamol can change the way alcohol affects you.
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
• You are in the last three months of pregnancy or in labour
You should not take this medicine if you are breastfeeding. This is because the codeine in
your breast milk may affect your baby.
Driving and using machines
You may feel dizzy or sleepy while taking co-codamol. If this happens, do not drive or use
any tools or machines.
Changing or stopping treatment
Chronic usage of co-codamol may lead to tolerance and dependence. If you have taken regular
daily doses of co-codamol for a long time, do not increase the dose or suddenly stop treatment
without discussing this with your doctor.

3. HOW TO TAKE CO-CODAMOL
Always take co-codamol exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
• Do not take more than the recommended dose.
• Do not take for longer than your doctor tells you to.
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LEAFLET
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Adults and children over 12
• Swallow the tablets whole with a drink of water.
• The usual dose of co-codamol is 2 tablets, taken together.
• Wait at least 4 hours before taking another dose.
• Do not take more than 8 tablets in any 24-hour period.
• Elderly people may be prescribed a lower dose.

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Use in children
Co-codamol should not be given to children under 12 years of age.

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If you take more co-codamol than you should
• 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.
• Remember to take any remaining tablets and the pack with you. This is so the doctor
knows what you have taken.

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If you forget to take co-codamol
If you forget to take a dose at the right time, take it as soon as you remember. However do
not take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours
between doses.

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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.

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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 tablets.
Stop taking co-codamol and see a doctor or go to a hospital straight away if:
• 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 co-codamol.
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.
• Yellowing of your skin or eyes and your urine becomes darker in colour. This could be a liver
problem, such as jaundice or hepatitis
• A severe blistering rash in which layers of the skin may peel off to leave large areas of raw
exposed skin over the body or you develop skin blisters. You may also feel generally unwell,
have a fever, chills and aching muscles.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts
longer than a few days:
• Constipation,
• Feeling sick (nausea), being sick (vomiting),
• Dizziness, light-headedness, drowsiness, confusion,
• Difficulty in passing water,
• Becoming dependent on codeine,
• You get infections or bruise more easily than usual. This could be because of a blood
problem (such as agranulocytosis, neutropenia or thrombocytopenia).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.

5. HOW TO STORE CO-CODAMOL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the pack. The expiry date refers to
the last day of that month.
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Black

FOR
ZENTIVA USE
ONLY
Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

N/A

THESE
SIGNATURES
Zentiva - Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD OFFICE USE
Other - as required
Approved: Yes
No
ONLY
Date:
Signature:

30305009
60101300

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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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