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CO-CODAMOL 15/500 TABLETS

Active substance(s): CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL

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10/07/2014 06:28 - VISTAlink folder 1085050 - Page 1/2

PACKAGE LEAFLET – INFORMATION FOR THE USER
CO-CODAMOL 15/500 TABLETS
Codeine Phosphate and Paracetamol
Read all of this leaflet carefully before you start taking 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.
 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.
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
1.
WHAT IS CO-CODAMOL AND WHAT IS IT USED FOR
The name of your medicine is Co-codamol 15/500 Tablets (called co-codamol throughout
this leaflet). Cocodamol contains two different medicines called codeine phosphate and
paracetamol. Codeine belongs to a group of medicines called opioid analgesics which act to
relieve pain. It can be used on its own or in combination with other painkillers such as
paracetamol. Co-codamol is used to treat moderate pain. Co-codamol can be used in
children over 12 years of age for the short-term relief of moderate pain that is not relieved
by other painkillers such as paracetamol or ibuprofen alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL
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
Warnings and Precautions
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 eyesight










You have recently had an operation on your liver, gallbladder or bile duct (biliary
tract)
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 cocodamol’)
You consume excessive amounts of alcohol on a regular basis
You are pregnant or breast-feeding
You are under 18 years of age and have had your tonsils or adenoids removed due to
obstructive sleep apnoea syndrome
You know that you metabolise very rapidly codeine into morphine
You are breastfeeding or planning to breastfeed

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.
Children
Co-codamol must not be given to children under 12 years of age
Take special care and check with your doctor before taking co-codamol if:
 You have severe kidney or liver problems
 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 have a disease of the adrenal gland called Addison’s disease
 You have a condition called myasthenia gravis which weakens the muscles
 You are elderly
Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance
that produces pain relief. Some people have a variation of this enzyme and this can affect
people in different ways. In some people, morphine is not produced or produced in very
small quantities, and it will not provide enough pain relief. Other people are more likely to
get serious side effects because a very high amount of morphine is produced. If you notice
any of the following side effects, you must stop taking this medicine and seek immediate
medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or
being sick, constipation, lack of appetite.
Children and adolescents
Use in children and adolescents after surgery
Co-codamol should not be used for pain relief in children and adolescents after removal of
their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.
Use in children with breathing problems
Co-codamol is not recommended in children with breathing problems, since the symptoms
of morphine toxicity may be worse in these children.

If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking
co-codamol.
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 or pharmacist if you are taking the
following:
them in the last 2 weeks. MAOIs are medicines such as moclobemide, phenelzine,
tranylcypromine
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 NEED TO KNOW
 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 cocodamol.
Co-codamol with alcohol
You should not drink alcohol while you are taking these tablets. This is because taking cocodamol 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 planning to breast-feed
 Do not take co-codamol while you are breastfeeding. Codeine and morphine passes
into breast milk
Driving and using machines
Co-codamol may affect your ability to drive as it 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:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in the
information provided with the medicine and
o 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.
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 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
Adults and children over 15 years:
 Swallow the tablets whole with a drink of water
 The usual dose of co-codamol is 2 whole tablets, taken together
 Adults should 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
Use in children and adolescents
Children aged 12 – 15 years:
 1 whole tablet every 4 hours
 Do not take more than 4 tablets in any 24-hour period.
 Children aged 12 years and over should wait at least 6 hours before taking another
dose
Children under 12 years: Co-codamol should not be given to children under 12 years of age
due to the risk of severe breathing problems.
This medicine should not be taken for more than 3 days. If the pain does not improve after 3
days, talk to your doctor for advice.
If you take more co-codamol 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.
 Remember to take any remaining tablets and the pack with you. This is so the doctor
knows what you have taken

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.
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 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 get serious skin reactions. Very rare cases have been reported.
Talk to 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 (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:
 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
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-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. Store your medicine in the original packaging in order to protect
from moisture. Do not store above 25oC.

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
What Co-codamol 15/500 Tablets contain
 The active substances are codeine phosphate and paracetamol. Each tablet contains
15mg of codeine phosphate and 500mg of paracetamol.
 The other ingredients are maize starch, povidone, potassium sorbate,
microcrystalline cellulose, stearic acid, magnesium stearate, talc, pregelatinised
starch and purified water.
What Co-codamol 15/500 Tablets look like and contents of the pack
White to off-white capsule-shaped tablets, marked PRO 15 and scored on one side with a
plain reverse. They come in cartons of 100 tablets.
The Marketing Authorisation Holder and Manufacturer is
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
This leaflet was last updated in October 2015LAKE CO-CODAMOL

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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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