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CO-CODAMOL 30/500 EFFERVESCENT TABLETS

Active substance(s): CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL / CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL / CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL

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419363 (alt 418555) GMID 657774 PB Cocodamol 500-30mg 10x10 GB Operator A.Schmitz 148 x 210 DC
Driving and using machines
Co-codamol can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive whilst 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:
- The medicine has been prescribed to treat a medical or dental problem and
- 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 you doctor or pharmacist if you are not sure whether it is safe for you to
drive whilst taking this medicine.
Co-codamol contains sodium and sorbitol
• Sodium: There is 388mg of sodium per effervescent tablet. This may be
harmful to people on a low sodium or low salt diet
• Sorbitol: This is a type of sugar. If you have been told by your doctor that you
cannot tolerate some sugars, talk to your doctor before 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 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
• Dissolve the effervescent tablets in a glass of water before taking
Adults: 2 tablets every 4 hours when necessary up to a maximum of 8 tablets in
24 hours.
Children aged 16 to 18 years: 1 to 2 tablets every 6 hours when necessary up to
a maximum of four doses in 24 hours.
Children aged 12 to 15 years: 1 tablet every 6 hours when necessary to a
maximum of four doses in 24 hours.
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.
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.
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

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PACKAGE LEAFLET – INFORMATION FOR THE USER

CO-CODAMOL 30/500 EFFERVESCENT 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 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 CO-CODAMOL IS AND WHAT IT IS USED FOR
The name of your medicine is Co-codamol 30/500 Effervescent Tablets (called
co-codamol throughout this leaflet). Co-codamol 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 severe 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
• 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
• Taking 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 (hypersensitive) 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
(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
co-codamol).
• You are an alcoholic
• The person going to take the tablets is under 12 years of age. Co-codamol
must not be given to children under 12 years of age.
• 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
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Do not take co-codamol if any of the above applies to you. If you are not sure,
talk to your doctor or pharmacist before taking co-codamol.
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 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 effect 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 any of the above applies 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 or pharmacist if you are taking the
following:
• 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, 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
• The oral contraceptive pill
If you are not sure if any of the above applies to you, talk to your doctor or
pharmacist before taking co‑codamol.
Co-codamol with alcohol
You should not drink alcohol while you are taking these tablets. This is because
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 planning to breastfeed
• Do not take co-codamol while you are breastfeeding. Codeine and morphine
passes into breast milk.
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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
• 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, it affects less than 1 in 10,000 people
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)
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 25°C.
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 Co-codamol 30/500 Effervescent 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 sodium bicarbonate, anhydrous citric acid, anhydrous
sodium carbonate, sorbitol powder, saccharin sodium, povidone, dimeticone and
sodium lauryl sulphate
What Co-codamol 30/500 Effervescent Tablets look like and contents of pack
White bevelled-edge tablets, scored on one face.
They are supplied in cartons of 100 tablets.
The Marketing Authorisation Holder is
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
The Manufacturer is
A. Nattermann & Cie. GmbH, Nattermannallee 1, 50829 Cologne, Germany
This leaflet was last updated in November 2016
“Zentiva” is a registered trademark © 2016

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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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