CO-CODAMOL 30/500 MG EFFERVESCENT TABLETS

Active substance: PARACETAMOL

View full screen / Print PDF » Download PDF ⇩

Transcript
Patient Information Leaflet

Co-codamol 30/500 mg Effervescent Tablets
(codeine phosphate and paracetamol)
Important information about Co-codamol
• Taking codeine regularly for a long time can lead to addiction. This means that when you stop taking the tablets,
you might feel restless and irritable
• Do not take this medicine for longer than your doctor tells you
• Taking a painkiller for headaches too often, or for too long, can make them worse
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, please 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist
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
The name of your medicine is Co-codamol 30/500 mg Effervescent Tablets (called Co-codamol in this leaflet).
Co-codamol contains two different medicines called:
• Codeine
• Paracetamol
These medicines both belong to a group of medicines called pain-killers (analgesics)
Co-codamol is used to provide relief from severe pain.
2. Before you take Co-codamol
Do not take Co-codamol if:
• You are allergic (hypersensitive) to codeine, paracetamol or any of the other ingredients (listed in Section 6 below)
• You have severe asthma attacks or severe breathing problems
• You have recently had a head injury
• You have recently had an operation on your gall bladder or a similar operation
• You have raised pressure in your brain
• You are taking a medicine for depression called an MAOI (monoamine oxidase inhibitor). This also applies if you have
taken them in the last 14 days
• You are an alcoholic
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.
Take special care with Co-codamol
Check with your doctor or pharmacist before taking Co-codamol if:
• You are pregnant or breast-feeding (see Pregnancy and breast-feeding section below)
• You have severe kidney or liver problems
• You have problems with your prostate (such as difficulty passing water)
• You have a bowel problem
• You are elderly
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co-codamol.
Taking other medicines
Please 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 or
codeine
This includes other pain-killers, and some cough and cold remedies. It also includes other medicines available from
your pharmacist and more widely in shops. Always check the name of the medicines inside anything you buy or are
prescribed, to see if they contain paracetamol or codeine.
Do not take this medicine and tell your doctor if you are taking:
• Medicines for depression called MAOIs (monoamine oxidase inhibitors). Also do not take if you have taken
them in the last 14 days
Tell your doctor or pharmacist if you are taking any of the following medicines:
• Medicines which make you sleepy including alcohol
• Medicines used to thin the blood (such as warfarin)
• Chloramphenicol - an antibiotic
• Metoclopramide or domperidone - used for feeling sick (nausea) or being sick (vomiting)
• Cholestyramine - used for high cholesterol and fat levels in the blood
• Oral contraceptives such as ‘the pill’
If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Co-codamol.
Taking Co-codamol with food and drink
Drinking alcohol while taking this medicine can make you feel sleepy.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.
Driving and using machines
You may feel sleepy or dizzy after taking Co-codamol. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of this medicine
• Sodium: There is about 410 mg of sodium in each Co-codamol Tablet. This may be harmful to people on a low
sodium diet
• Sorbitol: This is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars
(have an intolerance to sugars), talk to your doctor before taking this medicine
3. How to take Co-codamol
Always take Co-codamol as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• Do not take more than the dose you have been told
• Do not take for longer than your doctor tells you
How much to take
Adults and children over 12 years of age
• Dissolve the tablets in half a glass of water
• The usual dose of Co-codamol is 1 or 2 tablets
• Leave at least 4 hours between each dose of Co-codamol
• Do not take more than 8 tablets in any 24 hour period
• Elderly people may be given a lower dose
Children
• Co-codamol is not recommended for use in children under 12 years of age.
If you think that the effect of Co-codamol is too strong or too weak, talk to your doctor or pharmacist.
Changing the dose after taking Co-codamol regularly for a long time
Taking Co-codamol regularly and for a long time can make you addicted to the medicine. If you have taken regular daily
doses of Co-codamol for a long time, talk to your doctor before increasing the dose or before suddenly stopping treatment.
If you take more Co-codamol than you should
• If you take more Co-codamol than you should, talk to your doctor or go to a hospital straight away. This is because there
is a risk of serious liver damage, though this may not happen straight away
• Remember to take this medicine pack and any remaining tablets with you, so the doctor knows what you have taken
If you forget to take Co-codamol
• If you forget a dose, do not worry, take it as soon as you remember. However, if it is nearly time for your next dose, skip
the missed dose
• Do not take a double dose to make up for a forgotten dose
• Remember to leave at least 4 hours between doses
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Co-codamol can cause side effects, although not everybody gets them.
Important side effects you should know about Co-codamol
• Taking codeine regularly for a long time can make you addicted to the medicine. This means that when you stop taking
the tablets, you might feel restless and irritable
• Taking a painkiller for headaches too often or for too long can make them worse
Stop taking Co-codamol and see a doctor straight away if:
• You develop an allergic reaction. Signs of an allergic reaction include a rash, swelling of your face, lips, mouth and
throat, difficulty swallowing or difficulty breathing
Talk to your doctor as soon as possible if:
• You have problems passing urine
• You notice that you bruise or bleed more easily than usual. Also, if you get more infections than usual, such as a sore
throat or mouth ulcers
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
• Constipation
• Feeling sick (nausea) or being sick (vomitting)
• Feeling dizzy, light-headed or sleepy
• Feeling confused
If any of the side effects get serious or lasts for longer than a few days or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Co-codamol
Keep out of the reach and sight of children.
Do not use Co-codamol after the expiry date stated on label. The expiry date refers to the last day of the month.
Store your medicine in the original container and keep the container tightly closed in order to protect from moisture.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.
6. Further information
What Co-codamol 30/500 mg Effervescent Tablets contain:
• The active ingredients are codeine phosphate and paracetamol. Each tablet contains 30 mg of codeine phosphate
and 500 mg of paracetamol
• The other ingredients are sodium hydrogen carbonate, anhydrous sodium carbonate, anhydrous citric acid, sodium
docusate, sorbitol, saccharin sodium, dimeticone, sodium benzoate, macrogol 6000 and natural grapefruit flavour
What Co-codamol 30/500 mg Effervescent Tablets look like and the contents of the pack:
Co-codamol 30/500 mg Effervescent Tablets are white, bevelled, flat, round tablets with a break-line on one side. They are
available as packs of 30 or 100 effervescent tablets, in tubes or Aluminium/PE composite strips within an outer carton.
Not all pack sizes or pack types may be marketed.
Marketing Authorisation Holder:
Consilient Health Ltd.
5th floor, Beaux Lane House,
Mercer Street Lower, Dublin 2,
Ireland

Manufacturer:
TBC




Date of leaflet revision: November 2008
P0037(pre)

Expand view ⇕

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.

Hide
(web4)