Co-Codamol Effervescent Tablets
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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 because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist or nurse.
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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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 mg Effervescent Tablets (called Co-codamol in this leaflet). Co-codamol contains two different medicines called: Codeine and Paracetamol.
These medicines both belong to a group of medicines called pain-killers (analgesics).
Co-codamol is used to provide relief from 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.
This product contains codeine. 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.
What you need to know before you take Co Icodamol
Do ngt use 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
• For pain relief in children and adolescents (0 - 18years of age) after the removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome
• If you know you metabolise very rapidly codeine into morphine
• If you are breast-feeding.
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.
Warnings and precautions
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 or 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.
Talk to your doctor, or pharmacist or nurse before taking Co-codamol if:
• You are pregnant (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)
• Colestyramine - 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 or might become pregnant.
Do not take Co-codamol while you are breast-feeding. Codeine and morphine passes into breast milk.
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.
Co-codamol Tablets contain sodium and sorbitol
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. If symptoms persist consult your doctor.
How much to take Adults
• 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 over 12 years of age
Children over 12 years of age should take 1 or 2 tablets every 6 hours, as needed. Do not take more than 8 tablets 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 of age
Co-codamol should not be taken by children under 12 years of age, due to the risk of severe breathing problems.
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.
I f 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
I f 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.
Possible side effects
Like all medicines, Co-codamol can cause side effects, although not everybody gets them.
I 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 (vomiting)
• Feeling dizzy, light-headed or sleepy
• Feeling confused.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
How to store Co-codamol
5.
Keep out of the sight and reach 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.
Foil Strip: Do not store above 25°C.
Tubes: Do not store above 25°C. Store your medicine in the original container and keep the container tightly closed in order to protect from moisture.
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. Contents of the pack and other 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 and macrogol 6000.
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 within an outer carton. They are also available as packs of 32 or 100 tablets in foil strips in an outer carton. Not all pack sizes or pack types may be marketed.
Marketing Authorisation Holder:
Zanza Laboratories (Holdings) Ltd.,Unit 2A, Olympic Way, Sefton Business Park, Liverpool,
L30 IRD. UK
Distributed by: Zanza Laboratories Ltd, Liverpool, UK Date of leaflet revision: 06.06.2014
007/06