CO-CODAMOL TABLETS
Active substance: PARACETAMOL
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P0215T
PATIENT INFORMATION LEAFLET
CO-CODAMOL TABLETS Codeine Phosphate 8mg, Paracetamol 500mg
Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 Tablets are and what they are used for 2. Before you take Co-Codamol Tablets 3. How to take Co-Codamol Tablets 4. Possible side effects 5. How to store Co-Codamol Tablets 6. Further information
1.What Co-Codamol Tablets are and what they are used for
The name of this medicine is Co-Codamol. Each tablet contains Paracetamol and Codeine Phosphate as the active ingredients. Codeine belongs to a group of medicines called opioid analgesics which act directly in the central nervous system (CNS) to relieve pain. Paracetamol is used to relieve pain and reduce fever. Co-Codamol is used for the relief of mild to moderate pain and to bring down temperature in some feverish conditions.
2.Before you take Co-Codamol Tablets
Do not take these tablets if: you are allergic to codeine or paracetamol or to any of the ingredients (see section 6) you have sudden severe asthma attacks or have any difficulty breathing you have recently had a head injury or have increased pressure in your head you have recently had an operation on your liver, gall bladder or bile duct ou are taking or have taken in the last 2 weeks any medicines called monoamine oxidase inhibitors (MAOIs) e.g. y moclobemide, phenelzine which are used to treat depression you are an alcoholic. Check with your doctor before taking these tablets if: your liver and kidney are not functioning well, especially if you are an elderly person you have an enlarged prostate gland you have a bowel problem such as Crohns disease or a blockage of your bowel you are elderly you have alcoholic liver disease. Taking other medicines: Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buy without a prescription. This is especially important if you are taking: blood thinning medicines e.g. warfarin CNS depressants such as sleeping tablets, sedatives or tranquillisers metoclopramide or domperidone (for feeling or being sick, indigestion) chloramphenicol (to treat infections) oral contraceptives colestyramine (for high cholesterol levels).
Other special warnings:
This medicine is not recommended for children under 6 years of age.
Do not take for longer than directed by your prescriber aking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when T you stop taking the tablets Taking a painkiller regularly for headaches too often or for too long can make them worse. Pregnancy and breast feeding: Consult your doctor if you are pregnant or breast feeding. Usually it is safe to take Co-codamol while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice: feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.
Measure bar should be 150mm at 100% scale Customer Description Item Code Profile Size Min. Point Size Market Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clients brief, t he final responsibility must be taken by our client. If you sign this proof you are signifying full approval of design and text. Language Proof By Proof No. Date Artwork No. Crescent Pharma Co-Codamol Tablets 500mg PIL (POM) Colours Used Black Keyline (non-printing)
P0215T
-
210 x 297mm 9pt UK English Michael Casingena Two 08/11/2012
431446
Pharma Code
N/A
Effects on driving or operating machinery: This medicine may cause drowsiness or dizziness. Do not drive or operate machinery if the medicine has this effect on you. Alcohol: Avoid drinking alcohol while you are taking this medicine the effect of alcohol may be increased.
3.How to take Co-Codamol Tablets
Swallow the tablets whole with water. Adults: The usual dose for adults is one to two tablets every 4 to 6 hours as required. ALWAYS leave at least 4 hours between doses. DO NOT take more than four doses (eight tablets) in 24 hours. Children: The usual dose for children between 6 and 12 years is half to one tablet every 4 to 6 hours. ALWAYS leave at least 4 hours between doses. DO NOT give the child more than four doses (maximum of four tablets) in 24 hours. This medicine is not recommended for children under 6 years of age. Your doctor will decide the dose that is best for you. The pharmacists label will also tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist. DO NOT exceed the recommended dose. If you forget to take a dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSE. If you have taken too many tablets: If you think you have taken too many tablets, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified. 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.
4.Possible side effects
Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcard alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday-Friday) or fill in a paper form available from your local pharmacy. If any of the following effects occur STOP TAKING the tablets IMMEDIATELY and contact your doctor straightaway: llergic reaction such as skin rash, difficulty swallowing or breathing, dizziness or swelling of the face, lips, throat or tongue. a If any of the following effects occur tell your doctor or pharmacist: eduction in the numbers of white blood cells or in blood platelets, resulting in an increased risk of bleeding or bruising, r and making infections more likely inflammation of the pancreas, which causes severe pain in the abdomen and back drowsiness, dizziness, light-headedness, confusion nausea and vomiting (feeling or being sick), constipation loss of hearing difficulty in passing urine addiction and tolerance may occur when codeine is taken regularly for a long time.
5.How to store Co-Codamol Tablets
Keep this medicine in the original package and protect from heat, light and moisture. Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal. KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
6.Further information
Ingredients: Each tablet contains 500mg Paracetamol and 8mg Codeine Phosphate as the active ingredients. The tablets also contain the inactive ingredients maize starch, povidone, pregelatinised starch and magnesium stearate. What the medicine looks like: The tablets are white and round with a bar and A459 engraved on one face and company logo on the other. This medicine is available in pack sizes of 10, 12, 20, 24, 30, 50, 100, 250, 500 and 1000 tablets. (Not all pack sizes may be marketed). Who makes this medicine and holds the Product Licence: Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED Date leaflet revised: October 2012 If you would like this leaflet in a different format please contact the licence holder at the above address.
Measure bar should be 150mm at 100% scale Customer Description Item Code Profile Size Min. Point Size Market Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clients brief, t he final responsibility must be taken by our client. If you sign this proof you are signifying full approval of design and text. Language Proof By Proof No. Date Artwork No. Crescent Pharma Co-Codamol Tablets 500mg PIL (POM) Colours Used Black Keyline (non-printing)
P0215T
-
210 x 297mm 9pt UK English Michael Casingena Two 08/11/2012
431446
Pharma Code
N/A
PATIENT INFORMATION LEAFLET
CO-CODAMOL TABLETS Codeine Phosphate 8mg, Paracetamol 500mg
Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 Tablets are and what they are used for 2. Before you take Co-Codamol Tablets 3. How to take Co-Codamol Tablets 4. Possible side effects 5. How to store Co-Codamol Tablets 6. Further information
1.What Co-Codamol Tablets are and what they are used for
The name of this medicine is Co-Codamol. Each tablet contains Paracetamol and Codeine Phosphate as the active ingredients. Codeine belongs to a group of medicines called opioid analgesics which act directly in the central nervous system (CNS) to relieve pain. Paracetamol is used to relieve pain and reduce fever. Co-Codamol is used for the relief of mild to moderate pain and to bring down temperature in some feverish conditions.
2.Before you take Co-Codamol Tablets
Do not take these tablets if: you are allergic to codeine or paracetamol or to any of the ingredients (see section 6) you have sudden severe asthma attacks or have any difficulty breathing you have recently had a head injury or have increased pressure in your head you have recently had an operation on your liver, gall bladder or bile duct ou are taking or have taken in the last 2 weeks any medicines called monoamine oxidase inhibitors (MAOIs) e.g. y moclobemide, phenelzine which are used to treat depression you are an alcoholic. Check with your doctor before taking these tablets if: your liver and kidney are not functioning well, especially if you are an elderly person you have an enlarged prostate gland you have a bowel problem such as Crohns disease or a blockage of your bowel you are elderly you have alcoholic liver disease. Taking other medicines: Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buy without a prescription. This is especially important if you are taking: blood thinning medicines e.g. warfarin CNS depressants such as sleeping tablets, sedatives or tranquillisers metoclopramide or domperidone (for feeling or being sick, indigestion) chloramphenicol (to treat infections) oral contraceptives colestyramine (for high cholesterol levels).
Other special warnings:
This medicine is not recommended for children under 6 years of age.
Do not take for longer than directed by your prescriber aking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when T you stop taking the tablets Taking a painkiller regularly for headaches too often or for too long can make them worse. Pregnancy and breast feeding: Consult your doctor if you are pregnant or breast feeding. Usually it is safe to take Co-codamol while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice: feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.
Measure bar should be 150mm at 100% scale Customer Description Item Code Profile Size Min. Point Size Market Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clients brief, t he final responsibility must be taken by our client. If you sign this proof you are signifying full approval of design and text. Language Proof By Proof No. Date Artwork No. Crescent Pharma Co-Codamol Tablets 500mg PIL (POM) Colours Used Black Keyline (non-printing)
P0215T
-
210 x 297mm 9pt UK English Michael Casingena Two 08/11/2012
431446
Pharma Code
N/A
Effects on driving or operating machinery: This medicine may cause drowsiness or dizziness. Do not drive or operate machinery if the medicine has this effect on you. Alcohol: Avoid drinking alcohol while you are taking this medicine the effect of alcohol may be increased.
3.How to take Co-Codamol Tablets
Swallow the tablets whole with water. Adults: The usual dose for adults is one to two tablets every 4 to 6 hours as required. ALWAYS leave at least 4 hours between doses. DO NOT take more than four doses (eight tablets) in 24 hours. Children: The usual dose for children between 6 and 12 years is half to one tablet every 4 to 6 hours. ALWAYS leave at least 4 hours between doses. DO NOT give the child more than four doses (maximum of four tablets) in 24 hours. This medicine is not recommended for children under 6 years of age. Your doctor will decide the dose that is best for you. The pharmacists label will also tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist. DO NOT exceed the recommended dose. If you forget to take a dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSE. If you have taken too many tablets: If you think you have taken too many tablets, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified. 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.
4.Possible side effects
Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcard alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday-Friday) or fill in a paper form available from your local pharmacy. If any of the following effects occur STOP TAKING the tablets IMMEDIATELY and contact your doctor straightaway: llergic reaction such as skin rash, difficulty swallowing or breathing, dizziness or swelling of the face, lips, throat or tongue. a If any of the following effects occur tell your doctor or pharmacist: eduction in the numbers of white blood cells or in blood platelets, resulting in an increased risk of bleeding or bruising, r and making infections more likely inflammation of the pancreas, which causes severe pain in the abdomen and back drowsiness, dizziness, light-headedness, confusion nausea and vomiting (feeling or being sick), constipation loss of hearing difficulty in passing urine addiction and tolerance may occur when codeine is taken regularly for a long time.
5.How to store Co-Codamol Tablets
Keep this medicine in the original package and protect from heat, light and moisture. Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal. KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
6.Further information
Ingredients: Each tablet contains 500mg Paracetamol and 8mg Codeine Phosphate as the active ingredients. The tablets also contain the inactive ingredients maize starch, povidone, pregelatinised starch and magnesium stearate. What the medicine looks like: The tablets are white and round with a bar and A459 engraved on one face and company logo on the other. This medicine is available in pack sizes of 10, 12, 20, 24, 30, 50, 100, 250, 500 and 1000 tablets. (Not all pack sizes may be marketed). Who makes this medicine and holds the Product Licence: Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED Date leaflet revised: October 2012 If you would like this leaflet in a different format please contact the licence holder at the above address.
Measure bar should be 150mm at 100% scale Customer Description Item Code Profile Size Min. Point Size Market Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clients brief, t he final responsibility must be taken by our client. If you sign this proof you are signifying full approval of design and text. Language Proof By Proof No. Date Artwork No. Crescent Pharma Co-Codamol Tablets 500mg PIL (POM) Colours Used Black Keyline (non-printing)
P0215T
-
210 x 297mm 9pt UK English Michael Casingena Two 08/11/2012
431446
Pharma Code
N/A
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
