Co-Codamol 8/500mg Tablets
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Pharmacode
PATIENT INFORMATION LEAFLET
CO-CODAMOL 8/500mg TABLETS
Codeine Phosphate, Paracetamol
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. This product contains Paracetamol and Codeine Phosphate in combination as the active ingredients. Paracetamol is used to relieve pain and reduce fever. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain.
Co-Codamol Tablets can be used in adults and children older than 12 years of age for the short-term treatment of moderate pain that is not relieved by other painkillers such as paracetamol and ibuprofen alone.
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
• you are taking or have taken in the last 2 weeks any medicines called monoamine oxidase inhibitors (MAOIs) e.g. moclobemide, phenelzine which are used to treat depression
• you are an alcoholic
• you know that you metabolise very rapidly codeine into morphine
• you are breastfeeding
• do not use for pain relief in children and adolescents
(0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome.
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 Crohn's 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:
• Do not take for longer than directed by your prescriber
• 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 a painkiller regularly for headaches too often or for too long can make them worse.
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:
Codeine 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:
Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.
Pregnancy and breast feeding:
Consult your doctor if you are pregnant. Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.
Driving and using machines:
The medicine can affect your ability to drive and operate machinery 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:
- 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 your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Alcohol:
Avoid drinking alcohol while you are taking this medicine - the effect of alcohol may be increased.
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Pharmacode |
3. How to take Co-Codamol Tablets 6. Further information Swallow the tablets whole with water. Ingredients: Adults and children aged 12 years or above: ^ach tablet contains 500mg Paracetanriol and 8mg Codeine Adults and children aged 12 years or above should take one to Phosphate as the active ingredients The tablets also contain two tablets every 6 hours, as needed. ALWAYS leave at least tbf'nh^J|l9n^r^ ’ Povldone’ pregelatmised 6 hours between doses. DO NOT take more than eight tablets in starch and magnesium stearate. 24 hours. What the medicine looks like: This medicine should not be taken for more than 3 days. If The tablets are white and round with a bar and A459 engraved the pain does not improve after 3 days, talk to your doctor for on one face and company logo on the other. advice. This medicine is available in pack sizes of 10,12, 20, 24, 30, Children below the age of 12 years: 1 “-J50- 500 and 1000 tablets' <Not a" Pack sizes maV be Co-Codamol Tablets should not be taken by children below the marKetecv- age of 12 years, due to the risk of severe breathing problems. Who makes this medicine and holds the Product Licence: Your doctor will decide the dose that is best for you. The Crescent Pharma Limited, Units 3 & 4, Quidhampton Business pharmacist’s label will also tell you how many tablets to take Units, Polhampton Lane, Overton, Hants, RG25 3ED and how often. If you are not sure about anything, ask your Date leaflet revised: May 2016 doctor or pharmacist. If yOU would like this leaflet in a different format please contact DO NOT exceed the recommended dose. the licence holder at the above address. 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 Like all medicines Co-Codamol can cause side effects, although not everybody gets them. If any of the following effects occur STOP TAKING the tablets IMMEDIATELY and contact your doctor straightaway: • allergic reaction such as skin rash, difficulty swallowing or breathing, dizziness or swelling of the face, lips, throat or tongue • slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite as these could be symptoms of high amounts of morphine. If any of the following effects occur tell your doctor or pharmacist: • reduction in the numbers of white blood cells or in blood platelets, resulting in an increased risk of bleeding or bruising, and making infections more likely • inflammation of the pancreas, which causes severe pain in the abdomen and back • drowsiness, dizziness, light-headedness • loss of hearing • difficulty in passing urine • addiction and tolerance may occur when codeine is taken regularly for a long time. • Very rare cases of serious skin reactions have been reported. 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. 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 SIGHT AND REACH OF CHILDREN |
