Co-Codamol 30/500mg Effervescent Tablets
What is in this leaflet:
1. What Co-codamol 30/500 is and what it is used for
2. What you need to know before you take Co-codamol 30/500
3. How to take Co-codamol 30/500
4. Possible side-effects
5. How to store Co-codamol 30/500
6. Contents of the pack and other information
Package leaflet: Information for the user Co-codamol 30mg/500mg effervescent tablets.
Codeine phosphate/paracetamol
The name of this medicine is Co-codamol 30mg/500mg Effervescent Tablets, which will be referred to as Co-codamol 30/500 throughout this leaflet.
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 further questions, please ask your doctor or your 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. See Section 4.
1. What co-codamol 30/500 is and what it is used for
The active ingredients in Co-codamol 30/500 are codeine and paracetamol.
This medicine 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 pain killers such as paracetamol.
Co-codamol 30/500 are used for the relief of severe pain.
Codeine 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 30/500
Important things you should know about Co-codamol 30/500
Do not take for longer than your doctor tells you to
Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.
Taking a painkiller for headaches too often or for too long can make them worse Do not take Co-codamol 30/500 if you:
• are allergic to paracetamol, codeine or any of the other ingredients of this 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.
• are already taking other medicines containing paracetamol i.e. over-the-counter cold remedies
• have a dependency to alcohol
• suffer from severe asthma attacks or severe breathing problems
• have recently had a head injury
• have been told by doctor that you have increased pressure in your head.
Signs of this include: headache, being sick (vomiting) and blurred eyesight
• have recently had a operation on your liver, gall bladder or bile duct (biliary tract)
• are taking medicine to treat depression on called MAOIs (monoamine oxidase inhibitors) or have taken them in the last 2 weeks, MAOIs are medicines such as moclobemide, phenelzine or tranylcypromine (see "Other medicines and Co-codamol 30/500")
• 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
• know that you metabolise very rapidly codeine into morphine
• are breastfeeding
Do not take Co-codamol 30/500 if any of the above apply to you.
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Warnings and precautions
Talk to your doctor or pharmacist before taking Co-codamol 30/500
• If you have severe liver or kidney problems.
• Do not take for longer than directed by your doctor or pharmacist.
• Taking codeine regularly for a long period of time can lead to addiction, which might cause you to feel restless and irritable when you stop taking the tablets.
• Taking a painkiller for headaches too often or for too long can make them worse.
• if you are elderly.
• if you have problem passing water or prostate problems
• if you have a bowel problems such as colitis or Crohn's disease or a blockage of your bowel.
• 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.
Other medicines and Co-codamol 30/500
Do not take these tablets if you are already taking other medicines containing 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.
Tell your doctor or pharmacist if you are taking, have recently or might take any other medicines, including medicines obtained without a prescription, as they may decrease or increase the effect of Co-codamol 30/500:
• metoclopramide or domperidone (often taken for sickness or stomach problems)
• colestyramine (for high blood lipid levels)
• anticoagulants to reduce blood clotting (e.g. warfarin)
• CNS depressants such as sleeping tablets, sedatives and some antihistamines.
• MAOI's should not be taken concurrently or within 14 days of Co-codamol 30/500 treatment.
• Chloramphenicol - an antibiotic used for infections
• The oral contraceptive pill
It may still be all right for you to take Co-codamol 30/500 and your doctor will be able to decide what is suitable for you.
Co-codamol with food and drink
Co-codamol 30/500 should be dissolved in at least half a glass of water and can be taken with or without a meal.
• 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Co-codamol if you are in the last three months of pregnancy or in labor.
Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
These tablets may make you feel dizzy or drowsy. If this happens do not drive or operate machinery.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
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• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and o 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
Co-codamol 30/500 contains sodium and aspartame.
Each tablet contains about 438 mg of sodium and may interfere if you are on a low sodium diet.
This medicine also contains aspartame (a source of phenylalanine), which should not be given to anyone with phenylketonuria.
3. How to take co-codamol 30/500
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure
Do not exceed the recommended doses. If painful symptoms are not relieved in a few days, consult your doctor.
Dosage
Adults and children over 16
The usual doses for Co-codamol 30/500 are as follows:
• The usual dose of co-codamol is 2 effervescent tablets, taken together
• adults should wait at least 4 hours before taking another dose
• Children aged 16 years and over should wait at least 6 hours before taking another dose
• Do not take more than 8 effervescent tablets in any 24 hour period
• Elderly people may be prescribed a lower dose.
This medicine should not be taken for more than 3 days. If the pain does not improve after days, talk to your doctor for advice.
Children aged 12 years to 15 years
• The recommended dose is 1 effervescent tablet dissolved in water every 4 to 6 hours as needed.
• Do not take more than 4 effervescent tablets in any 24 hour period.
Use in children
Co-codamol should not be given to children under 12 years of age due to the risk of severe breathing problems.
Method of Administration
For oral administration only. These tablets should be dissolved in at least half a glass of water before taking them. The solution should be drunk immediately after preparation. These tablets are meant to be dissolved first so don't try to swallow them whole.
If you take more Co-codamol 30/500 than you should:
If you have accidentally taken more than your prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. This is so the doctor knows what you have taken.
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.
If you forget to take Co-codamol 30/500
If you forget to take one or more doses, take your next dose when you remember and then go on as prescribed. Do not take a double dose to make up for a forgotten dose.
If you have any further questions about this medicine ask your doctor or pharmacist.
4. possible side-effects
Like all medicines, Co-codamol 30/500 can cause side-effects although not everybody gets them. Important side effects you should know about Co-codamol 30/500
• Taking a painkiller for headache 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 the tablets Page 3
Stop taking Co-codamol 30/500 and see a doctor or get to a hospital straight away:
• if you get get swelling of the hands, feets, ankles, face, lips or throat which may cause difficulty in swallowing or breathing.
• 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.
• Very rare cases of serious skin reactions have been reported.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:
• Skin rashes
• Constipation
• Nausea, vomiting
• Light-headedness, dizziness,
• Confusion
• Drowsiness
• Difficulty in passing urine (urinary retention)
• 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)
• Difficulty breathing, wheezing, tightness in the chest (bronchospasm)
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 30/500
Do not store your tablets above 25°C. Store in a dry place and protect from light.
Do not take this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Do not dispose of medicines by flushing down a toilet or sink or by throwing out with your normal household rubbish.
Store your medicine in the original packaging in order to protect from moisture.
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 to protect the environment.
6. Contents of the pack and other information
What Co-codamol 30/500 contains
The active ingredients are paracetamol and codeine. Each tablet contains 500mg paracetamol and 30mg codeine phosphate hemihydrate.
The other ingredients are sodium hydrogen carbonate, citric acid anhydrous, sodium carbonate, povidone, simeticone, sodium saccharin, aspartame (E951) and polysorbate 80.
What Co-codamol 30/500 look like and the contents of the pack:
Co-codamol 30/500 are white, circular, with a flat bevelled edge and plain on both sides.
Your medicine is available in blister packs of 30, 32, 56, 60, 84, 90 and 100 tablets (not all pack sizes may be marketed)
Marketing Authorisation Holder and Manufacturer:
The Product Licence holder is Cipla (EU) Limited, Hillbrow House, Hillbrow Road,
Esher, Surrey, KT10 9NW, United Kingdom.
The manufacturers responsible for batch release:
Cipla (EU) Limited, 20 Balderton Street, London, W1K 6TL, United Kingdom.
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium
This leaflet was last revised in 10/2016. Cipla
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Date: 17-10-2016
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