Co-Codamol Effervescent Tablets
PATIENT INFORMATION LEAFLET CO-CODAMOL EFFERVESCENT TABLETS 8/500 mg
The name of this medicine is Co-codamol Effervescent Tablets 8/500 mg, which will be referred to as
Co-codamol 8/500 throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.
• You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice.
• This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it.
• If you take this medicine for headaches for more than three days it can make them worse.
• 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. 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 8/500 are and what they are used for
2. Before you take Co-codamol 8/500
3. How to take Co-codamol 8/500
4. Possible side effects
5. How to store Co-codamol 8/500
6. Further information
The active ingredients in Co-codamol 8/500 are paracetamol and codeine phosphate hemihydrate. Codeine can be used in children over 12 years of age for 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 pain killers. It is used to relieve muscular and rheumatic pains, headache, migraine, neuralgia (severe burning or stabbing pain following the line of a nerve), toothache and period pains.
2. BEFORE YOU TAKE CO-CODAMOL 8/500
This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it. If you take this medicine for headaches for more than three days it can make them worse.
Do not take Co-codamol 8/500 if you:
• know that you metabolise very rapidly codeine into morphine
• are breast feeding
• are a child or adolescents for pain relief (0-18 years of age) after removal of your tonsils or adenoids due to obstructive sleep apnoea syndrome
• are a child under the age of 12 years old
• are allergic (hypersensitive) to paracetamol, codeine or any of the other ingredients in the tablets (these are listed in Section 6, Further Information)
• have a dependency to alcohol
• have difficulty breathing or other chronic lung disease Page 1
• are having an asthma attack
• have bowel problems
• have raised intracranial pressure or head injury
Take special care with Co-codamol 8/500 if you:
• have an under-active thyroid gland
• have a disease of the Adrenal gland called Addison's disease
• have a condition which weakens the muscles called myasthenia gravis
• are elderly
• feel weak
• are debilitated
• are already taking other medicines containing paracetamol
• have liver or kidney problems
• are on a low sodium diet
The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
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: 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.
Taking other medicines
Do not take these tablets if you are already taking other medicines containing paracetamol.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as they may decrease or increase the effect of Co-codamol 8/500:
• metoclopramide or domperidone (often taken for sickness or stomach problems)
• colestyramine (for high blood lipid levels)
• anticoagulants to reduce blood clotting (e.g. warfarin)
• MAOI's and CNS depressants such as sleeping tablets, sedatives and some antihistamines
It may still be all right for you to take Co-codamol 8/500 and your doctor will be able to decide what is suitable for you.
Taking your medicine with food and drink
Co-codamol 8/500 should be dissolved in at least half a glass of water and can be taken with or without a meal.
Pregnancy, breast-feeding and fertility
Although there is no evidence that these tablets cause any ill effects during pregnancy, your doctor should advise you about taking them if you are pregnant.
Do not take codeine while you are breast feeding. Codeine and morphine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machinery
These tablets may make you feel dizzy or drowsy and If this happens do not drive or operate machinery.
Important information about some of the ingredients of Co-codamol 8/500
Each of these tablets contains about 438 mg of sodium and may interfere if you are on a low sodium diet.
This product also contains aspartame (a source of phenylalanine), which should not be given to anyone with phenylketonuria.
Do not take for more than three days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist.
Dosage
The usual doses for Co-codamol 8/500 is as follows:
Adults:
Should take 1 or 2 tablets dissolved in water every 4-6 hours, as needed. Do not take more than 8 tablets in 24 hours.
Children over 12 years:
Children aged 12 years and above should take 1 or 2 tablets dissolved in water 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. Do not exceed the recommended dose.
Co-codamol 8/500 should not be taken by children below the age of 12 years, 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 8/500 than you should
Talk to your 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. Remember to take the pack and any remaining tablets with you.
If you are giving this medicine to a child, immediate medical advice should be sought in the event of overdose, even if the child seems well, because of the risk of delayed, serious liver damage.
If you forget to take Co-codamol 8/500
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.
Withdrawal symptoms:This medicine contains codeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms. If you have any further questions about this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
• Skin rashes
• Constipation
• Nausea, vomiting
• Light-headedness, dizziness
• Confusion
• Drowsiness
• Urinary retention
• Rarely pancreatitis (inflammation of the pancreas which may cause severe abdominal pain that can spread through to your back)
There has been very rare reports of blood problems, so if you notice unusual bleeding or you bruise easily, tell your doctor as soon as possible.
How do I know if I am addicted?
If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:
• You need to take the medicine for longer periods of time
• You need to take more than the recommended dose
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
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 all medicines out of the sight and reach of children.
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.
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.
If you get any of the following symptoms after taking these tablets, you should contact your doctor immediately:
• Any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
• An acute allergic reaction (anaphylaxis) or swelling of the skin.
The following effects have been reported:
• Mood changes
• Severe stomach pains (pancreatitis)
• Stomach pains
• Deafness
• Problems with the blood (thrombocytopenia and agranulocytosis). This is usually shown by tiredness,
weakness, or unexplained bruising or bleeding. This side effect is very rare. Page 3
What Co-codamol 8/500 mg Effervescent Tablets contain:
The active ingredients are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500mg paracetamol and 8mg 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 8/500 look like and the contents of the pack:
Co-codamol 8/500 mg Effervescent Tablets are white, circular, with a flat bevelled edge and plain on both sides.
Your medicine is available in blister packs of 7, 10, 14, 28, 30 and 32 tablets (not all pack sizes may be marketed).
Marketing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK.
Manufacturer responsible for batch release:
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
This leaflet was last approved in June 2015. bxp028fuc Page 4