Co-Codamol 8/500mg Tablets
Package leaflet: Information for the user Co-codamol 8mg/500mg Tablets Codeine phosphate and paracetamol
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, ask your doctor or 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.
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 8mg/500mg Tablets. The active ingredients in Co-codamol are paracetamol and codeine phosphate. This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. Codeine can be used in combination with other pain killers such as paracetamol.
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. For the symptomatic relief of colds and flu and pain including headache, migraine, toothache, period pains, rheumatic pains, including muscle pains and backache.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL
If you take a painkiller for headaches for more than three days it can make them worse.
Do not take Co-codamol if:
• You are allergic (hypersensitive) to paracetamol, codeine, other opioid analgesics or any of the other ingredients in Co-codamol Tablets. Co-codamol Tablets contain parahydroxybenzoates (E218, E214 and E216), which may cause allergic reactions (possibly delayed). Refer to section 4 (possible side effects) for the signs and symptoms of an allergic reaction.
• You drink excessive amounts of alcohol.
• You have severe problems with breathing.
• You have recently had a head injury or have increased pressure within your head (raised intracranial pressure).
• You are in a coma
• You have been told you have liver disease.
• You are under 12 years of age.
• You are at risk from intestinal paralysis or have a swollen abdomen.
• You are suffering from severe diarrhoea.
• You are taking any other paracetamol or paracetamol-containing products.
• 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
• If you know that you metabolise very rapidly codeine into morphine
• If you are breastfeeding
Take special care with Co-codamol
Before taking this medicine, you need to know the following:
This product contains paracetamol.
• Do not take with any other paracetamol containing products.
• If your symptoms last for more than 3 days talk to your doctor.
• 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 the tablets.
• Taking a painkiller for headaches too often or for too long can make them worse.
Talk to your doctor or pharmacist before taking Co-codamol if:
• You are pregnant or breast-feeding (see ‘Pregnancy and breast-feeding' below).
• You have asthma, bronchitis or emphysema. If your asthma is controlled you can take co-codamol tablets, but use with care, especially if your asthma is known to be made worse by aspirin or other painkillers. You should not take codeine if you are having an acute asthma attack.
• You have serious problems with your liver or kidneys.
• You have an under active thyroid (hypothyroidism) or adrenal glands.
• You have an enlarged prostate (men) or have difficulty passing water.
• Your alcohol consumption is excessive.
• You suffer from low blood pressure, are in a state of severe shock or very run down.
• You are elderly
• You have inflammation of the bowel or a blockage of the bowel
• You suffer from myasthenia gravis (a disease characterised by weakness of certain groups of muscles)
• You suffer from biliary tract disorders such as gallstones
• You are a poor metaboliser of codeine
• You suffer from convulsions or have a seizure disorder (fits).
• You have had a drug addiction.
If you go into hospital for surgery or tests, tell your doctor you are taking co-codamol tablets, as they may interact with some anaesthetics and influence the results of certain tests and diagnostic procedures.
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.
Caution should be exercised when taking paracetamol products prior to (less than 72 hours before) or at the same time as intravenous busulfan.
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
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have bought yourself without a prescription.
In particular you should tell your doctor if you are taking any of the following:
• Paracetamol or paracetamol-containing products.
• Barbiturates (to help you sleep or treat epilepsy).
• Anticonvulsants such as carbamazepine, phenobarbital, phenytoin and primidone (drugs used to treat epilepsy).
• Antidepressants (tricyclics or MAOIs).
• Antipsychotics such as chlopromazine and haloperidol (used to treat mental illnesses including schizophrenia).
• Anxiolytics (to help with anxiety).
• Hypnotics e.g. diazepam and nitrazepam (to help you sleep).
• Anaesthetics, particularly general anaesthetics (used in surgery to numb pain)
• Antihistamines such as benadryl (used to treat allergies e.g. hay fever)
• Sodium oxybate (used to treat narcolepsy)
• Sedatives (to help you relax).
• Colestyramine (used to lower cholesterol).
• Cisapride, metoclopramide or domperidone (used to help stop nausea and vomiting).
• Anticoagulants (medicines used to thin the blood, such as warfarin).
• Cimetidine (for stomach ulcers).
• Quinidine, mexiletine (used to regularise heart rhythm).
• Isoniazid (used to treat tuberculosis).
• Diflunisal (a painkiller).
• Oral contraceptives.
• Probenecid (used to treat gout).
• Antidiarrhoeals such as loperamide or kaolin.
• Intravenous busulfan (used in chemotherapy to treat cancer).
Taking Co-codamol with food, drink and alcohol
Do not drink alcohol while you are taking Co-codamol. Alcohol may increase the sedative effects of Co-codamol and make you very sleepy. It can also increase the risk of some side effects.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding you should talk to your doctor or pharmacist before taking any medicine.
Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.
Driving and using machines
Codeine may cause drowsiness or changes in vision, including blurred or double vision in some people. Do not drive or use any tools or machines if you are affected in this way and do not drink alcohol, as this will make these effects worse. Other medicines may also increase these effects.
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.
• 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.
3. HOW TO TAKE CO-CODAMOL
Always take Co-codamol tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is described below. These tablets are for oral administration. They should be swallowed with a glass of water.
Dosage instructions
Adults and children over 12 years: Take one to two tablets every four hours. Do not take more than eight tablets in 24 hours.
Elderly: Your doctor may have reduced the dose for you. If this is the case follow your doctor's instructions.
You may need a reduced dose if your kidney or liver is not working as well as it should be. You may also be given a reduced dose if you suffer from any of the conditions listed above in the section headed 'Talk to your doctor or pharmacist before taking Co-codamol if'.
Children under 12 years: Co-codamol tablets should not be taken by children below the age of 12 years due to the risk of severe breathing problems.
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.
If you take more Co-codamol than you should
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
Take your usual dose as soon as you remember, provided it is at least 4 hours since your last dose.
Never take a double dose to make up for a missed dose.
If you stop taking Co-codamol
This medicine contains codeine which 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.
4. POSSIBLE SIDE EFFECTS
It is very unlikely that you will experience the following side effects. However, you should stop taking this medicine and talk to your doctor immediately if you notice any of the following symptoms:
• You bruise more easily, have bleeding gums or bleed for longer after cutting yourself or you feel tired or look pale.
• You seem to be getting more infections than usual or you develop ulcers in your mouth or throat.
• You have a severe abdominal pain (in the upper middle or upper left part of the belly) usually accompanied by sickness, diarrhoea or fever.
• You have an allergic reaction. The signs of an allergic reaction may include: a rash, wheals or itching, difficulty breathing or swallowing, swelling of your lips, face, throat or tongue.
• You have problems with vision.
• You have mood changes (including depression, sadness and euphoria).
• You develop pancreatitis (inflammation of the pancreas)
• You suffer from hypothermia
• You suffer from biliary spasms (causing a pain in the right side of your abdomen, particularly after eating a meal)
• You develop hyperglycaemia (abnormally high levels of glucose in the blood)
• You suffer from miosis (constriction of the pupil in the eye)
• You develop an enlarged spleen or swollen/ enlarged lymph nodes
• You have increased pressure within your head (raised intracranial pressure)
• You suffer from a low sex drive
• You suffer from confusion, dizziness or vertigo.
• You have a dry mouth or a general feeling of discomfort.
• You seem to be getting more headaches (which can be made worse by taking co-codamol tablets for too long).
• You have respiratory depression, sweating, flushing.
• You develop anorexia.
• You have a slower or faster heartbeat, palpitations (irregular heartbeat) or low blood pressure (which may cause fainting).
• You develop blood problems (which may cause sore throat or fever).
• You suffer from convulsions, hallucinations, nightmares, uncontrolled muscle movements, restlessness, muscle rigidity, pain or difficulties when passing urine, weak erection in men.
• Very rare cases of serious skin reactions have been reported.
Other more common side effects that some people notice when taking Co-codamol are listed below:
• Constipation
• Nausea
• Drowsiness
• Vomiting
Patients with asthma that is made worse by aspirin or other painkillers may find that co-codamol tablets also cause wheezing. Taking high doses of paracetamol for a long time can cause kidney problems.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How do I know if I am addicted?
If you take this 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, 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
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton or blister. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package or container in order to protect from light and moisture. Never transfer medicines from one container to another.
Never take medicines from an unlabelled container.
This medicine is for you. Never offer your tablets to other people, even if their symptoms seem the same as yours, the tablets may not be suitable for their use.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Co-codamol contains
The active substances are paracetamol, 500mg and codeine phosphate, 8mg.
The other ingredients are maize and potato starch, povidone, stearic acid, talc, magnesium stearate, methyl-p-hydroxy benzoate (E218), ethyl-p-hydroxy benzoate (E214) and propyl-p-hydroxy benzoate (E216)).
What Co-codamol looks like and contents of the pack
Co-codamol Tablets are white round tablets.
Packs of 48, 50, 96 and 100 tablets are only available on prescription from a doctor. Packs of 250, 500 and 1000 tablets are dispensary packs only.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following information:
|
Product name |
Reference number |
|
Co-codamol 8mg/500mg Tablets |
29831/0432 |