Co-Codamol 8mg/500mg Tablets
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24 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
Important things you should know about co-codamol
• 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 3 days at a time. If you need to take it for longer than 3 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 3 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 3 days it can make them worse
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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.
- You must talk to a doctor if you do not feel better or if you feel worse after three days.
What is in this leaflet:
Q What Co-Codamol Tablets are and what they are used for
El What you need to know before you take Co-codamol Tablets El How to take Co-Codamol Tablets El Possible side effects El How to store Co-Codamol Tablets El Contents of the pack and other information
• Co-codamol tablets contain a combination of two ingredients paracetamol and codeine phosphate. Paracetamol is a non-narcotic analgesic (pain killer) This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. Codeine can be used on its own or 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. It can be used to relieve pain caused by headache, migraine, toothache, period pain, muscular pains and backache.
• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it.
• If you take a painkiller for headaches for more than 3 days it can make them worse
Do not take Co-codamol:
• if you are allergic to paracetamol or codeine phosphate or any of the other ingredients of this medicine (listed in section 6)
• 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
Warnings and precautions
Take special care with this medicine and talk to your
pharmacist or doctor if you:
• suffer from kidney or liver problems
• have a liver problem caused by alcohol 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 ! This medicine contains paracetamol.
Do not take with any other paracetamol-containing products.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicines can affect Co-codamol:
• Other pain killers such as diflunisal
• Medicines to treat irregular heartbeats (e.g. mexiletine, quinidine)
• Medicines to prevent blood clotting (e.g. warfarin)
• Medicines to treat epilepsy (e.g. phenytoin, phenobarbital, primidone, carbamazepine)
• Medicines to treat ulcers (e.g. cimetidine)
• Medicines to reduce cholesterol in the blood (e.g. colestyramine)
• Antibacterial medicines (e.g. isoniazide)
• Oral contraceptives (the ‘pill')
• Medicines to treat gout (e.g. probenecid)
• Medicines to treat depression - such as monoamine oxidase inhibitors (MAOIs). Avoid Co-codamol tablets for 2 weeks after stopping the MAOIs
• Medicines to treat diarrhoea (e.g. loperamide, kaolin)
• Medicines to treat nausea or vomiting (e.g. metoclopramide or domperidone)
• Medicines to treat anxiety and insomnia (e.g. diazepam and nitrazepam)
• Medicines to treat mental illnesses including schizophrenia (e.g. chlorpromazine and haloperidol)
If you go into hospital for surgery or tests, tell your doctor you are taking Co-Codamol Tablets, as you may interact with some anaesthetics and influence the results of certain tests and diagnostic procedures.
Co-codamol tablets with food, drink and alcohol
• Do NOT drink alcohol whilst taking Co-Codamol Tablets.
Pregnancy, breast-feeding and fertility
• Do not take this medicine if you are pregnant, think you have become pregnant or intend to become pregnant whilst taking these tablets.
• 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 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 g your ability to drive.
260 mm
COCODAMOL Tablets INSERT
SAME SIZE ARTWORK
130 x 260 mm
Front
10 mm
• 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. Co-codamol tablets contain Benzoates
• This medicine contains ethyl hydroxybenzoate (E214), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), which may cause allergic reactions.
Always take co-codamol exactly as instructed on the leaflet
• You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
Adults over 18 years:
• The usual dose is one or two tablets to be swallowed with water.
• The dose should not be taken more frequently than every 4 hours and not more than 4 times in any 24 hour period.
• The maximum daily dose is 8 tablets (4g of paracetamol and 64mg of codeine phosphate) in any 24 hour period in divided doses.
Children aged 12 years to 18 years:
Children aged 12 years of above should take one to two tablets every 6 hours, as needed. Do not take more than 8 tablets in 24 hours.
Children aged less than 12 years:
Co-codamol 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.
This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your pharmacist if you are suffering from withdrawal symptoms.
Do not exceed the stated dose.
If symptoms persist consult your doctor.
If you take more Co-Codamol Tablets than you should Contact your nearest hospital A&E (casualty department) or your doctor immediately. 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.
Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.
Signs of overdose include difficulty in breathing; pupils may be pin-point in size, nausea, vomiting, loss of appetite and abdominal pain.
If you forget to take Co-Codamol Tablets
If you forget to take a dose, wait and take your next dose as usual.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE
• Yellowing of your skin or eyes and your urine becomes darker in colour. This could be a liver problem, such as jaundice or hepatitis
• A severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body or you develop skin blisters. You may also feel generally unwell, have a fever, chills and aching muscles.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:
• Constipation, feeling sick (nausea), being sick (vomiting)
• Dizziness, light-headedness, drowsiness, confusion
• Difficulty in passing water
• You get infections or bruise more easily than usual. This could be because of a blood problem.
• Becoming addicted to codeine 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.
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 to talk to your doctor,
• You need to take the medicine for longer periods of time.
• You need to take more than the recommended amount.
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again.
• Do not store above 250C. Store in the original package.
• Do not use these tablets after expiry date shown on the carton or label. The expiry date refers to the last day of that month.
• 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 protect the environment.
260 mm
Like all medicines, Co-Codamol Tablets can cause side effects, although not everybody gets them.
STOP taking and contact your doctor or go to a hospital straight away if you suffer from below conditions:
• itchy skin rash
• swelling of the face, lips, tongue or throat
• breathing difficulty or swallowing
Talk to your doctor straight away if you notice any of the following serious side effects:
• 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
What Co-Codamol Tablets contain
• The active substance is codeine phosphate and paracetamol
• The other ingredients are: maize starch, potato starch, povidone, stearic acid, talc, magnesium stearate, nipasept (nipasept contains: methyl-p-hydroxy benzoate (E218), ethyl-p-hydroxy benzoate (E214) and propyl-p-hydroxy benzoate (E216)).
What Co-Codamol Tablets look like and contents of the pack
• The tablets are white and round with a breakline on one side and <AB> debossed on the other side.
• They are available in packs of 8, 10, 12, 16, 20, 24, 28, 30 and 32 tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922 Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Co-Codamol 8mg/500mg Tablets; PL 17907/0162 This leaflet was last revised in June 2014
To request a copy of this leaflet in Braille, large print or audio format then please contact the licence holder at the address (or telephone, fax, email) above.
V7 07-06-14 D0
COCODAMOL Tablets INSERT
SAME SIZE ARTWORK
130 x 260 mm
Front
Kaypee Design