Co-Codamol 8mg/500mg Tablets
24 mm
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, please 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. See section 4.
In this leaflet:
1. What Co-codamol Tablets are and what they are used for
2. What you need to know 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. Contents of the pack and other information
1. What Co-codamol Tablets are and what they are used for
• Co-codamol contains two different medicines called codeine phosphate and paracetamol. Co-codamol tablets belong to a group of medicines called analgesics, which act to relieve pain. Co-codamol 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 Tablets
Important information:
• 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 regularly for headaches too often or for too long can make them
worse.
Do not take these tablets 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
• know that you metabolise very rapidly codeine into morphine
• are breast-feeding
• have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis)
• have difficulty breathing, or other chronic lung disease
• are having an asthma attack.
Warning and precautions:
Talk to your doctor or pharmacist before taking this medicine Take special care with this medicine if you have:
• liver or kidney problems (especially if severe)
• diseased adrenal glands (Addison's disease) or high blood pressure caused by a tumour near a kidney (phaeochromocytoma)
• inflammatory bowel disease
• gall bladder disease or gall stones
• recently had surgery on your gastro-intestinal tract or urinary system
• an enlarged prostate gland and have difficulty urinating and are male
• epilepsy or suffered head injury or raised pressure in the skull (may cause painful eyes, changes in vision or headache behind the eyes)
• an underactive thyroid gland
• muscle weakness (myasthenia gravis)
• low blood pressure or are in shock
• suffered from alcoholism, drug abuse or dependence or mental illness.
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
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:
• ciprofloxacin, isoniazid (antibacterial medicine)
• diflunisal (pain killer)
• probenecid (used to treat gout)
• Monoamine Oxidase Inhibitors (MAOIs, e.g. moclobemide)
• oral contraceptives (the "pill”)
• medicines to prevent blood clotting such as warfarin
• cyclizine, metoclopramide or domperidone (to prevent sickness)
• guanethidine or diuretics ("water tablets”) e.g. spironolactone, furosemide (to treat high blood pressure)
• mexiletine (to treat irregular heartbeats)
• loperamide or kaolin (to treat diarrhoea)
• selegiline (for Parkinson's disease)
• phenytoin (to treat epilepsy)
• cimetidine (to treat stomach ulcers)
• atropine or hyoscine (anticholinergic medicines)
• cisapride (to treat gastro-oesophageal reflux disease)
• medicines which affect the nervous system such as sleeping tablets, diazepam, hydroxyzine and medicines to treat mental illness such as chlorpromazine and haloperidol
• medicines to treat depression (e.g. tranylcypromine, amitriptyline)
• medicines which affect the liver (e.g. primidone and rifampicin)
• colestyramine (to treat high cholesterol levels)
• muscle relaxants
• barbiturates (e.g. phenobarbital)
• anaesthetics
• opioid antagonists (buprenorphine, naltrexone, naloxone)
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.
Diet
If your diet is poor or you have a low protein intake, you may be at a higher risk of serious paracetamol poisoning when taking Co-codamol tablets.
Taking this medicine with alcohol
Do NOT drink alcohol whilst taking Co-codamol Tablets.
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 while you are breast-feeding. Codeine and morphine passes into breast milk.
Driving and using machines
Co-codamol tablets may cause dizziness, blurred vision or the inability to think clearly. Make sure you are not affected before you 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.
• 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.
Co-codamol tablets contain Benzoates
• This medicine contains parahydroxybenzoates (E218-Methyl para hydroxy benzoate, E216-Propyl para hydroxy benzoate, E214- Ethyl para hydroxy benzoate), which may cause allergic reactions (possibly delayed).
130 mm
430 mm
COCODAMOL Tablets INSERT
SAME SIZE ARTWORK
430 x 130 mm
Front
3. How to take Co-codamol Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended 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 (4.0g 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.
Elderly: Dosage may be reduced in the elderly with liver problems.
Do not exceed the stated dose.
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.
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick, loss of appetite, stomach pain or liver damage, coma, pale or clammy skin, fits, confusion, drowsiness, tiredness, low blood pressure, pinpoint pupils, slow heart beat or breathing rate.
If you stop taking Co-codamol tablets
If you stop taking the tablets you may develop the following withdrawal symptoms.
difficulty sleeping, feeling or being sick, sweating and increased heart rate, breathing or blood pressure.
Contact your doctor for advice on how to stop taking Co-codamol tablets gradually to avoid withdrawal symptoms.
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
DEPENDENCE: Taking codeine regularly for a long time can lead to addiction, which might lead to withdrawal symptoms when you stop the tablets.
4. Possible Side Effects
Like all medicines, Co-codamol Tablets can cause side effects, although not everybody gets them.
Stop taking this medicine and talk to your doctor straightaway if you notice any of the following side effects:
• Allergic Reactions - skin rash or itchy skin, difficulty breathing, increased sweating, redness or flushed face, mucosal lesions (such as mouth ulcers), drug fever
• very rare cases of serious skin reactions have been reported.
• inflammation of the liver-symptoms include yellowing of the skin or whites of the eyes, abdominal pain, nausea, vomiting
• inflammation of the pancreas-symptoms include nausea, vomiting, diarrhoea, fever, abdominal pain
• Blood - anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice that you bruise more easily, have more infections, sudden sore throat, fever,mouth ulceration,tiredness talk to your doctor.
• Fits
• Increased pressure in the skull (painful eyes, changes in vision or headache behind the eyes
• Suffer from withdrawal symptoms e.g.tremor, difficulty sleeping, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly
Other side effects:
• Gastrointestinal system - stomach irritation (mild stomach pain, heartburn and
feeling sick), constipation, feeling or being sick, loss of appetite, dry mouth, difficulty in the passage of food through guts, abdominal pain (may be caused by spasm of the bile ducts)
• Heart - slow heart rate, palpitations, low blood pressure, inflammation of the heart muscle
• Urinary system - pain and difficulty in passing urine and a less frequent need to do so, kidney problems.
• Nervous system - confusion, drowsiness, dizziness, 'spinning' sensation, mood changes, depression, hallucinations (seeing or hearing things that are not real), restlessness, excitation, headache, difficulty sleeping, nightmares,reduced alertness, tolerance (medicine has less effect) or dependence
• Eyes - blurred or double vision, extremely small pupils
• Others - trembling, unusual tiredness or weakness, malaise, low body temperature
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 out of the sight and reach of children.
• Do not store above 250C. Store in the original package or container
• 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.
6. Contents of the pack and other information
What Co-codamol Tablets Contains
• The active substance is codeine phosphate and paracetamol
• The other ingredients are: maize starch, 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 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 48, 50, 96 and 100 tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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 17907/0478 This leaflet was last approved in July 2016
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 11-07-16 D0
130 mm
SAME SIZE ARTWORK
430 x 130 mm
Back
430 mm