Co-Codamol 30mg/500mg Tablets
130 mm
24 mm
Package leafletiinformation for the user
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 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.
What is in this leaflet:
O What Co-codamol Tablets are and what they are used for 0 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
The name of your medicine is Co-Codamol 30 mg/500 mg Tablets. Co-codamol Tablets contains two different medicines called paracetamol and codeine phosphate. 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. 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 such as paracetamol.
Do not take Co-codamol Tablets:
• if you are allergic to paracetamol, codeine or to any of the other ingredients of this medicine (listed in section 6)
• if you have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis)
• if you have difficulty breathing, or other chronic lung disease
• if you are having an asthma attack
• 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 breast-feeding.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Co-codamol
Tablets if you have:
• liver or kidney problems
• 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 illnessl
Important things you should know about Co-codamol Tablets
• 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.
• 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 Co-codamol 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
Co-codamol 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 Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:
• ciprofloxacin (antibacterial medicine)
• monoamine oxidase inhibitors (MAOIs, e.g. modobemide)
• 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
• 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) Co-codamol Tablets with food, drink and alcohol
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.
Do not drink alcohol whilst taking Co-codamol tablets. Pregnancy, Breast-feeding and Fertility Pregnancy
Ifyou are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.
Breast-feeding
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: g
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- 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. If you feel dizzy or sleepy, do not use any tools or machines.
Co-codamol Tablets contain sodium metabisulfite
• Co-codamol Tablets contain sodium metabisulfite (E223) which may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (tightening of the airways)
• Co-codamol Tablets contain 0.345 mg of sodium per dose. This should be taken into consideration by patients on a controlled sodium diet
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice.
Method of administration:
• Take this medicine by mouth.
• Swallow the tablets whole with a drink of water.
Doses:
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.
Adults:
The recommended dose is 1 to 2 tablets for at least 4 hours before taking another dose. Do not take more than 8 tablets in 24 hours.
Elderly: lower doses may be more suitable.
Children aged 16 years to 18 years:
Children aged 16 years or above should take 1 to 2 tablets every 6 hours, as needed. Do not take more than 8 tablets in 24 hours.
Children aged 12 years to 15 years:
The recommended dose for children aged 12 years to 15 years is 1 tablet every 6 hours when needed. Do not take more than 4 tablets in 24 hours.
Children under 12 years of age: Co-codamol should not be taken by children below the age of 12 years, due to risk of severe breathing problem. 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 Tablets 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.
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 forget to take Co-codamol Tablets Ifyou forget to take a dose at the right time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Co-codamol Tablets
If you stop taking the tablets you may develop the following withdrawal symptoms tremor, 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.
Ifyou have any further questions on the use of this medicine, ask your doctor or pharmacist.
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) and inflammation of the liver or pancreas.
• Heart - slow heart rate, palpitations, low blood pressure, inflammation of the heart muscle.
• 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 or have more infections talk to your doctor.
• 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, fits, increased pressure in the skull (painful eyes, changes in vision or headache behind the eyes), headache, difficulty sleeping, nightmares, reduced alertness, tolerance (medicine has less effect) or dependence (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).
• 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.
• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Store in the original package.
• Do not use this medicine after the expiry date (EXP.) as shown on the carton. 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.
What Co-codamol Tablets contain
• Each tablet contains 30 mg of codeine phosphate and 500 mg of paracetamol
• The other ingredients are: pregelatinised maize starch, microcrystalline cellulose, sodium starch glycolate, sodium metabisulfite (E223), magnesium stearate.
What Co-codamol Tablets look like and contents ofthe pack
• White to off white capsule shaped biconvex uncoated plain tablets, debossed with '30' on one side and 'BL' on other side.
• They are available in packs of 8's, 10's, 16's, 20's, 30's, 32's and 100's tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Limited
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 30 mg/500 mg Tablets; PL 17907/0235
This leaflet was last revised in September 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.
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Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Allergic Reactions - skin rash or itchy skin, difficulty breathing, increased sweating, redness or flushed face, mucosal lesions (such as mouth ulcers), drug fever Stop taking Co-Codamol tablets and seek medical attention if you notice any of the symptoms listed.
• Gastrointestinal system - stomach irritation (mild stomach pain, heartburn and feeling sick), constipation, feeling or
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