Co-Codamol 8/500mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Please read this leaflet carefully before you start to take Co-codamol 8/500 mg Capsules. It tells you some of the
more important things you should know. If you have any questions, or are unsure about anything, please ask your
occupational health department, doctor or pharmacist for advice.
• This medicine can only be used for the short term treatment of acute moderate pain when other painkillers have not worked.
• 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.
• 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
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
This product contains Codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. The product also contains the pain killer Paracetamol. Co-codamol Capsules are used in those over 12 years of age for:
• short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. For the relief of:
• headaches
• period pains
• migraine
• toothache
• neuralgia
• muscular and rheumatic pains.
2. What you need to know before you take Co-codamol
• You have Addison’s disease which can lead to weight loss, low blood pressure and bronzing of the skin
• You have phaeochromocytoma (a tumour near a kidney causing high blood pressure)
• You have an enlarged prostate gland which causes difficulty passing urine in men
• You have inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
• You have recently had surgery on your digestive system or urinary tract
• You have gall bladder disease or gallstones
• You suffer from a disease called myasthenia gravis
• You have experienced convulsions
• You have low blood pressure or are in shock
• You have suffered from drug dependence or abuse, 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.
• 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 a painkiller for headaches for more than three days it can make them worse.
Make sure it is safe for you to take Co-codamol Capsules.
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.
Do not take Co-codamol:
• If you are allergic (hypersensitive) to Paracetamol, Codeine Phosphate or other medicines known as opioids, e.g. Morphine, or any of the other ingredients of Co-codamol (see section 6. Further Information)
• If you have asthma or suffer from breathing difficulties which may be due to disease or brought on by taking other painkilling drugs such as Morphine, Fentanyl or Pethidine
• If you have diarrhoea caused by poisoning or have pseudomembranous colitis which causes severe bloody diarrhoea
• 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
Talk to your doctor or pharmacist before you take
Co-codamol if any of the following apply to you:
• You have kidney or liver problems
• You drink excessively, are alcoholic or suffer from non cirrhotic alcoholic liver disease
• You are suffering from, or have been treated in the past for, head injuries or pressure inside your head
• You have an under-active thyroid gland (hypothyroidism) which can cause tiredness or weight gain
Other medicines and Co-codamol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Whilst taking Co-codamol you should not take any other medicines which contain Paracetamol. This includes some painkillers, cough and cold remedies and a wide range of other medicines available from shops and pharmacies.
You should not take Co-codamol if you are taking or have taken any medicines for depression of the type known as Monoamine Oxidase Inhibitors (MAOIs) such as Phenylzine, Tranylcypromine or Isocarboxazide within the last 2 weeks.
If you are taking any of the following medicines, contact your doctor:
• Cimetidine, used to treat stomach ulcers
• Cyclizine, Metoclopramide or Domperidone (used to prevent nausea or vomiting)
• Colestyramine (used to reduce high cholesterol in the blood)
• Ciprofloxacin (an antibacterial medicine)
• Mexiletine (used to treat an irregular heartbeat)
• Cisapride (used to treat gastro-oesophageal reflux disease)
• Selegiline (used to treat Parkinson’s disease)
• Hydroxyzine (an antihistamine, also used to treat anxiety)
• Oral contraceptives (“the pill”)
• Warfarin and other medicines to thin the blood
• Anticholinergic medicines such as Atropine, which affect the central nervous system
• Any sedative or tranquiliser medicines, including phenothiazines such as Chlorpromazine, barbiturates such as Phenobarbital, and tricyclic antidepressants such as Amitriptyline
• Anaesthetics
• Medicines to treat high blood pressure such as Guanethidine or diuretics (“water tablets”) such as Furosemide
• Medicines known as opioid antagonists such as Buprenorphine, Naltrexone, Naloxone
• Muscle relaxants
• Medicines for diarrhoea.
Taking Co-codamol with food and drink
• Do not drink alcohol whilst taking Co-codamol.
• If you have a poor diet with a low intake of protein your risk of serious paracetamol poisoning when taking Co-codamol may be increased.
Pregnancy and Breast feeding
• Taking Co-codamol is not recommended during pregnancy, unless advised by your doctor.
• Do not take Co-codamol while you are breastfeeding. Codeine and morphine pass into breast milk.
Driving and using machines
Co-codamol may cause dizziness or blurred vision, or impair your ability to think clearly. Do not drive or use machinery if affected in this way.
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.
Stop taking the medicine and see a doctor or go to a hospital straight away if you develop a rash, start to itch, get short of breath or wheezy, develop swelling of the mouth, throat, face or eyes, have increased sweating, a red or flushed face. This may mean you are having an allergic reaction to Co-codamol.
Below is a list of other side effects which have occurred whilst taking Co-codamol:
• Drowsiness, reduced mental alertness
• Nausea, vomiting, constipation
• Heartburn, abdominal pain or bloating
• Loss of appetite, dry mouth
• Liver and kidney problems
• Pancreatitis (inflammation of the pancreas which causes severe pain in the abdomen and back)
• Vertigo, lightheadedness, dizziness or fainting
• Confusion, mood changes, restlessness, excitation
• Difficulty sleeping, nightmares
• Tolerance (your medicine has less effect)
• Raised pressure in the skull which causes headache and eye problems
• Blurred or double vision, very small pupils of the eyes
• Slow or irregular heartbeat, inflammation of the heart muscle
• Tiredness, sweating
• Feeling unwell, trembling, hypothermia
• Pain and difficulty in urinating
• Fits
• Hallucinations
• Mental depression
• Unexplained bruising and bleeding, sore throat and fever. This could be because of a blood problem which may require diagnosis by a blood test.
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.
3. How to take Co-codamol
You can swallow your capsules with or without food. Most people take the capsules with a drink of water.
Adults and Children aged 16 years and over:
• 1 or 2 capsules to be taken every 4 hours as required. Children aged 12-15 years:
• 1 capsule to be taken every 4-6 hours as required.
Do not exceed the stated dose:
- Do not take more frequently than - every 4 hours
- Do not take more than 1 capsule (children aged 12-15) or 2 capsules (adults and children aged 16 and over) at a time
- Do not take more than 4 times a day.
Co-codamol should not be taken by children below the age of 12 years, due to the risk of severe breathing problems. If you think you have taken too many capsules go to your doctor or nearest casualty department, taking your medicine with you.
Contains Paracetamol. Do not take with any other Paracetamol containing products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
Do not take for more than 3 days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist.
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. Website: 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 your capsules out of the sight and reach of children. Do not store above 25 °C.
Keep them in the pack in which they were supplied so they do not get mixed up with other medicines.
Return any unused capsules to your pharmacist. Do not use after the expiry date printed on the label.
6. Contents of the pack and other information
Stopping your medicine
• 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.
The active substances in these capsules are Codeine Phosphate 8 mg and Paracetamol 500 mg.
The other ingredients are Light Kaolin and Magnesium Stearate.
The capsule shells contain Gelatin and the colourant, Erythrosine E127.
The capsule ink contains Shellac and Black Iron Oxide E172.
Co-Codamol 8/500 mg Capsules are pink, translucent, hard gelatine capsules, printed CO COD 8.
They are available in packs of 32 capsules.
The MA holder and Manufacturer is:
Custom Healthcare Limited Conway Street, Hove East Sussex, BN3 3LW
This leaflet was last revised in August 2016.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.