Co-Codamol 8/500mg Tablets
Braille reads:-co-codamol 8/500 mg tablets
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©100 tablets
For oral use
Each tablet contains 8mg Codeine Phosphate and 500mg Paracetamol. Use as directed by physician. FOR DISPENSING PURPOSES ONLY. Do not exceed the stated dose. If symptoms persist consult your doctor. This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel. See the leaflet inside for more information. Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction. Keep out of the reach and sight of children.
Contains paracetamol. Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.
Store below 25°C in a dry place. Protect from light. 50822774 AAAH2186 PL 30306/0280
| POM |
Actavis, Barnstaple, EX32 8NS, UK
Overall Laminate Area -130mm
Co-codamol 8/500mg Tablets (Codeine Phosphate and Paracetamol)
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Index
1. What Co-codamol tablets are and what they are used for
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. Co-codamol can be used to reduce body temperature.
2. Before you take Do not take Co-codamol tablets: if you are allergic (hypersensitive) to paracetamol, codeine phosphate or other opioids, or any of the ingredients in the tablet (see 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 breastfeeding
Check with 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 illness.
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.
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.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially: ciprofloxacin (antibacterial medicine)
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
• 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 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.
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.
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Pregnancy and breast-feeding |
Adults and children over 12 years: 1 to 2 tablets every 6 hours, as needed. Do not take more than 8 tablets in 24 hours |
Contact your doctor for advice on how to stop taking Co-Codamol tablets gradually to avoid withdrawal symptoms. |
increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly) |
6. Further information | ||||
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Pregnancy |
Children under 12 years: should not be taken due to the risk of severe breathing problems |
• Eyes - blurred or double vision, extremely small pupils |
What Co-codamol tablets contain | |||||
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Do not take Co-codamol tablets during pregnancy, unless advised by your doctor. Regular use during pregnancy may cause |
Elderly: Dosage is usually reduced in the elderly with liver damage. |
4. Possible side effects |
• Others - trembling, unusual tiredness or weakness, malaise, low body temperature |
The active substances (the ingredients that makes the tablets work) are 8mg of | ||||
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withdrawal symptoms in the newborn. |
Like all medicines, Co-codamol tablets can cause side effects, although not everybody gets them. Please tell your doctor or |
codeine phosphate and 500mg paracetamol. | ||||||
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If you take more than you should |
pharmacist if you notice any of the following effects or any effects not listed. |
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side |
The other ingredients are colloidal anyhydrous silica, maize starch, stearic acid. | |||||
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Breastfeeding |
Talk to your doctor at once if you take too much of this medicine, even if you feel well. |
Allergic Reactions - skin rash or itchy skin, difficulty breathing, increased sweating, redness or flushed face, mucosal lesions |
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: | |||||
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Do not take Co-codamol while you are breastfeeding. Codeine and morphine passes into breast milk. |
This is because too much paracetamol can cause delayed, serious liver damage. |
(such as mouth ulcers), drug fever. Stop taking Co-Codamol tablets and seek medical attention if you notice any of the |
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this |
What Co-codamol tablets look like and contents of the pack | ||||
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f you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your |
symptoms listed. |
medicine. |
Co-codamol are white, uncoated tablets. | |||||
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3. How to take |
nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick, |
Gastrointestinal system - stomach irritation (mild stomach pain, heartburn and feeling sick), constipation, feeling or being |
3ack sizes are 100. | |||||
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Always take Co-codamol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or |
oss of appetite, stomach pain or liver damage, coma, pale or clammy skin, fits, confusion, drowsiness, tiredness, low blood |
sick, loss of appetite, dry mouth, difficulty in the passage of food through guts, abdominal pain (may be caused by spasm of |
5. How to store | |||||
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pharmacist. |
pressure, pinpoint pupils, slow heart beat or breathing rate. |
the bile ducts) and inflammation of the liver or pancreas |
Keep out of the reach and sight of children. Store below 25°C in a dry place, protected from light. |
Marketing Authorisation Holder | ||||
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Heart - slow heart rate, palpitations, low blood pressure, inflammation of the heart muscle |
Do not use Co-codamol tablets after the expiry date stated on the label/carton/bottle. |
Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfordur, Iceland. | ||||||
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Do not drink alcohol whilst taking Co-codamol tablets. Swallow the tablets with water. |
If you forget to take the tablets |
Blood - anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice |
The expiry date refers to the last day of that month. | |||||
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Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and |
that you bruise more easily or have more infections talk to your doctor |
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines |
Manufacturer | |||||
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Take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice. |
then take the next dose at the right time. |
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 |
no longer required. These measures will help to protect the environment. |
Actavis, Barnstaple, EX32 8NS, UK. | ||||
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Doses: |
If you stop taking the tablets |
or hearing things that are not real), restlessness, excitation, fits, increased pressure in the skull (painful eyes, changes in vision |
This leaflet was last revised in September 2014 | |||||
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This medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, talk to your |
f you stop taking the tablets you may develop the following withdrawal symptoms tremor, difficulty sleeping, feeling or |
or headache behind the eyes), headache, difficulty sleeping, nightmares, reduced alertness, tolerance (medicine has less | ||||||
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doctor for advice. |
being sick, sweating and increased heart rate, breathing or blood pressure. |
effect) or dependence (suffer from withdrawal symptoms e.g. tremor, difficulty sleeping, sweating, increased heart rate, |
012617 010308 >
©100 tablets
Each tablet contains 8mg Codeine Phosphate and 500mg Paracetamol. Use as directed by physician. 0r °0Q USe
FOR DISPENSING PURPOSES ONLY. Do not exceed the stated dose. If symptoms persist consult your doctor. This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel. See the leaflet inside for more information. Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction. Keep out of the reach and sight of children.
Contains paracetamol. Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.
Store below 25°C in a dry place. Protect from light.
Actavis, Barnstaple, EX32 8NS, UK 50822774 AAAH2186
| POM |
PL 30306/0280
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Page 1/Front Cover - 101mm
text free to right of
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