Co-Codamol 30mg/500mg Tablets
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24 mm
PACKAGE LEAFLET: INFORMATION 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:
Q What Co-codamol Tablets are and what they are used for EJ 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 30mg/500mg 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.
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.
Do not take Co-codamol Tablets if:
• you are allergic to paracetamol, codeine (or other opioid pain killers), sodium metabisulphite (E223) or to any of the other ingredients (listed in Section 6)
• Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue
• you experience severe asthmatic attacks or severe breathing problems
• you suffer from severe kidney or liver disease.
• you have 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 breast-feeding
• you have recently had a head injury
• you have been told by your doctor that you have increased pressure in your head. Signs of this include: headaches, being sick (vomiting) and blurred eyesight
• you have recently had an operation on your liver, gall bladder or bile duct (biliary tract)
• you are taking medicine to treat depression called MAOIs (monoamine oxidase inhibitors) or have taken them in the last 14 days MAOIs are medicines such as modobemide, phenelzine or tranylcypramine (see 'Other medicines and Co-codamol Tablets')
• you are an alcoholic
• the person going to take the tablets is under 12 years of age
Do not take Co-codamol Tablets if any of the above apply to you Warnings and Precautions
Talk to your doctor or pharmacist before taking Co-codamol Tablets if;
• you have severe kidney or liver problems
• you have problems passing water or prostate problems (in men)
• you have an underactive thyroid gland
• you have a disease of the biliary tract
• you have problems with your adrenal glands (Addison's disease)
• you have a bowel problem such as colitis or Crohn's disease or a blockage of your bowel
• you are elderly
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 Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Co-codamol can affect the way some other medicines work. Also, some other medicines can affect the way Co-codamol works.
Medicines not to be taken with Co-codamol Tablets:
• Other paracetamol-containing products. This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.
• Medicines to treat depression called MAOIs (monoamine oxidase inhibitors), or have taken them in the last 14 days. MAOIs are medicines such as moclobemide, phenelzine, tranylcypramine.
Tell your doctor if you are taking any of the medicines
• chloramphenicol (an antibiotic used for infections)
• medicines which make you drowsy or sleepy (CNS depressants)
• medicines used to thin the blood (anticoagulants), such as warfarin
• medicines used to stop you feeling sick (nausea) or being sick (vomiting) (e.g. metoclopramide and domperidone)
• medicines to reduce cholesterol in the blood (e.g. colestyramine)
• oral contraceptives ("the pill”)
• Sedatives and sleeping tablets, e.g. temazepam and diazepam
• Phenothiazines (medicines that calm your mood) or tricyclic antidepressants
• Antihypertensive drugs, diuretics (water pills)
• Medicines for irregular heart beats (mexiletine, quinine or quinidine)
• Drugs used to dry fluids in the mouth and lungs known as anticholinergics
• Medicines used to treat problems of the stomach, gall bladder, heart burn or sickness, (e.g. cimetidine, colestyramine)
• Sodium oxybate used to treat sleepiness and sudden loss of muscle tone
• Other strong painkillers called opioids
Co-codamol can interfere with some laboratory tests used for determining some diseases. g
260 mm
COCODAMOL Tablets INSERT
SAME SIZE ARTWORK
130 x 260 mm
Front
10 mm
Co-codamol Tablets with food, drink and alcohol
• You should not drink alcohol while you are taking these tablets. This is because Co-codamol Tablets can change the way alcohol affects you.
Pregnancy, Breast-feeding and Fertility Pregnancy
Talk to your doctor before taking these tablets if:
• You are pregnant, think you may be pregnant or plan to get pregnant
Breast-feeding
Do not take codeine while you are breast-feeding. 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 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.
If you feel dizzy or sleepy, do not use any tools or machines. Changing or stopping treatment Long term usage of Co-codamol Tablets may lead to tolerance and dependence. If you have taken regular daily doses of Co-codamol Tablets for a long time, do not increase the dose or suddenly stop treatment without discussing this with your doctor. Co-codamol Tablets contain sodium metabisulphite
• Co-codamol Tablets contain sodium metabisulphite (E223) which may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (tightening of the airways)
• Co-codamol Tablets contain 0.35mg of sodium per dose. This should be taken into consideration by patients are on a controlled sodium diet
Important side-effects you should know about Co-codamol Tablets
• Taking a painkiller for headaches too often or for too long can make them worse
• 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
Stop taking Co-codamol Tablets and see a doctor or go to a hospital straight away if:
• You have difficulty in breathing or you feel dizzy
• You get swelling of the hands, feet, ankles, face lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Co-codamol Tablets
• Very rare cases of serious skin reactions have been reported. Talk to your doctor straight away ifyou notice 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
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
• hearing loss
• liver damage, especially in heavy drinkers
• restlessness or irritability
• Difficulty in passing water (urine)
• Becoming dependent on codeine
• You get infections or bruise more easily than usual.
This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia) Long-term usage of high doses of codeine + paracetamol can be rarely associated with sensorineural hearing loss.
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/yellowcarrt. By reporting side effects you can help provide more information on the safely of this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Do not take more than the recommended dose
• Do not take for longer than your doctor tells you to Method of administration:
• Take this medicine by mouth
• Swallow the tablets whole with a drink of water Adults:
• The usual 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.
Older People: lower doses may be more suitable Children aged 12 years to 18 years:
• Children aged 12 years of above should take 1 to 2 tablets every 6 hours, as needed.
• Do not take more than 240mg of codeine 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.
• Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken
If you forget to take your 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.
Ifyou have any further questions on the use of this medicine, ask your doctor or pharmacist.
• Keep out of the sight and reach of children
• Do not store above 250C. 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:
• Active substances: codeine phosphate and paracetamol. Each tablet contains 30mg of codeine phosphate and 500mg of paracetamol
• Other ingredients: pregelatinised maize starch, microcrystalline cellulose, sodium starch glycollate, sodium metabisulphite (E223), magnesium stearate
What Co-codamol Tablets look like and contents ofthe pack:
• These tablets are white to offwhite capsule shaped, biconvex, uncoated plain tablets.
• 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, Uinted Kingdom
Telephone: 0044 (0) 1442 200922
Fax: 0044 (0) 1442 873717
Email: info@bristol-labs.co.uk
Co-codamol 30mg/500mg Tablets; PL 17907/0235
This leaflet was last revised in November 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.
260 mm
Like all medicines, Co-codamol Tablets can cause side effects, although not everybody gets them.
V9 13-11-14 D0
COCODAMOL Tablets INSERT
SAME SIZE ARTWORK
130 x 260 mm
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