Co-Dydramol 10/500mg Tablets
Package leaflet: Information for the patient
Co-Dydramol 10/500mg Tablets
(Dihydrocodeine Tartrate 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 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.
J What Co-Dydramol is and what it is used for ^
2 What you need to know before you take Co-Dydramol S
3 How to take Co-Dydramol Q
Possible side effects
How to store Co-Dydramol
Contents of the pack and other information
What Co-Dydramol is and what it is used for
Co-Dydramol belongs to a group of medicines called analgesics. Co-Dydramol contain a combination of dihydrocodeine tartrate and paracetamol (see Section 6 "Contents of the pack and other information”).
Co-Dydramol is used for the relief of mild to moderate pain, fever (pyrexia) and also as a cough suppressant.
What you need to know before you take Co-Dydramol
Do not take Co-Dydramol Tablets if:
■ You are allergic (hypersensitive) to paracetamol, codeine, dihydrocodeine, other opioids or any of the other ingredients of this medicine (Listed in section 6).
■ You have difficulty in breathing or suffer from lung disease.
■ You have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis).
Warnings and precautions
Talk to your doctor before taking Co-Dydramol:
■ Do not take for longer than directed by your prescriber.
■ Taking dihydrocodeine 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 pain reliever for headaches too often or for too long can make them worse.
■ If you suffer from asthma or are prone to asthmatic attacks.
■ If you are an older person.
■ If you have an underactive thyroid gland (hypothyroidism).
■ If you have liver problems, especially if you have alcoholic liver disease.
■ If you have kidney problems.
■ If you have inflammatory bowel disease.
■ If you suffer from or have a history of fits (convulsions).
■ If you suffer from alcoholism, mental illness, drug abuse or dependence.
■ If you have a head injury or raised pressure in the skull (may cause painful eyes, changes in vision or headache behind the eyes).
■ If you have gall bladder disease or gall stones.
■ If you have recently had surgery on your gastro-intestinal tract or urinary system.
■ If you have an enlarged prostate gland (prostatic hypertrophy).
■ If you have muscle weakness (myasthenia gravis).
■ If you have low blood pressure (hypotension) or you are in shock.
■ If you have high blood pressure caused by a tumour near a kidney (phaeochromocytoma).
■ If you have diseased adrenal glands (Addison's disease).
Other medicines and Co-Dydramol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
Do not take Co-Dydramol with any other paracetamol-containing products.
Medicines which may interact with or be affected by
Co-Dydramol:
■ Mexiletine (used to treat irregular heartbeat).
■ Antidepressant medicines known as Monoamine Oxidase Inhibitors (MAOIs) such as tranylcypromine.
■ Warfarin or nicoumalone (medicines used to thin the blood).
■ Cholestyramine (for lowering cholesterol levels).
■ Metoclopramide and domperidone (for gastric disorders such as heartburn, feeling sick [nausea] and being sick [vomiting]).
■ Anaesthetics.
■ Medicines which affect the nervous system such as sleeping tablets, diazepam (muscle relaxant), hydroxyzine (sedative) and medicines to treat mental illness (anti-psychotics).
■ Ciprofloxacin (antibacterial medicine).
■ Cyclizine (to prevent sickness).
■ Cisapride (to treat gastro-oesophageal reflux disease).
■ Selegiline (for Parkinson's disease).
■ Cimetidine (to treat stomach ulcers).
■ Atropine or hyoscine (anticholinergic medicines).
■ Loperamide or kaolin (to treat diarrhoea).
■ Guanethidine or diuretics ("water tablets”) e.g. spironolactone, furosemide (to treat high blood pressure).
■ Opioid antagonists (buprenorphine, naltrexone, naloxone).
■ Oral contraceptives (the "pill”).
■ Hepatic enzyme inducers (increased risk of serious paracetamol poisoning):
o Phenytoin, to treat epilepsy (anticonvulsant).
o Barbiturates (Central Nervous System [CNS] depressants) e.g. phenobarbital (for anxiety and sleep disorders).
o Medicines to treat depression such as, amitriptyline (tricyclic antidepressants).
A poor diet (low protein) may also have a similar effect (increased risk of serious paracetamol poisoning) to hepatic enzyme inducers.
Taking Co-Dydramol with food and drink and alcohol
Do not drink alcohol whilst taking these 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 for advice before taking this medicine.
Pregnancy
Co-Dydramol should not be taken during pregnancy, unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn.
Breast-feeding
Co-Dydramol is passed into breast milk, but is not known to be harmful but it is advisable to avoid taking Co-Dydramol whilst breastfeeding.
Driving and using machines
Co-Dydramol may cause dizziness, blurred vision or the inability to think clearly. Make sure you are not affected before you operate machinery.
This 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.
How to take Co-Dydramol
Always take Co-Dydramol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
■ These tablets are to be taken orally.
■ These tablets should be taken during or after meals.
■ The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
continued....
Manufacturer:
■ No more than a maximum of 8 tablets should be taken daily.
■ The risk-benefit of continued use should be assessed regularly by the prescriber.
Adults
■ For pain relief: 1 or 2 tablets every four to six hours.
■ For cough relief: 1 tablet every four hours.
Older people
The dosage should be reduced for older people.
Use in children
For children over 12 years of age:
■ For pain relief: 1 or 2 tablets every four to six hours.
■ For cough relief: 1 tablet every four hours.
Co-Dydramol is not recommended for children under 12 years of age.
If you take more Co-Dydramol than you should:
If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.
Symptoms of an overdose include: paling of the skin (pallor), feeling (nausea) or being sick (vomiting), loss of appetite (anorexia), stomach pain or liver damage, coma, cold clammy skin, fits (convulsions), confusion, drowsiness, tiredness, low blood pressure, pinpoint pupils, slow heart beat or breathing rate.
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.
If you forget to take Co-Dydramol:
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop taking Co-Dydramol:
It is important that you keep taking Co-Dydramol for as long as your doctor has told you to.
If you stop taking the tablets you may develop the following withdrawal symptoms; tremor, difficulty sleeping (insomnia), feeling (nausea) or being sick (vomiting), sweating and increased heart rate, breathing or blood pressure.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Co-Dydramol can cause side effects,
although not everybody gets them.
Seek medical advice immediately if you develop the
following symptoms:
■ Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness
■ Other allergic reactions may include: skin rash, skin rashes with the formation of wheals (urticaria), fever, mouth ulcers, increased sweating, redness or flushed face
■ Toxic megacolon - a swelling and widening of the large intestine and accumulation of excessive amounts of gas which occurs as a complication of inflammatory bowel disease such as ulcerative colitis, Crohn's disease and infections of the colon
Other side effects (frequency not known)
■ Inflammation of the heart muscle (myocarditis)
■ Slow heart rate (bradycardia)
■ Feeling your heartbeat (palpitations)
■ Low blood pressure (hypotension)
■ Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)
■ More prone to infections due to a severe reduction in number of white blood cells (agranulocytosis)
■ A blood disorder where blood clots form in small blood vessels throughout the body causing bruising or bleeding (thrombocytopenic purpura)
■ A blood disorder in which an abnormal amount of methemoglobin (a form of haemoglobin) is produced (methaemoglobinaemia)
■ A reduction in white blood cells (neutropenia/leukopenia)
■ Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (pancytopenia)
■ Pain and difficulty in passing urine (ureteral spasm)
■ Less frequent need to pass urine
■ Kidney problems
■ Confusion
■ Drowsiness
■ Reduced alertness
■ Liver problems
■ Inflammation of the pancreas (pancreatitis)
■ Dizziness
■ Feeling of dizziness or "spinning” (vertigo)
■ Mood changes
■ Seeing or hearing things that are not real (hallucinations)
■ Restlessness, excitation
■ Fits (convulsions)
■ Depression
■ Increased pressure in the skull (may cause painful eyes, changes in vision or headache behind the eyes)
■ Headache (prolonged use of a pain reliever can make them worse)
■ Difficulty sleeping or nightmares
■ Tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms - see Section 3 'If you stop taking'). Tolerance diminishes rapidly after withdrawal so a dose that was previously tolerated may be dangerous
■ Constipation
■ Stomach irritation (wind, stomach pain, bloating, heartburn)
■ Feeling (nausea) or being sick (vomiting)
■ Loss of appetite
■ Dry mouth
■ Difficulty in the passage of food through the digestive tract (paralytic ileus)
■ Trembling
■ Unusual tiredness or weakness
■ Feeling unwell (malaise)
■ Low body temperature (hypothermia)
■ Blurred or double vision
■ Extremely small pupils (miosis)
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 at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Co-Dydramol
■ Keep this medicine out of the sight and reach of children.
■ Store in a dry place, below 20°C.
■ Store in the original package in order to protect from light.
■ Do not use Co-Dydramol after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of that month.
■ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Co-Dydramol contains:
Each tablet contains 10mg of Dihydrocodeine Tartrate and 500mg Paracetamol.
The other ingredients are: povidone, stearic acid, croscarmellose sodium type 1 (AC-Di- Sol), talc, sodium starch glycollate and colloidal silicon dioxide.
What Co-Dydramol looks like and the contents of the pack:
Co-Dydramol are white, cylindrical, biplane, tablets with an approximate diameter of 12.7mm, embossed with logo reversed side scored and embossed "T2” on either side of a score line.
Co-Dydramol are available in:
Co-Dydramol are available in packs of 25, 50, 100, 250, 500 or 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Tillomed Laboratories Ltd.
3 Howard Road,
Eaton Socon,
St. Neots,
Cambridgeshire,
PE19 8ET,
UK.
Product Licence Number: PL 11311/0521
This leaflet was last revised in April 2016
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