Co-Dydramol Tablets
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(Paracetamol BP 500 mg and Dihydrocodeine tartrate BP 10 mg)
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
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.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Co-dydramol Tablets are and what they are used for
2. Before you take Co-dydramol Tablets
3. How to take Co-dydramol Tablets
4. Possible side effects
5. How to store Co-dydramol Tablets
6. Further information
1. WHAT CO-DYDRAMOL TABLETS ARE AND WHAT THEY ARE USED FOR
Co-dydramol Tablets contain paracetamol and dihydrocodeine tartrate. Paracetamol is an analgesic (relieves pain) and an antipyretic (lowers raised temperatures). Dihydrocodeine tartrate is a strong painkiller, known as an opioid.
Co-dydramol Tablets are used for the relief of pain and for the prevention and relief of coughs.
2. BEFORE YOU TAKE CO-DYDRAMOL TABLETS Do not take Co-dydramol Tablets if:
•You know that you are allergic to paracetamol or dihydrocodeine tartrate, or any of the other ingredients (refer to section 6 below)
•You suffer from breathing problems, for example chronic bronchitis or acute asthma (a condition of shortness of breath, wheezing and chest tightness)
•You have just had a head injury or suffer from increased pressure on the brain
•You have severe kidney or liver problems
•You have had over the daily allowance of alcohol
•You have recently had gall bladder surgery
• You have been advised previously not to use ‘opioids’ (used for pain relief).
Co-dydramol Tablets are not recommended for children under 12 years.
If you need to use this medicine for more than three days at a time, see your doctor or pharmacist.
Take special care and tell your doctor or pharmacist before taking Co-dydramol Tablets if:
• You have liver, kidney or thyroid problems, as the dose might need to be lowered
• You have a disease of the adrenal glands called Addison’s disease
• You have a condition associated with stomach pain, vomiting, diarrhoea, bright red blood in stools, weight loss and swelling in your abdomen generally know as bloating (megacolon)
• You have a history of fits or have had a head injury
• You are male and have an enlarged prostate gland and have difficulty urinating
• You have low blood pressure or you are suffering from shock
• You are suffering from serious muscle weakness (myasthenia gravis)
• You have a tumor of the adrenal glands (phaeochromocytoma)
• You are elderly, very weak and in poor health
• You have a narrowing in your urinary passage blocking the flow of the urine (gall bladder disease or kidney stones)
• You have a group of conditions called ‘acute abdomen’ in which there is a sudden severe pain in the stomach.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines interact with each other and this can alter their effect.
Paracetamol can interact with the following:
• Medicines which alter gastric emptying time (e.g. cimetidine, ethyl alcohol, certain types of contraceptives)
• Medicines for treating motion sickness (e.g. metoclopramide or domperidone)
• Medicines to treat high cholesterol levels (cholestyramine)
• Medicines which interfere with the metabolism of paracetamol (e.g. medicine to treat fits (phenytoin), alcohol, medicines to treat depression & associated conditions)
• Low protein diet
• Medicine to prevent blood clotting (e.g. warfarin).
Dihydrocodeine can interact with the following:
• Medicines which affect the nervous system such as sleeping tablets, diazepam, hydroxyzine and medicines to treat mental illness
• Antibacterials, e.g. ciprofloxacin
• Monoamine Oxidase Inhibitors (MAOIs, e.g. moclobemide can interact with Co-dydramol if MAOIs have been taken within the last 2 weeks)
• Medicines to treat allergy (e.g. antihistamines)
• Medicines to treat heart disease (e.g. mexiletine)
• Medicines for treating motion sickness (e.g. metoclopramide or domperidone)
• Medicines to treat constipation (e.g. cisapride)
• Medicine used to treat a condition known as parkinson’s disease (e.g. selegiline) Parkinson’s affects the nervous system
• Ulcer healing drug (e.g. cimetidine)
• A group of medicines called anticholinergics (e.g atropine)
• Medicines for treating diarrhoea (e.g. loperamide, kaolin)
• Medicines for blood pressure (e.g. guanethidine, water tablets)
• Medicines to treat addiction & overdose (e.g. buprenorphine, naltrexone, naloxone)
• Medicines used with anaesthesia for surgery (e.g. neuromuscular blocking agents).
Co-dydramol Tablets must not be taken with any other medicines containing paracetamol or dihydrocodeine tartrate. Some products which can be bought without a prescription may contain paracetamol or dihydrocodeine tartrate, so always check the labels for ingredients.
Taking Co-dydramol Tablets with food and drink:
The tablets should be taken after food if possible. Avoid alcohol whilst taking Co-dydramol Tablets.
Pregnancy and breast feeding:
Co-dydramol Tablets should not be used during pregnancy or whilst breast-feeding. Regular use during pregnancy may cause withdrawal symptoms in the newborn.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines:
Co-dydramol Tablets can impair mental function and can cause blurred vision and dizziness. Do not drive or use machines if you develop these symptoms.
You should ask your doctor for advise on 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:
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.
3. HOW TO TAKE CO-DYDRAMOL TABLETS
Always take Co-dydramol Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults and children over 12 years:
For the relief of pain:
The usual dosage is one tablet, increasing to two tablets every four hours as needed.
Taking a painkiller for headaches too often or for too long can make them worse.
For prevention and relief of coughs:
The usual dosage is one tablet every four hours as needed.
A lower dosage may be needed if you are elderly or have other medical problems.
Check with your doctor about this.
Do not take for longer than directed by your doctor. Taking dihydrocodeine regularly over a long period of time can lead to addiction, which might cause you to feel restless and irritable when you stop taking the tablets. If you need to use this medicine for more than three days at a time, see your doctor or pharmacist.
Co-dydramol Tablets are not recommended for children under 12 years.
If you take more Co-dydramol Tablets than you should:
You should not take more than 8 tablets in 24 hours. If you think you have taken too many tablets contact your doctor or hospital immediately, take this leaflet and any remaining tablets with you so that the medical staff know what you have taken. 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.
If you forget to take Co-dydramol Tablets:
Do not take more than one dose at a time. If you forget to take a dose then take your next dose at the usual time. Never take two doses at the same time.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-dydramol Tablets can cause side effects, although not everybody gets them.
Paracetamol may cause the following side effects:
• Allergic reactions. These are rare but may include skin rash, fever, changes in the lining of the nose and/or mouth (mucosal lesions)
• Drowsiness & impaired mental functions
• Liver damage, especially in heavy drinkers of alcohol
• Inflammation of the pancreas (i.e. feeling a severe abdominal pain often radiating through the back, usually accompanied by a nausea and vomiting)
• Heart disorder like inflammation of the heart muscle (e.g. toxic myocarditis)
• Changes in the blood, such as low numbers of red blood cells which carry oxygen, cells which fight infection and of cells which are involved in blood clotting (the first signs you might notice could be bruising, bleeding, fever, unusally pale complexion or sore throat), bluish coloring of the skin (methaemoglobinaemia), these will be seen by blood tests
• Kidney damage & inflammation.
Dihydrocodeine may cause following side effects:
• Rash & itching
• Confusion, drowsiness, spinning feeling, dizziness, changes in mood, abnormal imagination, restlessness/excitement, fits, depression, headache, difficulty sleeping or nightmares, feeling of increased pressure in the head often causing severe headache
• Tolerance to, or dependence on dihydrocodeine
• Constipation, abdominal pain & irritation, contractions of the intestine causing pain, nausea, vomiting, loss of appetite, dry mouth, difficulty in the passage of food through the gut, feeling bloated (megacolon)
• Abnormal heart beats & blood pressure
• Difficulty in breathing
• Increased sweating, redness or flushed face
• Smaller pupils, blurred or double vision
• Difficulty and pain in urinating (passing water)
• Uncontrollable muscle movement
• Unusual tiredness or weakness & low body temperature
• Effects of withdrawal or withdrawal syndrome: symptoms may include unintentional muscle movement, restlessness and sleep disturbance, nausea, vomiting, sweating and increase in heart rate, breathing rate and blood pressure.
If any of the side effects become serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CO-DYDRAMOL TABLETS
• Keep out of the reach and sight of children
• Do not use Co-dydramol Tablets after the expiry date which is stated on the carton
• Keep this medicine in a dry place
• Do not store above 25°C
• Protect from light.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Co-dydramol Tablets contain
• The active substances are Paracetamol, 500mg and Dihydrocodeine tartrate, 10mg
• The other ingredients are starch, povidone, sodium starch glycollate, stearic acid, colloidal silicone dioxide and talc.
What Co-dydramol Tablets look like and contents of the pack
Co-dydramol Tablets are available in containers of 25, 50, 100, 250, 500 or 1000 tablets and in blister pack of Opaque PVC film and aluminium foil of 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Mercury Pharma (Generics) Ltd Capital House, 85 King William Street,
London EC4N 7BL, UK
Manufactured By
Bristol Laboratories Ltd.,
Laporte Way, Luton, Bedfordshire, LU4 8WL, UK.
This leaflet was last revised in October 2014.