Co-Dydramol Tablets
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Co-Dydramol Tablets BP
Please read this entire leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• These tablets are for oral administration.
In this leaflet:
1. What is Co-Dydramol and what is it used for?
2. Before you take Co-Dydramol Tablets
3. How to take Co-Dydramol Tablets
4. Possible side effects
5. Storing Co-Dydramol Tablets
The name of this medicine is Co-Dydramol Tablets BP (referred to as Co-Dydramol Tablets or Co-Dydramol throughout this leaflet).
• The active substances are 10mg dihydrocodeine tartrate BP and 500mg Paracetamol BP.
• Other ingredients are povidone, stearic acid, croscarmellose sodium type 1 (AC-Di-Sol), talc, sodium starch glycollate and colloidal silicon dioxide.
Marketing Authorisation Holder & Manufacturer:
ZeCare Ltd.
Unit 5 Blenheim Court,
Brownfields, Welwyn Garden City, Hertfordshire,
AL7 1AN, UK.
1. What is Co-Dydramol and what is it used for?
Co-Dydramol belongs to a group of medicines called analgesics and antipyretics.
Co-Dydramol Tablets are used for the relief of mild to moderate pain, fever and also as a cough suppressant.
Co-Dydramol Tablets are available in packs containing 25, 50, 100, 250, 500 and 1000 tablets in a plastic tub with a plastic tamper evident cap.
Please note that all pack sizes may not be marketed.
2. Before taking this medicine
Do not take Co-Dydramol Tablets if any
of the following apply to you:
• If you are allergic to paracetamol, codeine, dihydrocodeine, other opoids or any of the other ingredients in this tablet.
• If you have difficulty in breathing or suffer from lung disease.
• If you are a child under 12 years of age.
• If you have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis).
Take special care with Co-Dydramol
Tablets
• If you suffer from asthma or are prone to asthmatic attacks.
• If you are elderly.
• If you have an underactive thyroid gland.
• 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 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.
• If you have an underactive thyroid gland.
• If you have muscle weakness (myasthenia gravis).
• If you have low blood pressure 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).
You should avoid drinking alcohol whilst taking these tablets.
Other important warnings:
• 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 painkiller for headaches too often or for too long can make them worse.
If any of the above apply to you or if you are unsure, you should seek advice from your doctor or pharmacist.
Pregnancy and breast-feeding
Co-Dydramol should not be taken during pregnancy or whilst breast-feeding, unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn.
Driving or 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.
Food and drink
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-Dydramol tablets.
You should avoid drinking alcohol whilst taking these tablets.
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed but bought without a prescription.
You should inform your doctor or pharmacist if you are taking any of the following since some medicines may influence the effect of, or, be influenced by Co-Dydramol Tablets:
• mexiletine (used to treat irregular heart beat).
• medicines known as monoamine oxidase inhibitors (MAOIs).
• warfarin or nicoumalone (drugs used to thin the blood).
• cholestyramine (for lowering cholesterol levels).
• metoclopramide and domperidone (for gastric disorders such as heartburn, nausea and vomiting).
• anaesthetics.
• medicines which affect the nervous system such as sleeping tablets, diazepam, hydroxyzine and medicines to treat mental illness.
• medicines to treat depression such as. tranylcypromine, amitriptyline.
• ciprofloxacin (antibacterial medicine).
• cyclizine, metoclopramide or domperidone (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”).
• phenytoin (to treat epilepsy).
• barbiturates (e.g. phenobarbital).
3. How to take Co-Dydramol Tablets
You should always take this medicine as prescribed by your doctor. Do not take more than the doctor has told you to. Read and follow the instructions on the pharmacist’s label. If you are not sure about anything please ask your doctor or pharmacist.
Co-Dydramol Tablets are for oral use only and should be taken during or after meals.
Adults, elderly and children over 12 years old: For pain relief: 1 tablet every four to six hours. No more than a maximum of 8 tablets should be taken daily.
For cough relief: 1 tablet every four hours.
If you forget to take Co-Dydramol Tablets
at the right time, take them as soon as you remember. Do not take a double dose to make up for forgotten individual doses.
If you have taken too many Co-Dydramol Tablets:
Immediate medical advice should be sought in the event of an overdose, even if you feel well. Contact you doctor immediately or go to the nearest accident and emergency department. Remember to take this leaflet or any remaining tablets with you.
Symptoms of an overdose include feeling or being sick, loss of appetite, stomach pain or liver damage, coma, clammy skin, fits, confusion, drowsiness, tiredness, low blood pressure, pinpoint pupils, slow heart beat or breathing rate.
If you stop taking Co-Dydramol tablets:
If you stop taking the tablets you may develop the following withdrawal symptoms tremor, difficulty sleeping, feeling or being sick, sweating and increased heart rate, breathing or blood pressure.
4. Possible side effects
Like most medicines, Co-Dydramol Tablets can cause unwanted side effects in some patients.
Contact your doctor at once if the
following side effects occur:
• Allergic reactions - skin rash or itchy skin, difficulty breathing, increased sweating, redness or flushed face, mucosal lesions (such as mouth ulcers), drug fever
• Abdominal pain - may be caused by spasm of the bile ducts and inflammation of the liver or pancreas
Other possible side effects
• Inflammation of the heart muscle, which may cause heart palpitations or shortness of breath
• Slow heart rate
• Feeling your heart beat (palpitations)
• Low blood pressure especially on standing, inflammation of the heart muscle
• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (anaemia)
• Skin rash resulting from bleeding into the skin
• Changes in numbers and types of blood cells, which may make infections, bruising and bleeding more likely
• Pain and difficulty in passing urine
• Less frequent need to pass urine
• Kidney problems
• Confusion
• Drowsiness
• Reduced alertness
• Dizziness
• Feeling of dizziness or "spinning” (vertigo)
• Mood changes, depression,
• Seeing or hearing things that are not real (hallucinations)
• Restlessness, excitation
• Fits
• Depression
• Increased pressure in the skull (painful eyes, changes in vision)
• Headache
• Difficulty sleeping or nightmares
• Tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms - see Section 3 ‘If you stop taking’)
• Constipation
• Stomach irritation (mild stomach pain, heartburn and feeling sick)
• Feeling or being sick
• Loss of appetite
• Dry mouth
• Difficulty in the passage of food through guts.
• Trembling
• Unusual tiredness or weakness
• Feeling unwell
• Low body temperature
• Blurred or double vision
• Extremely small pupils
Long-term use of Co-Dydramol may cause liver damage.
If concerned about this, please consult your doctor or pharmacist.
If you suffer from any of these or notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
5. Storing Co-Dydramol Tablets
Keep out of reach and sight of children.
Store in a dry place, below 20°C and protected from light.
If your doctor tells you to stop taking your medicine you should return any remaining tablets to the pharmacist, unless your doctor tells you to keep them at home.
Do not use Co-Dydramol Tablets after the expiry date on the package.
REMEMBER
This medicine is only for YOU. Do not offer it to anybody else. It may harm them, even if their symptoms seem to be the same as yours.
Product Licence Number:
PL 24581/0008: Co-Dydramol Tablets BP
Date of revision: April 2014
ZeCare°
MB—BB
ZC-ver.4