Co-Dydramol Tablets Bp
10 mm
10 mm
E
E
in
Package leaflet: Information for the user
CO-DYDRAMOL TABLETS
(Dihydrocodeine Tartrate 10 mg and Paracetamol 500 mg)
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, 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
1. What Co-dydramol Tablets are and what are they used for
2. What you need to know 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. Contents of the pack and other information
Co-dydramol tablets belong to a group of medicines called analgesics and are used for the relief of mild to moderate pain. They contain the active ingredients dihydrocodeine tartrate and paracetamol which belong to a group of medicines called strong analgesics or ‘painkillers’.
Do not take Co-dydramol Tablets if you:
• Are allergic to dihydrocodeine, other opioids, paracetamol or any of the other ingredients this medicine (see section 6 ‘Contents of the pack and other information’);
• Have difficulty breathing, or other chronic lung disease;
• Are having an asthma attack;
• Have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis).
Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine 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 the tablets for longer than as directed by your doctor. 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 the headache worse.
Other medicines and Co-dydramol Tablets
Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Ciprofloxacin (antibacterial medicine);
• Monoamine Oxidase Inhibitors (MAOIs, e.g. moclobemide or have taken these within the last 2 weeks);
• 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).
Co-dydramol with food and alcohol
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.
Do not drink alcohol whilst taking Co-dydramol 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 or pharmacist for advice before taking this medicine.
Driving and using machines
Co-dydramol 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.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablets with water, during or after meals.
SAME SIZE ARTWORK 130 x 430 mm Front
10 mm
E
E
E
E
IX?
Co-dydramol tablets are normally used only for short-term relief of symptoms. Take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice.
The recommended dose is:
• Adults and children over 16 years: 1-2 tablets every 4 hours up to a maximum of 8 tablets in a day;
• Children between 12 and 15 years old: 1 tablet every 4-6 hours when necessary to a maximum of 4 doses in 24 hours;
• Children under 12 years: Not recommended;
• Elderly: Dosage is usually reduced in the elderly.
If you take more Co-dydramol Tablets than you should:
Talk to your 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 (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. 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 forget to take Co-dydramol Tablets:
If you miss a dose you should take it as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten tablet.
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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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.
Possible Side Effects
• Gastrointestinal system - stomach irritation (mild stomach pain, heartburn and feeling sick), constipation, feeling or being sick, loss of appetite, dry mouth, difficulty in the passage of food through guts;
• Heart - slow heart rate, palpitations, low blood pressure especially on standing, inflammation of the heart muscle;
• Blood - anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor;
• 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 or hearing things that are not real), restlessness, excitation, fits, increased pressure in the skull (painful eyes, changes in vision or headache behind the eyes), headache, difficulty sleeping, nightmares, reduced alertness. Tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms e.g. tremor, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly);
• Eyes - blurred or double vision, extremely small pupils;
• Skin - Very rare cases of serious skin reactions have been reported;
• Others - trembling, unusual tiredness or weakness, malaise, low body temperature.
If any of the above side effects are troublesome or last more than a few days or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
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/ yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
• Keep this medicine out of the sight and reach of children.
• Store below 25°C. Protect from light and moisture.
• Do not use Co-dydramol tablets after the expiry date on the carton, pot and blister. 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 dispose of medicines no longer required. These measures will help to protect the environment.
What Co-dydramol Tablets contain:
- The active substances are paracetamol and dihydrocodeine tartrate. Each tablet contains 500 mg of paracetamol and 10 mg of dihydrocodeine tartrate.
- The other ingredients are: starch, polyvinylpyrrolidone, sodium starch glycollate, stearic acid, colloidal silicon dioxide, talc and potable water.
What Co-dydramol Tablets look like and contents of the pack
• Co-dydramol Tablets are white, flat bevel edged tablet engraved with company logo on one face and A476 and a bar on the other face.
• Co-dydramol Tablets are available in pots of 10, 12, 20, 24, 25, 30, 50, 100, 250, 500 or 1000 tablets and blisters of 30 or 100 tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder
Name and address:
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922 Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Manufacturer:
Auden Mckenzie (Pharma Division) Ltd. Mckenzie House Bury Street, Ruislip, Middlesex HA4 7TL, UK
Co-dydramol tablets; PL 17907/0353
This leaflet was last approved in September 2016
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, email) above.
V5 02-09-16 D0 Q
SAME SIZE ARTWORK
130 x 430 mm
Back