Patient Information leaflet

CO-DYDRAMOL 500/1 Omg TABLETS

(Paracetamol 500mg/Dihydrocodeine 10mg)

Read all of this leaflet carefully before you start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

1.    WHAT CO-DYDRAMOL IS AND WHAT IT IS USED FOR

Co-Dydramol tablets contain paracetamol and dihydrocodeine, which are used to relieve moderate pain and reduce temperature.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-DYDRAMOL Do NOT take Co-Dydramol if:

•    you are allergic (hypersensitive) to paracetamol, dihydrocodeine, other opioids or any of the other ingredients of this medicine (listed in section 6)

•    you have a medical condition where you find it difficult to breathe

•    you are having an asthma attack

•    you have liver disease

•    you have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembraneous colitis).

DO NOT TAKE WITH ANY OTHER PARACETAMOL-CONTAINING PRODUCTS

Warnings and precautions

■    Do not take for longer than directed by your doctor or pharmacist or take more tablets than recommended.

•    Do not drink alcohol on the same day that you take these tablets.

•    Taking dihydrocodeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop taking the tablets.

•    Taking a painkiller for headaches too often or for too long can make them worse.

Talk to your doctor or pharmacist before you take this medicine if you have:

•    kidney or liver problems, including alcoholic liver disease

•    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

•    epilepsy or fits (may be made worse by co-dydramol)

•    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

•    you are elderly (you may need a lower dose).

Other medicines and Co-Dydramol

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

•    ciprofloxacin (antibacterial medicine)

•    Monoamine Oxidase Inhibitors (MAOIs for depression, 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)

Diet

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.

Driving and using machines

If these tablets make you feel drowsy, dizzy, or you experience blurred vision or vertigo (a type of dizziness), or cannot think clearly, do not 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.

Continued overleaf

Pregnancy and breast feeding

Do not take Co-Dydramol tablets during pregnancy or whilst breast feeding, unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn.    |

3.    HOW TO TAKE CO-DYDRAMOL

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. These tablets are not recommended for children under 12 years of age.

Adults and children over 12 years of age:

•    the tablets should be swallowed with or shortly after food

•    take 1 tablet up to four times a day. Your doctor may increase this to 2 tablets 4 times a day if necessary

•    the dose may be reduced if you are elderly or have under-active thyroid or severe liver problems ■ do not take more often than every 4 hours

•    do not take more than 8 tablets in any 24-hour period

•    if symptoms persist consult your doctor.

DO NOT EXCEED THE RECOMMENDED DOSE.

IF YOU OR ANYONE ELSE TAKES TOO MUCH CO-DYDRAMOL: 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 an overdose has been taken contact your doctor immediately or go to your local hospital casualty department. Please take this leaflet, any remaining tablets and the container with you.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Co-Dydramol tablets can cause side effects, although not everybody gets them. Prolonged use may lead to addiction, which may cause you to feel restless or irritable when you stop taking the tablets. Taking a painkiller for headaches too often or for too long can make them worse.

Contact your doctor at once or go to the nearest casualty department if the following rare side effects occur:

•    Allergic reactions - skin rash or itchy skin, swelling of the lips, tongue or throat, difficulty breathing, mucosal lesions (such as mouth ulcers), drug fever, increased sweating, redness or flushed face.

•    Abdominal pain and back pain - may be caused by spasm of the bile ducts and inflammation of the liver or pancreas.

Tell your doctor if you notice any of the following 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 the guts

•    Liver damage

•    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 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, impaired mental function

•    Tolerance (medicine has less effect) or dependence (leading to withdrawal symptoms e.g. tremor, sweating, increased heart rate, increased breathing rate, raised blood pressure, sleeplessness (insomnia) and feeling or being sick if the medicine is stopped too quickly)

•    Eyes - blurred or double vision, extremely small pupils

•    Others - trembling, unusual tiredness or weakness, feeling unwell, low body temperature.

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.

5.    HOW TO STORE CO-DYDRAMOL

Keep out of the sight and reach of children. Do not store above 25 °C. Store them in a cool dry place. Protect from light.

Keep the container well closed. Do not use after the expiry date printed on the pack. 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.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Co-Dydramol Tablets contain: The active ingredients in each tablet are paracetamol 500mg and dihydrocodeine tartrate 10mg. The other ingredients are maize starch, povidone, colloidal silica, magnesium stearate and potassium sorbate (E202).

What Co-Dydramol Tablets look like and contents of the pack: The tablets are white, flat and round. Plain on one side (or marked “M&A”) and engraved with “CO” and “DYD” on either side of a breakline on the other. They are available in packs of 30 and 100 tablets. Dispensing packs are also available.

Marketing Authorisation Holder and Manufacturer: M&A Pharmachem Ltd, Bolton BL5 2AL, UK.

Date of last revision: March 2014

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