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Patient Information leaflet

CO-CODAMOL TABLETS 8/500 mg

(Codeine Phosphate 8mg/Paracetamol 500mg)

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

•    Keep this leaf atYou may need to read it again.

■    If you have any further questions, ask your doctor or pharmacist

■    This medicine can only be used for the short term treatment of acute, moderate pafo which is not relieved by paracetamol, ibuprafen or aspirin alone.

■    You shoiid only takB this product fcr a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice.

•    This medicine contains codefoe which carcauseaddictiorifyoutakeit continuously for more than three days. This car give you withdrawal symptoms from the medicine when you stop taking it

•    If you take thismedidnefor headaches for more than three days itcarmakethemworse.

1.    WHAT CO-CODAMOL TABLETS 8/500 mg ARE AND WHAT THEY ARE USED FOR

Co-cod am ol 8/500mg Tablets contain paracetamol and codeine (painkillers), and are used for the short term treatment of acute moderate pain which is not reieved by paracetamol, ibuprofon or aspirin alone. For headache, toothache, period pain, arthritic and iheumatic pain. Codeine belongs to a group of meddnes called opioid analgesics which act to relieve pain. Co-cod am ol tablets can be used In children over 12 years of age for the short-term relief of moderate pain that Is not relieved by other painkillers such as paracetamol or Ibuprofon alone.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL TABLETS 8/500 mg

•    Thlsmedldnecontalns codefoe which cancauseaddlctlonlfyoutakeltcontlnuouslyformorethanthree days. This can give you withdrawal symptoms from the medctoe when you stop taking It

•    If you take a palnklllerfor headaches for more than three days It can make them worse.

Do NOT take this medicine If you:

•    are allergic (hypersensitive) to paracetamol, codeine phosphate, other opioid pafokillets or any of the other ingredients of this medicfoe (listed in section 6)

■    have moderate or severe kidney foilire or liver disease

•    have asthma or another lung disease which makes breathing difiictft

■    have increased pressure in the brain, e.g. folkwfog a head injury

■    have darrhoea associated with inflanimation of the bowel orfollowing poisoning

■    are an alcoholic

■    are at risk of paralysis of the intestine (paralytic lens)

■    are taking Monoamine Oxidase Inhibitors far depression or have taken them within the fast 14 days

■    know that you metabolise very rapidly codefoe foto morphine

■    are breastfeeding.

■    Do not use for pain relief in chidren and adolescents (0-18 years of age) after remoral of their tonsils or adenoids due to obstructive sleep apnoea syndrome.

DO NOT TAKE WITH ANY OTHER PARACETAMOL OR CODEINE CONTAINING PRODUCTS.

Children and adolescents

Use in children and adolescents after surgery:

Codeine should not be used for pain refief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.

Use in children with breathing problems:

Codeine Is not recommended In children with breathing problems, since the symptoms of morphine toxicity may be worse In these children.

Warnings and precautions

Tell your doctor before you start to take this medicine If you:

•    sufferfrnm myasthenia gravis (muscle weakness and fatigue)

■    have low blood pressure or are suffering from shock

•    have a history of cardiac arrhythmias (erratic heartbeat)

•    have thyroid or adrenal disease

•    have mild kirfoey or liver disease

•    have prostate or urinary problems e.g. difficulty passing water

•    suffer from conviJsions

•    have a history of drug abuse or emotional instability

•    suffer from bowel disease

•    have recently had gastro-intestinal surgery

•    are elderly or infirm

•    have gall stones.

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people In different ways. In some people, morphfoe Is not produced or produced In very small quantities, and It will not provide enough pafo relief. Other people are more likely to get serious side effects because a very high amount of morphine Is produced. If you notice any of the following side effects, you must stop taking this medicine and seek Immediate medical advice: slow or shallow breathfog, confusion, sleepfoess, small pupils, feeling or being sick, constipation, lack of appetite.

Other medicines and Co-codamol

Talk to your doctor or pharmacist before you take this madidne if you are taking any of the followfog:

•    sedatives, tranquillisers, antidepressants, sleeping tablets, or alcohol

•    medicfoes used to treat water retention or high blood pressure

•    medicfoes to treat mental illness (anti-psychotics)

•    medicfoes to prevent blood dotting, such as warfarin

•    medicfoes to treat diarrhoea, such as loperamide and kaolin

■    muscle relaxante, such as atropine

•    anaesthetics or other dregs used in surgery (such as neuromuscular blockfog agents)

•    medicfoes that affect the fiver e.g. carbamazeplne, phenobarbltal, phenytoln (anti-epleptJcs) or rtfompldn (antibiotic).

•    naloxone or naltrexone (used to treat dreg abuse or overdose)

•    colestyramfoe (used to reduce cholesterol in the blood)

•    quinidine or mexiletine (used to treat certain heart conditions)

•    metodopramlde or domperidone (used to treat nausea and vomiting)

■    dmetidtoe (used to treat stomach Jeers)

•    cisapride (used to treat heart bum)

« hydroxyzine (an antl-hlstamlne)

•    probenecid (used to treat gout)

•    isoniazid (used to treat tuberculosis).

Please tell you^- doctor or pharmacist If you are taking or have recently takenanyothermedldnesjndudlngthose obtained without a prescription.

Pregnancy and bread feeding

Do not take Co-codamol during pregnancy unless advised by your doctor.

Do not take Co-codamol while you are breastfeeding. Codeine and morphine passes into breast milk.

Driving and using machines

If these tablets make you feel drowsy, do not drive or operate machtoery.The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not iivewhie taking this medicaie intil you know how it affects you.

•    It Is an offence to dive If this medicare affects you ability to cttve.

•    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 prescrfeer 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.

Tel the hospital staff, your doctor or dentist that you are taking these tablets before you have any treatment or operation, or before the appointment date if you are to have a blood or urine test

3.    HOW TO TAKE CO-CODAMOL TABLETS 8/SOO mg

Always taka this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

•    Adults (Including the elderly) and children over 12 years of age: one or two tablets 4 times a day.

•    Swallow the tablets with a glass of water.

•    Do not take more often than every 4 hours.

•    Do not take for more than 3 days. If the pain does not Improve after 3 days, talk to your doctor for advice.

DO NOT EXCEED THE STATED DOSE

Cocodamol stated not be taken by chkton below the age of 12 years, due to the risk of severe breathing problems If you take more Co-codamol Tablet* than you should:

If an overdose has been taken telephone your doctor immediately. If the doctor is not there, go to your local hospital casualty department Take this leaflet and any remaining tablets with you.

Talk to a doctor at once if you take too much of this medicine even if you feel well.

Thle Is because too much paracetamol can cause delayed, serious liver damage.

The hazard of overdose with paracetamol is greater in those with alcoholic liver disease.

Risk of addiction

This medicine contains codefee and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should tab to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

4.    POSSIBLE SIDE EFFECTS

Like al medicines, Co-codamol can cause side effects, although not everybody gets them.

Stop taking the tablets and tell your doctor Immediately or go to the nearest hospital casualty department If you have any of the following:

•    symptoms of an allergic reaction (rare side effect), such as skfe rash or hives, swaling of the lips, face or neck fearing to severe diffiaJty breathing.

•    mflammation of the pancreas which causes severe pain in the abdomen and back (very rare side effect)

Tell your doctor or pharmacist if any of the following gets worse or lasts longer than a few days:

Common side effects

•    constipation

•    confusion and drowsiness

Uncommon side effects

•    nausea, vomitfeg, stomach cramps, anorexia

•    diarrhoea, incontfeence

•    abdomfeal pain (may be caused by spasm of the bile or urinary ducte)

•    skin rash, itching, sweatfeg, fecial flushing, lew body temperature

•    dry mouth, blurred or double vision, pin-point pupis

•    malaise, tiredness, headache

•    dizziness, vertigo, light-headedness

•    slow or rapid heartbeat, palpitations, breathing difficulties, problems in passing urine

•    low blood pressure, feeling faint on standfeg from a seated or lying position

•    decreased ibido or potency

•    convulsions, hallucinations, nightmares, depression, anxiety, mood changes

•    ircontroled muscle movement or rigidity.

There have been a few reports of low blood cell rxxsitB (platelets and white cells) associated with paracetamol-containing products but these were not necessaily due to paracetamol.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This fedudes any possible side effects not listed to this leaflet You can also report side effecte directiy via the Yellow Card Scheme at www.mhra.gov.uk/yellowcaid.

By reporting side effects you can help provide more information on the safety of this medicfee.

How do I know If I am addicted?

If you take this medicfee accordrg to the instructions on the pack it is unlikely that you wil become addicted to this medidne. However, If the followfeg apply to you It Is Important that you talk to your doctor.

•    You need to take the medicine for longer periods of time.

•    You need to take more than the recommended dose.

•    When you stop taking this medidne you feel vary unwell but you feel better If you start taking the meddne again.

5.    HOW TO STORE THIS MEDICINE Keep out of the sight and reach of children

Do not store above 25 "C. Store in a well-dosed container in a dry place, protected from light.

Do not use after the expiry date printed on the pack.

Do not throw away any medidnes via waste water or household waste. Ask your pharmacist how to threw away medldnes you no longer use. These measures will help prated the envkonment

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What this medicine contains:

The adtve Ingredients In each tablet are paracetamol 500mg and codeine phosphate hemlhydrate 8mg.

The other ingBdiante are maize starch, povidone, colloidal silica, majjiesium stearate and potassium sorbate (E2Q2).

What this medicine looks like and contents of the pack:

Co-codamol Tablets 8/500mg are white, flat, round tablets with‘CO’and COD'on either side of a breaktine on one side and plain on the other.

They are available in packs of 30 and 32 tablets.

Marketing Authorisation Holder and Manufacturer:

M & A Phatmachem Ltd. Bolton BL5 2AL, UK

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