Patient Information Leaflet

CO-CODAMOL 30/500 mg TABLETS

(Codeine 30mg/Paracetamol 500mg)

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-CODAMOL 30/500 mg TABLETS ARE AND WHAT THEY ARE USED FOR

Co-codamol 30/500mg Tablets contain paracetamol and codeine (painkillers), which are used to relieve severe pain.

Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain.

Co-codamol 30/500mg 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 ibuprofen alone.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL 30/500 mg TABLETS

Do NOT take this medicine if you:

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

•    have moderate or severe kidney failure or liver disease

•    have asthma or another lung disease which makes breathing difficult

•    have increased pressure in the brain, e.g. following a head injury

•    have diarrhoea associated with inflammation of the bowel or following poisoning

•    have recently had gall bladder surgery

•    are an alcoholic

•    are at risk of paralysis of the intestine (paralytic ileus).

•    are taking Monoamine Oxidase Inhibitors for depression or have taken them within the last 14 days

•    know that you metabolise very rapidly codeine into morphine

•    are breastfeeding.

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

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

Warnings and precautions

•    Do not take for longer than directed by your doctor.

•    Taking codeine 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.

Children and adolescents

Use in children and adolescents after surgery Codeine should not be used for pain relief 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.

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

•    suffer from 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 prostate or urinary problems e.g. difficulty passing water

•    have mild kidney or liver disease

•    suffer from convulsions

•    have a history of drug abuse or emotional instability

•    suffer from bowel disease

•    have recently had gastro-intestinal surgery

•    have gall stones

•    are elderly or infirm.

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, morphine is not produced or produced in very small quantities, and it will not provide enough pain 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 breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Other medicines and Co-codamol Tablets

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

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

•    medicines used to treat water retention or high blood pressure

•    medicines to treat mental illness (anti-psychotics)

•    medicines to prevent blood clotting, such as warfarin

•    medicines to treat diarrhoea, such as loperamide and kaolin

•    muscle relaxants, such as atropine

•    anaesthetics or other drugs used in surgery (such as neuromuscular blocking agents)

•    medicines that affect the liver e.g. carbamazepine, phenobarbital, phenytoin (anti-epileptics) or rifampicin (antibiotic)

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

•    colestyramine (used to reduce cholesterol in the blood)

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

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

•    cimetidine (used to treat stomach ulcers)

•    cisapride (used to treat heart burn)

•    chloramphenicol (an antibiotic)

•    oral contraceptives (the “pill")

•    hydroxyzine (an anti-histamine)

•    probenecid (used to treat gout)

•    isoniazid (used to treat tuberculosis).

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

Pregnancy and breast 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.

Continued overleaf

Driving and using machines

If these tablets make you feel drowsy, 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.

Tell 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 blood or urine tests.

3.    HOW TO TAKE CO-CODAMOL 30/500mg TABLETS

Always take this medicine exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

Dose for Adults and Children over 12 years of age:

•    Swallow the tablets with a glass of water.

•    Take one or two tablets every 4 hours.

•    Do not take more than two tablets at once and no more than 8 tablets in 24 hours.

•    Do not take more often than every 4 hours.

•    Avoid drinking alcohol when taking these tablets.

•    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

Co-codamol should not be taken by children below the age of 12 years, due to the risk of severe breathing problems.

If you take more Co-codamol Tablets than you should:

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 the doctor is not there, go to your local hospital casualty department. Take this leaflet and any remaining tablets with you.

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Co-codamol Tablets 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 swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives

•    inflammation 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 side effects gets worse or lasts longer than a few days:

Common side effects

•    constipation, drowsiness

Uncommon side effects

•    nausea, vomiting, anorexia, diarrhoea, incontinence

•    abdominal pain (may be caused by spasm of the bile or urinary ducts)

•    skin rash, itching, sweating, facial flushing, low body temperature

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

•    malaise, tiredness, headache

•    dizziness, vertigo, light-headedness

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

■    low blood pressure, feeling faint on standing from a seated or lying position

■    decreased libido or potency

•    confusion, anxiety, mood changes.

Rare side effects

•    convulsions, hallucinations, nightmares, depression

•    stomach cramps

•    uncontrolled muscle movement or rigidity.

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

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 THIS MEDICINE Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original package.

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 this medicine contains:

The active ingredients in each tablet are paracetamol 500mg and codeine phosphate hemihydrate 30mg.

The other ingredients are maize starch, povidone, colloidal silica, magnesium stearate and potassium sorbate (E202).

What this medicine looks like and contents of the pack: Co-codamol 30/500mg Tablets are off-white, flat, round tablets, available in packs of 10,20,30,50 and 100 tablets.

Marketing Authorisation Holder and Manufacturer:

M&APharmachem Ltd, Bolton BL5 2AL, UK

Date of last revision: March 2014    PP2376

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