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PATIENT INFORMATION LEAFLET CO-CODAMOL 30/500 mg EFFERVESCENT TABLETS

The name of this medicine is Co-codamol 30/500 mg Effervescent Tablets, which will be referred to as Co-codamol 30/500 throughout this leaflet.

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 further questions, please ask your doctor or your 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.

•    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.

1.    WHAT CO-CODAMOL 30/500 IS AND WHAT IT IS USED FOR |

The active ingredients in Co-codamol 30/500 are paracetamol and codeine.

This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paracetamol.

Co-codamol 30/500 are used for the relief of severe pain.

Codeine 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 I

Do not take for longer than directed by your prescriber.

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 Do not take Co-codamol 30/500 if you:

•    are allergic (hypersensitive) to paracetamol, codeine or any of the other ingredients

in the tablets (these are listed in section 6, Contents of the pack and other information)

•    are already taking other medicines containing paracetamol i.e. over-the-counter cold remedies

•    have a dependency to alcohol

•    suffer from severe asthma attacks or severe breathing problems

•    are on a low sodium diet

•    have bowel or prostate problems

•    are receiving monoamine oxidase inhibitor (MAOI) therapy. Co-codamol 30/500 should not be taken concurrently or within 14 days of MAOI’s

•    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

•    know that you metabolise very rapidly codeine into morphine

•    are breastfeeding

Take special care with Co-codamol 30/500:

•    If you have liver or kidney problems.

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

•    Taking codeine regularly for a long period of 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.

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•    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.

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.

Taking other medicines

Do not take these tablets if you are already taking other medicines containing paracetamol. This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as they may decrease or increase the effect of Co-codamol 30/500:

•    metoclopramide or domperidone (often taken for sickness or stomach problems)

•    colestyramine (for high blood lipid levels)

•    anticoagulants to reduce blood clotting (e.g. warfarin)

•    CNS depressants such as sleeping tablets, sedatives and some antihistamines.

•    MAOI’s should not be taken concurrently or within 14 days of Co-codamol 30/500 treatment.

•    Chloramphenicol - an antibiotic used for infections

•    The oral contraceptive pill

It may still be all right for you to take Co-codamol 30/500 and your doctor will be able to decide what is suitable for you.

Taking your medicine with food and drink

Co-codamol 30/500 should be dissolved in at least half a glass of water and can be taken with or without a meal.

•    You should not drink alcohol while you are taking these tablets. This is because co-codamol can change the way alcohol affects you.

Pregnancy and breast-feeding

Talk to your doctor before taking these tablets if:

You are pregnant, think you may be pregnant or plan to get pregnant You are breast-feeding or planning to breast-feed

Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machinery

These tablets may make you feel dizzy or drowsy. If this happens 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:

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

Important information about some of the ingredients of Co-codamol 30/500

Each of these tablets contains about 438 mg of sodium and may interfere if you are on a low sodium diet.

This product also contains aspartame (a source of phenylalanine), which should not be given to anyone with phenylketonuria.    _{Page 2}

3. HOW TO TAKE CO-CODAMOL 30/500 |

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure

Do not exceed the recommended doses. If painful symptoms are not relieved in a few days, consult your doctor.

Dosage

The usual doses for Co-codamol 30/500 are as follows:

-- The usual dose of co-codamol is 2 effervescent tablets, taken together -- adults should wait at least 4 hours before taking another dose

-- Children aged 12 years and over should wait at least 6 hours before taking another dose -- Do not take more than 8 effervescent tablets in any 24 hour period -- Elderly people may be prescribed a lower dose.

This medicine should not be taken for more than 3 days. If the pain does not improve after days, talk to your doctor for advice.

Use in children

Co-codamol should not be given to children under 12 years of age due to the risk of severe breathing problems.

Method of Administration

For oral administration only. These tablets should be dissolved in at least half a glass of water before taking them. The solution should be drunk immediately after preparation. These tablets are meant to be dissolved first so don’t try to swallow them whole.

If you take more Co-codamol 30/500 than you should:

If you have accidentally taken more than your prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. This is so the doctor knows what you have taken.

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 you forget to take Co-codamol 30/500

If you forget to take one or more doses, take your next dose when you remember and then go on as prescribed. Do not take a double dose to make up for a forgotten dose.

If you have any further questions about this product ask your doctor or pharmacist.

4. POSSIBLE SIDE-EFFECTS |

Like all medicines, Co-codamol 30/500 can cause side-effects although not everybody gets them. If you get any of the following symptoms after taking these tablets, you should contact your doctor immediately:

•    Any sudden wheeziness, difficulty in breathing or dizziness, swelling of the hands, feet,ankles, face, lips or throat which may cause difficulty in swallowing or breathing.

•    You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).

This may mean you are having an allergic reaction to co-codamol.

•    Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This is a very rare side effect.

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

•    Skin rashes

•    Constipation

•    Nausea, vomiting

•    Light-headedness, dizziness,

•    Confusion

•    Drowsiness

•    Difficulty in passing urine (urinary retention)

•    Becoming dependent on codeine

Very rare side effects:

There have been very rare reports of blood disorders which can include lower levels of red blood cells, white blood cells and platelets (known as blood dyscrasias).

Very rare cases of serious skin reactions have been reported.

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.

5. HOW TO STORE CO-CODAMOL 30/500

Do not store your tablets above 25°C. Store in a dry place and protect from light.

Do not take this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.

Keep this medicine out of the sight and reach of children.

Medicines should not be disposed of via wastewater or household waste. Do not dispose of medicines by flushing down a toilet or sink or by throwing out with your normal household rubbish.

Store your medicine in the original packaging in order to protect from moisture.

Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Co-codamol 30/500 mg Effervescent Tablets contain:

The active ingredients are paracetamol and codeine. Each tablet contains 500mg paracetamol and 30mg codeine phosphate hemihydrate.

The other ingredients are sodium hydrogen carbonate, citric acid anhydrous, sodium carbonate, povidone, simeticone, sodium saccharin, aspartame (E951) and polysorbate 80.

What Co-codamol 30/500 look like and the contents of the pack:

Co-codamol 30/500 mg Effervescent Tablets are white, circular, with a flat bevelled edge and plain on both sides.

Your medicine is available in blister packs of 30, 32, 56, 60, 84, 90 and 100 tablets (not all pack sizes may be marketed)

Marketing Authorisation Holder and Manufacturer:

The Product Licence holder is Cipla (EU) Limited, Hillbrow House, Hillbrow Road,

Esher, Surrey, KT10 9NW, United Kingdom.

The manufacturer responsible for batch release is Fannin (UK) Limited, 57 High Street, Odiham, Hants, RG29 1LF, United Kingdom.

This leaflet was last revised in Date of variation approval.

Cipla

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