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PACKAGE LEAFLET: INFORMATION FOR THE USER

| CO-CODAMOL 8MG/500MG TABLETS |

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, please 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.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. In this leaflet:

1.    What Co-Codamol Tablets are and what they are used for

2.    What you need to know before you take Co-Codamol Tablets

3.    How to take Co-Codamol Tablets

4.    Possible side effects

5.    How to store Co-Codamol Tablets

6.    Contents of the pack and other information

1. What Co-Codamol Tablets are and what they are used for

•    Co-codamol tablets contain a combination of two ingredients paracetamol and codeine phosphate. Paracetamol is a non-narcotic analgesic (pain killer) This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. Codeine can be used on its own or in combination with other pain killers such as paracetamol.

•    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 Tablets

Warning:

•    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 regularly for headaches too often or for too long can make them worse.

Do not take these tablets if you:

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

•    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

•    if you know that you metabolise very rapidly codeine into morphine

•    if you are breast-feeding

Take special care with this medicine if you:

•    suffer from liver or kidney problems (especially if severe)

•    have a liver problem caused by alcohol

•    suffer from hyperthyroidism.

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.

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.

Other medicines and Co-codamol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following medicines can affect Co-codamol:

•    other pain killers such as diflunisal

•    medicines to treat irregular heartbeats (e.g. mexiletine, quinidine)

•    medicines to prevent blood clotting (e.g. warfarin). The other effect of warfarin and other coumarins may be enhanced by prolonged regular

use of paracetamol with an increased risk of bleeding, however occasional doses have no significant effect.

•    medicines to treat epilepsy (e.g. phenytoin, phenobarbital, primidone, carbamazepine)

•    medicines to treat ulcers (e.g. cimetidine)

•    medicines to reduce cholesterol in the blood (e.g. colestyramine)

•    antibacterial medicines (e.g. isoniazide)

•    oral contraceptives (the 'pill')

•    medicines to treat gout (e.g. probenecid)

•    medicines to treat depression such as monoamine oxidase inhibitors (MAOIs). Avoid Co-codamol tablets for 2 weeks after taking the MAOIs

•    medicines to treat diarrhoea (e.g. loperamide or kaolin)

•    medicines to treat nausea or vomiting (e.g. metoclopramide or domperidone)

•    medicines to treat anxiety and insomnia (e.g. diazepam and nitrazepam)

•    medicines to treat mental illnesses including schizophrenia (e.g. chlorpromazine and haloperidol)

If you go into hospital for surgery or tests, tell your doctor you are taking

Co-Codamol Tablets, as you may interact with some anaesthetics and

influence the results of certain tests and diagnostic procedures.

Taking this medicine with alcohol

Do NOT drink alcohol whilst taking Co-Codamol Tablets.

Pregnancy and breast-feeding

•    Do not take this medicine if you are pregnant, think you have become pregnant or intend to become pregnant whilst taking these tablets

•    Do not take codeine while you are breast-feeding. Codeine and morphine passes into breast milk.

Driving and using machines

•    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

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-    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.

Co-codamol tablets contain Benzoates • This medicine contains parahydroxybenzoates (E218, E214 and E216), which may cause allergic reactions (possibly delayed).

|    3. How to take Co-Codamol Tablets    |

Always take co-codamol exactly as instructed on the leaflet

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

The usual dose is:

Adults over 18 years:

The usual dose is one or two tablets to be swallowed with water. The dose should not be taken more frequently than every 4 hours and not more than 4 times in any 24 hour period.

The maximum daily dose is 8 tablets (4.0g of paracetamol and 64mg of codeine phosphate) in any 24 hour period in divided doses.

Children aged 12 years to 18 years:

Children aged 12 years of above should take one to two tablets every 6 hours, as needed. Do not take more than 8 tablets in 24 hours.

Children aged less than 12 years:

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

This medicine should not be taken 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.

If you take more Co-Codamol Tablets than you should

Contact your nearest hospital A&E (casualty department) or your doctor immediately. 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.

Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

Signs of overdose include difficulty breathing, pupils may be pin-point in

size, nausea, vomiting, anorexia and abdominal pain.

If you forget to take Co-Codamol Tablets

If you forget to take a dose, wait and take your next dose as usual.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE DEPENDENCE: Taking codeine regularly for a long time can lead to addiction, which might lead to withdrawal symptoms when you stop the tablets.

I    4. Possible Side Effects    |

Like all medicines, Co-Codamol Tablets can cause side effects, although not everybody gets them.

Talk to your doctor straight away if you notice any of the following serious side effects:

•    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

•    Yellowing of your skin or eyes and your urine becomes darker in colour. This could be a liver problem, such as jaundice or hepatitis

•    A severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body or you develop skin blisters. You may also feel generally unwell, have a fever, chills and aching muscles.

Very rare cases of serious skin reactions have been reported.

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

•    Constipation, feeling sick (nausea), being sick (vomiting)

•    Dizziness, light-headedness, drowsiness, confusion

•    Difficulty in passing water

•    You get infections or bruise more easily than usual. This could be because of a blood problem.

•    Becoming addicted to codeine 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 Tablets ~|

•    Keep out of the sight and reach of children.

•    Do not store above 25⁰C. Store in the original package or container

•    Do not use these tablets after expiry date shown on the carton or label. 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-Codamol Tablets Contains

•    The active substance is codeine phosphate and paracetamol

•    The other ingredients are: maize starch, potato starch, povidone, stearic acid, talc, magnesium stearate, methyl-p-hydroxy benzoate (E218), ethyl-p-hydroxy benzoate (E214) and propyl-p-hydroxy benzoate (E216).

What Co-Codamol Tablets look like and contents of the pack

•    The tablets are white and round with a breakline on one side and <AB> debossed on the other side.

•    They are available in packs of 48, 50, 96 and 100 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom 0044 (0)1442 200922 0044 (0)1442 873717 info@bristol-labs.co.uk

Name and addre

Telephone:

Fax:

Email:

Co-Codamol 8mg/500mg Tablets; PL 17907/0478 This leaflet was last approved in Decmber 2014

To request a copy of this leaflet in Braille, large print or audio format then please contact the licence holder at the address (or telephone, fax, email) above.

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