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Co-Codamol 8mg/500mg Tablets

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130 mm

270 mm

lnformation for the user PL4&

Paracetamol & Codeine Tablets j

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• This medicine can only be used for the short term treatment of acute moderate pain such as headache, migraine, toothache, period pain and rheumatic pains including muscle pains and backache that is not relieved by aspirin, ibuprofen or paracetamol alone

• You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it

• If you take this medicine for headaches for more than 3 days it can make them worse

• Keep this leaflet, you may need to read it again

• Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine can be used for the short term treatment of acute moderate pain such as headache, migraine, toothache period pain and rheumatic pains including muscle pains and backache that is not relieved by aspirin, ibuprofen or paracetamol alone.

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

This codeine-containing medicine can be used in adults and children aged 12 years and over.

This medicine also conlains Paracetamol. Paracetamol, an analgesic, acts to relieve pain.

Before you take this medicine

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it

• If you take a painkiller for headaches for more than 3 days it can make them worse

This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

XDo not take:

• 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 allergic to any of the ingredients (see "What is in this medicine")

• If you are pregnant

• If you are breastfeeding (see "Other important information")

? Talk to your pharmacist or doctor:

• If you have kidney or liver problems (including liver problems caused by drinking alcohol)

Other important information

If you are having any blood tests, stomach tests, or go into hospital, tell your doctor that you are taking this medicine.

Driving and using machines: This medicine can affect your ability to drive or use machines as it may make you feel sleepy or dizzy.

• Do not drive or use machines while taking this medicine until you are sure you are not affected

• 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.

Do not drink alcohol (wine, beer, spirits) whilst taking this medicine.

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.

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

Information about some of the ingredients: Ethyl parahydroxybenzoate (E214), methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) in this medicine may cause allergic reactions.

^L If you take other medicines

f This medicine contains paracetamol.

Do not take anything else containing paracetamol while taking this medicine.

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Diflunisal (another painkiller)

• Metoclopramide or domperidone (for feeling sick)

• Colestyramine (to reduce blood fat levels)

• Medicines to thin your blood (e.g. warfarin)

• Oral contraceptives

• Carbamazepine, phenobarbital, phenytoin or primidone (for epilepsy)

• Probenecid (for gout), isoniazid (an antibiotic), mexiletine or quinidine (for heart rhythm problems)

• Medicines for depression (tricyclic antidepressants and MAOIs), for other mental health conditions, for anxiety, or sleeping tablets

• Medicines for diarrhoea (e.g. loperamide), cimetidine (for stomach ulcers)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

/'How to take this medicine

Check the foil is not broken before use. If it is, do not take that tablet.

Age

How many How often to take to take

Adults over 18 years

One or two

Every 4 to 6 hours. Don’t take more than

8 tablets in 24 hours.

Children aged 12 years to 18 years

One or two

Every 6 hours.

Don’t take more than

8 tablets in 24 hours.

Swallow each tablet with water.

Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist for advice.

Do not give to children under 12 years, due to the risk of severe breathing problems.

Do not take more medicine than the table above tells you to.

If you do not get better, talk to your doctor.

! If you take too many tablets: 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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible withdrawal effects when stopping treatment This medicine contains codeine and can cause addiction if you lake it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

Possible side effects

Most people will not have problems, but some people may have side effects when taking this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional.

! If you get any of these serious side effects, stop taking the tablets. See a doctor at once:

• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

• Allergic skin reactions (which can sometimes be severe and include peeling, blistering and lesions of the skin)

• Severe stomach pain, which may reach through to the back. This may be a sign of pancreatitis, which is

_L_veryrare__

If you get any of the following side effects see i your pharmacist or doctor: |

• Other allergic reactions (e.g. skin rash) ¹

• Constipation, feeling sick, being sick !

• Confusion, dizziness, drowsiness, vertigo ]

• Difficulty in passing urine

• Unusual bruising, bleeding, fever, or infections such |

as sore throats - this may be a sign of very rare '

changes in the blood !

Reporting of side effects

If you get any side effects, talk to your doctor, i 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.aov.ukA/ellowcard. By reporting side ]

effects you can help provide more information on the i safety of this medicine. j

! How do I know if I am addicted? |

If you take the medicine according to the instructions! on the pack it is unlikely that you will become j addicted to the medicine. However, if the i

following apply to you it is important feat you talk ) to your doctor: '

• You need to take fee medicine for longer periods of !

time |

•You need to take more than fee recommended !

amount |

• When you stop taking the medicine you feel very i

unwell but you feel better if you start taking the ! medicine again ;

How to store this medicine

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