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

I 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 I 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 I You must contact a doctor if your symptoms worsen or do not improve.

In this leaflet

1.    What Co-codamol is and what it is used for

2.    What you need to know before you take Co-codamol

3.    How to take Co-codamol

4.    Possible side effects

5.    How to store Co-codamol

6.    Contents of the pack and other information

1.    What Co-codamol is and what it is used for

Co-codamol 30mg/500mg Effervescent Tablets (hereinafter referred to as Co-codamol) are painkillers (analgesics) containing two medicines, codeine and paracetamol. They are recommended for the relief of severe pain in adults.

They can be used in children older than 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.

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 (which is in this medicine).

2.    What you need to know before you take Co-codamol

Important things you should know about Co-codamol

■    Do not take for longer than your doctor tells you to

■    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 if you:

are allergic to codeine, paracetamol or any of the other ingredients in your medicine (listed in Section 6: Further information) know that you metabolise very rapidly codeine into morphine

experience severe asthmatic attacks or severe

breathing problems

have recently had a head injury

■    have an obstruction of the intestines

■    have recently had an operation on your liver, gall bladder or bile duct (biliary tract)

■    have raised pressure in the brain. Signs of this include headaches, being sick (vomiting) and blurred eyesight

take monoamine oxidase inhibitors - MAOIs -(used to treat depression) or you have taken them in the last 14 days. MAOIs are medicines such as moclobemide, phenelzine or tranylcypromine

■    are an alcoholic

■    are breast feeding your baby.

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.

Take special care with Co-codamol and tell your doctor if you have or have had:

severe kidney or liver problems

prostate problems (e.g. difficulty passing water)

■    a bowel disorder

sensitivity to aspirin or other medicines used for the treatment of inflammation (NSAIDs) eg ibuprofen.

Co-codamol should not be given to children under 12 years of age and should be taken with care in the elderly.

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation in this enzyme and this can affect people in different ways. In some people, morphine is not produced or is 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 Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription. Co-codamol may affect the way some medicines work. You must tell your doctor or pharmacist if you are taking any of the following medicines:

■    chloramphenicol (an antibiotic)

drugs which make you sleepy, including alcohol drugs used to thin the blood (e.g. warfarin).

In addition the following medicines may change the effectiveness of Co-codamol. However, this medicine should not affect their action:

■    metoclopramide/domperidone (used to treat nausea and vomiting)

■    cholestyramine (used to treat high blood cholesterol (fat) levels)

oral contraceptives ("the pill")

■    sodium oxybate (helps in the management of certain sleep disorders).

Pregnancy, breast feeding and fertility Talk to your doctor before taking Co-codamol if you are pregnant, think you may be pregnant or are planning to have a baby.

Do not take this medicine and speak to your doctor if you are in the last three months of pregnancy or in labour.

Do not take this medicine if you are breast feeding your baby.

Children and adolescents

Use in children and adolescents after surgery This medicine 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.

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

i It is an offence to drive if this medicine affects your ability to drive

However, you would not be committing an offence if:

(continued overleaf)

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 pharrmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Co-codamol tablets contain sodium and paracetamol

Co-codamol contains paracetamol. Do not take any other medicine containing paracetamol on the same day that you take Co-codamol.

Each Co-codamol tablet contains 410mg of sodium which amounts to 3.28g of sodium daily at a maximum dose of 8 effervescent tablets per day.

If you are on a sodium controlled diet please tell your doctor. The medicine also contains sorbitol and saccharin. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    How to take Co-codamol

Always take Co-codamol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Do not take for longer than directed by your prescriber.

Dissolve the effervescent tablets in at least half a tumbler-full of water before taking.

Adults

The recommended dose of Co-codamol is 1 or 2 effervescent tablets. You must leave at least 6 hours in between doses. Do not take more than 8 effervescent tablets in any 24 hour period.

If you are elderly you may be prescribed a lower dose. Use in children and adolescents Children aged 12 years and older: Your doctor will tell you what dose should be used. The recommended dose is 1 or 2 effervescent tablets every 6 hours as needed. Do not take more than 8 effervescent tablets in any 24 hour period.

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.

Children under 12 years

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 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 you forget to take Co-codamol

If you forget to take a tablet, take one as soon as you remember.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Co-codamol

If you have taken regular daily doses of Co-codamol over a long period of time, you should not increase the dosage or suddenly stop your treatment without discussing this with your doctor.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects you should know about Co-codamol

■    Taking a painkiller for headaches too often or for too long can make them worse

■    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.

Stop taking Co-codamol and see a doctor or go to a hospital straight away if:

■    you get 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 (frequency of this effect cannot be estimated from the available data)

you get serious skin reactions (very rare: may affect up to 1 in 10,000 people) i you get severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (very rare: may affect up to 1 in 10,000 people).

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

Very rare: may affect up to 1 in 10,000 people

■    bruising or more infections than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia), due to the effect of paracetamol on blood cell counts.

Frequency not known: cannot be estimated from the available data

■    constipation, nausea (feeling sick), vomiting, loss of appetite

■    dizziness, light-headedness

■    drowsiness, confusion

■    difficulty in passing water

■    shallow breathing, wheezing, tightness in the chest (bronchospasm)

■    pupils in eyes become small.

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

Keep out of the sight and reach of children.

Do not use after expiry date stated on the pack.

Store your medicine in the original package in order to protect from light and moisture.

Do not store above 25°C.

6.    Contents of the pack and other information

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

Each tablet contains 30mg of the active ingredient Codeine phosphate hemihydrate and 500mg of the active ingredient Paracetamol. Other ingredients are included to aid the manufacture of the tablets and to make them soluble. These other ingredients are sodium hydrogen carbonate, anhydrous sodium carbonate, anhydrous citric acid, sodium docusate, sorbitol (E420), saccharin sodium, dimeticone, sodium benzoate and macrogol.

What Co-codamol 30mg/500mg Effervescent Tablets look like and contents of the pack

Co-codamol 30mg/500mg Effervescent Tablets are white, bevelled, flat, round tablets.

Co-codamol 30mg/500mg Effervescent Tablets are available in blister packs of 28, 30, 50, 56 and 100 or in tube packs of 10, 16, 32 and 96. Not all pack sizes or types may be marketed.

Marketing Authorisation Holder

Manx Pharma Ltd, Taylor Group House

Wedgnock Lane, Warwick, CV34 5YA, United Kingdom.

Manufacturer

Manx Healthcare Ltd, Taylor Group House Wedgnock Lane, Warwick, CV34 5YA, United Kingdom.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call 01926 482511.

This leaflet was last revised in June 2016

MANX

Pharma

URN: GC01-PIL-25-010616

WIP URN
APPROVED URN	y	GC01-PIL-25-010616
Job		Co-codamol Tablets PIL
Size		305 x 148mm
Date		2 June 2016
BOH Approval Date
Saved as		13816/25 PIL.ai M1X
Prints		1 Colour - Black