PATIENT INFORMATION LEAFLET CO-CODAMOL EFFERVESCENT TABLETS 8/500 mg

The name of this medicine is Co-codamol Effervescent Tablets 8/500 mg, which will be referred to as Co-codamol 8/500 throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

•    This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.

•    You should only take this product for a maximum of three days at a time. If you need to take it for longer than three 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 three 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 three days it can make them worse.

•    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 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.

In this leaflet:

1.    What Co-codamol 8/500 are and what they are used for

2.    Before you take Co-codamol 8/500

3.    How to take Co-codamol 8/500

4.    Possible side effects

5.    How to store Co-codamol 8/500

6.    Further information

1. WHAT CO-CODAMOL 8/500 ARE AND WHAT THEY ARE USED FOR

The active ingredients in Co-codamol 8/500 are paracetamol and codeine phosphate hemihydrate.

Co-codamol 8/500 is for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. It is used to relieve muscular and rheumatic pains, headache, migraine, neuralgia (severe burning or stabbing pain following the line of a nerve), toothache and period pains.

2. BEFORE YOU TAKE CO-CODAMOL 8/500

This medicine contains codeine which can cause addiction if you take it continuously for more than three 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 three days it can make them worse.

Do not take Co-codamol 8/500 if you:

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

the tablets (these are listed in Section 6, Further Information)

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•    have a dependency to alcohol

•    have difficulty breathing or other chronic lung disease

•    are having an asthma attack

•    have bowel problems

•    have raised intracranial pressure or head injury Take special care with Co-codamol 8/500 if you:

•    are already taking other medicines containing paracetamol

•    have liver or kidney problems

•    are on a low sodium diet

The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Taking other medicines

Do not take these tablets if you are already taking other medicines containing paracetamol. 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 8/500:

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

•    colestyramine (for high blood lipid levels)

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

•    MAOI's and CNS depressants such as sleeping tablets, sedatives and some antihistamines

It may still be all right for you to take Co-codamol 8/500 and your doctor will be able to decide what is suitable for you.

Taking your medicine with food and drink

Co-codamol 8/500 should be dissolved in at least half a glass of water and can be taken with or without a meal.

Pregnancy and breast-feeding

Although there is no evidence that these tablets cause any ill effects during pregnancy, your doctor should advise you about taking them if you are pregnant. If you are breast-feeding, you may take these tablets but keep an eye on the baby for signs of drowsiness or poor feeding. If you notice this, stop taking the tablets and see your doctor.

Usually it is safe to take Co-codamol 8/500 while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.

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

Driving and using machinery

These tablets may make you feel dizzy or drowsy and if this happens do not drive or operate machinery.

Important information about some of the ingredients of Co-codamol 8/500

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.

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PACKAGING DEVELOPMENT

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Path : F:atul/Pawan/Neolab Piggyback UK/Co - codomol Effervecent Neolab Piggyback UK /IL56 A Co - codomol 32's (PIL).ai

3. HOW TO TAKE CO-CODAMOL 8/500

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

Dosage

The usual dose for Co-codamol 8/500 is as follows:

Adults and children over 12 years:

1 or 2 tablets dissolved in water every 4 - 6 hours as required, to a maximum of 8 tablets a day. Do not continue to take these tablets for more than 3 days unless instructed by your doctor. Do not exceed the recommended dose.

Method of Administration

For oral administration only. These tablets should be dissolved in at least half a glass of water before taking them. These tablets are meant to be dissolved first so don't try to swallow them whole.

If you take more Co-codamol 8/500 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.

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. An overdose of paracetamol can cause serious liver damage, which may not show any signs for a day or two, by which time treatment may not be successful.

If you are giving this medicine to a child, immediate medical advice should be sought in the event of overdose, even if the child seems well, because of the risk of delayed, serious liver damage.

If you forget to take Co-codamol 8/500

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.

Withdrawal symptoms:

This medicine contains codeine and can cause addiction if you take it continuously for more than three 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.

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

4. POSSIBLE SIDE EFFECTS

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. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.vellowcard.gov.uk: alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday - Friday) or fill in a paper form available from your local pharmacy.

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 eyelids, face, lips or throat.

•    An acute allergic reaction (anaphylaxis) or swelling of the skin

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The following effects have been reported:

•    Skin rashes

•    Constipation

•    Nausea, vomiting

•    Light-headedness, dizziness

•    Confusion

•    Drowsiness

•    Urinary retention

•    Rarely pancreatitis (inflammation of the pancreas which may cause severe abdominal pain that can spread through to your back)

There have been very rare reports of blood problems, so if you notice unusual bleeding or you bruise easily, tell your doctor as soon as possible.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

•    You need to take the medicine for longer periods of time

•    You need to take more than the recommended dose

•    When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again

5. HOW TO STORE CO-CODAMOL 8/500

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 all medicines out of the reach and sight of children.

Medicines should not be disposed of via wastewater or household waste.

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

These measures will help to protect the environment.

6. FURTHER INFORMATION

What Co-codamol 8/500 mg Effervescent Tablets contain:

The active ingredients are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500mg paracetamol and 8mg codeine phosphate hemihydrate.

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

What Co-Codamol 8/500 look like and the contents of the pack:

Co-codamol 8/500 mg Effervescent Tablets are white, circular, with a plain on both sides.

Your medicine is available in blister packs of 7, 10, 14, 28, 30 and 32 may be marketed).

Marketing Authorisation Holder and Manufacturer:

The Product Licence holder responsible for the batch release is Neolab Ltd, 57 High Street, Odiham, Hants, RG29 1LF.

This leaflet was last approved in MM/YYYY. NL/PB/CO/8500/1-L

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