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PARAMOE

SOLUBLE TABLETS

Paracetamol 500mg and Dihydrocodeine Tartrate 7.46mg

•    This medicine can only be used for the short term treatment of acute moderate pain when other pain killers have not worked.

•    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 dihydrocodeine 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.

What are these tablets used for?

Paramol Soluble Tablets are used for the short term treatment of acute moderate pain which is not relieved by

paracetamol, ibuprofen and aspirin alone such as headache, migraine, period pain, toothache and other dental pain,

back pain, muscular and joint pains and neuralgia.

Before taking these tablets

•    This medicine contains dihydrocodeine 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 a pain killer for headaches for more than three days it can make them worse.

Do not take Paramol Soluble Tablets...

•    If you are allergic to paracetamol, dihydrocodeine, other opioids or any of the ingredient in this product.

See 'What these tablets contain' for the full list of ingredients.

•    If you are suffering from respiratory depression, obstructive airways disease or convulsive disorders.

•    If you are currently taking a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking one within the last two weeks.

•    If you are suffering from diarrhoea caused by poisoning, or diarrhoea caused by pseudomem branous colitis (inflammation of the colon often associated with long term use of antibiotics).

•    With any other paracetamol-containing products.

Speak to your doctor or pharmacist if you...

•    Have kidney or liver disease, including non-cirrhotic alcoholic liver disease, where the hazard of overdose

is increased.

•    Suffer from any adrenal gland problems including Addison's Disease.

•    Suffer from low blood pressure, thyroid problems, asthma, an enlarged prostate gland, shock, convulsions, drug abuse or dependence, inflammatory or obstructive bowel disorders, head injuries or conditions where the pressure within the skull is raised, gall bladder disease or gall stones, or myasthenia gravis (a disease affecting the nervous system, causing muscular fatigue).

•    Are elderly or debilitated; there may be a greater risk of overdose.

•    Are taking or have recently taken any other medicines, including warfarin or other drugs to thin the blood, metoclopramide or domperidone (used to treat nausea and vomiting), cholestyramine (used to treat high cholesterol), anxiolytics (used to treat anxiety), hypnotics (used to aid sleeping) tricyclic antidepressants or antipsychotics (to treat mental disorders), antiarrhythmics (to normalise heart rate or rhythm), or cimetidine (used to treat stomach ulcers).

•    Are pregnant or breast feeding.

•    Have recently undergone stomach, intestine or urinary tract surgery.

Take special care.

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

•    If you need to use this medicine for more than three days at a time, see your doctor, pharmacist or healthcare professional.

•    Avoid alcohol whilst taking Paramol Soluble Tablets.

If you are pregnant or breast feeding.

•    Paramol Soluble Tablets are not recommended for use during pregnancy or whilst breastfeeding.

Important information about some of the ingredients.

•    Paramol Soluble Tablets contain 15.7mmoles sodium per tablet, which should be taken into account by patients on a controlled sodium diet.

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How to take these tablets

Paramol Soluble Tablets should be taken during or after meals. The tablets should be dissolved in water.

Adults and children 12 years and over:

•    Take one or two tablets every four to six hours.

•    Do not take more than eight tablets in any 24 hour period.

•    Do not exceed the stated dose.

•    Take care when increasing the dose in the elderly.

If symptoms persist or worsen, consult your doctor or pharmacist.

Children under 12 years:

•    Not recommended for children under 12 years.

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

Possible withdrawal effects

This medicine contains dihydrocodeine 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 take too many of the tablets.

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.

Possible side effects

Important: 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.yellowcard.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.

•    There have been rare reports of blood disorders, but these were not necessarily causally related to paracetamol. Possible symptoms might include unexplained bruising or bleeding, sore throat or fever.

•    Constipation, if it occurs, is readily treated with a mild laxative.

•    Nausea, headache, vertigo, dizziness and urinary retention may occur in a few patients.

If you feel you are reacting badly to this medicine in any way stop taking the tablets and tell your doctor or pharmacist.

How do I know if I'm 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.

How to store these tablets

•    Keep out of the reach and sight of children.

•    Do not store above 25°C.

•    Do not use after the expiry date stated on the foil and carton.

•    If you find that you still have this medicine after its expiry date, return it to your local pharmacist who will dispose of it properly.

What these tablets contain

Paramol Soluble Tablets contain 500mg of the active ingredient paracetamol and 7.46mg of the active ingredient dihydrocodeine tartrate. Paracetamol acts as an analgesic (pain killer) and antipyretic (lowers body temperature.) Dihydrocodeine tartrate is also a powerful analgesic. They also contain citric acid (anhydrous), sodium hydrogen carbonate, sodium carbonate (anhydrous), sodium benzoate, saccharin sodium and povidone.

Paramol Soluble Tablets are available in packs containing 24 effervescent tablets.

Marketing Authorisation Holder: SSL International Plc, Trafford Park, Manchester, M41 7HA, UK.

Manufactured by: Swiss Co Services A.G., Bahnhofstrasse 14, CH-4334, Sisseln, Switzerland.

Date of revision: February 2010

Distributed by

SSL Irnefnationa^^

Trafford Park, Manchester, M41 7HA, UK. Paramol is a trade mark of the SSL Group.

FG:00000000 Item: 00000000

922 - 923 Yeovil Road, Slough, Berkshire. SL1 4NH.

T: 01753 518 080

E: sales@pulsecreative.uk.com

www.pulsecreative.uk.com

NOTES FOR PRINTER: The PANTONE colours on this proof are for REFERENCE ONLY. Please match to an original PANTONE Swatch Library. ARTWORK