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By kanagasabaic at 2:25 pm, Mar 04, 2011 PATIENT INFORMATION LEAFLET

MEDISED TABLETS

Please read this leaflet carefully before you take any Medised Tablets, as it contains important information about this product. If you have any questions or are unsure about anything, please ask your doctor or pharmacist.

What is in the pack?

Medised Tablets contain the active ingredients: Paracetamol EP 500.0mg and promethiazine hydrochloride EP 10.0mg per tablet.

They also contain: povidone, maize starch, talc, magnesium stearate, modified starch, purified water.

Your medicine

Medised Tablets contain Paracetamol which has pain killing and temperature reducing properties (helps fight fever) and promethiazine hydrochloride, which is used as a sedative (helps you sleep). Medised Tablets come in packs of 4, 8, 12, 16, 20 or 24 tablets.

MA Holder: Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate,

Runcorn, Cheshire, WA7 1NU.

Manufacturer: Dales Pharmaceuticals Ltd, Skipton

Uses

For the treatment of mild to moderate pain, including headaches, toothaches and muscular aches and pains. Also for the relief from flu, feverishness and feverish colds.

Before taking Medised Tablets

The following information should be read before taking this product:

•    Do not take this product if you are sensitive to any of the ingredients listed at the beginning of this leaflet.

•    Do not take with any other Paracetamol-containing products.

•    Do not take if you suffer from any liver of kidney problems, or if you have noncirrhotic liver disease.

•    Avoid alcoholic drinks whilst using this product.

•    Do not take any other medicines containing either Paracetamol of promethiazine hydrochloride at the same time as taking this product.

•    Metroclopramide, domperidone and chloestyramine affct the absorption of Paracetamol. If you are taking any of these medicines, consult your doctor or pharmacist before taking this product.

•    Consult your doctor if you are taking warfarin or any other medication for thrombophlebitis (inflammation of the vein walls) or pulmonary embolism (obstruction of the lung).

•    Consult you doctor before use if you are pregnant or breast feeding.

• This product may cause drowsiness, if affected do not drive or operate machinery.

How to take Medised Tablets

Adults and the elderly:

Take 2 tablets, usually at night, to be taken up to four times a day.

Dose should not be repeated more frequently than four hour intervals, and no more than 4 doses should be taken in any 24 hour period.

Not recommended for children.

If symptoms persist, dosage should not be continued for more than three days without consulting your doctor. Do not exceed the stated dose.

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of serious delayed liver damage.

Side effects

Although side effects are uncommon, the following may occur:

Dryness of the mouth, throat and nose Dizziness, stomach pain, vomiting and diarrhoea Allergic reactions including skin rash

Paracetamol may very rarely cause blood abnormalities, agranulocytosis (decrease in the number of neutrophil blood cells), or a reduction in the number of platelets in the blood.

If you experience any of these reactions or any other not mentioned here, stop taking the product and tell your doctor or pharmacist who will inform you if any action is necessary.

Storing the product

Keep all medicines out of the reach of children Do not use this product after the expiry date This product has a two year shelf life

Leaflet Revised: January 2011