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Paracetamol 500mg Soluble Tablets

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A/s: 06/05/10

Milpharm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol 500 mg Soluble Tablets

(paracetamol)

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

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after several days.

•    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 Paracetamol 500mg Soluble Tablets are and what they are used for

2.    Before you take Paracetamol 500mg Soluble Tablets

3.    How to take Paracetamol 500mg Soluble Tablets

4.    Possible side effects

5.    Howtostore Paracetamol 500mg Soluble Tablets

6.    Further information

1. WHAT PARACETAMOL 500MG SOLUBLE TABLETS ARE AND WHAT THEY ARE USEDFOR

These tablets contain paracetamol which is an analgesic (pain-killer) and antipyretic (brings down the body temperature in case of fever).

Paracetamol Soluble Tablets are used for headache, migraine, tension headaches, toothache, neuralgia, rheumatic and muscle pain, period pain, sore throat and for relieving the fever, aches and pains of cold and flu.

Do not take Paracetamol 500mg Soluble Tablets

•    If you are allergic (hypersensitive) to paracetamol or to any of the ingredients in the product (see Section 6 and end of Section 2).

•    If you are taking any other products that contain paracetamol

•    If you are a child below 12 years of age.

Takespecial care with Paracetamol 500mg Soluble Tablets

•    If you suffer from severe liver disease (including alcoholic liver disease).

•    If you sufferfrom severe kidney disease.

Taking other medicines

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:

•    Metoclopramide ordomperidone (forfeeling sick)

•    Colestyramine (to reduce blood fat levels)

•    Warfarin or other blood thinners - If you take warfarin and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding.

Pregnancy and breast-feeding Pregnancy:

Please consult yourdoctorfor advice before taking these tablets.

Breast-feeding:

You can take Paracetamol 500mg Soluble Tablets whilst breastfeeding.

Effect on the ability to drive and use machines:

Your tablets are unlikely to have any effect on your ability to drive and use machines.

Important information about some of the ingredients of Paracetamol 500mg Soluble Tablets

•    Lactose -if you know you have an intolerance to some sugars, contact your doctor before taking this medicine.

•    Sodium-there is392mg of sodium per soluble tablet. If you are on low sodium diet, contact your doctor before taking this medicine.

Always take Paracetamol 500mg soluble tablets as your doctor or pharmacist has told you. You should check with yourdoctoror pharmacist if you are not sure.

The tablets should be dissolved in a glass of water before taking orally. The usual oral dose is:-Adults (including elderly) and children over 12 years:

1-2 tablets every four to six hours as required.

If you take more Paracetamol 500mg Soluble Tablets than you should

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. If you or anyone takes more than the correct number of tablets (overdose), contact your doctor, pharmacist or hospital emergency department immediately. Always take the box or any tablets left over with you, if you can.

Symptoms of an overdose include feeling or being sick, loss of appetite, stomach pain or liver damage.

If you forget to take Paracetamol 500mg Soluble Tablets

If you forget to take a dose, take it as soon as you remember, then continue as usual. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all other medicines, Paracetamol 500mg Soluble Tablets can have side effects.

Side effects are usually mild and may include skin rashes and other allergic reactions occasionally. Very rarely there have been reports of blood disorders but these were not necessarily caused by paracetamol. These effects should go away once you stop taking yourtablets.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep all medicines away from the reach and sight of children.

On the label you will find a date after which the medicine is no longer fit for use. Do not use this medicine afterthis date.

Do not store above 25°C. Store in original container. Keep the container tightly closed in dry place.

Store away from heat and direct sunlight.

Do not store in bathroom, near the kitchen sink, or in damp places. Heat or moisture may cause the medicine to breakdown.

6. FURTHER INFORMATION

What Paracetamol 500mg Soluble Tablets contains

The active substance is paracetamol, 500mg.

Other ingredients are citric acid anhydrous, sodium sulphate anhydrous, lactose monohydrate, sodium hydrogen carbonate, povidone K25, simethicone, saccharin sodium, lemon flavour H & R 213 841 and macrogol 6000.

What Paracetamol 500mg Soluble Tablets looks like and contents of the pack

The tablets are white, biplane with facets on both sides. They are available in the tube packof8,12, and 16tablets.

Marketing Authorisation Holder and Manufacturer

Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip, HA4 6QD United Kingdom

This leaflet was last approved in {05/2010}