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180 x180mm - sidel

PACKAGE LEAFLET: INFORMATION FOR THE USER

PARACETAMOL 500mg TABLETS

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

This medicine is available without prescription. However, you still need to take Paracetamol 500mg Tablets carefully to get the best results from them.

•    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 3 days.

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

In this leaflet:

1.    What Paracetamol 500mg Tablets are and what they are used for

2.    Before you take Paracetamol 500mg Tablets

3.    How to take Paracetamol 500mg Tablets

4.    Possible side effects

5.    How to store Paracetamol 500mg Tablets

6.    Further information

1. WHAT PARACETAMOL 500mg TABLETS ARE AND WHAT THEY ARE USED FOR

Paracetamol 500mg Tablets contain the active ingredient paracetamol and are used for the relief of mild to moderate pain, including:

•    rheumatic aches and pains

•    neuralgia (severe nerve pain), period pain

•    migraine, headache

•    sore throat, toothache

•    fevers, colds, flu and influenza.

2. BEFORE YOU TAKE PARACETAMOL 500mg TABLETS

DO NOT take Paracetamol 500mg Tablets if you are:

•    allergic (hypersensitive) to Paracetamol, other pain relievers or any

of the other ingredients in the product (see Section 6 and end of Section 2)

•    taking any other Paracetamol-containing medicines, i.e.

over-the-counter cold remedies.

This medicine is NOT recommended for children under 6 years of age.

Take special care with Paracetamol 500mg Tablets Consult your doctor before taking these tablets if you:

•    have kidney or liver problems.

•    are an alcoholic.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription, particularly:

•    other products containing paracetamol (see 'DO NOT take Paracetamol Tablets').

•    warfarin and other drugs which thin the blood.

•    cholestyramine (reduces blood cholesterol levels).

•    metoclopramide and domperidone (used to treat nausea, vomiting or other stomach problems).

•    chloramphenicol (an antibiotic).

Taking Paracetamol 500mg Tablets with food and drink Avoid alcoholic drinks whilst taking these tablets.

Pregnancy and Breast Feeding

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, planning to become pregnant or breast-feeding.

Driving and using machines

Paracetamol 500mg Tablets are not expected to affect your ability to drive or operate machinery.

PL 28444/0085

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

Sodium metabisulphite (E223) - may cause severe hypersensitivity reactions and bronchospasm (narrowing of airways in the lungs, causing difficulty in breathing).

3. HOW TO TAKE PARACETAMOL 500mg TABLETS

Always take Paracetamol 500mg Tablets exactly as your doctor has told you. Swallow each tablet with a drink of water.

Adults, the elderly and children over 12 years:

Take one or two tablets every 4 to 6 hours, up to a maximum of 8 tablets in any 24 hour period.

Children (6-12 years):

Take half to one tablet every 4 to 6 hours, up to a maximum of 4 tablets in any 24 hour period.

This medicine is not recommended for children under 6 years of age.

The dose should not be repeated more frequently than 4 hourly intervals. You should not take Paracetamol 500mg Tablets for longer than 3 days.

WARNING: DO NOT EXCEED THE STATED DOSE Contains paracetamol. Do not take with other paracetamol containing products.

If symptoms persist consult your doctor. Do not use for more than 3 days without consulting your doctor.

If you take more Paracetamol 500mg Tablets than you should

It is extremely important to follow the dosage instructions that have been given to you. Do not change your dose without discussing it with your doctor first. Symptoms of overdose include pallor (paleness of skin), nausea, vomiting, anorexia and stomach pain. If you accidentally take more than the recommended dose, or know someone who has, contact your doctor or nearest hospital casualty immediately. Take any remaining medicine and this leaflet with you if possible.

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 forget to take Paracetamol 500mg Tablets

If you miss a dose, take it as soon as you remember. NEVER take a double dose to make up for the dose you have forgotten.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Paracetamol 500mg Tablets can cause side effects, although not everybody gets them.

You may suffer an allergic reaction, symptoms of which include skin rashes, hives and itching. If this happens to you, stop taking the tablets immediately and seek urgent medical help.

There have been few reports of blood abnormalities including pancreatitis (inflammation of the pancreas) in patients taking paracetamol, but these were not necessarily due to the paracetamol treatment.

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

5. HOW TO STORE PARACETAMOL TABLETS

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package.

Do not use Paracetamol 500mg Tablets after the expiry date shown on the pack.

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 Paracetamol 500mg Tablets contain The active substance is paracetamol 500mg.

The other ingredients are maize starch, povidone K-30, sodium Metabisulphite (E223), sodium starch glycollate, colloidal anhydrous silica and magnesium stearate (see also end of Section 2 on ‘Important information about some of the ingredients of Paracetamol Tablets’).

What Paracetamol 500mg Tablets look like and contents of the pack

The tablets are white with a breakline on one face and embossed ‘P500’ on the other face. They are supplied in:

*    cartons containing blister strips of 24 and 32 tablets

*    bottles of 25 tablets.    _|

Marketing Authorisation Holder and Batch Release Site:

LPC Medical (UK) Limited, 30 Chaul End Lane, Luton, Bedfordshire LU4 8EZ, U.K.

Marketing Authorisation Number: PL 19348/0116 This leaflet was last revised in May 2009.

Item code

To be confirmed

PL 28444/0085

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