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PACKAGE LEAFLET - INFORMATION FOR THE USER

Paracetamol 500mg Tablets (Paracetamol)

Read all of this leaflet carefully before you

start taking this medicine.

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

•    If you have any further questions, ask your doctor or 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 are Paracetamol Tablets and what are they used for

2.    Before you take Paracetamol Tablets

3.    How to take Paracetamol Tablets

4.    Possible side effects

5.    How to store Paracetamol Tablets

6.    Further information

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

Paracetamol tablets belongs to a group of medicines called Analgesics and Antipyretics.

It works by relieving pain and reducing high temperature and fever.

Paracetamol tablets are used for the relief of mild to moderate pain including headache, migraine, tension headaches, neuralgia (severe pain in nerves), backache, toothache, sore throat, period pain, symptomatic relief of sprains, strains, rheumatic pain, sciatica (low back pain and leg pain), lumbago (low back pain), fibrositis (muscle and connective tissue pain), muscular aches and pains, joint swelling and stiffness, influenza , feverishness and feverish colds. It may also be used for symptomatic relief of pain due to non-serious arthritis.

2. BEFORE YOU TAKE PARACETAMOL TABLETS

Do not take Paracetamol tablets:

•    If you are allergic to paracetamol or any of the other ingredients of Paracetamol tablets (see section 6).

•    If you are taking any other products that contain Paracetamol.

•    If you are under 6 years of age.

Take special care with Paracetamol Tablets

Before taking Paracetamol Tablets, Tell your doctor if:

• you are suffering from liver or kidney disease, including non-cirrhotic alcoholic liver disease.

Taking other medicines

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

In particular, tell your doctor if you are taking any of the following medicines:

•    Anticoagulants to thin your blood e.g. warfarin

•    Some antibiotics e.g. chloramphenicol

•    Medicines to control nausea and vomiting e.g. metoclopramide, domperidone

•    Medicines to control high lipid levels e.g. colestyramine

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or planning to become pregnant, or are breast-feeding.

Ask your doctor or pharmacist for advice before taking any other medicine.

Driving and using machines

Paracetamol tablets has no influence on the ability to drive and operate machinery.

Consult your doctor if you are suffering from joint pain and need to take painkillers every day.

3. HOW TO TAKE PARACETAMOL TABLETS

Always take Paracetamol Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

For oral administration and short term use only. Swallow the tablets with water.

Dosage

Adults, Elderly and Children over 12 years:

Take 1-2 tablets up to four times a day as required.

Do not take more than 8 tablets per day (24 hours)

Children 6-12 years of age

Take ¹^-1 tablet up to four times a day as required.

Do not take more than 4 tablets per day (24 hours)

Leave at least 4 hours between doses.

Do not take with any other paracetamol containing products.

Do not give to children under 6 years of age.

Do not exceed the stated dose.

If symptoms persist for more than 3 days or get worse consult your doctor or pharmacist.

If you take more Paracetamol 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 someone else swallows several of these tablets all together, or you think a child has swallowed any of these tablets, contact your doctor or pharmacist or hospital emergency department immediately.

Always take any tablets left over with you, also the box and leaflet as this will allow easier identification of the tablets.

If you forget to take Paracetamol Tablets

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and just carry on as before. 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 medicines, paracetamol can cause side-effects, although not everybody gets them.

If you experience any of the following serious effects STOP taking this medicine immediately and contact your doctor or pharmacist:

Severe allergic reactions include:

•    difficulty in breathing

•    skin rash and itching

•    swelling of the face and throat

•    runny nose

Other possible side effects

•    Occasionally the blood does not clot well, which may result in easy bruising or bleeding.

•    Rarely, a severe reduction in the number of white blood cells, which makes infections more likely.

Very rare cases of serious skin reactions have been reported

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.

5. HOW TO STORE

PARACETAMOL TABLETS

Keep out of the sight and reach of children.

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

Do not use your tablets after the expiry date stated on the label or carton.

Medicines should not be disposed of via waste water 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

L_J

What Paracetamol Tablet contains?

The Active substance in your tablet is Paracetamol.

The Other ingredients are Maize Starch, Gelatin, Sodium Starch Glycollate , Magnesium Stearate , Purified Talc and Colloidal Anhydrous Silica.

What Paracetamol Tablet looks like and contents of the pack?

Paracetamol Tablets are white, uncoated caplet with inscription (^-b?Rt') on one side and plain on the other side.

They are available in blister pack of 100 Tablets. Each Blister strip contains 10 Tablets.

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

This leaflet was last approved in {04/2014} 10 8304 2 654655 INP010