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Paracetamol 500mg Tablets

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PARACETAMOL 500mg TABLETS


PACKAGE LEAFLET: INFORMATION FOR THE USER


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 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 tablets are and what they are 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 PARACETAMOL TABLETS ARE AND WHATTHEYARE USEDFOR


Paracetamol 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 TABLETS


DO NOT take paracetamol 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 forchildren under

6 years of age.

Take special care with paracetamol tablets

Consult yourdoctor 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 otherdrugs which thin the blood

•    colestyramine (reduces blood cholesterol levels)

•    metoclopramide and domperidone (used to treat nausea, vomiting orotherstomach problems)

•    enzyme inhibiting drugs such as Carbamazepine.

Taking paracetamol 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 Tablets are not expected to affect your ability to drive oroperate machinery.

Important information about some of the ingredients of paracetamol tablets

Lactose if you know you have an intolerance to some sugars, inform your doctor before use.


3. HOW TO TAKE PARACETAMOL TABLETS


Always take Paracetamol 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 (6-12years):

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

Do not give this medicine to children under 6 years

of age, except on medical advice.

The dose should not be repeated more frequently than 4 hourly intervals..


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

There have been few reports of blood abnormalities in patients taking paracetamol, but these were not necessarily due to the paracetamol treatment.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Tel: Freephone 0808100 3352 Website: ww.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.


5. HOW TO STORE PARACETAMOL TABLETS


WARNING: 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 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.


Keep out of the reach and sight of children.

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


Talk to a doctor at once if you take too much of this medicine even if you feel well, this is because too much paracetamol can cause delayed, serious liver damage.


If you forget to take paracetamol tablets

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

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


What paracetamol tablets contain

The active substance is paracetamol 500mg.

The other ingredients are povidone, lactose, starch (maize), magnesium stearate, sodium starch glycollate, colloidal anhydrous silica (see also end of Section 2 on 'Important information about some of the ingredients of Paracetamol Tablets').

What paracetamol tablets look like and contents of the pack

Paracetamol Tablets are white capsule shaped tablets with break-line. They are supplied in child-resistant blister packs containing 48,60,96 and 100 tablets (not all pack sizes may be marketed).

MarketingAuthorisation Holder and manufacturer:

Relonchem Limited,

Cheshire house, Gorsey lane, Widnes WA8 ORP, UK


4. POSSIBLE SIDE EFFECTS


Like all medicines, paracetamol tablets can cause side effects, although not everybody gets them.


MarketingAuthorisation Number: PL 20395/0078


POM


This leaflet was last revised in September 2013.