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Active substance: PARACETAMOL

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Patient Information Leaflet

Paracetamol 500mg Tablets


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

This medicine is available without prescription, for you to treat a mild illness without a doctor's help. Nevertheless,
you still need to use Paracetamol 500mg Tablets carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must see 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


Each tablet contains 500mg of the active ingredient paracetamol.
Paracetamol 500mg Tablets are analgesics (pain relievers) which may be used for the treatment of mild to moderate
pain including headache, migraine, neuralgia, toothache, period pains and the symptomatic relief of rheumatic aches
and pains. They also reduce temperature and can be used for the symptomatic relief of feverishness, feverish colds
and influenza.

Do not take Paracetamol Tablets:

• If you are allergic to paracetamol or any of the other ingredients listed.
• If you suffer from any kidney or liver impairment or alcoholic liver disease.

Taking Paracetamol Tablets with food and drink

You are advised NOT to drink alcohol whilst taking Paracetamol Tablets.

Pregnancy and breastfeeding:

There is no evidence that Paracetamol Tablets will harm your baby if you are pregnant. Paracetamol is excreted in
breastmilk but in insignificant amounts. However, if you are pregnant or breast-feeding, if you think you may be pregnant
or if you are trying for a baby, you should let your doctor know.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Paracetamol is not expected to impair your ability to drive or to operate machinery.

Taking/using other medicines:

You should always make sure that you are not taking any other paracetamol-containing preparations. If you have
been prescribed chloramphenicol, or are taking cholestyramine or anti-coagulants (blood thinning preparations), or
preparations to counteract nausea or vomiting, particularly after radiotherapy or other anti-cancer treatment, you
should consult your doctor. Please note that these statements may also apply to products used some time ago or at
some time in the future. Please inform your doctor or pharmacist if you are taking, or have recently taken any other
medicine - even those not prescribed.

Important information about some of the ingredients of Paracetamol Tablets

Sodium Metabisulphite can cause allergic type reactions including anaphylactic symptoms and bronchospasm in
susceptible people, especially those with a history of asthma or allergy.


The normal dose for adults, the elderly and children over 12 years of age, is one or two tablets to be swallowed with
a drink of water. The dose may be taken every 4 - 6 hours, as required. Do not exceed 8 tablets in one day.
For children between 6 and 12 years, a half to one tablet can be given up to 4 times a day. Do not exceed 4 tablets in
one day. Not for use in under 6 year olds. Do not take more frequently than every 4 hours. If symptoms persist for more
than three days, consult your doctor.

If you forget to take Paracetamol Tablets:

If you forget to take one dose, you should never make up for the missing dose by doubling the dose next time. Instead
you should simply continue with the next dose when it is due.

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


Like all medicines, paracetamol can have side effects. Adverse effects of paracetamol are rare but hypersensitivity
including skin rash can occur. There are usually no ill effects due to paracetamol being used in the recommended
dosage during pregnancy, but patients should follow the advice of their doctor regarding its use.

If you are concerned about these or if you notice any side effects not mentioned in this leaflet,
please inform your doctor or pharmacist.


The tablets should be stored below 25°C in the original package.
This medicine must not be used after the expiry date printed on the pack. Return any left over medicine to your
Do not use Paracetamol Tablets if you notice any changes in the colour or the appearance of the tablets.
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.
Keep this medicine out of the reach and sight of children.


What Paracetamol Tablets contains

These tablets contain 500mg of Paracetamol as the active ingredient.
They also contain Maize Starch, Magnesium Stearate (E572), Stearic Acid (E570) and Sodium Metabisulphite (E223).

What Paracetamol Tablets look like and contents of the pack

Paracetamol Tablets are flat, white bevelled edge tablets with a breakline on one face, containing 500 mg of the active
ingredient paracetamol. Paracetamol Tablets are available in blister packs of 2, 4, 8 and 16 tablets. Not all pack sizes
may be marketed.

Marketing Authorisation Holder and Manufacturer:

Intrapharm Laboratories Limited, Kidwells Park House, Kidwells Park Drive, Maidenhead, Berkshire SL6 8AQ

Distributed by:

Bradberry Summers, a trade name of GlobalTech Holdings
1st Floor Stanmore House, 15/19 Church Road, Stanmore, Middx, HA7 4AR
PL 17509/0056
You can get more information on Paracetamol 500mg Tablets from your doctor or pharmacist.

June 2011


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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.