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Paracetamol 500mg Capsules

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Document: leaflet MAH GENERIC_PL 12063-0006 change

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Paracetamol 500 mg Capsules

PATIENT INFORMATION LEAFLET


Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

1.    What is this medicine and what is it used for?

This medicine contains:

   paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever.

These capsules are for the relief of mild to moderate pain including headache, migraine, toothache, nerve pain, sore throat and period pains. They are also for the symptomatic relief of sprains and strains, rheumatic pains, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness, flu, feverishness and feverish colds.

2.    Is this medicine suitable for you?

Do not take this medicine if you:

•    are allergic to paracetamol or any of the other ingredients.


Adults, the elderly and children over 12 years: 2 capsules every 4 hours as required. Do not take more than 4 doses (8 capsules) in any 24 hour period.

Do not take more often than every 4 hours.

Do not give to children under 12 years.

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

4. Possible side effects

Most people do not have any side effects while taking this medicine. However, if you experience any of the following side effects, or anything else unusual happens, stop taking the medicine immediately, and see your doctor or pharmacist.

Rare side effects are:

•    allergic reactions such as skin rash

•    mouth sores

•    fever

•    difficulty breathing

•    you may become more prone to bleeding, bruising, fever and infections, such as sore throat and ulcers, due to changes in your blood.

•    Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.


Please see your doctor or pharmacist

before taking this medicine if you:

•    are pregnant or breastfeeding

•    suffer from kidney or liver problems, including alcoholic liver disease

•    are alcohol dependent.

If you are taking any of the following

medicines please see your doctor:

•    medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine

•    medicines to control feeling sick or being sick such as metoclopramide or domperidone

•    carbamazepine, a medicine used to treat epilepsy and bipolar disorder

•    medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins - you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis.

   Contains paracetamol.

   Do not take anything else containing paracetamol while taking this medicine.

3. How to take this medicine

Swallow the capsules whole with water.

Do not chew.

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Very rare case of serious skin reactions have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store your medicine

Keep out of the sight and reach of children. Do not use this medicine after the expiry date printed on the pack.

Do not store above 25°C.

6.    What is in this medicine?

Each blue / white capsule contains the active ingredient: paracetamol 500 mg.

The other ingredients are: maize starch, croscarmellose sodium, sodium laurilsulfate and magnesium stearate. The capsule shell is made of gelatin and contains the colours titanium dioxide (E171), indigo carmine (E132) and erythrosine (E127).

This product is available in pack sizes of 16 and 32 capsules.

7.    Who makes this medicine?

The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.

Text revised: February 2016.

PL 12063/0006    2753180

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