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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 i s 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.

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.

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.

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3.    How to take this medicine

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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, cough, wheezing and tightness of the chest.

More rarely, the following side effects can happen:

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

Reporting of side effects

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5.    How to store your medicine

Keep all medicines out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the pack.

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: March 2013.

PL 12063/0006    2742768

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Perrigo

Product Description

Generic Paracetamol 500mg Capsules

Colour Swatches Black

Component

Leaflet

HUB No.

7748

- -

Parrigo Is the trading name of

Component No.

2742768

Supplier

Perrigo, Braunton

! !

Dodworlti Business Park, Barnsley, South tforkshire S75 3SP TEL +44 (0) 1226 779911 | FAX: +44(0) 1226 779158

Date

15/03/13

Supplier Code

N/A

IHH i

Wrafton Laboratories Limited,

Wrafton, Brairton, North Devon EX33 2DL

TEL +44 (0)1271 815815 | FAX:+44 (0) 1271 818997

www.pefrigouk.com

Version

2

Cutter Profile

139.7x150mm (L101)

Additional Swatches

Amended By

DH

Pharmacode

243

Cutter