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Paracetamol 500mg Capsules

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Document: leaflet MAH BRAND_PL 12063-0006 change

Paramed Paracetamol Capsules

Patient Information Leaflet

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

This medicine is available without prescription, nowever, 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?

[rhis 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 jnoderate pain including headache, migraine, toothache, nerve pain, sore throat and period ains. They are also for the symptomatic relief of prains 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 breast feeding

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 with any other paracetamol-containing products.

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 then every 4 hours. Do not give to children under 12 years.

Do not exceed the stated dose.

If your symptoms persist or worsen, you must see a doctor or pharmacist.

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

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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.

5.    How to store your medicine

Keep all medicines out of the reach and sight 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).

7. Who makes this medicine?

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

Text Revised: August 2011.

This product is available in a pack size of 16 capsules.


PL12063/0006


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