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PL 16028/0053 - Label/Leaflet/Generic text - Galpharm livery. Label

Paracetamol 500mg Tablets

Effective Pain Relief 16 Tablets

Please read the attached leaflet carefully before use. Keep out of the reach and sight of children.

For dosage instructions please see attached leaflet.

Batch No.-Exp. Date:

Each tablet contains 500mg Paracetamol.

Also contains E223.

Galpharm Healthcare Ltd., South Yorkshire, EX33 2DL PL 16028/0053 Barcode

Leaflet

PATIENT INFORMATION

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

•    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.

1.    WHAT THIS MEDICINE IS FOR

Paracetamol relieves pain and brings down high temperatures (reduces fever).

Paracetamol 500mg Tablets are used for relief of:

•    mild to moderate pain including headache, migraine, nerve pain (neuralgia), toothache, sore throat and period pains.

•    symptoms of rheumatic and muscular aches and pains, sciatica, back pain (lumbago), joint swelling and stiffness.

•    symptoms of colds and flu.

2.    BEFORE YOU TAKE THE MEDICINE Do not take Paracetamol 500mg Tablets:

•    if you are allergic to paracetamol, sodium metabisulphite or any of the other ingredients listed in section 6.

DO NOT TAKE ANYTHING ELSE CONTAINING PARACETAMOL WHILE TAKING THIS MEDICINE.

Talk to your pharmacist or doctor before taking if:

•    you suffer from severe liver or kidney disease, including alcoholic liver disease If you are taking other medicines:

Talk to your pharmacist or doctor before taking the tablets if you are taking any of the following:

•    medicines for nausea or sickness, such as metoclopramide or domperidone.

•    colestyramine for high cholesterol or high blood fats

•    warfarin (or other medicines used to thin the blood and reduce the risk of clotting). The risk of bleeding may be increased if you take paracetamol daily over a long period of time. However you can take occasional doses of paracetamol.

Pregnancy and breast feeding:

Talk to your doctor before taking paracetamol if you are pregnant. You can take Paracetamol while breast feeding.

Important information about some of the ingredients of this medicine:

Paracetamol 500mg Tablets contain sodium metabisulphite (E223) which may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (narrowing of the windpipe).

3.    HOW TO TAKE THE MEDICINE

Swallow the tablets, preferably with a drink of water. Adults, the elderly and children over 12 years: Take 1 or 2 tablets up to four times a day, as required. Children 6 to 12 years: Half to one tablet up to four times a day, as required.

Do not give to children under 6 years.

•    Do not take more often than every 4 hours

•    Do not exceed 4 doses in any 24 hour period

•    Do not continue to take for more than 3 days unless instructed by your doctor.

•    Do not take more medicine than the label tells you to. If you do not get any 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.

4.    POSSIBLE SIDE EFFECTS

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

Side effects are rare with paracetamol.

Stop taking the tablets and contact your doctor immediately if you notice:

•    skin rashes or other signs of allergic reaction such as itching, swelling of the lips, tongue or throat, or difficulty in breathing.

•    unexpected bruising or bleeding, persistent tiredness, or increase in the number of infections (e.g. sore throats) which you get. These are possible signs of changes in the blood.

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.gov.uk/yellowcard.

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

5.    STORING THE MEDICINE

There are no special storage requirements.

Do not use after the expiry date shown on the label.

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

6.    FURTHER INFORMATION What is in this medicine:

The active ingredient is: Paracetamol 500mg per tablet.

Other ingredients are: Pregelatinised maize starch, sodium metabisulphite (E223) and magnesium stearate.

What this medicine looks like and contents of the pack: Paracetamol 500mg Tablets are white, round, flat tablets with a break line on one side. Pack contains 16 tablets.

Marketing Authorisation Holder:

Galpharm Healthcare Limited, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.

Manufacturer: Galpharm International Limited, Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire, S75 4LS, United Kingdom.

Text revised: April 2015.