Paracetamol 500mg Tablets

Informations for option: Paracetamol 500mg Tablets, show other option

Document: leaflet MAH GENERIC_PL 16028-0012 change

Manufacturer Profile 1

PARACETAMOL 500MG CAPLETS

0 HOW TO TAKE THE MEDICINE

Swallow the caplets, preferably with a drink of water.

Age	Dose and how often to take
Adults, the elderly and children over 12 years	Take 1 or 2 caplets up to four times a day, as required.
Children 6 to 12 years	Half to one caplet 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 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.

PATIENT INFORMATION LEAFLET

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

• Keep this leaflet. You may need to read it again.

• 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.

IN THIS LEAFLET:

1. What this medicine is for

2. Before you take the medicine

3. How to take the medicine

4. Possible side effects

5. Storing the medicine

6. Further information

Q WHAT THIS MEDICINE IS FOR

Paracetamol relieves pain and brings down high temperatures (reduces fever). Paracetamol 500mg Caplets 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.

Q BEFORE YOU TAKE THE MEDICINE Do not take Paracetamol 500mg Caplets:

• 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 Caplets contain sodium metabisulphite (E223) which may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm

^(narrowing ^{of the wind}pⁱp^e). Further information overleaf *

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 caplets 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.

• skin rash or peeling, or mouth ulcers

• breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin

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

Very rare cases 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.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

0 STORING THE MEDICINE

There are no special storage requirements. Do not use after the expiry date shown on the carton. Keep out of the sight and reach of children.

[j] 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 Caplets are white, capsule-shaped tablets with a break line on one side. This pack contains 16 or 32 caplets (not all packs may be marketed, pack sizes of 32 are only available from your pharmacist).

Marketing Authorisation Holder: Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.

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

Text revised: November 20 1 5 . 4006083