Patient Information leaflet

PARACETAMOL 500 mg CAPLETS

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

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

Ask your doctor or pharmacist if you need more information or advice.

1.    WHAT PARACETAMOL CAPLETS ARE AND WHAT THEY ARE USED FOR

Paracetamol reduces pain and fever.

Paracetamol 500 mg Caplets are used in the treatment of painful and feverish conditions such as headache, migraine, toothache, colds, influenza, sore throat, period pains, muscular aches and pains, nerve pain and rheumatic pain.

2.    BEFORE YOU TAKE PARACETAMOL CAPLETS Do NOT take Paracetamol Caplets if:

•    you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6).

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

Talk to your doctor or pharmacist before you take this medicine if:

•    you have severe kidney or liver disease, including alcoholic liver disease

•    you are pregnant or trying to become pregnant.

Taking other medicines:

Talk to your doctor or pharmacist before you take this medicine 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 to thin the blood and reduce the risk of clotting

•    imatinib, used to treat certain cancers

•    some antibiotics (chloramphenicol)

•    any other tablets or medicines including any not prescribed by your doctor.

3.    HOW TO TAKE PARACETAMOL CAPLETS

The caplets should be swallowed, preferably with a drink of water.

Adults and children over 12 years of age:

Take 1 or 2 caplets every 4 hours, as required. Do not take more than 8 caplets in any 24 hour period. Children 6-12 years of age:

Give half to one caplet every 4 hours, as required. Do not give more than 4 caplets in any 24 hour period. Do not give for more than 3 days without consulting a doctor.

•    Not recommended for children under 6 years.

•    Do not take more often than every 4 hours.

•    Do not take more medicine than the label tells you to.

•    If you do not get better, talk to your doctor.    Continued overleaf

IF YOU OR ANYONE ELSE TAKES TOO MANY PARACETAMOL CAPLETS:

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.

If an overdose has been taken contact your doctor immediately or go to your local hospital casualty department. Please take this leaflet, any remaining caplets and the container with you.

4.    POSSIBLE SIDE EFFECTS

Some people may have side effects when taking this medicine. Side effects are rare with Paracetamol Caplets and may include signs of an allergic reaction such as skin rash, swelling of the lips, tongue or throat or difficulty breathing. Very rare cases of serious skin reactions have been reported.

Symptoms could include skin reddening, blisters or rash.

If you experience any of these symptoms see your doctor or go to the nearest hospital immediately. Other side effects reported are:

Unexpected bruising or bleeding, or an increased number of infections e.g. sore throats, these may indicate changes in your blood.

Difficulty breathing or wheezing (more likely in asthmatics who are sensitive to aspirin or non-steroidal anti-inflammatory drugs - NSAIDs).

Liver problems.

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.    HOW TO STORE PARACETAMOL CAPLETS Keep out of the sight and reach of children.

Store below 25°C, in a dry place and protect from light. Keep in the original container.

Keep well closed. Do not use after the expiry date printed on the pack.

6.    FURTHER INFORMATION What Paracetamol Caplets contain:

•    The active ingredient in each caplet is paracetamol 500mg.

•    The other ingredients are maize starch, colloidal anhydrous silica, magnesium stearate, potassium sorbate (E202).

What Paracetamol Caplets look like and contents of the pack:

•    The caplets are white, capsule shaped tablets with "PARA 500” on one side and a breakline on the other.

•    They are available in packs of 16,32 or 100 caplets. Packs of 32 are available only from your pharmacist, and packs of 100 are available only on prescription.

Marketing Authorisation Holder and Manufacturer:

M & A Pharmachem Ltd, Bolton BL5 2AL, UK. Date of Last Revision: 03/2015    PP2421

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