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Paracetamol Tablets Bp 500mg

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PATIENT INFORMATION LEAFLET

PARACETAMOL TABLETS BP 500mg

Read all of this leaflet carefully before you start taking this medicine. o Keep this leaflet. You may need to read it again.

o If you have further questions, please ask your doctor or your pharmacist. o This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. o If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET

1.    What your medicine is and what it is used for

2.    Before you take your medicine

3.    How to take your medicine

4.    Possible side effects

5.    How to store your medicine

6.    Further information


1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR


The name of your medicine is Paracetamol Tablets BP 500mg. The active ingredient in your medicine is paracetamol. Paracetamol is an:

o analgesic, which means it acts as a painkiller

o antipyretic, which means it helps to reduce fever and lower your temperature

Paracetamol tablets are usually used for: o backache o toothache o period pains

o headaches, including migraine and tension headaches o relieving the fever, aches and pains of colds and flu o rheumatic pain and muscle pain o relieving pain due to non-serious arthritis o nerve pains (neuralgia) o sore throat

2. BEFORE YOU TAKE YOUR MEDICINE


DO NOT give to children under 6 years of age.

DO NOT take Paracetamol Tablets BP 500mg if you are:

o allergic (hypersensitive) to paracetamol or any of the other ingredients in this medicine

o taking other medicines containing paracetamol

Tell your doctor or pharmacist before taking Paracetamol Tablets BP 500mg if the above applies to you.

Take special care with Paracetamol and talk to your doctor before taking this medicine if you:

o are pregnant or breastfeeding (see ‘Pregnancy and Breast-feeding’ below)

o have severe kidney or liver problems o are an alcoholic

o are suffering from a persistent headache

Important information about some of the ingredients in your medicine

Lactose: Your medicine contains lactose. If you have been told by your doctor that you have

an intolerance to some sugars, contact your doctor before taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have bought yourself without a prescription.

Please check with your doctor or pharmacist if you are taking any of the following: o metoclopramide or domperidone (used to treat nausea and vomiting) o cholestyramine (used to lower cholesterol). Should not be taken at least one hour before and one hour after taking paracetamol. o anti-coagulants (used to thin the blood e.g. warfarin) o anti-epileptics (used to treat epilepsy e.g. carbamazepine) o cytotoxic drugs (used to treat certain types of cancers e.g. busulfan and imatinib) o chloramphenicol (used to treat bacterial infections) o other medicines containing paracetamol

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant, or you are breast-feeding always ask your doctor or pharmacist for advice before taking any medicine.

3. HOW TO TAKE YOUR MEDICINE


Always take your tablets exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are unsure.

If symptoms persist for more than 3 days or get worse, talk to your doctor.

For oral administration. The tablets should be taken with water.

Dosage instructions

Adults (including the elderly) and children over 12 years

1-2 tablets every 4-6 hours, as required.

Do not take more than 8 tablets in any 24-hour period.

Children 6-12 years

1/2-1 tablet every 4-6 hours, as required.

Do not give more than 4 tablets in any 24-hour period to your child.

Do not give to children for more than 3 days without consulting your doctor.

Children under 6 years

DO NOT give to children under the age of 6 years.

If you take more of your medicine than you should

If you, or someone else, have taken too much medicine tell your doctor or go to the nearest hospital casualty department IMMEDIATELY. Symptoms of an overdose include nausea, vomiting, paleness of the skin, abdominal pain, loss of appetite and breathing difficulties. 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.

If you forget to take your medicine

Take your usual dose as soon as you remember, as long as it is at least 4 hours since your last dose. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS


Like all medicines, Paracetamol Tablets BP 500mg can have side effects, although not everybody gets them. Tell your doctor if you think your medicine is making you feel unwell.

STOP taking your medicine and contact your doctor or nearest hospital casualty department immediately if you experience:

o an allergic reaction. The signs of an allergic reaction may include a skin rash, swelling of the lips, face, throat or tongue, itching or difficulty in breathing or swallowing.

o pancreatitis (inflammation of the pancreas). Symptoms include abdominal pain, nausea and vomiting

If you experience any of the following common side effects you should tell your doctor or pharmacist:

o bleed for longer after cutting yourself o bruise more easily o increased number of nosebleeds o bleeding gums o feeling tired o pale complexion

These symptoms may be signs of a blood disorder (e.g. thrombocytopenia, leucopenia and neutropenia). Blood disorders are a result of a change in the number and types of blood cells.

If you suffer any unusual symptoms or notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE YOUR MEDICINE


Do not use after the expiry date stated on the pack.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 25oC. Keep the container tightly closed.

Store your medicine in the original package in order to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION


What your medicine contains

Active ingredient: Each tablet contains 500mg of the active ingredient paracetamol.

Other ingredients: maize starch, lactose, povidone, magnesium stearate (E572), sodium starch glycollate, colloidal silicon dioxide and purified water.

What your medicine looks like and the contents of the pack

Paracetamol Tablets BP 500mg are white, flat bevelled edged, round tablets with a break-line on one side.

The tablets are available in blister packs of 10, 12, 16, 20, 24, 30, 32, 40, 48, 50, 60, 70, 80, 90, 96 and 100 tablets and in containers of 10, 16, 20, 25, 30, 32, 40, 50, 60, 70, 80, 90, 100, 500, 1000 and 5000 tablets.

Marketing Authorisation Holder:

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.

Distributor: Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL, U.K. PL 30464/0133

This leaflet was last revised August 2012.