Patient Information Leaflet

Paracetamol 500 mg Tablets BP

This medicine will be called Paracetamol Tablets in this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

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

•    This medicine is only for you. Do not give it to anyone else to take. It may harm them, even if their symptoms are the same as yours.

•    If you have any further questions, please ask your doctor or pharmacist.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Paracetamol Tablets are and what they are used for

2.    Before you take Paracetamol Tablets

3.    How to take Paracetamol Tablets

4.    Possible side effects

5.    How to store Paracetamol Tablets

6.    Further information

1. What Paracetamol Tablets are and what they are used for

Taking other medicines

Paracetamol Tablets and other medicines you may be taking may affect how each other work. Make sure your doctor knows if you are taking/using any of the following:

•    Anticoagulants to thin the blood (e.g. warfarin)

•    Colestyramine (used to lower the amount of fats in your blood)

•    Metoclopramide or domperidone (used to treat nausea and vomiting)

•    Chloramphenicol (used to treat conjunctivitis).

Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor.

Other special warnings

If you are sufferingfrom a headache and it becomes persistent consult your doctor.

The tablets contain sodium metabisulphite (E223) which may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties).

Driving and using machinery

Paracetamol Tablets should not affect your ability to drive or operate machinery.

These tablets contain the active ingredient, paracetamol. Paracetamol is an analgesic and an antipyretic which means it relieves pain and lowers temperature.

Paracetamol Tablets are used for the relief of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, rheumatic aches and pains. Also for the relief of symptoms of influenza, feverishness and feverish colds.

3. How to take Paracetamol Tablets

2. Before you take Paracetamol Tablets

Some people must not take these tablets.

Do not take these tablets If:

•    You know you are allergic to paracetamol or to any of the other ingredients (these are listed in section 6)

Do not take anything else containing paracetamol while taking this medicine.

You must be especially careful if:

•    You suffer from any liver or kidney problems

•    You suffer from alcoholic liver disease

•    You suffer from mild arthritis and need to take painkillers every day

•    You are pregnant or breastfeeding.

If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.

The tablets should be swallowed with a drink of water.

Adults, the elderly and children over 12 years: Take one or two tablets up to 4 times a day, or as instructed by your doctor.

Children 6 to 12 years of age: Take half to one tablet up to 4 times a day.

Not recommended for children under 6 years of age.

The dose should not be repeated more frequently than every 4 hours and not more than 4 doses should be taken in any 24 hour period.

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

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

If you take more tablets than you should

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 you forget to take a dose of Paracetamol Tablets

If you miss a dose don’t worry. Do not take a double dose to make up for the forgotten dose, just carry on with the normal routine.

Continued, please turn over

4. Possible side effects

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

Some side effects can be serious. Stop taking the tablets and tell your doctor straight away if you notice the following effects:

•    Swelling of the face, lips or throat difficulty in breathing or dizziness. These may be signs of a serious allergic reaction

•    Allergic skin reactions including rash, blistering of the skin, mouth, eyes and genitals

•    Breathing problems or wheezing. These effects are more likely if you have asthma and have experienced them before when taking aspirin or other medicines called NSAIDs e.g. ibuprofen

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

•    Changes in blood which may lead to bruising or bleeding gums.

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.

Product licence holder and manufacturer

The product licence holder is Special Concept Development (UK) Ltd., Units 1-7, Colonial Way, Watford, Hertfordshire, WD24 4YR Manufactured by Crescent Pharma Ltd., Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED.

Product licence number

PL 36722/0015 - 100's pack PL 36722/0016 - 32's pack PL 36722/0017 - 16's pack

Date of revision: November 2013.

If you would like this leaflet in a different format, please contact the licence holder at the above address.

5. How to store Paracetamol Tablets

Keep out of the sight and reach of children.

Do not store above 25 °C. Store in the original package in order to protect the tablets from moisture.

Do not use the tablets after the expiry date shown on the carton.

Please take any unused medicine back to your pharmacist to be destroyed.

6. Further Information

Ingredients

Each tablet contains 500mg of the active ingredient, paracetamol. The other ingredients are pregelatinised maize starch, sodium metabisulphite (E223) and magnesium stearate.

What the medicine looks like

The tablets are white and capsule shaped with a break line on one side. The tablets are available in packs containing 16,32 or 100 tablets. Not all pack sizes may be available.