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PACKAGE LEAFLET: INFORMATION FOR THE USER

PARACETAMOL 500MG CAPLETS

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

This medicine is available without a prescription, for you to treat a mild illness without a doctor's help. However, you still need to take it carefully to get the best results from it.

•    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.

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

In this leaflet:

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

2.    Before you take Paracetamol Caplets

3.    How to take Paracetamol Caplets

4.    Possible side effects

5.    How to store Paracetamol Caplets

6.    Further information_

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

Paracetamol is an analgesic and an antipyretic which means it relieves pain and reduce high temperature and fever.

These Caplets are used for the relief of:

•    mild to moderate pain including headache, migraine, sharp

nerve pain (neuralgia), toothache, sore throat, period pains, aches and pains

•    rheumatic aches and pains, influenza symptoms, feverishness and feverish colds

2. Before you take Paracetamol Caplets

Please read the following information. Do not give to children under 6 years.

Do not take these Caplets if you:

•    are allergic to paracetamol or any other ingredients (these are listed in Section 6, Further Information) for example sodium metabisulphite contained in these tablets may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties)

•    are taking any other paracetamol-containing products Take special care with this medicine if you:

•    suffer from any liver or kidney problems (especially if serious) or G-6-PD deficiency ( an hereditary condition leading to low red blood cell counts).

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, even those not prescribed, for example, herbal remedies and health supplements from a pharmacy, supermarket or health food shop, as these tablets may interact with Paracetamol Caplets.

The following medicines can affect Paracetamol:

•    warfarin (to thin the blood). The effect of warfarin and other coumarins may be enhanced by prolonged regular use of

paracetamol with an increased risk of bleeding, however occasional doses have no significant effect.

•    colestyramine (for high cholesterol levels)

•    metoclopramide and domperidone (to treat nausea and vomiting)

•    chloramphenicol (antibiotic to treat infections)

•    Drugs used to treat diarrhoea caused by gall bladder disease

Pregnancy and breast-feeding

•    You should let your doctor know if you are pregnant or breast-feeding, or wish to become pregnant or start breastfeeding whilst taking this medicines.

•    Ask your doctor or pharmacist for advice before taking any product.

Important information about some of the ingredients of Paracetamol Caplets

•    Paracetamol Caplets contain sodium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties).

3. How to take Paracetamol Caplets

You should check with your doctor or pharmacist if you are not sure. The usual dose is:

Adults, the elderly and children over 12 years:

Take one or two Caplets up to 4 times a day or as instructed by your doctor.

Children 6 to 12 years of age:

Take half a Caplet to one Caplet up to 4 times a day.

DO NOT GIVE TO CHILDREN UNDER 6 YEARS OF AGE.    1

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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 with any other paracetamol-containing products.

DO NOT EXCEED THE STATED DOSE.

If you take more Paracetamol Caplets than you should

If you accidently take more Caplets than you should, tell your doctor immediately or go to the nearest hospital A & E (casualty) department, even if you feel well, because of the risk of delayed, serious liver damage. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

Children (aged 12 years and under)

Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.

If you forget to take a dose

If necessary, take the missed dose when you remember and then leave at least 4 hours before taking the next dose.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE

_4. Possible side effects_

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

You can reduce the chances of experiencing side effects by using the minimum dose required. Side effects may be more serious in the elderly patients.

If you experience any of the following serious effects STOP

TAKING this medicine immediately and contact your doctor

or pharmacist:

•    Severe allergic reactions: difficulty breathing, skin rash, swollen facial features or a runny nose.

Tell your doctor if you notice any of the following side effects

or notice any other effects not listed:

•    occasionally the blood does not clot well, which may result in easy bruising or bleeding

•    rarely, a severe reduction in the number of white blood cells, which makes infections more likely

•    other rare side effect like shortness of breath

5. How to store Paracetamol Caplets

•    Keep out of the reach and sight of children.

•    Do not store above 25⁰C. Store in the original package in order to protect the Caplets from moisture.

•    Do not use the Caplets after the expiry date printed on the carton or label (exp.). The expiry date refers to the last day of that month.

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

_6. Further information_

What Paracetamol Caplets Contain:

•    The active substance is Paracetamol.

•    The other ingredients are: pregelatinised maize starch, sodium metabisulphite (E223) and magnesium stearate.

What Paracetamol Caplets look like and contents of the pack

•    The Caplets are white capsule shaped with a breakline on one side.

•    They are available in cartons containing 8, 12, 16, 24, 30, 32 or 100 Caplets or containers of 16 and 100 Caplets for dispensing purposes.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder

Name and address: Bristol Laboratories Limited,

Unit 3, Canalside,

Northbridge Road,

Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Paracetamol 500mg Caplets ; PL 17907/0001 This leaflet was last revised in May 2012 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

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