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PACKAGE LEAFLET: INFORMATION FOR THE USER

PARACETAMOL 500mg CAPSULES

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 gets 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 Capsules are and what they are used for

2.    Before you take Paracetamol Capsules

3.    Howto take Paracetamol Capsules

4.    Possible side effects

5.    Howto Store Paracetamol Capsules

6.    Further Information_

1. What Paracetamol Capsules are and what _they are used for_

Paracetamol is an analgesic and an antipyretic which means it relieves pain and lowers temperature. These capsules are used for the relief of:

•    fever, pain, headache, migraine, sharp nerve pain (neuralgia), toothache, sore throat, period pains, aches and pain.

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

2. Before you take Paracetamol Capsules

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

Do not take these capsules if you:

•    are allergic to paracetamol or any other ingredients (these are listed in Section 6, Further Information)

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

•    suffer from any severe liver or severe kidney problems 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 capsules may interact with Paracetamol capsules.

The following medicines can affect Paracetamol:

•    warfarin or other anti-coagulants (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 (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 medicine.

•    Ask your doctor or pharmacist for advice before taking any medicine

Important Information about some of the ingredients of

Paracetamol Capsules

•    The capsule shell contains propyl parahydroxybenzoate

(E216) and methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed)_

3. How to take Paracetamol Capsules

•    Always take these capsules exactly as advised by your doctor. Check with your doctor or pharmacist if you are not sure

•    If symptoms persist consult your doctor. Do not continue to take these capsules for more than 3 days unless instructed by your doctor

•    The capsules should be swallowed whole with a drink of water

Adults, the elderly and children over 12 years: Take one

or two capsules up to 3 to 4 times a day if required or as

instructed by your doctor.    g

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Children 6-12 years: Take one capsule 3 to 4 times a day if required.

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

Do not take with any other paracetamol-containing products. Not recommended for children under 6 years of age. DO NOT EXCEED THE STATED DOSE.

If you take more Paracetamol capsules than you should

If you accidentally take more Capsules 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 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 of Paracetamol capsules If necessary, take the missed dose when you remember, however, if it is almost time for your next dose, skip the missed dose and then take your next dose when it is due. DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE

4. Possible side effects

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

STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following:

•    severe allergic reactions: difficulty breathing, skin rashes, swollen facial features or a runny nose

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:

•    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 capsules

•    Keep the medicine in a safe place where children can not see or reach it.

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

•    Do not use the capsules after the expiry date printed on the pack (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 capsules contain:

•    The active substance is Paracetamol.

•    The other ingredients are: pregelatinised maize starch, magnesium stearate and sodium laurilsulphate.

•    The capsule shell contains: titanium dioxide (E171), erythrosine (E127), quinolone yellow (E104), patent blue (E131), gelatin, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)

What Paracetamol capsules look like and contents of the pack

•    They are red and white hard gelatine capsule, containing white free flowing powder.

•    They are available in cartons containing 6,8,10,12 or 16 capsules.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,

HP41EG, United Kingdom Telephone:    0044(0)1442200922

Fax:    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Paracetamol 500mg Capsules; PL 17907/0048 This leaflet was last revised in September 2011 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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