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Paracetamol 500mg Capsules

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PACKAGE LEAFLET: INFORMATION FOR THE USER


PARACETAMOL 500mg CAPSULES


Paracetamol

Read all of this leaflet carefully because it contains

important information for you.

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

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

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet.


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

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


pharmacist for advice before taking this medicine.

Paracetamol Capsules contain Parahydroxybenzoates

• The capsule shell contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed)


2. What you need to know before you take Paracetamol Capsules


3. How to take Paracetamol Capsules


What is in this leaflet

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

2.    What you need to know before you take Paracetamol Capsules

3.    How to take Paracetamol Capsules

4.    Possible side effects

5.    How to Store Paracetamol Capsules

6.    Contents of the pack and other 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:


Do not take these capsules if you:

•    are allergic to paracetamol or any other ingredients (listed in Section 6)

•    are taking any other paracetamol-containing products Warnings and precautions

Take special care and talk to your doctor or pharmacist before taking Paracetamol Capsules if you:

•    suffer from any severe liver or severe kidney problems

•    have suffered from alcoholism

Other medicines and Paracetamol Capsules Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, even those not obtained without a prescription.

The following medicines can affect Paracetamol:

•    warfarin or other anti-coagulants (to thin the blood).

•    colestyramine (to treat high cholesterol levels)

•    metoclopramide and domperidone (to treat sickness)

•    chloramphenicol (to treat infections)

Fertility, pregnancy and breast-feeding

•    If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or


•    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 and the elderly:

Take two capsules not more than every 4 hours as required,

to a maximum of 8 capsules in a day.

Children aged 12-15 years:

One to two capsules every 4-6 hours as required, to a

maximum of 6 capsules daily in divided doses.

Do not take more than 6 capsules in any 24 hour period

Children under 12 years:

Not recommended

DO NOT EXCEED THE STATED DOSE.

If you take more Paracetamol capsules than you should

Immediate medical advice should be sought in the


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event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If you (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick, loss of appetite, stomach pain or liver damage.

If you forget to take the Paracetamol Capsules

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.


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 Capsules


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:

   Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath

•    Serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome or Toxic epidermal necrolysis)

   Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin.

•    Unexplained bruising and bleeding

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


•    Keep out of the sight and reach of children

•    Do not store above 250C. Store in the original package.

•    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 measures will help protect the environment.


6. Contents of the pack and other 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 capsules, containing white free flowing powder.

•    They are available in cartons containing 100 capsules. Marketing Authorisation Holder and Manufacturer Name and address: Bristol Laboratories Ltd,

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 Capsules; PL 17907/0245

This leaflet was last revised in March 2015

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.


V9 07-03-2015 D0


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