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Paracetamol 500mg Caplets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PARACETAMOL 500mg CAPLETS

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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 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 Caplets contain the active ingredient paracetamol and are used for the relief of mild to moderate pain including:

•    rheumatic aches and pains

•    neuralgia (severe nerve pain), period pain

•    migraine, headache

•    sore throat, toothache

•    fevers, colds, flu and influenza.


2. BEFORE YOU TAKE PARACETAMOL CAPLETS


DO NOT take Paracetamol Caplets if you are:

•    allergic (hypersensitive) to Paracetamol, other pain relievers or any of the other ingredients in the product (see Section 6 and end of Section 2)

•    taking any other Paracetamol-containing medicines, i.e. over-the-counter cold remedies.

This medicine is NOT recommended for children under 6 years of age.


Take special care with Paracetamol Caplets

Consult your doctor before taking these caplets if you:

•    have kidney or liver problems

•    are an alcoholic.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription, particularly:

•    other products containing paracetamol (see 'DO NOT take Paracetamoi Capiets’)

•    warfarin and other drugs which thin the blood

•    cholestyramine (reduces blood cholesterol levels)

•    metoclopramide and domperidone (used to treat nausea, vomiting or other stomach problems).

Taking Paracetamol Caplets with food and drink

Avoid alcoholic drinks whilst taking these caplets.

Pregnancy and Breast Feeding

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

Driving and using machines

Paracetamol Caplets are not expected to affect your ability to drive or operate machinery.


Important information about some of the ingredients of Paracetamol Caplets

Lactose - if you know you have an intolerance to some sugars, inform your doctor before use.

3. HOW TO TAKE PARACETAMOL CAPLETS

Always take Paracetamol Caplets exactly as your doctor has told you. Swallow each caplet with a drink of water.

Adults, the elderly and children over 12 years:

Take one or two caplets every 4 to 6 hours, up to a maximum of 8 caplets in any 24 hour period.

Children (6-12 years):

Take half to one caplet every 4 to 6 hours, up to a maximum of 4 caplets in any 24 hour period.

Do not give this medicine to children under 6 years of age,

except on medical advice.

The dose should not be repeated more frequently than 4 hourly intervals. You should not take Paracetamol Caplets for longer than 3 days.

WARNING: DO NOT EXCEED THE STATED DOSE Contains paracetamol. Do not take with other paracetamol containing products.

Do not exceed the treatment for more than 3 days and if symptoms persist seek medical advice before continuing treatment.

If symptoms persist for more than 3 days, speak to your doctor.

If you take more Paracetamol Caplets than you should

It is extremely important to follow the dosage instructions that have been given to you. Do not change your dose without discussing it with your doctor first. Symptoms of overdose include pallor (paleness of skin), nausea, vomiting, anorexia and stomach pain. If you accidentally take more than the recommended dose, or know someone who has, contact your doctor or nearest hospital casualty immediately. Take any remaining medicine and this leaflet with you if possible.

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 Paracetamol Caplets

If you miss a dose, take it as soon as you remember. NEVER take a double dose to make up for the dose you have forgotten.

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 Caplets can cause side effects, although not everybody gets them.

You may suffer an allergic reaction, symptoms of which include skin rashes, hives. If this happens to you, stop taking the caplets immediately and seek urgent medical help.

There have been few reports of blood abnormalities in patients taking Paracetamol, but these were not necessarily due to the Paracetamol treatment.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effect directly via the Yellow Card Scheme (Tel: Freephone 0808 100 3352 or website: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 CAPLETS

Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original package.

Do not use Paracetamol Caplets after the expiry date shown on the pack.

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 Paracetamol Caplets contain The active substance is paracetamol 500mg.

The other ingredients are povidone, lactose, starch (maize), magnesium stearate, sodium starch glycollate, colloidal anhydrous silica (see also end of Section 2 on 'Important information about some of the ingredients of Paracetamol Caplets’).

What Paracetamol Caplets look like and contents of the pack

Paracetamol Caplets are white capsule shaped caplets with break-line. They are supplied in child-resistant blister packs of 16s, 24s, 32s, 48s, 96s and 100s (not all pack sizes may be marketed).

Marketing Authorisation Holder: Fourrts (UK) Pharmacare Ltd, First Floor, No. 2, Victoria Road.Harpenden, Hertfordshire, AL5 4EA

Marketing Authorisation Number: PL 39484/0038

This leaflet was last revised in August 2014.    Item code