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Paracetamol 500mg Caplets

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Document: label-leaflet MAH GENERIC_PL 04077-0001 change
PARACETAMOL TABLETS 500mg

Read all of this leaflet carefully because It contains Important Information for you. Keep this leaflet. You may need to read it again. Ask your doctor or pharmacist if you need more information or advice.

1. WHAT PARACETAMOL TABLETS ARE AND WHAT THEY ARE USED FOR

Paracetamol reduces pain and fever. Paracetamol 500mg Tablets are used in the treatment of painful and feverish conditions such as headache, migraine, toothache, colds, influenza, sore throat, period pains, muscular aches and pains, nerve pain and rheumatic pain.

2. BEFORE YOU TAKE PARACETAMOL TABLETS

Do NOT take Paracetamol Tablets if:

•    you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6).

DO NOT TAKE WITH ANYTHING ELSE CONTAINING PARACETAMOL WHILE TAKING THIS MEDICINE.

Talk to your doctor or pharmacist before you take this medicine if:

•    you have severe kidney or liver disease, including alcoholic liver disease

•    you are pregnant or trying to become pregnant.

Taking other medicines:

Talk to your doctor or pharmacist before you take this medicine if you are taking any of the following:

•    medicines for nausea or sickness, such as metoclopramide or domperidone

•    colestyramine for high cholesterol or high blood fats

•    warfarin or other medicines to thin the blood and reduce the risk of clotting

•    imatinib, used to treat certain cancers

•    any other tablets or medicines including any not prescribed by your doctor.

3. HOW TO TAKE PARACETAMOL TABLETS

The tablets should be swallowed, preferably with a drink of water.

Adults and children over 12 years of age:

Take 1 or 2 tablets every 4 hours, as required.

Do not take more than 8 tablets in any 24 hour period.

Children 6-12 years of age:

Give >2 to 1 tablet every 4 hours, as required. Do not give more than 4 tablets in any 24 hour period. Do not give for more than 3 days without consulting a doctor.

•    Not recommended for children under 6 years.

•    Do not take more often than every 4 hours.

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

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

IF YOU OR ANYONE ELSE TAKES TOO MANY PARACETAMOL TABLETS: 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 an overdose has been taken contact your doctor immediately or go to your local hospital casualty department. Please take this leaflet, any remaining tablets and the container with you.

4. POSSIBLE SIDE EFFECTS

Some people may have side-effects when taking this medicine. Side effects are rare with Paracetamol Tablets and may include signs of an allergic reaction such as skin rash, swelling of the lips, tongue or throat or difficulty breathing. If you experience any symptoms of an allergic reaction see your doctor or go to the nearest hospital immediately.

Other side effects reported are:

Unexpected bruising or bleeding, or an increased number of infections e.g. sore throats, these may indicate changes in your blood.

Difficulty breathing or wheezing (more likely in asthmatics who are sensitive to aspirin or non-steroidal anti-inflammatory drugs - NSAIDs), Liver problems.

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 TABLETS

Keep out of the sight and reach of children.

Store in a cool dry place and protect from light.

Keep in the original container. Keep well closed.

Do not use after the expiry date printed on the pack.

6.    FURTHER INFORMATION

What Paracetamol Tablets contain:

The active ingredient in each tablet is paracetamol 500mg.

The other ingredients are maize starch, colloidal anhydrous silica, magnesium stearate, potassium sorbate (E202).

What Paracetamol Tablets look like and contents of the pack:

The tablets are white, round and flat with ”PARA” and “500” on either side of a break line on one side and plain on the other.

They are available in packs of 16, 32 or 100 tablets. Packs of 32 are available only from your pharmacist and packs sizes of 100 tablets are available only on prescription.

Marketing Authorisation Holder and Manufacturer:

M & A Pharmachem Ltd, Bolton BL5 2AL, UK.

Date of Last Revision: 05/2013

Each tablet contains Paracetamol 500 mg. Please read the leaflet before use. Tablets for oral use. For the relief of headache, migraine, | Tablets 500mg 16 Tablets toothache, colds, influenza, sore throat, period pains, muscular aches Do not take anything else and pains, nerve pain and rheumatic pains. containing paracetamol while Dose: Adults & children over 12 years: Take 1 or 2 tablets every 4 taking this medicine. Talk to hours. Do not take more than 8 tablets in 24 hours. a doctor at once if you take Children 6-12 years: Give '/ to 1 tablet every 4 hours. Do not give more to° mucli of this meihmim, than 4 tablets in 24 hours. Do not give for more than 3 days without even if you feel weM. consulting a doctor. Not recommended for children under 6 years.

Keep out of die sqm and reach of Do not take more medicine than the label tells you to. cliUdiem Stoie m a cool d/y pta. If you do not get better talk to your doctor.

Keep in the original container. Keep

well closed Protect from light MA Holder: M&A Pharmachem Ltd, Bolton, BL5 2AL PL 4077/0001


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containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.

Keep out of the sight and reach of children. Store in a cool dry place. Keep in the original container. Keep well closed. Protect from light.


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Each tablet contains Paracetamol 500 mg. Please read the le before use. Tablets for oral use. For the relief of headache, migr: toothache, colds, influenza, sore throat, period pains, muscular at and pains, nerve pain and rheumatic pains.

Dose: Adults A children over 12 years: Take 1 or 2 tablets every 4 hours. Do not take more than 8 tablets in 24 hours.

Children 6-12 years: Give'/to 1 tablet every 4 hours. Do not give more than 4 tablets in 24 hours. Do not give for more than 3 days without consulting a doctor. Not recommended for children under 6 years.

Do not lake more medicine than the label tells you to. li you do not gel heller talk lo your doctor.

MA Holder: M&A Pharmachem Ltd, Bolton, BL5 2AL PL4077/0001


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Page 1    82 x 35


All text size is 7pt. Exceptions being headings 1 to 6 plus PARACETAMOL heading (first line) on page 2 which are set in 8pt.

Cover text is 7pt Under Blue panel is 6.5pt

NEW^^ Job No.: 300835

Date: 23rd May 2013

PROOF 13    100% Label Code

Colour Reference: Black    ???


Base Label:    35 x 110mm

Leaflet Page 1:    35 x 82mm

Right Hand Opening \z\ Overall Leaflet Size: 35 x 399 Page Widths: 82 80 79 79 79