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Paracetamol 500mg Tablets

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Document: label-leaflet MAH BRAND_PL 36722-0015 change

Pocketpak text - 100 caplets

OUTER CARTON TEXT


Pocketpak Paracetamol 500mg Caplets will appear in Braille also on front of pack


USES

For the relief of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, rheumatic aches and pains; also for the relief of the symptoms of influenza, feverishness and feverish colds.

DOSAGE

Adults, the elderly and children over 12 years: Tablets for oral use. Swallow 1 or 2 caplets with a drink of water up to 4 times a day, or as instructed by your doctor. Do not take more than 8 tablets in 24 hours.

Children 6 to 12 years: Take half to one caplet up to 4 times a day.

Children under 6 years: NOT RECOMMENDED.

Do not take more frequently than every 4 hours, and do not take more than 4 doses in any 24 hours.

WARNING

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

Do not take anything else 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.

Please read the leaflet carefully before use.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

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

Each caplet contains Paracetamol 500 mg. Also includes sodium metabisulphite (E223)

BN:

EXP:


PocketPak Paracetamol 500 mg Caplets


PocketPak Paracetamol 500 mg Caplets

Handy pop-out pack Effective pain relief

100 Caplets


PL Holder: Special Concept Development (UK) Ltd., Colonial Way, Watford, WD24 4YR

Distributed by The Healthcare Branding Company, 2 Park Street, Woburn, MK17 9PG

PL 36722/0015


POM


POP-OUT CARD TEXT


USES

For the relief of mild to moderate pain of:

Headaches

Migraine

Neuralgia

Toothache

Sore Throat

Period Pains

Rheumatic aches and pains

For the symptomatic relief of:

Colds and Flu Feverishness


LEAFLET TEXT (Leaflet attached to pop-out card)


Patient Information Leaflet

PocketPak Paracetamol 500 mg Caplets

This medicine will be called Paracetamol Tablets in this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

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

•    This medicine is only for you. Do not give it to anyone else to take. It may harm them, even if their symptoms are the same as yours.

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

•    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 Tablets are and what they are used for

2.    Before you take Paracetamol Tablets

3.    How to take Paracetamol Tablets

4.    Possible side effects

5.    How to store Paracetamol Tablets

6.    Further information


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


These tablets contain the active ingredient, paracetamol. Paracetamol is an analgesic and an antipyretic which means it relieves pain and lowers temperature.

Paracetamol Tablets are used for the relief of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, rheumatic aches and pains. Also for the relief of symptoms of influenza, feverishness and feverish colds.


Taking other medicines

Paracetamol Tablets and other medicines you may be taking may affect how each other work. Make sure your doctor knows if you are taking/using any of the following:

•    Anticoagulants to thin the blood (e.g. warfarin)

•    Colestyramine (used to lower the amount of fats in your blood). Should not be taken at least one hour before and after taking paracetamol

•    Metoclopramide or domperidone (used to treat nausea and vomiting)

•    Chloramphenicol (used to treat conjunctivitis).

•    Imatinib (used to treat leukaemia and some stomach tumours).

Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor.

Other special warnings

If you are suffering from a headache and it becomes persistent, consult your doctor.

The tablets contain sodium metabisulphite (E223) which may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties).

Driving and using machinery

Paracetamol Tablets should not affect your ability to drive or operate machinery.


3. How to take Paracetamol Tablets


4. Possible side effects


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

Some side effects can be serious. Stop taking the tablets and tell your doctor straight away if you notice the following effects:

•    Swelling of the face, lips or throat, difficulty in breathing or dizziness. These may be signs of a serious allergic reaction

•    Allergic skin reactions including rash, blistering of the skin, mouth, eyes and genitals

•    Breathing problems or wheezing. These effects are more likely if you have asthma and have experienced them before when taking aspirin or other medicines called NSAIDs e.g. ibuprofen

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

•    Very rare cases of serious skin reactions have been reported.

•    Changes in blood which may lead to bruising or bleeding gums. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor

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.


Product licence holder and manufacturer

The product licence holder is Special Concept Development (UK) Ltd., Units 1-7, Colonial Way, Watford, Hertfordshire, WD24 4YR

Manufactured by RX Farma Limited.

Unit 3, Colonial Way, Watford, Hertfordshire,

WD24 4YR, United Kingdom.

Product licence number

PL 36722/0015 - 100's pack PL 36722/0016 - 32’s pack PL 36722/0017 - 16's pack

Date of revision: June 2015.

If you would like this leaflet in a different format, please contact the licence holder at the above address.


2. Before you take Paracetamol Tablets


Some people must not take these tablets.

Do not take these tablets If:

•    You know you are allergic to paracetamol or to any of the other ingredients (these are listed in section 6)

Do not take anything else containing paracetamol while taking this medicine.

You must be especially careful if:

•    You suffer from any liver or kidney problems

•    You suffer from alcoholic liver disease

•    You suffer from mild arthritis and need to take painkillers every day

•    You are pregnant or breastfeeding.

If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.


The tablets should be swallowed with a drink of water.

Adults, the elderly and children over 12 years: Take one or two tablets up to 4 times a day, or as instructed by your doctor.

Children 6 to 12 years of age: Take half to one tablet up to 4 times a day.

Not recommended for children under 6 years of age.

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 more medicine than the label tells you to.

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

If you take more tablets than you should

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 a dose of Paracetamol Tablets

If you miss a dose don’t worry. Do not take a double dose to make up for the forgotten dose, just carry on with the normal routine.

Continued, please turn over


5. How to store Paracetamol Tablets


Keep out of the sight and reach of children.

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

Do not use the tablets after the expiry date shown on the carton.

Please take any unused medicine back to your pharmacist to be destroyed.


6. Further Information


Ingredients

Each tablet contains 500mg of the active ingredient, paracetamol. The other ingredients are pregelatinised maize starch, sodium metabisulphite (E223) and magnesium stearate.

What the medicine looks like

The tablets are white and capsule shaped with a break line on one side. The tablets are available in packs containing 16,32 or 100 tablets. Not all pack sizes may be available.