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Paracetamol 500mg Tablets

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Document: leaflet MAH GENERIC_PL 43870-0006 change

Paracetamol 500mg Tablets BP

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

•    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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Paracetamol is and what it is used for

2.    What you need to know before you take Paracetamol

3.    How to take Paracetamol

4.    Possible side effects

5.    How to store Paracetamol

6.    Contents of the pack and other information

1. What Paracetamol is and what it is used for

The name of your medicine is Paracetamol 500mg Tablets (called Paracetamol throughout this leaflet). It belongs to a group of medicines called painkillers (analgesics).

It is used for:

•    Mild to moderate pain including headache, neuralgia, toothache and pain caused by rheumatism

•    Relief of symptoms from colds and flu

•    Lowering high temperature (fever).

2. What you need to know before you take Paracetamol

Do not take Paracetamol if:

•    You are allergic to Paracetamol or any of the other ingredients of this medicine (listed in Section 6)

•    You are taking anything else with Paracetamol in it.

If you are not sure, talk to your doctor or pharmacist before taking Paracetamol.

Warnings and precautions:

Talk to your doctor or pharmacist or nurse before taking Paracetamol if:

•    You have severe kidney or liver problems

•    You have liver disease due to a dependence on alcohol.

Other medicines and Paracetamol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because paracetamol and some medicines can affect the way each other work.

In particular, tell your doctor if you are taking any of the following:

•    Metoclopramide or domperidone - used for nausea (feeling sick), vomiting (being sick) and other stomach problems

•    Colestyramine - used for high cholesterol and other fats in the blood

•    Anti-coagulants - used to thin the blood (such as warfarin). You can take an occasional dose of paracetamol while taking anti-coagulants. However, if you need to take pain-killers every day, talk to your doctor

•    Chloramphenicol (an antibiotic)

•    Other medicines containing Paracetamol. You should not take other medicines containing Paracetamol at the same time as taking this medicine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Pregnancy and breast-feeding

There have been no ill effects due to Paracetamol in pregnancy, when used in the recommended doses. However, you should talk to your doctor or pharmacist before taking any medicine if you are pregnant or planning to become pregnant.

You may take Paracetamol if you are breast-feeding.

Paracetamol contains lactose

If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine. Each tablet contains 6.7mg of lactose.

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3. How to take Paracetamol

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

•    Swallow the tablets with a drink of water.

How much to take

Adults and children over 12 years

The recommended dose is 1 or 2 tablets up to four times a day as required.

•    Wait at least 4 to 6 hours before taking another dose

•    Do not take more than four doses in 24 hours

•    Do not take these tablets for more than 3 days unless your doctor tells you to

•    Do not take other medicines which contain paracetamol while taking these tablets Children from 6 to 12 years of age

The recommended dose is half to one tablet up to four times a day as required.

Children under 6 years of age

Do not give Paracetamol to children under 6 years of age unless the doctor advises you to.

If you take more Paracetamol 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. Take the medicine pack with you so the doctor knows what you have taken.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them Very rare cases of serious skin reactions have been reported.

Stop taking Paracetamol and tell your doctor as soon as possible if you notice any of the following:

•    Skin rash or other signs of allergic reaction such as swelling of the lips, tongue or throat.

•    Becoming unusually tired, unexpected bruising or bleeding, blood in the urine, mouth ulcers, a rash of pinpoint red spots and getting more infections (such as colds) than usual. These are very rare effects in people taking paracetamol.

If you show any of these signs stop taking Paracetamol immediately and talk to a 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 effects via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide information on the safety of this medicine.

5. How to store Paracetamol

•    Keep out of the sight and reach of children, preferably in a locked cupboard or medicine cabinet.

•    Do not use Paracetamol after the expiry date (month, year) on the label and carton. The expiry date refers to the last day of that month.

6. Contents of the Pack and other information

What Paracetamol contains

•    The active substance of Paracetamol 500mg Tablets is paracetamol. Each tablet contains 500mg of paracetamol.

•    The other ingredients are: starch, lactose, povidone, magnesium stearate, sodium starch glycollate and aerosil.

What Paracetamol looks like and contents of the pack

Paracetamol 500mg Tablets are white capsule-shaped tablets. They are available in packs of 100 tablets.

Marketing Authorisation Holder

Medley Pharma Limited, UNIT 2A, Sefton Business Park, Aintree, Liverpool, L30 IRD, UK.

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This leaflet was last revised in July 2016