139.7 mm

150 mm

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Information for the user

1!

Paracetamol 500 mg Capsules

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

fl.What is this medicine and what is it used for?

This medicine contains:

paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever.

These capsules are for the relief of mild to moderate pain including headache, migraine, toothache, nerve pain, sore throat and period pains. They are also for the symptomatic relief of sprains and strains, rheumatic pains, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness, flu, feverishness and feverish colds.

If you are taking any of the following medicines please see your doctor:

>    medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine

>    medicines to control feeling sick or being sick such as metoclopramide or domperidone

>    carbamazepine, a medicine used to treat epilepsy and bipolar disorder

>    medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins -you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis.

>    Contains paracetamol.

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

.Is this medicine suitable for you?

Do not take this medicine if you:

¹ are allergic to paracetamol or any of the other ingredients.

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Please see your doctor or pharmacist before taking this medicine if you:

» are pregnant or breastfeeding ¹ suffer from kidney or liver problems, including alcoholic liver disease ¹ are alcohol dependent.

.How to take this medicine

Swallow the capsules whole with water. Do not chew. Adults, the elderly and children over 12 years:

2 capsules every 4 hours as required. Do not take more than 4 doses (8 capsules) in any 24 hour period. Do not take more often than every 4 hours.

Do not give to children under 12 years.

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

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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you

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7. Who makes this medicine? “

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Wrafton Laboratories Limited Braunton Devon EX33 2DL

Leaflet prepared April 2016 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information: Product name: Paracetamol 500 mg Capsules Reference number: 12063/0006

This is a service provided by the Royal National Institute of Blind People.

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Information for the user

4. Possible side effects    7. Who makes this medicine?

Paracetamol 500 mg Capsules

Read all of this leaflet carefully because it contains important information for you.

I

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

I.What is this medicine and what is it used for?

This medicine contains:

• paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever.

These capsules are for the relief of mild to moderate pain including headache, migraine, toothache, nerve pain, sore throat and period pains. They are also for the symptomatic relief of sprains and strains, rheumatic pains, sciatica, lumbago, fibrositis, muscular aches and pains, < joint swelling and stiffness, flu, feverishness and ' feverish colds.

.Is this medicine suitable for you?

Do not take this medicine if you:

>    are allergic to paracetamol or any of the other ingredients.

Please see your doctor or pharmacist before taking this medicine if you:

>    are pregnant or breastfeeding

>    suffer from kidney or liver problems, including alcoholic liver disease

>    are alcohol dependent.

If you are taking any of the following medicines please see your doctor:

>    medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine

>    medicines to control feeling sick or being sick such as metoclopramide or domperidone

>    carbamazepine, a medicine used to treat epilepsy and bipolar disorder

>    medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins -you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis.

>    Contains paracetamol.

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

.How to take this medicine

Swallow the capsules whole with water. Do not chew. Adults, the elderly and children over 12 years:

2 capsules every 4 hours as required. Do not take more than 4 doses (8 capsules) in any 24 hour period. Do not take more often than every 4 hours.

Do not give to children under 12 years.

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

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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you

H

Most people do not have any side effects while i taking this medicine. However, if you experience | any of the following side effects, or anything else , unusual happens, stop taking the medicine i immediately, and see your doctor or pharmacist.

< Rare side effects are:

] • allergic reactions such as skin rash i • mouth sores ¹ • fever

| • difficulty breathing

i • you may become more prone to bleeding, bruising,

| fever and infections, such as sore throat and ulcers, i due to changes in your blood.

¹ • Nausea, sudden weight loss, loss of appetite and | yellowing of the eyes and skin.

| Very rare cases of serious skin reactions have been i reported.

! Reporting of side effects

¹ If you get any side effects, talk to your doctor,

| pharmacist or nurse. This includes any possible i side effects not listed in this leaflet. You can also | report side effects directly via the Yellow Card i Scheme at: www.mhra.aov.uk/yellowcard.

¹ By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store your medicine

| Keep out of the sight and reach of children.

i Do not use this medicine after the expiry date ¹ printed on the pack.

Do not store above 25°C.

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Wrafton Laboratories Limited Braunton Devon EX33 2DL

Leaflet prepared April 2016 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information: Product name: Paracetamol 500 mg Capsules Reference number: 12063/0006

This is a service provided by the Royal National Institute of Blind People.

TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.

6. What is in this medicine?

] Each blue / white capsule contains the active i ingredient: paracetamol 500 mg.

The other ingredients are: maize starch, croscarmellose sodium, sodium laurilsulfate and magnesium stearate. The capsule shell is made of gelatin and contains the colours titanium dioxide (E171), indigo carmine (E132) and erythrosine (E127).

This product is available in pack sizes of 16 and . _ 32 capsules______________________

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ARTWORK TEXT SIZE

Main Headings:    12pt

Sub Headings:    10pt

Body Copy:    8pt

PACK MOCK OP

Product Name:    Paracetamol 500 mg    Capsules

Product Licence No.: 12063/0006

Wording Ref:    MHRAapprovedv1 dated 03/02/2016(BTC208942action D)

Status:    Internally approved

Pack Details:    30 micron pyamidallyembossed hard temper Al

(with 250 micron PVC blisters) or 35 gsm glassine paper/9 micron soft tamper Al foil/250 micron PVC