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Paracetamol 500mg Caplets

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Document: leaflet MAH GENERIC_PL 20416-0123 change

PATIENT INFORMATION LEAFLET Taking other medicines:

PARACETAMOL 500mg Caplets

Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet, you may need to read it again.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further information

1.    What this medicine is and what it is used for

Paracetamol is an analgesic (pain killer) and an antipyretic (helps to reduce body temperature when you have a fever).

This medicine is used for the relief of headache, migraine, neuralgia and rheumatic aches and pains. Also for the relief of symptoms of colds and influenza.

2.    Before you take this medicine Do not take these caplets if:

■    you are allergic to paracetamol or any of the other ingredients (see section 6).

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

Check with your doctor before taking these caplets if:

• you suffer from any liver or kidney problems

■    you suffer from alcohol dependence.


Check with your doctor or pharmacist before taking these caplets if you are taking other medicines, including any that you can buy without a prescription. This is especially important if you are taking:

■    anticoagulants to thin the blood e.g. warfarin

■    colestyramine (to lower cholesterol levels)

■    metoclopramide or domperidone (for feeling sick or being sick).

Pregnancy and breast feeding

Check with your doctor before taking if you are pregnant or breast feeding.

3. How to take this medicine

The caplets should be swallowed with a drink of water. The caplet can be divided into equal doses.

Dose

Unless instructed otherwise by your doctor:


Age

Dose

How Often

Adults, the elderly and children 16 years and over

1 or 2 caplets

Every 4-6 hours.

Do not take more than 4 doses in any 24 hour period.

Children 12 -15 years

1 or 1% caplets

Children 10 -12 years

1 caplet

Children 6-10 years

V2 caplet

Children under 6 years

Not recommended

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


<- »

/leasure bar shi

ould be 150mm at 100% scale -

—>

f

Customer

Crescent Pharma |

Colours Used ^

Description

Paracetamol Caplets 500mg

PANTONE 288 C

Item Code

P0438T

keyline (does not print)

Profile

N/A

Size

120x170mm

Min. Point Size

8pt

Approval

Market

UK

Signature

Language

English

Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client’s brief, the final responsibility must be taken by our client.

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Proof By

Proof No.

4

Date

31/10/2016

Artwork No.

698448 Code™ N/A

-J


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 have taken too many caplets, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining caplets and the pack so that the medicine can be identified.

If you forget to take a dose:

Do NOT take a double dose to make up for the missed dose. 4. Possible side effects Like all medicines, paracetamol can cause side effects, although not everybody gets them.

If any of the following occur, STOP taking the caplets and contact your doctor IMMEDIATELY:

•    allergic reactions which may be severe, such as skin rash and itching, sometimes with swelling of the mouth or face or shortness of breath

•    skin rash or peeling, or mouth ulcers

•    breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen or aspirin

■ unexplained bruising or bleeding (may be signs of a problem with your blood)

•    feeling sick, sudden weight loss, loss of appetite and yellowing of the eyes and skin (may be signs of a problem with your liver lunction).

Very rare cases of serious skin reactions have been reported. 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 this medicine

Keep this medicine in the original package and protect from heat, light and moisture.

Do not take the caplets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

6.    Further information Ingredients:

Paracetamol 500mg Caplets contain paracetamol 500mg as the active substance. They also contain the following other ingredients: maize starch, povidone, pregelatinised maize starch, sodium starch glycollate and magnesium stearate.

What the medicine looks like:

Paracetamol Caplets are white capsule shaped tablets, plain on one side and with a breakline on the other side. This medicine is available in pack sizes of 16, 24, 32,100, or 500 caplets. (Not all pack sizes may be marketed).

Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED

Date leaflet prepared: October 2016

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

P0438T


<

/leasure bar shi

ould be 150mm at 100% scale -

—>

f

Customer

Crescent Pharma |

Colours Used ^

Description

Paracetamol Caplets 500mg

PANTONE 288 C

Item Code

P0438T

keyline (does not print)

Profile

N/A

Size

120x170mm

_

Min. Point Size

8pt

Approval

Market

UK

Signature

Language

English

Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client’s brief, the final responsibility must be taken by our client.

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Proof By

Proof No.

4

Date

31/10/2016

Artwork No.

698448 Code™ N/A

-J


Check with your doctor or pharmacist before taking these caplets if you are taking other medicines, including any that you can buy without a prescription. This is especially important if you are taking:

PARACETAMOL 500mg Caplets

Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet, you may need to read it again.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further information

1.    What this medicine is and what it is used for

Paracetamol is an analgesic (pain killer) and an antipyretic (helps to reduce body temperature when you have a fever).

This medicine is used for the relief of headache, migraine, neuralgia and rheumatic aches and pains. Also for the relief of symptoms of colds and influenza.

2.    Before you take this medicine Do not take these caplets if:

•    you are allergic to paracetamol or any of the other ingredients (see section 6).

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

Check with your doctor before taking these caplets if:

•    you suffer from any liver or kidney problems

•    you suffer from alcohol dependence.


•    anticoagulants to thin the blood e.g. warfarin

•    colestyramine (to lower cholesterol levels)

•    metoclopramide or domperidone (for feeling sick or being sick).

Pregnancy and breast feeding

Check with your doctor before taking if you are pregnant or breast feeding.

3. How to take this medicine

The caplets should be swallowed with a drink of water. The caplet can be divided into equal doses.

Dose

Unless instructed otherwise by your doctor:


Age

Dose

How often

Adults, the elderly and children 16 years and over

1 or 2 caplets

Every 4 -6 hours. Do not take more than 4 doses in any 24 hour period.

Children 12-15 years

1 or 156 caplets

Children 10-12 years

1 caplet

Children 6-10 years

Vz caplet

Children under 6 years

Not recommended

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

- Measure bar should be 150mm at 100% scale -

r

Customer

Crescent Pharma

Colours Used ^

Description

Paracetamol 500mg Caplets leaflet

c

PANTONE 288 C

Keyline (non-printing)

Item Code

P0480T

Code Position (non-printing)

Profile

As supplied

Size

200 x 145mm

_

Min. Point Size

Approval

Market

Signature

Language

_■>■_

English

Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client’s brief, the final responsibility must be taken by our client.

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING ^ FULL APPROVAL OF DESIGN AND TEXT.

Proof By

Proof No.

3

Date

31/10/2016

Artwork No.

698443 codema FPO

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 have taken too many caplets, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining caplets and the pack so that the medicine can be identified.

If you forget to take a dose:

Do NOT take a double dose to make up for the missed dose. 4. Possible side effects Like all medicines, paracetamol can cause side effects, although not everybody gets them.

If any of the following occur, STOP taking the caplets and contact your doctor IMMEDIATELY:

•    allergic reactions which may be severe, such as skin rash and itching, sometimes with swelling of the mouth or face or shortness of breath

•    skin rash or peeling, or mouth ulcers

•    breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen or aspirin

•    unexplained bruising or bleeding (may be signs of a problem with your blood)

•    feeling sick, sudden weight loss, loss of appetite and yellowing of the eyes and skin (may be signs of a problem with your liver function).

Very rare cases of serious skin reactions have been reported. 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 this medicine

Keep this medicine in the original package and protect from heat, light and moisture.

Do not take the caplets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

6.    Further information Ingredients:

Paracetamol 500mg Caplets contain paracetamol 500mg as the active substance. They also contain the following other ingredients: maize starch, povidone, pregelatinised maize starch, sodium starch glycollate and magnesium stearate.

What the medicine looks like:

Paracetamol Caplets are white capsule shaped tablets, plain on one side and with a breakline on the other side. This medicine is available in pack sizes of 16, 24, 32,100, or 500 caplets. (Not all pack sizes may be marketed).

Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED

Date leaflet prepared: October 2016

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

P0480T


<-1

Measure bar shi

ould be 150mm at 100% scale -

—►

/

Customer

Crescent Pharma |

Colours Used ^

Description

Paracetamol 500mg Caplets leaflet

PANTONE 288 C

Item Code

P0480T

o

Keyline (non-printing)

Profile

As supplied

_

Code Position (non-printing)

Size

200 x 145mm

r ^*i ■■ i. r ■ . B IBaj. '

1_

Min. Point Size

8pt (main body) 6pt (Item code)

Approval

Market

UK

Signature

Language

English

_■>■_

Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client’s brief, the final responsibility must be taken by our client.

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING ^ FULL APPROVAL OF DESIGN AND TEXT.

Proof By

Proof No.

3

Date

31/10/2016

Artwork No.

698443 codema FPO