24mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

PARACETAMOL 500 mg TABLETS

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after 3 days.

•    If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

What is in this leaflet:

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

2.    What you need to know before you take Paracetamol Tablets

3.    How to take Paracetamol Tablets

4.    Possible side effects

5.    How to store Paracetamol Tablets

6.    Contents of the pack and other information

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

Paracetamol is an analgesic and an antipyretic which means it relieves pain and reduces high temperature and fever. These tablets are used for the relief of:

•    headache, tension headache, migraine, neuralgia (nerve pain), rheumatic and muscle pain, toothache and period pain.

•    sore throat and the fever, aches and pains of colds and flu.

2. What you need to know before you take Paracetamol Tablets

Do not take these Tablets if you:

•    are allergic to paracetamol or any other ingredients (these are listed in Section 6)

•    are taking any other paracetamol-containing products

Ask your doctor before you take this medicine if:

•    you suffer from any liver or kidney problems including alcoholic liver disease

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

•    your headaches become persistent

Other medicines and Paracetamol Tablets

Tell your doctor or pharmacist if you are taking, have recently

taken or might take any other medicines.

The following medicines can affect Paracetamol:

•    blood thinning drugs (anti-coagulants e.g. warfarin) The effect of anti-coagulants may be increased by prolonged regular use of paracetamol with an increased risk of bleeding, however occasional doses have no significant effect.

•    colestyramine to lower blood cholesterol

•    metoclopramide and domperidone (to treat nausea and vomiting)

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Paracetamol is not known to cause any effects on the ability to

drive and use machines.

Paracetamol Tablets contain Sodium metabisulphite

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

3. How to take Paracetamol Tablets

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

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

The recommended dose is:

Adults, the elderly and children over 12 years:

•    Take 2 tablets every four hours up to four times a day as needed.

•    Do not take more than 8 tablets in 24 hours.

Children 6 to 12 years of age:

•    Take half to one tablet every four hours up to four times a day as needed.

Do not give to children for more than three days without seeing your doctor.    |

120 mm

Paracetamol Tablets BP 500 mg Insert Luton

SAME SIZE ARTWORK

240 x 120mm

Front

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 anything else containing paracetamol while taking this medicine.

If you take more Paracetamol Tablets than you should

If you accidently take more tablets than you should, tell your doctor immediately or go to the nearest hospital A & E (casualty) department. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

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

If necessary, take the missed dose when you remember and then leave at least 4 hours before taking the next dose.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE

4. Possible side effects

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

STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following:

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

•    Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin.

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

•    Unexplained bruising and bleeding

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

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.

•    Do not store above 25⁰C. Store in the original package.

•    Do not use the tablets after the expiry date printed on the carton or label (EXP.). The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These medicines will help protect the environment.

6. Contents of the pack and other information

What Paracetamol Tablets contain:

•    The active substance is Paracetamol.

•    The other ingredients are: pregelatinised maize starch, sodium metabisulphite (E223) and magnesium stearate.

What Paracetamol Tablets look like and contents of the pack

•    The tablets are white capsule shaped with a breakline on one side.

•    They are available in cartons containing 8, 12, 16, 24, 30, 32 or 100 tablets or containers of 16 and 1000 tablets for dispensing purposes.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Name and address: Bristol Laboratories Limited,

Unit 3, Canalside,

Northbridge Road,

Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Paracetamol 500 mg Tablets; PL 17907/0001 This leaflet was last revised in March 2015 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

V10 11-03-2015 D0

120 mm

SAME SIZE ARTWORK

240 x 120 mm

Back

PACKAGE LEAFLET: INFORMATION FOR THE USER

PARACETAMOL 500MG CAPLETS

Read all of this leaflet carefully before you start taking this medicine,because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after 3 days.

•    If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

What is in this leaflet:

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

2.    What you need to know before you take Paracetamol Caplets

3.    How to take Paracetamol Caplets

4.    Possible side effects

5.    How to store Paracetamol Caplets

6.    Contents of the pack and other information

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

Paracetamol is an analgesic and an antipyretic which means it relieves pain and reduces high temperature and fever.

These caplets are used for the relief of:

•    headache, tension headache, migraine, neuralgia (nerve pain), rheumatic and muscle pain, toothache and period pain.

•    sore throat and fever, aches and pains of colds and flu.

2. What you need to know before you take Paracetamol Caplets

Do not take these Caplets if you:

•    are allergic to paracetamol or any other ingredients (these are listed in Section 6)

•    are taking any other paracetamol-containing products

Ask your doctor before you take this medicine if:

•    you suffer from any liver or kidney problems including alcoholic liver disease

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

•    your headaches become persistent

Other medicines and Paracetamol Caplets

Tell your doctor or pharmacist if you are taking,have recently

taken or might take any other medicines.

The following medicines can affect Paracetamol:

•    blood thinning drugs (anti-coagulants e.g. warfarin)

The effect of anti-coagulants may be increased by prolonged regular use of paracetamol with an increased risk of bleeding, however occasional doses have no significant effect.

•    colestyramine to lower blood cholesterol

•    metoclopramide and domperidone (to treat nausea and vomiting)

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Paracetamol is not known to cause any effects on the ability to drive and use machines.

Paracetamol Caplets contain Sodium metabisulphite

•    Paracetamol caplets contain sodium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties).

3. How to take Paracetamol Caplets

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

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

The recommended dose is:

Adults, the elderly and children over 12 years:

•    Take 2 caplets every four hours up to four times a day as needed.

•    Do not take more than 8 caplets in 24 hours.

Children 6 to 12 years of age:

•    Take half to one caplet every four hours up to four times a day as needed.

•    Do not give to children for more than three days without

seeing your doctor.    g

130 mm

Paracetamol 500 mg Caplets Insert Luton

240 mm

SAME SIZE ARTWORK

240 x 130mm

Front

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 anything else containing paracetamol while taking this medicine.

If you take more Paracetamol Caplets than you should

If you accidently take more caplets than you should, tell your doctor immediately or go to the nearest hospital A & E (casualty) department. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

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

If necessary, take the missed dose when you remember and then leave at least 4 hours before taking the next dose.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE

_4. Possible side effects_

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

STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following:

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

•    Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin.

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

•    Unexplained bruising and bleeding

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

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 Caplets

•    Keep out of the sight and reach of children.

•    Do not store above 25⁰C. Store in the original package.

•    Do not use the caplets after the expiry date printed on the carton or label (EXP.). The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These medicines will help protect the environment.

6. Contents of the pack and other information

What Paracetamol Caplets contain:

•    The active substance is Paracetamol.

•    The other ingredients are: pregelatinised maize starch, sodium metabisulphite (E223) and magnesium stearate.

sWhat Paracetamol Caplets look like and contents of the pack

•    The caplets are white capsule shaped with a breakline on one side.

•    They are available in cartons containing 8, 12, 16, 24, 30, 32 or 100 caplets or containers of 16 and 1000 caplets for dispensing purposes.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories Limited,

Unit 3, Canalside,

Northbridge Road,

Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Paracetamol 500mg Caplets ; PL 17907/0001 This leaflet was last revised in March 2015 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

V2 09-03-2015 D0

130 mm

SAME SIZE ARTWORK

240 x 130mm

Back

PACKAGE LEAFLET: INFORMATION FOR THE USER

PARACETAMOL 500MG CAPLETS

Read all of this leaflet carefully before you start taking this medicine,because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after 3 days.

•    If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

What is in this leaflet:

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

2.    What you need to know before you take Paracetamol Caplets

3.    How to take Paracetamol Caplets

4.    Possible side effects

5.    How to store Paracetamol Caplets

6.    Contents of the pack and other information

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

Paracetamol is an analgesic and an antipyretic which means it relieves pain and reduces high temperature and fever.

These caplets are used for the relief of:

•    headache, tension headache, migraine, neuralgia (nerve pain), rheumatic and muscle pain, toothache and period pain.

•    sore throat and fever, aches and pains of colds and flu.

2. What you need to know before you take Paracetamol Caplets

Do not take these Caplets if you:

•    are allergic to paracetamol or any other ingredients (these are listed in Section 6)

•    are taking any other paracetamol-containing products

Ask your doctor before you take this medicine if:

•    you suffer from any liver or kidney problems including alcoholic liver disease

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

•    your headaches become persistent

Other medicines and Paracetamol Caplets

Tell your doctor or pharmacist if you are taking,have recently

taken or might take any other medicines.

The following medicines can affect Paracetamol:

•    blood thinning drugs (anti-coagulants e.g. warfarin)

The effect of anti-coagulants may be increased by prolonged regular use of paracetamol with an increased risk of bleeding, however occasional doses have no significant effect.

•    colestyramine to lower blood cholesterol

•    metoclopramide and domperidone (to treat nausea and vomiting)

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Paracetamol is not known to cause any effects on the ability to drive and use machines.

Paracetamol Caplets contain Sodium metabisulphite

•    Paracetamol caplets contain sodium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties).

3. How to take Paracetamol Caplets

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

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

The recommended dose is:

Adults, the elderly and children over 12 years:

•    Take 2 caplets every four hours up to four times a day as needed.

•    Do not take more than 8 caplets in 24 hours.

Children 6 to 12 years of age:

•    Take half to one caplet every four hours up to four times a day as needed.

•    Do not give to children for more than three days without seeing your doctor.

120 mm

Paracetamol 500 mg Caplets Insert Luton

SAME SIZE ARTWORK

240 x 120mm

Front

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 anything else containing paracetamol while taking this medicine.

If you take more Paracetamol Caplets than you should

If you accidently take more caplets than you should, tell your doctor immediately or go to the nearest hospital A & E (casualty) department. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

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

If necessary, take the missed dose when you remember and then leave at least 4 hours before taking the next dose.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE

4. Possible side effects

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

STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following:

• Allergic reactions which may be severe such as skin

rash and itching sometimes with swelling of the mouth or face or shortness of breath

•    Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin.

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

•    Unexplained bruising and bleeding

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

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 Caplets

•    Keep out of the sight and reach of children.

•    Do not store above 25⁰C. Store in the original package.

•    Do not use the caplets after the expiry date printed on the carton or label (EXP.). The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These medicines will help protect the environment.

What Paracetamol Caplets contain:

•    The active substance is Paracetamol.

•    The other ingredients are: pregelatinised maize starch, sodium metabisulphite (E223) and magnesium stearate.

What Paracetamol Caplets look like and contents of the pack

•    The caplets are white capsule shaped with a breakline on one side.

•    They are available in cartons containing 8, 12, 16, 24, 30, 32 or 100 caplets or containers of 16 and 1000 caplets for dispensing purposes.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Name and address: Bristol Laboratories Limited,

Unit 3, Canalside,

Northbridge Road,

Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Paracetamol 500mg Caplets ; PL 17907/0001 This leaflet was last revised in March 2015 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.    s

V9 09-03-2015 D0    |

120 mm

SAME SIZE ARTWORK

240 x 120mm

Back