Paracetamol 500mg Caplets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL TABLETS BP 500 MG
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
This medicine is available without a prescription, for you to treat a mild illness without a doctor's help. However, you still need to take it carefully to get the best results from it.
• 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.
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_
Paracetamol is an analgesic and an antipyretic which means it relieves pain and reduce high temperature and fever.
These tablets are used for the relief of:
• mild to moderate pain including headache, migraine, sharp nerve pain (neuralgia), toothache, sore throat, period pains,
aches and pains
• rheumatic aches and pains, influenza symptoms, feverishness and feverish colds
2. Before you take Paracetamol Tablets
Please read the following information. Do not give to children under 6 years.
Do not take these tablets if you:
• are allergic to paracetamol or any other ingredients (these are listed in Section 6, Further Information) for example sodium metabisulphite contained in these tablets may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties)
• are taking any other paracetamol-containing products Take special care with this medicine if you:
• suffer from any liver or kidney problems (especially if serious) or G-6-PD deficiency ( an hereditary condition leading to low red blood cell counts).
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, even those not prescribed, for example, herbal remedies and health supplements from a pharmacy, supermarket or health food shop, as these tablets may interact with Paracetamol Tablets.
The following medicines can affect Paracetamol:
• warfarin (to thin the blood). The effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with an increased risk of bleeding, however occasional doses have no significant effect.
• colestyramine (for high cholesterol levels)
• metoclopramide and domperidone (to treat nausea and vomiting)
• chloramphenicol (antibiotic to treat infections)
• Drugs used to treat diarrhoea caused by gall bladder disease
Pregnancy and breast-feeding
• You should let your doctor know if you are pregnant or breast-feeding, or wish to become pregnant or start breastfeeding whilst taking this medicines.
• Ask your doctor or pharmacist for advice before taking any product.
Important information about some of the ingredients of Paracetamol Tablets
• Paracetamol Tablets contain sodium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties).
3. How to take Paracetamol Tablets
You should check with your doctor or pharmacist if you are not sure. The usual dose is:
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 a tablet to one tablet up to 4 times a day.
DO NOT GIVE TO 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
120 mm
Paracetamol 500 mg Tablets Insert
SAME SIZE ARTWORK
240 x 120mm
Front
24 hour period. Do not take with any other paracetamol-containing products.
DO NOT EXCEED THE STATED DOSE.
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, even if you feel well, because of the risk of delayed, serious liver damage. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.
Children (aged 12 years and under)
Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of 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.
You can reduce the chances of experiencing side effects by using the minimum dose required. Side effects may be more serious in the elderly patients.
If you experience any of the following serious effects STOP TAKING this medicine immediately and contact your doctor or pharmacist:
• Severe allergic reactions: difficulty breathing, skin rash, swollen facial features or a runny nose.
Tell your doctor if you notice any of the following side effects
or notice any other effects not listed:
• occasionally the blood does not clot well, which may result in easy bruising or bleeding
• rarely, a severe reduction in the number of white blood cells, which makes infections more likely
• other rare side effect like shortness of breath
5. How to store Paracetamol Tablets
• Keep out of the reach and sight of children.
• Do not store above 250C. Store in the original package in order to protect the tablets from moisture.
• 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.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These medicines will help to protect the environment.
_6. Further 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 100 tablets for dispensing purposes.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder
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 Tablets BP 500 mg; PL 17907/0001 This leaflet was last revised in September 2011 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.
120 mm
SAME SIZE ARTWORK
240 x 120mm
Back
Text................9 points
Sub heading ----10 points main heading - ---11 points
15 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL TABLETS BP 500 MG
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
This medicine is available without a prescription, for you to treat a mild illness without a doctor's help. However, you still need to take it carefully before you start taking this medicine, to get the best results from it.
• 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.
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
Paracetamol is an analgesic and an antipyretic which means it relieves pain and reduce high temperature and fever.
These tablets are used for the relief of:
• mild to moderate pain including headache, migraine, sharp nerve pain (neuralgia), toothache, sore throat, period pains, aches and pains
• rheumatic aches and pains, influenza symptoms, feverishness and feverish colds
2. Before you take Paracetamol Tablets
Please read the following information. Do not give to children under 6 years.
Do not take these tablets if you:
• are allergic to paracetamol or any other ingredients (these are listed in Section 6, Further Information) for example sodium metabisulphite contained in these tablets may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties)
• are taking any other paracetamol-containing products Take special care with this medicine if you:
• suffer from any liver or kidney problems (especially if serious) or G-6-PD deficiency (an hereditary condition leading to low red blood cell counts).
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, even those not prescribed, for example, herbal remedies and health supplements from a pharmacy, supermarket or health food shop, as these tablets may interact with Paracetamol Tablets.
The following medicines can affect Paracetamol:
• warfarin (to thin the blood). The effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with an increased risk of bleeding, however occasional doses have no significant effect.
• colestyramine (for high cholesterol levels)
• metoclopramide and domperidone (to treat nausea and vomiting)
• chloramphenicol (antibiotic to treat infections)
• Drugs used to treat diarrhoea caused by gall bladder disease Pregnancy and breast-feeding
• You should let your doctor know if you are pregnant or breast-feeding, or wish to become pregnant or start breastfeeding whilst taking this medicines.
• Ask your doctor or pharmacist for advice before taking any product.
Important information about some of the ingredients of Paracetamol Tablets
• Paracetamol Tablets contain sodium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties).
3. How to take Paracetamol Tablets You should check with your doctor or pharmacist if you are not sure. The usual dose is:
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 a tablet to one tablet up to 4 times a day.
Paracetamol 500 mg Tablets Insert
SAME SIZE ARTWORK 220 x 125 mm Front
Kaypee Design Version - 001 - 130910 Version - 002 -- 130711 Version - 003 -- 170911
E
E
LO
DO NOT GIVE TO 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 with any other paracetamol-containing products.
DO NOT EXCEED THE STATED DOSE.
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, even if you feel well, because of the risk of delayed, serious liver damage. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.
Children (aged 12 years and under)
Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of 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, your medicine can cause side effects, although not everybody gets them.
You can reduce the chances of experiencing side effects by
using the minimum dose required. Side effects may be more serious in the elderly patients.
If you experience any of the following serious effects STOP TAKING this medicine immediately and contact your doctor or pharmacist:
• Severe allergic reactions: difficulty breathing, skin rash, swollen facial features or a runny nose.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
• occasionally the blood does not clot well, which may result in easy bruising or bleeding
• rarely, a severe reduction in the number of white blood cells, which makes infections more likely
• other rare side effect like shortness of breath
5. How to store Paracetamol Tablets
• Keep out of the reach and sight of children.
• Do not store above 250C. Store in the original package in order to protect the tablets from moisture.
• 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.
• Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of medicines no longer required. These medicines will help to protect the environment._
_6. Further 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 100 tablets for dispensing purposes.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder
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@bri.stol-labs.co.uk
Paracetamol Tablets BP 500 mg; PL 17907/0001 This leaflet was last revised in September 2011 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.
E
E
SAME SIZE ARTWORK
220 x 125 mm
Back
Text--9points
Sub heading -10 points
main heading - 11 points
220 mm