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PARACETAMOL 500 MG TABLETS

Active substance(s): PARACETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Paracetamol 500mg Tablets
paracetamol

Read this entire 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 minor conditions. However, you still need to use your medicine carefully to get the best
results.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- You must talk to a doctor or pharmacist, if you do not feel better or if you feel worse after 3 days.
What is in this leaflet:
1. What Paracetamol Tablet is and what it is used for
2. What you need to know before you take Paracetamol Tablet
3. How to take Paracetamol Tablet
4. Possible side effects
5. How to store Paracetamol Tablet
6. Contents of the pack and other information
1. What Paracetamol Tablet is and what it is used for
Paracetamol belongs to a group of medicines called analgesics and antipyretics, which act to relieve pain and reduce fever.
Paracetamol Tablets are used for the relief of headache, migraine, rheumatic and sharp nerve pain (neuralgia), toothache and period pain. They also
relieve fever, sore throat, aches and pains of colds and flu.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
2. What you need to know before you take Paracetamol Tablet
Do not take Paracetamol 500 mg Tablet:
• if you are allergic to Paracetamol or any of the other ingredients of this medicine (listed in section 6).
• if you are taking other paracetamol containing medicine.
Warnings and precautions
Take special care and talk to your doctor or pharmacist before taking Paracetamol Tablet
• if you have kidney problems
• if you have liver problems (including alcoholic liver damage)
• if you have G-6-PD deficiency (an hereditary condition leading to low red blood cell counts)
Other medicines and Paracetamol Tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially if you are taking following:
• Anticoagulants to thin your blood e.g warfarin, coumarins
• Medicines to control nausea and vomiting e.g Metoclopramide, Domperidone
• Medicines to control high levels of fat or cholesterol in your body e.g. Colestyramine
• Antibiotic such as chloramphenicol
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 500mg tablet has no influence on the ability to drive and use machines.
3. How to take Paracetamol Tablet
Tablet to be taken orally and must be swallowed whole with water.
Adults aged 16 and over:
• The usual dose is 2 whole tablets, taken together
• Wait at least 4 hours before taking another dose
• Do not take more than 8 tablets in any 24-hours period
Adolescents aged 12 to 15 years:
• One whole tablet every 4 -6 hours
• Do not take more than 6 tablets in any 24-hours period

Do not exceed the stated dose.
If you take more Paracetamol Tablet 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. Bring any remaining medicine with you to show the doctor.
If you forget to take Paracetamol Tablet
Do not take a double dose to make up for a forgotten tablet.
4. Possible side effects
Like all medicines, this 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 side effects stop taking your tablets and tell your doctor immediately or go to the nearest hospital
accident and emergency department.
Severe allergic reactions: difficulty in breathing, skin rash, swollen facial features or a runny nose.
Other possible side effects
If any of the following side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist:
• 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 (may affect up to 1 in 1,000 people) like shortness of breath.
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 Tablet
Do not store above 25ºC
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister or outer packaging after {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
measures will help to protect the environment.
6. Contents of the pack and other information
What Paracetamol Tablet contains
The active substance is paracetamol. Each tablet contains 500 mg paracetamol.
The other ingredients are: pregelatinised starch, sodium starch glycolate, stearic acid, magnesium stearate and colloidal anhydrous silica.
What Paracetamol Tablet looks like and contents of the pack
Paracetamol 500 mg tablets are white round flat tablets debossed with BPL on one side and NAT and score line on the other side.
Paracetamol tablets are marketed in PVC blister packs.
The tablets are available in blister packs containing 16 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Beximco Pharma UK Ltd.
102, College Road,Harrow HA1 1ES, United Kingdom
Manufacturer
Cemelog-BRS Ltd.
H-2040, Budaors, Vasut utca 13, Hungary
This leaflet was last revised in 02/2015

Children under 12 years:
• Paracetamol 500 mg tablets are not recommended for children under 12 years of age
The score line is not intended for breaking the tablet.
Do not take with other paracetamol containing products.

Leaflet for Paracetamol Exp/UK
188x 295 mm
080215

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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