Paracetamol Tablets Bp 500mg
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL TABLETS BP 500mg
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
o Keep this leaflet. You may need to read it again. o If you have further questions, ask your doctor or your pharmacist. o This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. o If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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
The name of your medicine is Paracetamol tablets. The active ingredient in your medicine is paracetamol. Paracetamol is an:
o analgesic, which means it acts as a painkiller
o antipyretic, which means it helps to reduce fever and lower your temperature
Paracetamol tablets are usually used for: o backache o toothache o period pains
o headaches, including migraine and tension headaches o relieving the fever, aches and pains of colds and flu o rheumatic pain and muscle pain o relieving pain due to non-serious arthritis o nerve pains (neuralgia) o sore throat
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL TABLETS
DO NOT give to children under 6 years of age.
DO NOT take Paracetamol tablets if you are:
o allergic (hypersensitive) to paracetamol or any of the other ingredients in this medicine (listed in section 6)
o taking other medicines containing paracetamol Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol tablets if you:
o are pregnant or breastfeeding (see ‘Pregnancy and Breast-feeding’ below) o have severe kidney or liver problems, including alcoholic liver disease. o are an alcoholic o are suffering from a persistent headache
o If you suffer from non-serious arthritis and need to take painkillers every day.
Children and adolescents
This product is not suitable for children under 6 years Other medicines and Paracetamol;
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have bought yourself without a prescription.
Please check with your doctor or pharmacist if you are taking any of the following:
o metoclopramide or domperidone (used to treat nausea and vomiting) o cholestyramine (used to lower cholesterol). Should not be taken at least one hour before and one hour after taking paracetamol. o anti-coagulants (used to thin the blood e.g. warfarin) o anti-epileptics (used to treat epilepsy e.g. carbamazepine) o cytotoxic drugs (used to treat certain types of cancers e.g. busulfan and imatinib) o chloramphenicol (used to treat bacterial infections) o other medicines containing paracetamol
Pregnancy and breast-feeding
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.
Paracetamol contains Lactose:
Your medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE PARACETAMOL TABLETS
Always take your tablets exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are unsure.
For oral administration. The tablets should be taken with water.
The recommended dose is:
Adults (including the elderly) and children over 12 years
Swallow 1-2 tablets every 4-6 hours, as required.
Do not take more than 8 tablets in any 24-hour period.
Children 6-12 years
/ -1 tablet every 4-6 hours, as required.
Do not give more than 4 tablets in any 24-hour period to your child.
Do not give to children for more than 3 days without consulting your doctor.
Children under 6 years
DO NOT give to children under the age of 6 years.
If symptoms persist for more than 3 days or get worse, talk to your doctor.
If you take more Paracetamol tablets than you should
Symptoms of an overdose include nausea, vomiting, paleness of the skin, abdominal pain, loss of appetite. 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 your medicine
Take your usual dose as soon as you remember, as long as it is at least 4 hours since your last dose. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol tablets can have side effects, although not everybody gets them. Tell your doctor if you think your medicine is making you feel unwell.
STOP taking your medicine and contact your doctor or nearest hospital casualty department immediately if you experience:
o an allergic reaction. The signs of an allergic reaction may include a skin rash, swelling of the lips, face, throat or tongue, itching or difficulty in breathing or swallowing.
If you experience any of the following side effects you should tell your doctor or pharmacist: o bleed for longer after cutting yourself o bruise more easily o increased number of nosebleeds o bleeding gums o feeling tired o pale complexion
These symptoms may be signs of a blood disorder (e.g. thrombocytopenia, leucopenia and neutropenia). Blood disorders are a result of a change in the number and types of blood cells. o Skin Rash or peeling, or mouth ulcers
o Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin o 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 or pharmacist. 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 use after the expiry date stated on the pack.
Do not store above 25oC. Keep the container tightly closed.
Store your medicine in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What your medicine contains
Active ingredient: Each tablet contains 500mg of the active ingredient paracetamol.
Other ingredients: maize starch, lactose, povidone, magnesium stearate, sodium starch glycollate, colloidal silicon dioxide and purified water.
What your medicine looks like and the contents of the pack
Paracetamol tablets are white, flat bevelled edged, round tablets with a break-line on one side.
The tablets are available in blister packs of 10, 12, 16, 20, 24, 30, 32, 40, 48, 50, 60, 70, 80, 90, 96 and 100 tablets and in containers of 10, 16, 20, 25, 30, 32, 40, 50, 60, 70, 80, 90, 100, 500, 1000 and 5000 tablets.
Marketing Authorisation Holder:
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.
Distributor:
Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL, U.K.
PL 30464/0133
This leaflet was last revised May 2016