Paracetamol 500mg Tablets
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Read all of this leaflet carefully before you start taking this medicine because It contains Important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Whatisinthis 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
Paracetamol Tablets contain the active ingredient paracetamol It belongs to a group of medicines called analgesics (pain killers) and are used for the relief of mild to moderate pain including:
• rheumatic aches and pains
• neuralgia (severe nerve pain), period pain
• migraine, headache
• sore throat, toothache
• fevers, colds, flu and influenza.
DO NOT take Paracetamol Tablets if you are:
• allergic (hypersensitive) to paracetamol, other pain relievers or any of the other ingredients in the product (see Section 6 and end of Section 2) Signs of an allergic reaction including a rash and breathing problems, there can also be swelling of the legs, arms, face, throat ortongue
• taking anything else containing paracetamol, i.e. over-the-counter cold remedies.
This Medicine is NOT recommended for children under 10 years of age.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Paracetamol Tablets if you:
• have kidney or liver problems.
• are an alcoholic.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Other medicines and Paracetamol Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, including herbal medicines. This is because paracetamol can affect the way some other medicines work. Also some other medicines can affect the way paracetamol works.
While taking paracetamol you should not take any other medicines which contain paracetamol.
This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops. Tell your doctor if you are taking any of the following medicines:
• anything else containing paracetamol (see 'DO NOT take paracetamol Tablets')
• warfarin and otherdrugs which thin the blood
• colestyramine (reduces blood cholesterol levels)
• metoclopramide and domperidone (used to treat nausea, vomiting or other stomach problems)
• enzyme inhibiting drugs such as Carbamazepine.
Taking Paracetamol Tablets with alcohol
You should not drink whilst taking these tablets. Taking alcohol with paracetamol can increase your chances of getting side effects.
Pregnancy and Breast-Feeding
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, planning to become pregnant or breast-feeding.
Paracetamol can be used during pregnancy. You should use lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor or midwife if the pain and/or fever are not reduced or if you need to take the medicine more often.
Driving and using machines
Paracetamol Tablets are not expected to affect your ability to drive oroperate machinery.
Paracetamol Tablets contain lactose
If you know you have an intolerance to some sugars, inform your doctor before use.
Always take Paracetamol Tablets exactly as your doctor has told you. Swallow each tablet with a drink of water.
Adults, the elderly and children 16 years and over:
take one or two tablets up to 4 times a day. Maximum dose of 8 tablets in 24 hours.
You may suffer an allergic reaction, symptoms of which include skin rashes, hives, rapid swelling of the face, mouth, tongue and throat. Very rare cases of serious skin reactions have been reported. Symptoms could include skin reddening, blisters or rash. If these happen to you, stop taking the tablets immediately and seek urgent medical help.
The following have also been reported:
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:
• the blood does not clot well, which may result in easy bruising or bleeding.
• a severe reduction in the number of white blood cells, which makes infections more likely.
Children 10 to 15 years of age: take one tablet up to 4 times a day. Maximum dose of 4 tablets in 24 hours.
Not recommended for children under 10 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 any24 hourperiod.
Dosage should not be continued for more than 3 days without consulting a doctor.
Reporti ng 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.
WARNING: Do not take anything else containing paracetamol while taking this medicine.
Do not take more medicine than the label tells you to.
If you do not get better, talk to your doctor.
If you take more Paracetamol Tablets than you should
It is extremely important to follow the dosage instructions that have been given to you. Do not change your dose without discussing it with your doctor first. Symptoms of overdose include pallor (paleness of skin), nausea, vomiting, anorexia and stomach pain. If you accidentally take more than the recommended dose, or know someone who has, contact your doctor or nearest hospital casualty immediately. Take any remaining medicine and this leaflet with you if possible.
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package. Do not use Paracetamol Tablets after the expiry date shown on the pack.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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 Paracetamol Tablets
If you miss a dose, take it as soon as you remember. NEVER take a double dose to make up forthe dose you have forgotten.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
What Paracetamol Tablets contain
The active substance is paracetamol 500mg.
The other ingredients are povidone, lactose, starch (maize), magnesium stearate, sodium starch glycollate, colloidal anhydrous silica (see also end of Section 2 on 'Important information about some of the ingredients of Paracetamol Tablets').
What Paracetamol Tablets look like and contents of the pack
Paracetamol Tablets are white capsule shaped tablets with break-line. They are supplied in child-resistant blister packs containing 48,60,96 and 100 tablets (not all pack sizes may be marketed).
MarketingAuthorisation Holder and manufacturer:
Relonchem Limited,
Cheshire house, Gorseylane, WidnesWA80RP, UK
MarketingAuthorisation Number: ,-,
PL 20395/0078 I POM I
Date leaflet Approved: November 2016.