What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17907/0001.

Boots Paracetamol 500 mg Tablets (32 Caplets)

Information for the user

Boots Paracetamol 500 mg Caplets

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. 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
  • If you have any further queries, ask your doctor or pharmacist.
  • 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. This includes any possible side effects not listed in this leaflet. See section 4.

What this medicine is for

This medicine contains Paracetamol which belongs to a group of medicines called analgesics and antipyretics, which act to relieve mild to moderate pain and reduce fever.

It can be used to relieve headache, including migraine and tension headache, neuralgia, toothache, sore throat, period pain, rheumatic aches and pains, fever and the symptoms of colds and flu.

Before you take this medicine

This medicine can be taken by adults and children aged 10 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

  • If you are allergic to paracetamol or any of the other ingredients

Tell your doctor before you take this medicine if you:

  • Are suffering from liver problems including liver problems due to excessive alcohol consumption
  • Suffer from Gilbert’s syndrome (mild jaundice)
  • Are suffering from kidney problems
  • Are suffering from dehydration and chronic malnutrition
  • Suffer from asthma and are sensitive to aspirin
  • Are taking any other paracetamol containing medicines
  • Have a fever that does not improve after taking this medicine
  • Have glucose-6-phosphate dehydrogenase deficiency (enzyme deficiency)
  • Have hemolytic anemia (abnormal breakdown of red blood cells)

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)
  • Probenecid (medicine used to treat high levels of uric acid in the blood stream (gout))
  • Medicine to treat fever or mild pain (aspirin, salicyamide)
  • Barbiturates and tricyclic antidepressants (to treat depression)
  • Medicines used to treat epilepsy (lamotrigine)
  • Medicines to treat tuberculosis (isoniazid)

Effects of paracetamol on laboratory tests

Uric acid and blood sugar tests may be affected.

Paracetamol Caplets with food and drink

This medicine may be taken with or without food. Alcohol should not be used during the treatment with Paracetamol.

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.

If necessary, paracetamol can be used during pregnancy. You should use the 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.

Small amounts of paracetamol pass into breast milk. This medicine may be taken, as instructed in the section 'How to take this medicine', by mothers who are breastfeeding.

Driving and using machines

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

Paracetamol Caplets contain sodium metabisulfite

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

How to take this medicine

Check the foil is not broken before use. If it is, do not take that caplet.

Adults, the elderly and children 16 years and over: Take one to two caplets every 4 to 6 hours, if you need to. Don’t take more than 8 caplets in any 24 hours.

Children of 10 to 15 years: Take one caplet every 4 to 6 hours, if you need to. Don’t take more than 4 caplets in any 24 hours.

Do not take more often than every 4 hours.

Swallow each caplet with water.

The break-line is only there to help you break the tablet if you have difficulty swallowing it whole.

Do not give to children under 10 years of age.

Do not give to children for more than 3 days, unless your doctor tells you to.

Do not take more than the amount recommended above.

If you do not get better, talk to your doctor.

If you take too many caplets: 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.

Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

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

  • very rare cases of serious skin reactions have been reported
  • accumulation of fluid in the larynx including an itchy rash, throat swelling (severe allergic reaction)
  • swelling on the face, mouth, hands (angioedema)

You should stop taking this medicine and see your doctor immediately if you experience symptoms like:

  • serious skin disease causing rash, skin peeling and sores
  • severe blistering and peeling of the skin

Rare (may affect up to 1 in 1,000 people):

Oedema (abnormal accumulation of fluid under the skin), abnormal vision, simple skin rash or urticaria (dark red rash on the skin), haemorrhage (bleeding), abdominal pain, diarrhoea, nausea, vomiting, dizziness, fever, reduction of irritability or agitation (sedation), platelet disorders (clotting disorders), stem cell disorders (disorders of the blood forming cell in the bone marrow), abnormal liver function, liver failure, hepatic necrosis (death of liver cells), jaundice, overdose and poisoning, tremor, headache, depression, confusion, hallucinations, sweating, pruritus (itching), feeling lousy (malaise).

Very rare (may affect up to 1 in 10,000 people): hepatotoxicity (damage caused to the liver), thrombocytopenia (reduction in blood platelets, which increases the risk of bleeding or bruising), leucopenia (frequent infections due to poorly functioning white blood cells or decrease in white blood cells), neutropenia (reduced neutrophil count in blood), agranulocytosis (severe decrease in white blood cells which may lead to severe infections), hemolytic anemia (abnormal breakdown of red blood cells, which may cause weakness or pale skin), hypoglycemia (low levels of glucose in the blood), cloudy urine and kidney disorders.

Other adverse reactions of paracetamol whose frequency cannot be estimated from available data are: anaemia (decrease in red blood cells), problems with the way your kidneys work (kidney alteration), problems with the way your liver works (liver alteration), haematuria (blood in urine), anuresis (inability to urinate), gastrointestinal effects, vertigo. There have been cases of difficulty breathing, wheezing, coughing, and shortness of breath with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs such as ibuprofen.

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: ww.mhra.gov.uk/yellowcard or search for MHRA Yellow Pages in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Do not store above 25°C.

Store in the original package in order to protect from moisture.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each tablet contains Paracetamol 500 mg, which is the active ingredient.

As well as the active ingredient, the tablets also contain pregelatinised maize starch, sodium metabisulfite (E223), magnesium stearate.

The pack contains 16 or 32 white, capsule shaped tablets with a break-line on one side and plain on the other side.

Who makes this medicine

Manufactured for

The Boots Company PLC

by the Marketing Authorisation holder

Bristol Laboratories Ltd
Unit 3
Northbridge Road

Leaflet prepared December 2019

If you would like any further information about this medicine, please contact

The Boots Company PLC

Artwork number: WBAG407538