Paracetamol 500 mg Tablets BP – patient leaflet, side effects, dosage

1. What Paracetamol is and what it is used for

The name of your medicine is Paracetamol 500mg Tablets (called Paracetamol throughout this leaflet). It belongs to a group of medicines called painkillers (analgesics).

It is used for:

• Mild to moderate pain including headache, migraine, neuralgia (sharp nerve pain), toothache, sore throat, period pains and pain caused by rheumatism • Relief of symptoms from colds and flu
• Lowering high temperature (fever).

2. What you need to know before you take Paracetamol

Do not take Paracetamol:

• if you are allergic to Paracetamol or any of the other ingredients in your medicine (listed in

  Section 6)

• if you are taking anything else with Paracetamol in it.
• If you are not sure, talk to your doctor or pharmacist before taking Paracetamol.

Take special care and talk to a pharmacist or your doctor before taking this medicine if you are:

• suffering from liver or kidney diseases (including alcoholic liver disease) or G-6-PD deficiency (an hereditary condition leading to low red blood cell counts).

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Paracetamol

• if you have severe kidney or liver problems
• if you have liver disease due to a dependence on alcohol.
• if you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

Other medicines and Paracetamol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because paracetamol and some medicines can affect the way each other work.

In particular, tell your doctor if you are taking any of the following:

• Metoclopramide or domperidone - used for nausea (feeling sick), vomiting (being sick) and other stomach problems
• Some treatments for diarrhoea caused by gall bladder disease
• Colestyramine - used for high cholesterol and other fats in the blood • Anti-coagulants - used to thin the blood (such as warfarin). Do not use this medicine if you are taking medicines that reduce the clotting of the blood. However, if you need to take pain-killers every day, talk to your doctor
• Chloramphenicol (an antibiotic)

• Other medicines containing Paracetamol. You should not take other medicines containing

  Paracetamol at the same time as taking this medicine.

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality ( called metabolic acidosis) that must have urgent treatment (see section 2).

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Pregnancy and breast-feeding

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. You may take Paracetamol if you are breast-feeding

Paracetamol contains lactose

If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine. Each tablet contains 6.7 mg of lactose.

3. How to take Paracetamol

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

For oral administration and short term use only

Taking this medicine

• Swallow the tablets with a drink of water.

How much to take

Adults, the elderly and children 16 or over :

• The minimum effective dose should be used for the shortest time necessary to relieve.

The recommended dose is 1 or 2 tablets up to four times a day as required.

• Wait at least 4 hours before taking another dose

  Do not take more than 8 tablets in 24 hours

• Do not take these tablets for more than 3 days unless your doctor tells you to

  Do not take other medicines which contain paracetamol while taking these tablets

Children from 10 to 15 years of age

• The recommended dose is one tablet up to 4-6 hours as required. • Do not give more than 4 tablets in 24 hours.
• Do not give for more than 3 days at a time unless your doctor tells you to.

Children under 10 years of age

• Do not give Paracetamol to children under 10 years of age unless the doctor advises you to.

Do not exceed the stated dose.

If symptoms persist, consult your doctor.

If you take more Paracetamol 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. Take the medicine pack with you so the doctor knows what you have taken.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them

Very rare cases of serious skin reactions have been reported.

Frequency “Not known’’ (frequency cannot be estimated from the available data): “A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2)”

You can reduce the chances of experiencing side effects by using the minimum dose required. Side effects may be more serious in elderly patients.

Stop taking Paracetamol and tell your doctor as soon as possible if you notice any of the following:

• Skin rash or other signs of allergic reaction such as difficulty in breathing, a runny nose, rash, swollen facial features, swelling of the lips, tongue or throat.
• Becoming unusually tired, unexpected bruising or bleeding, blood in the urine, mouth ulcers, skin reddening, blisters or rash, a rash of pinpoint red spots and getting more infections (such as colds) than usual. These are very rare effects in people taking paracetamol. If you show any of these signs stop taking Paracetamol immediately and talk to a doctor.

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 effects like shortness of breath.
• Frequency “Not known’’ (cannot be estimated from the available data): Metabolic acidosis (serious condition that can make blood more acidic, see Section 2).

•

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 information on the safety of this medicine.

5. How to store Paracetamol

• Keep out of the sight and reach of children, preferably in a locked cupboard or medicine cabinet.
• Do not use Paracetamol after the expiry date (month, year) on the label and carton. The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What Paracetamol contains

• The active substance of Paracetamol 500 mg Tablets is paracetamol. Each tablet contains

  500 mg of paracetamol.

• The other ingredients are: starch, lactose, povidone, magnesium stearate, sodium starch glycollate and aerosol.

What Paracetamol looks like and contents of the pack

Paracetamol 500 mg Tablets are white capsule-shaped tablets. They are available in packs of 100 tablets.

Marketing Authorisation Holder

Medley Pharma Limited, Unit 2A, Olympic Way, Sefton Business Park, Bootle, Merseyside, L30 1RD, United Kingdom.

This leaflet was last revised in August 2025 317/10