What it is and what it is used for

for 2. What you need to know before you take Paracetamol 500mg Tablets 3. How to take Paracetamol 500mg Tablets 4. Possible side effects 5. How to store Paracetamol 500mg Tablets 6. Contents of the pack and other information

1. What Paracetamol 500mg Tablets are and what they are used for

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Paracetamol relieves pain and brings down high temperatures (reduces fever). Paracetamol 500mg Tablets are used for relief of

• mild to moderate pain including headache, migraine, nerve pain (neuralgia), toothache, sore throat and period pains
• symptoms of rheumatic and muscular aches and pains, sciatica, back pain (lumbago), joint swelling and stiffness
• symptoms of colds and flu.

What you need to know before you take it

e Paracetamol 500mg Tablets Do not take Paracetamol 500mg Tablets

• if you are allergic to paracetamol, sodium metabisulfite or any of the other ingredients listed in section 6. Do not take anything else containing paracetamol while taking this medicine.

Warnings and precautions

Talk to your pharmacist or doctor before taking if

• you suffer from severe liver or kidney disease, including alcoholic liver disease. During treatment with this medicine, tell your doctor straight away 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).

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Other medicines and Paracetamol 500mg Tablets

Talk to your pharmacist or doctor before taking the tablets if you are taking any of the following:

• medicines for nausea or sickness, such as metoclopramide or domperidone
• colestyramine for high cholesterol or high blood fats
• warfarin (or other medicines used to thin the blood and reduce the risk of clotting). The risk of bleeding may be increased if you take paracetamol daily over a long period of time. However you can take occasional doses of paracetamol
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

Pregnancy and breastfeeding

If necessary, Paracetamol 500mg Tablets 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 can take paracetamol while breastfeeding

Important information about some of the ingredients of this medicine

Paracetamol 500mg Tablets contain less than 1 mmol sodium (23 mg) per 2 tablets, that is to say essentially 'sodium-free'. Sodium metabisulfite (E223) may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (narrowing of the windpipe).

How to take it

Paracetamol 500mg Tablets

Swallow the tablets, preferably with a drink of water. Age

How much 1 or 2 tablets

How often

Adults and children over 16 years Children 1 to 11⁄2 12 – 15 tablets years

Every 4-6 hours, as required. Don't take more than 8 tablets (4 doses) in any 24 hours Every 4-6 hours, as required. Don't take more than 6 tablets (4 doses) in any 24 hours Children 1 tablet Every 4-6 hours, as required. Don't 10 – 12 take more than 4 years tablets (4 doses) in any 24 hours Children Half a Every 4-6 hours, 6 – 10 tablet as required. Don't years take more than 2 tablets (4 doses) in any 24 hours Do not give to children under 6 years. Do not take more often than every 4 hours. Do not take for more than 3 days unless instructed by your doctor.

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Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. 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.

4. Possible side effects

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

Possible side effects

are rare with paracetamol.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name: Boots Paracetamol 500mg Tablets Reference number: 16028/0012

Stop taking the tablets and contact your doctor immediately if you notice

• skin rashes or other signs of allergic reaction such as itching, swelling of the lips, tongue or throat, or difficulty in breathing
• unexpected bruising or bleeding, persistent tiredness, or increase in the number of infections (e.g. sore throats) which you get. These are possible signs of changes in the blood
• skin rash or peeling, or mouth ulcers
• breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin
• nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin. 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).

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.

How to store it

Paracetamol 500mg Tablets

There are no special storage requirements. Do not use after the expiry date shown on the carton. Keep this medicine out of the sight and reach of children.

Contents of the pack and other information

What Paracetamol 500mg Tablets contain The active ingredient is: Paracetamol 500mg per tablet. Other ingredients are: Pregelatinised maize starch, sodium metabisulfite (E223) and magnesium stearate.

What Paracetamol 500mg Tablets look like and contents of the pack

Paracetamol 500mg Tablets are white, capsule-shaped tablets with a break line on one side. This pack contains 16 tablets.

Marketing Authorisation Holder:

Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom. Manufacturer(s): Omega Pharma Ltd., DMC 02, County Way, Barnsley, South Yorkshire, S70 2AG, United Kingdom. Wrafton Laboratories Limited, Exeter Road, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom. Distributed by: The Boots Company PLC, Nottingham, NG2 3AA. Text revised: January 2025 E7J73QAJB6