Paracetamol 500 mg capsules – patient leaflet, side effects, dosage

1. WHAT PARACETAMOL 500mg CAPSULES ARE AND WHAT THEY ARE USED FOR

Paracetamol 500mg capsules contain the active ingredient paracetamol It belongs to a group of medicines called analgesics (painkillers) and are used for the treatment of:

• joint pain, muscle pain.
• backache, toothache.
• nerve pain, period pain.
• headaches (including migraine, tension headache).
• sore throat.

It is also used to lower a high temperature and relieve the symptoms of cold and flu.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL 500mg CAPSULES

DO NOT take paracetamol 500mg Capsules if you:

• are allergic (hypersensitive) to paracetamol, other pain relievers or any of the

  other ingredients in the product (see Section 6 on ‘What Paracetamol 500mg Capsules contain’). Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue. Children

Paracetamol 500mg Capsules must not be given to children under 10 years of age. Do not take paracetamol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking paracetamol.

Warnings and precautions

Consult your doctor before taking these capsules if you:

• have severe kidney or liver problems.

• have a liver problem caused by alcohol

  • 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 lucloxacillin (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 500mg capsules

Please tell your doctor if you are taking or have recently taken any other medicines, including those 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. Please inform your doctor or pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2)
• warfarin and other drug which thin the blood
• cholestyramine (reduces blood cholesterol levels)
• metoclopramide and domperidone: used to stop you feeling sick (nausea) or being sick (vomiting)

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

Taking Paracetamol 500mg Capsules with food and drink

Avoid alcoholic drinks whilst taking these capsules. Taking paracetamol with alcohol can increase your chances of getting side effects.

Pregnancy and Breast Feeding

Ask your doctor or pharmacist before taking these capsules if you:

• are pregnant, planning to become pregnant or think you may be pregnant
• are breast-feeding or planning to breast-feed.

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.

Driving and using machines

Paracetamol 500mg capsules are not expected to affect your ability to drive or operate machinery.

3. HOW TO TAKE PARACETAMOL 500mg CAPSULES

Always take Paracetamol 500mg Capsules exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

This medicine is available without prescription. However, you still need to take Paracetamol 500mg capsules carefully to get the best results from them.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve.

• 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.

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What is in this leaflet:

1. 1. What Paracetamol 500mg Capsules are and what they are used for
2. 2. What you need to know before you take Paracetamol 500mg capsules
3. 3. How to take Paracetamol 500mg capsules
4. 4. Possible side effects
5. 5. How to store Paracetamol 500mg capsules
6. 6.

   2 Paracetamol 500mg capsules

   P h a r m a c o d e

7. • Do not take more than the recommended dose
8. • If you need to use this medicine for more than three days at a time, see your doctor

Adults and children over 16 years:

• The usual dose of paracetamol is 2 capsules
• Swallow the capsules whole with a drink of water
• Wait at least 4 hours before taking another dose
• Do not take more than 4 doses in any 24-hour period

Children 10-15 years of age:

Take One capsule every 4-6 hours when necessary to a maximum of 4 doses in 24 hours.

Use in children under 10

This medicine is not recommended for children under 10 years of age.

If you take more Paracetamol 500mg Capsules 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.
• Remember to take any remaining capsules and the pack with you. This is so the doctor knows what you have taken.

If you forget to take Paracetamol 500mg capsules

If you miss a dose, take it as soon as you remember. NEVER take a double dose to make up for the dose you have forgotten. Remember to leave at least 4 hours between doses.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Paracetamol 500mg Capsules can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop taking the capsules immediately and seek urgent medical help if:

• you get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice anitchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to paracetamol.
• you get serious skin reactions. Very rare cases have been reported.

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

• you get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia). This side effect has only happened in a few people taking paracetamol. 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 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 500mg CAPSULES

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C, Store in the original package.
• Do not use Paracetamol 500mg Capsules after the expiry date shown on the package. The expiry date refers to the last day of that month.
• 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Paracetamol 500mg Capsule contain

The active substance is paracetamol. Each capsule contains 500mg of paracetamol.

The other ingredients are starch 1500, magnesium stearate, sodium lauryl sulphate. The capsule shell is opaque red/white gelatin 100mg, containing as colours erythrosine (E127), patent blue V (E131), titanium dioxide (E171) and quinoline yellow (E104).

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

Paracetamol 500mg Capsules are clean, oblong shaped red and white capsules. They are supplied in cartons containing blister strips of 8 and16 capsules.

Not all pack sizes may be marketed.

This leaflet was last revised in July 2026.

Other sources of information:

To listen to or request a copy of this leaflet in braille, large print or audio please call, 020 33998960 (UK only) Please be ready to give the following information: Product name: Reference number: Paracetamol 500mg Capsules PL 39484/0057

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Marketing Authorisation Holder and Manufacturer: Fourrts (UK) Pharmacare Ltd.,

5 Braemore Court, Cockfosters Road, Barnet,

Hertfordshire EN4 0AE, United Kingdom.