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

Last updated: · Text from the MHRA, as of · About this document

Medicine status: Pharmacy medicine (P) Details

Medicine strength:
500 mg
Contains active substance:

Patient leaflet - Paracetamol 500 mg suppositories

1. WHAT PARACETAMOL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR

The active ingredient Paracetamol is a medicine with pain relieving properties.

Paracetamol Suppositories are used:

  • for the relief of mild to moderate pain
  • for the relief of a high temperature (fever)
  • if you are unable to take Paracetamol orally e.g. after an operation or if you are feeling or being sick.

2. BEFORE YOU USE PARACETAMOL SUPPOSITORIES

You or your child should not take Paracetamol Suppositories if:

  • you or your child are allergic (hypersensitive) to Paracetamol or to any of the ingredients listed in section 6 of this leaflet

If this applies to you or your child please tell your doctor before taking this medicine.

Take special care with Paracetamol Suppositories if:

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  • you or your child suffer from severe liver or kidney problems
  • you or your child suffer from alcoholism

If your’s or your child’s symptoms persist you should consult your doctor.

Do not use Paracetamol Suppositories with other medicines that contain Paracetamol.

Do not exceed the recommended dose.

During treatment with Paracetamol Suppositories, tell your doctor straight away if:

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).

Taking other medicines

Please tell your doctor, nurse or pharmacist if your child is taking, or has recently taken, any other medicine including medicines obtained without prescription.

Please tell your doctor, nurse or pharmacist if you or your child are taking, or have recently taken, any other medicine including medicines obtained without prescription.

Please tell your doctor if you or your child are taking any of the following medicines:

  • medicines used to thin your blood (anticoagulants) e.g. warfarin
  • medicines used to stop you feeling or being sick such as metoclopramide and domperidone
  • colestyramine, a medicine used to prevent coronary heart disease and diarrhoea caused by certain disorders

If you have any doubts as to whether Paracetamol Suppositories are suitable for you or your child please consult your doctor. Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment (see section 2).

Pregnancy and breast-feeding

If necessary, Paracetamol Suppositories 500mg 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

There are no known side effects of taking Paracetamol Suppositories on driving or using machines.

3. HOW TO USE PARACETAMOL SUPPOSITORIES

Always use Paracetamol Suppositories exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

  1. 1.

    If your child needs to empty their bowels this should be done before inserting the

    • suppository.
  2. 2. Wash hands before opening individual packaging. If the suppository is too soft, it may be chilled in the refrigerator or under cold running water before unwrapping.
  3. 3. To remove a suppository, tear one from the strip along the perforations then peel it from the plastic wrapping by grasping the two halves of the wrapping at the tip of the suppository and pulling them gently apart. The tip should be moistened with a little cold water to aid insertion.
  4. 4.

    Using your index finger or middle finger, whichever you find

    • easier, gently push the suppository into the rectum (back passage), making sure the rounded end of the suppository is inserted first.
  5. 5. The suppository should be inserted as far as possible, pushing the end of the suppository sideways to ensure contact with the wall of the bowel.

How much to use

The usual dose for adults, elderly and children 12 - 18 years is 1 or 2 suppositories every 4 to 6 hours up to a maximum of 4 doses in 24 hours.

The dose should be based on age and weight i.e.12 years (39 kg) – (500 mg) 1 suppository, adults and the elderly (1 g) 2 suppositories.

You must not exceed the stated dose.

If you use more Paracetamol Suppositories than you should

Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.

If these suppositories are swallowed contact your doctor or nearest casualty unit immediately taking the carton, any leftover suppositories and this leaflet with you.

4. POSSIBLE SIDE EFFECTS

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

Side effects that may occur include:

  • A skin rash. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE PARACETAMOL SUPPOSITORIES

Keep out of the sight and reach of children.

Do not use Paracetamol Suppositories after the expiry date on the carton label. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not use if the strip containing the suppositories is damaged.

If your doctor decides to stop treatment, return any leftover medicine to the pharmacist. Only keep them if the doctor tells you to.

If your medicine appears to be discoloured or shown any other signs of deterioration, take them back to your pharmacist who will advise you.

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. FURTHER INFORMATION

What Paracetamol Suppositories contain

The active ingredient in Paracetamol suppositories is paracetamol.

Each suppository contains 500mg of paracetamol.

Paracetamol Suppositories contains the following inactive substances: hard fat and Macrogol Stearate.

What Paracetamol Suppositories look like and contents of the pack:

Paracetamol Suppositories are bullet-shaped, semi-solid and white which are packed individually in plastic cavities.

There are five suppositories in each strip.

Each box contains 10 Paracetamol 500mg Suppositories.

Manufacturer

Paracetamol 500mg Suppositories are manufactured by:

Rice Steele Manufacturing Limited, Tallaght, Dublin 24, Ireland

Or

Phoenix Healthcare Limited, Unit 31, 2nd Avenue, Cookstown Industrial Estate, Tallaght,

Dublin 24, D24 TP60, Ireland.

Procured from within the EU and repackaged by: BModesto B.V., Minervaweg 2, 8239 DL, Lelystad, Netherlands.

Product Licence holder: Doncaster Pharma Limited, Crompton Road, Doncaster, DN2 4PW, UK.

PL No: 56830/0113

Leaflet revision and issue date (ref): 23.10.2025

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Product name:

Paracetamol 500mg Suppositories

Reference No: 56830/0113

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk) · Marketing authorisation: PLPI 56830/0113

Last revision stated in the text: 23 October 2025 · MHRA data as of 13 October 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Paracetamol 500 mg suppositories

Prescription needed? No, but it is sold only in pharmacies (P)
Active substance Paracetamol
Strength 500 mg
Pharmaceutical form Suppository
How is it taken Rectal
Is it available? Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Drug group (ATC)
  1. N Nervous system drugs
    1. N02 Analgesics
      1. N02B Other analgesics and antipyretics
        1. N02BE Anilide analgesics and antipyretics
          1. N02BE01 paracetamol
Marketing authorisation PLPI 56830/0113
Codes BNF 04070100

Sources: the MHRA product information (products.mhra.gov.uk) and the NHS Dictionary of Medicines and Devices (dm+d), release 10.2.0 of 19 October 2026, NHS Business Services Authority. Contains public sector information licensed under the Open Government Licence v3.0.