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PARACETAMOL 500 MG SUPPOSITORIES - patient leaflet, side effects, dosage

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Patient leaflet - PARACETAMOL 500 MG SUPPOSITORIES

Do not give your child these suppositories if:

  • They are allergic to paracetamol or to the other main ingredient which is called ‚hard fat‘.

Take special care with Paracetamol Suppositories

Check with your doctor or pharmacist before using these suppositories if

  • Your child has liver or kidney problems.

Taking other medicines

Please tell your child's doctor or pharmacist if your child is taking, or has recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because the suppositories can affect the way some medicines work and some medicines can have an effect on Paracetamol Suppositories.

In particular, tell your child's doctor or pharmacist if your child is taking any of the following:

  • Other medicines that contain paracetamol – do not give your child Paracetamol Suppositories at the same time.
  • Barbiturates (a type of sedative).
  • Medicines for epilepsy or fits (also called ‚anti-convulsants‘).
  • Medicines such as warfarin for treating blood clots.

Do not give your child alcohol, or any medicines containing alcohol, whilst they are being given these suppositories.

  • 3) How to give Paracetamol Suppositories to your child

This medicine is for rectal use only. If your child's doctor or pharmacist has told you how to use this medicine, do exactly as they have told you. Otherwise, follow the instructions below. If you do not understand the instructions, or you are not sure, ask the doctor or pharmacist.

How many Paracetamol Suppositories to give your child

Paracetamol 250mg Suppositories

Children aged 6 to 9 years (20-30kg) - one 250mg suppository

Children aged 10 to 12 years (30-40kg) - one to two 250mg suppositories

Paracetamol 500mg Suppositories

Children aged 10 to 12 years (30-40kg) - one 500mg suppository

Children aged 12 years and older - one to two 500mg suppositories

The dosage should be based on your child’s age and weight.

These doses may be repeated up to a maximum of 4 times in 24 hours.

Suppositories should not be given more often than every 4 hours

If you are not sure how many suppositories to give your child, don't guess, ask your child’s doctor or a pharmacist. Do not give your child this medicine for more than 3 days, without speaking to your child’s doctor

Do not give your child more suppositories than stated above.

How to use Paracetamol Suppositories

  • 1.Your child's bowels need to be empty when you give them this medicine. If your child needs to go to the toilet, make sure that they do so before you give them the suppository.

  • 2.You may find it easier to give your child the suppository if they are lying on their front or side. Do whichever is more comfortable for your child.

  • 3.Wash your hands. Then peel the wrapping apart to remove the suppository. Do not break the suppository before use.

  • 4.Gently push the suppository into your child's back passage, pointed end first. Then wash your hands.

  • 5.Try to keep your child still for a minute or two.

6.If your child needs to be given another suppository, remove another one from the wrapper. Then insert it into your child's back passage as before. Once again you should try to keep your child still for a minute or two. Then wash your hands

If you forget to give Paracetamol Suppositories to your child

  • Give them as soon as you remember, then go on as before.
  • However, if it is almost time for the next dose, skip the missed dose.
  • Do not give your child a double dose (two doses at the same time) next time, to make up for a forgotten dose.

If you give too many Paracetamol Suppositories to your child

  • Do not give your child more suppositories than stated in the section called „How many Paracetamol Suppositories to give your child“
  • 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.

4) possible side effects

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

The following side effects can happen with this medicine.

  • Redness or soreness in or around the back passage are common.
  • Allergic reactions.
  • Skin problems such as a rash or itching.
  • Blood problems. If these happen, your child may bruise or bleed more easily, get infections more easily, or get a high temperature (fever) and ulcers in the mouth and throat.
  • Liver problems.

Very rare cases of serious skin reactions have been reported.

If your child gets any of the side effects mentioned above, or gets any side effects not mentioned in this leaflet, talk to your child's doctor or pharmacist.

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

5) how to store paracetamol suppositories

  • Keep this medicine out of the sight and reach of children
  • Do not use after the expiry date shown on this pack. The expiry date refers to the last day of that month.
  • Do not store above 25°C. Store in the original package in order to protect from light.
  • Return any unused suppositories to the pharmacist, unless your child's doctor has told you to keep them.
  • If your medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
  • 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 contains

  • The active ingredient is paracetamol.
  • Each suppository contains 500mg paracetamol.
  • The other ingredient is Witepsol S58.

What Paracetamol Suppositories look like and contents of the pack

Each suppository is a small, torpedo shaped medicine which is inserted into the back passage (rectum). Each pack contains 10 white suppositories.

PL 46420/0270 Paracetamol 500mg Suppositories P

Who makes and repackages your medicine?

Your medicine is manufactured by Przedsiebiorstwo Produckcji Farmaceutycznej Hasco-Lek S.A. 51–131 Wroclaw, ul. Zmigrodzka 242 E Poland. Procured from within the EU by the Product Licence holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS and repackaged by Primecrown Ltd, Northolt, UB5 5QS.

Leaflet date: 26.09.2019

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