PARACETAMOL 250MG SUPPOSITORIES

Active substance: PARACETAMOL

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Paracetamol 250mg Suppositories
FOR RECTAL ADMINISTRATION ONLY
This medicine is available in other strengths (500mg). Your medicine is
known by the above name, but will be referred to as Paracetamol
Suppositories throughout this:

Patient Information Leaflet
Read all of this leaflet carefully because it contains important information
for you and your child.
This medicine is available without prescription. However, you still need to use it
carefully to get the best results from it.
 Keep this leaflet. You may need to read it again.
 Ask your pharmacist if you need more information or advice.
 You must contact your child's doctor if your child's symptoms get worse
or do not improve.
 If your child gets any side effects after being given this medicine, please tell a
doctor or pharmacist.
In this leaflet:
1) What Paracetamol Suppositories are and what they are used for
2) Before you give Paracetamol Suppositories to your child.
3) How to administer Paracetamol Suppositories to your child.
4) Possible side effects.
5) How to store Paracetamol Suppositories.
6) Further information.

1) What Paracetamol Suppositories are and what they are
used for

Paracetamol Suppositories contain a medicine called paracetamol.
Paracetamol is one of a group of medicines called pain-killers (analgesics).
A suppository is a small, torpedo-shaped medicine which is inserted into
the back passage (rectum). Paracetamol Suppositories are used to treat
pain and high temperature (fever) in children from the age of 6 years. They
are used by children who find it difficult to take paracetamol as tablets or
syrup.

2) Before you give Paracetamol Suppositories to your child
Do not give your child these suppositories if:
 They are allergic to paracetamol or to the other main ingredient which
contains '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 administer 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.






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.

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 250mg 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 10383/2052

Paracetamol 250mg 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 and repackaged by the Product
Licence holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road,
Northolt, Middlesex, UB5 5QS.
Leaflet date: 30.11.2012.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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