PARACETAMOL 125 MG SUPPOSITORIES

Active substance: PARACETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PARA-SUPPS PARACETAMOL 125 MG SUPPOSITORIES
Paracetamol
PLEASE READ ALL OF THIS LEAFLET CAREFULLY. IT PROVIDES
IMPORTANT INFORMATION REGARDING THE USE OF
THESE SUPPOSITORIES
This product is available without a prescription. However, you still need to use the product
carefully to get the best results from it.





Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist, if you need further information.
You must contact your doctor if the symptoms become worse or if there is no
improvement after three days.
If any of the side effects becomes serious, or if you notice any side effects not listed
in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:
1.
2.
3.
4.
5.
6.

1.

What Para-Supps Paracetamol 125 mg Suppositories are and what they are used for
Before you use Para-Supps Paracetamol 125 mg Suppositories
How to use Para-Supps Paracetamol 125 mg Suppositories
Possible side effects
How to store Para-Supps Paracetamol 125 mg Suppositories
Further information
WHAT PARA-SUPPS PARACETAMOL 125 MG SUPPOSITORIES ARE AND
WHAT THEY ARE USED FOR

Para-Supps Paracetamol 125 mg Suppositories contain paracetamol which belongs to a group
of medicines called anti-inflammatory painkillers.
A suppository is a small, torpedo-shaped medicine which is inserted in to the back passage
(rectum). These may be useful in children who find it difficult to take tablets or syrup.
Para-Supps Paracetamol 125 mg Suppositories can be used to relieve mild to moderate pain
and fever in children from 1 to 5 years of age. For children over 5 years' old Para-Supps
Paracetamol 250 mg Suppositories should be used.
2.

BEFORE YOU USE PARA-SUPPS PARACETAMOL 125 MG
SUPPOSITORIES

Do not use Para-Supps Paracetamol 125 mg Suppositories


if your child is allergic (hypersensitive) to paracetamol or any of the other ingredients in
this medicine

Take special care with Para-Supps Paracetamol 125 mg Suppositories


if your child has liver or kidney problems

Taking other medicines
Do not use any other products that contain paracetamol while using Para-Supps Paracetamol
125 mg Suppositories.
Tell your doctor or pharmacist if your child is taking any of the following medicines:




medicines used as sedatives, such as barbiturates
warfarin or other coumarins, which are medicines used to thin the blood
medicines used to treat epilepsy or fits, such as carbamazepine, phenobarbital or
phenytoin

Please tell your doctor or pharmacist if your child is taking or has recently taken any other
medicines, including medicines obtained without a prescription.
If you have any doubts about whether your child should take this medicine, then talk to your
doctor or pharmacist.
Pregnancy and breast-feeding
If your child is pregnant or breast-feeding you should ask your doctor for advice before
taking Para-Supps Paracetamol 125 mg Suppositories.
3.

HOW TO USE PARA-SUPPS PARACETAMOL 125 MG SUPPOSITORIES

For rectal use only.
The dosage schedule given below should be followed, unless otherwise directed by your
doctor.
The number of suppositories to give your child depends on their age and weight.
The usual dose is 125-250 mg (1-2 suppositories) up to 4 times a day. Ask your doctor or
pharmacist for advice on how many suppositories to give.
Do not give more than 4 doses in any 24-hour period. Leave at least 4 hours between
doses. Only use whole suppositories.
Para-Supps Paracetamol 125 mg Suppositories are designed to be inserted in the back
passage (rectum).








Always wash your hands before and after using the suppositories.
If your child needs to empty their bowels, this should be done before inserting the
suppository.
It may be easier to do if your child lies on a bed on their front or side.
The blister should be opened immediately before use. Remove one suppository from
the mould. Do not break the suppository.
Moisten the tip of the suppository with a little water before insertion.
Using one finger, slide the suppository as high up into the rectum as it can go without
pushing or applying force.
Try to keep your child still for a minute or two.

If you need to insert more than one suppository, insert them one at a time – there is no need
to wait between insertions for the previous suppository to melt – there is plenty of room in
the rectum.
Please refer to the diagram, which shows the insertion procedure. If you have any concerns
you should seek advice from your doctor or pharmacist.

Do not give more medicine than the label tells you to. If your child does not get better, talk to
your doctor or pharmacist.
Do not give more suppositories than the recommended dose given Section 3 of this leaflet.
Do not use for longer than three days without consulting your doctor.
If a dose is missed, administer the normal dose as soon as possible. Do not give a double
dose. Then allow at least 4 hours before the next dose.
If you use more than you should: Talk to a doctor at once if your child takes too much
of this medicine even if they seem well. This is because too much paracetamol can cause
delayed, serious liver damage.

4.

POSSIBLE SIDE EFFECTS

Like all medicines Para-Supps Paracetamol 125 mg Suppositories can have some side effects
although not everyone gets them. Side effects that may occur are listed below.
Common side effects (affecting less than 1 in 10 people)

Redness or soreness in or around the back passage (rectum)
Rare side effects (affecting less than 1 in 1,000 people)

Allergic reactions

Skin rashes or itching

Blood problems. If these happen your child may get a high temperature/fever, ulcers in
the mouth and throat, a tendency to bleed or bruise easily or to get infections.

Liver problems
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5.

HOW TO STORE PARA-SUPPS PARACETAMOL 125 MG SUPPOSITORIES

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep in the outer carton.
Do not use this medicine after the expiry date on the carton or blister strip.
Do not use a suppository that is damaged or shows signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines that you no longer need. These measures will help
to protect the environment.
5.

FURTHER INFORMATION

What Para-Supps Paracetamol 125 mg Suppositories contain:
Each suppository contains:
Active ingredient: 125 mg of paracetamol
Other ingredient: hard fat
What Para-Supps Paracetamol 125 mg Suppositories look like and contents of the pack:
Para-Supps Paracetamol 125 mg Suppositories are white to ivory-coloured, torpedo-shaped
suppositories that are available in packs of 10 and packed in plastic-coated aluminium blister
strips.
Manufactured by:
bene Arzneimittel GmbH, Herterichstrasse 1, D-81479 Munich, Germany
Marketing authorisation holder:
Amdeepcha Ltd., 85, Yarmouth Road, Blofield, Norwich, Norfolk NR13 4LQ, UK
This leaflet was last approved in: December 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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