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PARASERTS 125MG SUPPOSITORIES

Active substance(s): PARACETAMOL / PARACETAMOL

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Title:

Paracetamol 125mg Suppositories

Ref:

PIL - Patient Information Leaflet

Date:

05/01/16

Size (mm):

265(W) x 360(H)

Modified:

11/02/17

Colours
(Printed)

Colours
(Non printed)
LIMITED

Black

TRIM

Process

REFERENCE

PERF
REFERENCE

Do not give your child more suppositories than stated above.
Consult your child’s doctor if symptoms get worse or do not improve within 3 days.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paraserts 125mg Suppositories
Paracetamol

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Paraserts 125mg Suppositories Paracetamol
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 symptoms worsen or do not improve after 3 days.
- If any of the listed side effects get serious, or if you notice any side effects which are not listed in this leaflet,
please tell your doctor or pharmacist.
- Your product is called Paraserts 125mg Suppositories Paracetamol but will be referred to as Paraserts Suppositories
throughout this leaflet.
In this leaflet:
1. What Paraserts Suppositories are and what they are used for
2. Before you use Paraserts Suppositories
3. How to use Paraserts Suppositories
4. Possible side effects
5. How to store Paraserts Suppositories
6. Further information

How to use the suppositories:
• 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 it before you give them the suppository
• It may be easier to give your child the suppository if they are lying on their front or side on a bed
• Wash you hands. Then peel the wrapping apart to take out the suppository. Do not break the suppository before use
• Gently push the suppository into you child’s back passage with the pointed end first. To make it easier to give the
suppository you may warm it slightly between your hands beforehand
• Try to keep your child still for a minute or two and then wash your hands
• If you need to give another suppository, then follow the above procedure again.
If you have given more Paraserts Suppositories to your baby than you should:
• Immediate medical advice should be sought in the event of an overdose, even if your child seems well, because of
the risk of delayed, serious liver damage.
If you have any further questions regarding the use of this medication, please ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

1. WHAT PARASERTS SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Paraserts Suppositories contain a medicine called paracetamol. This belongs to a group of medicines called pain-killers
(analgesics). A suppository is a small, torpedo-shaped, medicine which is inserted into the back passage (rectum).
Paraserts Suppositories are used to treat pain and high temperature (fever) in children from 1 to 5 years of age. They can be
used in children who find it difficult to take paracetamol as tablets or syrup.

2. BEFORE YOU USE PARASERTS SUPPOSITORIES
Do not give Paraserts Suppositories to your child if:
• your child is allergic (hypersensitive) to paracetamol, soya, peanuts or any of the other ingredients of Paracetamol
Suppositories (listed in Section 6 at the end of this leaflet).

Like all medicines, Paraserts Suppositories can cause side effects, although not everybody gets them.
Stop giving Paraserts Suppositories to your child immediately and call your doctor if you notice your child has any
signs of allergic reaction.
Signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
The following side effects can happen with this medicine.
Common side effects (affects more than 1 in 100 people taking this medicine):
• Redness or soreness in and around the back passage.
Rare side effects (affects less than 1 in 1000 people taking this medicine):
• Blood problems. If these happen, your child may bruise or bleed more easily than usual, be more susceptible to
infections, or get a high temperature (fever) and ulcers in the mouth and throat
• Liver problems. Symptoms may include jaundice (yellowing of the skin or whites of the eyes).
If your child gets any of the side effects mentioned above, or get any side effect not mentioned in this leaflet, talk to your child’s
doctor or pharmacist.

5. HOW TO STORE PARASERTS SUPPOSITORIES

Take special care with the use of Paraserts Suppositories and talk to your pharmacist or doctor if:
• your child has problems with their liver or kidneys.
Taking other medicines
Please tell your child’s doctor or pharmacist if your child is taking, or has recently taken, any other medicines, including
medicines obtained without a prescription and herbal medicines. This is because Paraserts Suppositories can have an affect
on the way some medicines work and some medicines can have an affect on how Paraserts Suppositories work.
In particular tell your child’s doctor or pharmacist if your child is taking any of the following:
• Other medicines containing paracetamol – do not give your child Paraserts Suppositories at the same time
• Medicines to treat nausea (feeling sick) and vomiting (being sick), such as metoclopramide and domperidone
• Colestyramine, used to reduce the level of cholesterol (fat) in the blood
• Medicines called anticoagulants, such as warfarin, used for treating blood clots
• Medicines called anticonvulsants used for treating epilepsy or fits (e.g. phenytoin, carbamazepine)
• The antibiotic rifampicin.

3. HOW TO USE PARASERTS SUPPOSITORIES
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 are not sure, ask the doctor
or pharmacist.
How many Paraserts Suppositories to give your child:

Keep out of reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister strip. The expiry date refers to the
last day of that month. Do not store over 30°C.

6. FURTHER INFORMATION
What Paraserts Suppositories contains:
The active substance is paracetamol. Each suppository contains 125mg of paracetamol. The other ingredients are: hydrogenated
fat, soyabean lecithin.
What Paraserts Suppositories look like and contents of the pack:
Cream coloured, torpedo shaped suppository, available in packs of 10 suppositories.
Marketing authorisation holder:
Amdeepcha Limited, 85 Yarmouth Road, Blofield, Norwich, Norfolk NR13 4LQ, UK.
Manufacturer:
Dr. R. Pfleger Chemische Fabrik GmbH, D-96045 Bamberg,
This package leaflet was last revised in December 2016

Age

Number of
Suppositories

Minimum Length of
time between doses

Maximum number of
suppositories in 24 hours

1 year (10kg)

1

4 – 6 hours

4

Over 1 year to 5 years (20kg)

1 or 2

4 – 6 hours

4-8

Expand Transcript

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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