Paracetamol 500mg Suppositories

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol

Available from:

Phoenix Labs

ATC code:

N02BE; N02BE01

INN (International Name):

Paracetamol

Dosage:

500 milligram(s)

Pharmaceutical form:

Suppository

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

2010-12-21

Patient Information leaflet

PHOENIX LABS
Information for the user
FOR RECTAL ADMINISTRATION ONLY
PARACETAMOL 250MG SUPPOSITORIES
PARACETAMOL 500MG SUPPOSITORIES
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GIVE THIS MEDICINE TO
YOUR CHILD 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.
•
If your child gets any side effects
talk to your child’s doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section
4.YOU MUST TALK TO A DOCTOR
IF YOUR CHILD DOES NOT FEEL BETTER OR IF YOUR CHILD FEELS WORSE.
What is in this leaflet:
1 .
What Paracetamol Suppositories are and what are they used for
2.
What you need to know before you give Paracetamol Suppositories to
your child
3.
How to use Paracetamol Suppositories
4.
Possible side effects
5.
How to store Paracetamol Suppositories
6.
Contents of the pack and other 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
medi-cines 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.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE PARACETAMOL SUPPOSITORIES TO
YOUR CHILD
DO NOT GIVE YOUR CHILD THESE SUPPOSITORIES IF:
•
They are allergic to paracetamol or the other main ingredient which is
called "hard fat".
WARNINGS AND PRECAUTIONS
Talk to your child’s doctor or pharmacist before using these
suppositories:
•
If your child has liver or kidney problems
OTHER MEDICINES AND PARACETAMOL SUPPOSITORIES
Please tell y

Summary of Product characteristics

Health Products Regulatory Authority
24 May 2022
CRN00CY1Y
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 500mg Paracetamol
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suppository
White, torpedo shaped, suppository
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of mild to moderate pain and fever in children.
Paracetamol 500 mg Suppositories are indicated in children aged from 6
years.
Paracetamol suppositories may be especially useful in patients unable
to take oral forms of paracetamol e.g. Post-operative
patients or patients with nausea and/or vomiting.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric Population_
The dosage should be based on the child's age and weight. Ages and
weight ranges presented below are provided as an
accompanying guide only.
Children aged 10 – 12 years (30 - 40kg): 1 suppository
12 years and over: 1 - 2 suppositories
Method of administration
For rectal use only
The dosage should be based on the child's age and weight. These doses
may be repeated up to a maximum of 4 times in 24
hours. The dose should not be repeated more frequently than every 4
hours. The recommended dose should not be
exceeded. The product should not be used for more than 3 days, except
on the advice of a doctor. Higher doses do not
produce any increase in analgesic effect. Only whole suppositories
should be administered – do not break the suppository
before administration.
4.3 CONTRAINDICATIONS
Patients who are hypersensitive to paracetamol or any of the other
constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Paracetamol suppositories should not be combined with other analgesic
medications that contain paracetamol. Paracetamol
suppositories should be administered with care to patients with
impaired kidney or liver function. The hazards of overdose are
greater in those with non-cirrhotic liver disease.
Health Prod