Paracetamol 125 mg 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:

125 milligram(s)

Pharmaceutical form:

Suppository

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

2012-02-10

Patient Information leaflet

PHOENIX LABS
Information for the user
FOR RECTAL ADMINISTRATION ONLY
PARACETAMOL 125MG 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.
IN THIS LEAFLET:
1. WHAT PARACETAMOL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE PARACETAMOL SUPPOSITORIES TO
YOUR CHILD
3.
HOW 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
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 babies and children from the age of I year.
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 your child's doctor or pharmacist i

Summary of Product characteristics

Health Products Regulatory Authority
24 May 2022
CRN00CY0R
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 125 mg suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 125mg 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 125 mg Suppositories are indicated in children from the
age of 1 year.
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_
Dosage should be based on the child's weight, with a recommended
dosage of 15mg/kg per administration. Ages and weight
ranges presented below are provided as an accompanying guide only.
1 – 3 years (10kg): One suppository
4 – 6 years (15kg): Two suppositories
Method of administration
For rectal use only
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.
Hepatic / renal dysfunction
Caution should be exercised when administering the product to patients
with severe hepatic or renal impairment.
4.3 CONTRAINDICATIONS
Hypersensitivity to paracetamol or to any of the excipients listed in
section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
24 May 2022
CRN00CY0R
Page 2 of 5
Paracetamol suppositories should not be combined with other analgesic
medications that contain paracetamol.
Paracetamol