Paracetamol 80 mg suppositories

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Paracetamol

Sẵn có từ:

Phoenix Labs

Mã ATC:

N02BE; N02BE01

INN (Tên quốc tế):

Paracetamol

Liều dùng:

80 milligram(s)

Dạng dược phẩm:

Suppository

Loại thuốc theo toa:

Product not subject to medical prescription

Khu trị liệu:

Anilides; paracetamol

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

2012-02-10

Tờ rơi thông tin

PHOENIX LABS
Information for the user
FOR RECTAL ADMINISTRATION ONLY
PARACETAMOL 80MG 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 THEY ARE 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 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 3
months. 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 d

Đặc tính sản phẩm

Health Products Regulatory Authority
24 May 2022
CRN00CY0R
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 80 mg suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 80mg 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 babies and
children.
Paracetamol 80 mg suppositories are indicated in children from the age
of 3 months.
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 presented
below are provided as an accompanying guide only.
3 – 12 months (5kg): One suppository
Method of administration
For rectal use only.
This dose 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
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.
Health Products Regu