Paracetamol 125mg suppositories

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Paracetamol

Disponible des:

Phoenix Labs Ltd

Codi ATC:

N02BE01

Designació comuna internacional (DCI):

Paracetamol

Dosis:

125mg

formulario farmacéutico:

Suppository

Vía de administración:

Rectal

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04070100

Informació per a l'usuari

PRODUCT NAME:
PARACETAMOL
125mg 2022
PIP CODE:
COMP
PIL
SIZE
165 x 270 mm
ITEM NUMBER
DRAWING
MARKET
IE
PRODUCT SITE
SCALE
100%
COLOURS
BLACK
CUTTER
DATE
06.06.221
VERSION NO.
1
AMENDED BY
B.MCCOMBE
PHARMATECH
FONT
9 pt
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 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 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

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 125mg 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
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