GACET-250 Paracetamol Suppositories BP 250 mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Paracetamol BP

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

Paracetamol BP

Unit dalam pakej:

2x5 Suppositories; 20x5 Suppositories

Dikeluarkan oleh:

Bliss GVS Pharma Ltd

Risalah maklumat

GACET (PARACETAMOL SUPPOSITORIES)
Paracetamol (125mg, 250mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Gacet is used for
2.
How Gacet works
3.
Before you use Gacet
4.
How to use Gacet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Gacet
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT GACET IS USED FOR
Gacet is used for the treatment of mild to
moderate
pain
and
fever
in
children.
Gacet
suppositories
may
be
especially
useful
in
patients
unable
to
take
oral
forms
of
paracetamol
e.g
post
operatively or with nausea and vomiting.
HOW GACET WORKS
Paracetamol had been thought to work
by
inhibiting
the
production
of
a
compound in the central nervous system.
Recently, is was found that paracetamol
may have been acting via interaction in
spinal cord pathways and inhibition of
spinal substance.
BEFORE YOU USE GACET
-
_When you must not use it_
_ _
Do
not
use
Gacet
if
you
are
hypersensitive
to
Paracetamol
or
any
other ingredients in the product.
Do not use Gacet if you have any of the
following conditions:
•
Serious liver disorder
•
Bleeding
or
swelling
of
the
rectal
(contraindication related directly to the
administration route of the medicine).
_ _
_Pregnancy and lactation _
Ask your doctor or pharmacist for advice
before using Gacet if you are pregnant,
trying to get pregnant or think you may
be pregnant or if you are breast-feeding.
_ _
_ _
_ _
_ _
_ _
-
_Before you start to use it _
Paracetamol should be taken with care
to if you have impaired liver or kidney
function. In the event of uric acid or
sugar
content
tests,
you
may
be
advised
to
disclose
your
intake
of
paracetamol. If the pain persists for
more than 5 days or the fever for more
than
3
days,
or
in
the
event
of
worsening,
stop
taking
paracetamol
without
seeking
advice
from
the
doctor.
Gacet
contains
paracetamol.
Do
not
take any other paracetamol containing
medicines at the same time.
Allergy alert: Paracetamol may cause
severe skin reactions. Sym

Ciri produk

DRUG INTERACTIONS :
Drugs which include hepatic microsomal enzymes such as alcohol,
Rifampicin, barbiturates and
other anti-convulsants may increase the hepatotoxicity of Paracetamol
particularly after overdosage.
The therapeutic effects of Paracetamol may also be decreased.
DOSAGE: GACET-125 SUPPOSITORY:
1-5years (10-20kg): 1-2 Suppositories
GACET-250 SUPPOSITORY:
6-12years (20-40kg): 1-2 Suppositories
METHOD OF ADMINISTRATION:
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. Higher doses do not produce any increase in
analgesic effect. Only whole
suppositories should be administered – do not break suppository
before administration.
OVERDOSAGE:
In the event of overdosage or accidental ingestion of a very high dose
(150mg/kg), the doctor should
be immediately consulted. Specific antidote is N Acetyl Cysteine.
PREGNANCY AND LACTATION : Epidemiological studies in human pregnancy
have shown no ill effects
due to Paracetamol used in the recommended dosage, but patients should
follow the advice of their
doctor regarding its use. Paracetamol is excreted in breast milk but
not in clinically significant
amounts. Available published data does not contraindicate breast
feeding.
FOR RECTAL ADMINISTRATION ONLY.
NOT TO BE TAKEN ORALLY.
STORAGE:
Store in a dry place, below 30ºC. Protect from light.
Keep medicine out of reach of children.
Jauhkan daripada capaian kanak-kanak.
PRESENTATION:
Pack of 2 x 5 & 20 x 5 Suppositories packed in a carton along with
leaflet.
DATE OF REVISION: 08/2020.
HOW TO USE SUPPOSITORY
The suppositories should be inserted deeply in to the anus, if
possible after having the bowels open.
1.
When practical, clean the area around the rectum with mild soap
and
warm
water,
and
rinse
thoroughly.
Gently
dry
by
patting
or
blotting with toilet tissue or a soft cloth.
2.
Detach one suppository from the strip.
3.
Remove
wrapper
before
inserting
suppository
by
holding
suppository