Napa Extend (Paracetamol 665 mg ER Tablet)

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

Paracetamol

متاح من:

Vitamode Sdn.bhd

INN (الاسم الدولي):

Paracetamol

الوحدات في الحزمة:

8 x 12 Tablets; 1x12 Tablets

المصنعة من قبل:

BEXIMCO PHARMACEUTICAL LTD

نشرة المعلومات

NAPA EXTEND (PARACETAMOL 665MG ER
TABLET)
Paracetamol ER (665mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Napa Extend_
is used for
2.
How
_Napa Extend _
works
3.
Before you use
_Napa Extend_
4.
How to use
_Napa Extend_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Napa _
_Extend_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _NAPA EXTEND_ IS USED FOR
Napa Extend Tablet is used for the relief
of fever and the relief of mild to
moderate
pain
including:
headache,
migraine,
toothache,
pain
after
dental
procedures, neuralgia, muscular aches
and
joint
pains,
pain
of
osteoarthritis
(inflammation of joints), rheumatic pain,
period pain, pain after vaccination, sore
throat and the discomfort from colds and
influenza.
HOW _NAPA EXTEND _WORKS
Paracetamol
is
a
para-aminophenol
derivative
that
exhibits
analgesic
(pain
relief)
and
antipyretic
(reduce
fever)
activity.
The
mechanism
of
action
of
paracetamol
is
believed
to
include
the
inhibition
of
prostaglandin
synthesis,
primarily
within
the
central
nervous
system.
It
does
not
possess
anti-
inflammatory activity.
It
provides relief
from
mild
to
moderate
pain
and
fever.
The combination of immediate release and
sustained release paracetamol provides pain
relief, which may last up to 8 hours.
BEFORE YOU USE _NAPA EXTEND _
This preparation contains paracetamol. Do
not take any other paracetamol containing
medicines at the same time.
_ _
-
_When you must not use it _
Do not use
_Napa Extend _
if you are allergic
to paracetamol or to any of the other
ingredients of this medicine.
_ _
_ _
_Pregnancy and lactation_
_Napa Extend _
can be used in pregnancy
and breastfeeding.
Ask your doctor or pharmacist for advice
before taking any medicine.
_ Before you start use it _
Tell your doctor or pharmacist if:
•
You are taking other paracetamol-
containing medication.
•
You have liver or kidney disease
•
You are severely malnourished,
anorexic (loss of appetite for food)

خصائص المنتج

NAPA® EXTEND
Paracetamol 665 mg ER Tablet
PRODUCT DESCRIPTION
A bi-layer white colored caplet shaped film coated tablet, engraved
BPL on one side and plain
on the other. Each modified release tablet contains 665 mg
paracetamol.
PHARMACODYNAMICS
Paracetamol is a para-aminophenol derivative that exhibits analgesic
and antipyretic activity.
The mechanism of action of paracetamol is believed to include the
inhibition of prostaglandin
synthesis, primarily within the central nervous system. It does not
possess anti-inflammatory
activity. It provides relief from mild to moderate pain and fever. The
combination of immediate
release and sustained release paracetamol provides pain relief, which
may last up to 8 hours.
PHARMACOKINETICS
Absorption
Napa Extend are bilayer tablets incorporating an immediate release and
a sustained release
dose of paracetamol.
The sustained release layer is formulated in such a manner that it
rapidly hydrates to form a gel
layer at the matrix periphery; the drug is then released from the
matrix by a combination of
diffusion and erosion of the gel layer.
Napa Extend releases drug at a rate which ensures that therapeutically
active plasma
paracetamol concentrations are rapidly attained and maintained until
up to 8 hours after
administration.
Distribution
Paracetamol is distributed into most body tissues. Binding to the
plasma proteins is minimal at
therapeutic concentrations but increases with increasing doses.
Metabolism
Paracetamol is metabolised extensively in the liver and excreted in
the urine mainly as inactive
glucuronide and sulfate conjugates. The metabolites of paracetamol
include a minor
hydroxylated intermediate which has hepatotoxic activity. This
intermediate metabolite is
detoxified by conjugation with glutathione, however, it can accumulate
following paracetamol
overdosage (more than 150 mg/kg or 10 g total paracetamol ingested)
and if left untreated can
cause irreversible liver damage.
Paracetamol is metabolised differently by premature infants, newborns,
infants and young
child