Fasdol 500 mg Tablet

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

Paracetamol

Commercializzato da:

Advance Pharma Sdn Bhd

INN (Nome Internazionale):

Paracetamol

Confezione:

3 x 10 Tablets; 1 x 10s Tablets; 20 x 10 Tablets

Prodotto da:

AV MANUFACTURING SDN.BHD

Foglio illustrativo

Consumer Medication Information Leaflet (RiMUP)
FASDOL 500 MG TABLET
Paracetamol 500 mg
1
WHAT IS IN THIS LEAFLET
1.
What is Fasdol used for
2.
How Fasdol works
3.
Before you take Fasdol
4.
How to use Fasdol
5.
While you are using Fasdol
6.
Side effects of Fasdol
7.
Storage and disposal
8.
Product description
9.
Manufacturer
10.
Product registration holder
11.
Date of revision
1.
WHAT IS FASDOL USED FOR
Fasdol helps to relieve fever, mild to
moderate pain including:
headache,
migraine, backache, musculoskeletal
pain, myalgia, dysmenorrhea (period
pain), pain of osteoarthritis, toothache,
and
the
discomfort
from
colds,
influenza and sore throats.
2.
HOW FASDOL WORKS
Fasdol is rapidly absorbed through oral
administration, and the absorption takes
place mainly in the small intestine. The
excretion of paracetamol is rapid and
occurs via the urine.
3.
BEFORE YOU USE FASDOL
_-When you must not use it _
If you have ever had

hypersensitivity to paracetamol or any
of the other ingredients/ components
of the product.

taking other medicines containing
paracetamol.

Severe and active hepatic impairment.
_-Before you start to use it _
Check with your doctor

If you suffer from liver or kidney
problems, including alcoholic liver
disease

If you suffer from mild arthritis and
need to take painkillers every day

If you are with impaired kidney or
liver function.
_-Taking another medicines _
Please talk to your doctor or pharmacist,
if you are taking these medicines:

if you are taking blood thinning drugs
(anticoagulants e.g. warfarin) and you
need to take a pain reliever on a daily
basis

If you have recently taken any other
medicines, including medicines
obtained without prescription.
_Pregnancy and breast-feeding _
Use in pregnancy:

Considered to be the analgesic of
choice in pregnant patients.

Although it crosses placenta,
paracetamol is considered to be safe in
normal therapeutic doses for short-
term use as a minor
analgesic/antipyretic in pregnancy.
Use in Lactation:

Excreted in breas

Scheda tecnica

FASDOL 500MG
TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Paracetamol 500mg
PRODUCT DESCRIPTION
FASDOL is a white to off-white, round tablet with “Fasdol”
debossed on one side and plain on the other side.
PHARMACODYNAMICS
Paracetamol is a centrally acting analgesic and antipyretic with
minimal anti-inflammatory properties.
Analgesic
The mechanism of analgesic action has not been fully determined.
Paracetamol may act predominantly by inhibiting prostaglandin
synthesis in the
central nervous system (specifically cyclooxygenase (COX)-2) and, to a
lesser extent, through a peripheral action by blocking pain- impulse
generation.
The peripheral action may also be due to inhibition of prostaglandin
synthesis or to inhibition of the synthesis or actions of other
substances that
sensitize pain receptors to mechanical or chemical stimulation
Antipyretic
Paracetamol
act centrally
on
the
hypothalamic
heat-regulating
center to
produce
peripheral vasodilatation resulting in increased blood flow
through the skin, sweating and heat loss. Paracetamol reduces fever by
inhibiting the formulation and release of prostaglandins in the CNS
and by
inhibiting endogenous pyrogens at the hypothalamic thermoregulator
center.
PHARMACOKINETICS
Following oral administration paracetamol is rapidly absorbed.
Paracetamol absorption takes place mainly in the small intestine and
therefore the rate of absorption is depending on the rate of gastric
emptying.
It
has
been
shown
that
drugs
which delay gastric emptying also delay the absorption of paracetamol
whereas metoclopramide (a drug which
increases the rate of gastric emptying) accelerates absorption of the
analgesic through the total amount absorbed doses not increase.
The presence of food in the stomach has also been reported to reduce
the rate of absorption of paracetamol. Alterations in gastric pH have
no
appreciable effect on paracetamol absorption. During absorption, the
amount of paracetamol which is inactivated is negligible and it has
been shown
that
paracetamol
dose
not
affect
gast