MUCOSTOP 600mg Effervescent Tablet
Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIL active_ingredient:
Acetylcysteine
MAH:
MEDISPEC (M) SDN.BHD
INN:
Acetylcysteine
units_in_package:
10 Tablets
manufactured_by:
Neutec Ilac Sanayi Ticaret A.S.
PIL
MUCOSTOP 600 MG EFFERVESCENT TABLET
Acetylcysteine (600 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
MUCOSTOP_ _
is used for
2.
How
MUCOSTOP
works
3.
Before you use
MUCOSTOP
4.
How to use
MUCOSTOP
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
MUCOSTOP
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MUCOSTOP
IS USED FOR
MUCOSTOP
is
used
for
treatment
of
respiratory diseases which leads to the
formation
of
a
lot
of
thick
secretions
which are difficult to be coughed out
such
as
acute
and
chronic
bronchitis
(inflammation of the airways that carry
air to your lungs), inflammation of the
throat, sinus and trachea, flu infection,
asthma and mucoviscidosis (abnormal
mucus production in lungs).
HOW MUCOSTOP WORKS
Acetylcysteine has strong fluidification
activity to mucus and pus secretion. It
acts
by
reducing
inflammation
and
increasing mucosa regeneration speed.
BEFORE YOU USE MUCOSTOP
-
_When you must not use it _
DO NOT USE MUCOSTOP IN THE
FOLLOWING SITUATIONS:
•
If you are allergic to acetylcysteine
or any of the other ingredients of
MUCOSTOP
•
In children below 2 years old
•
If
you
are
suffering
from
phenylketonuria
•
If you have an active peptic ulcer.
_ _
_Pregnancy and lactation _
•
Pregnancy category B.
•
Not known whether acetylcysteine is
distributed into milk.
_ _
•
Ask your doctor or pharmacist for
advice before taking any medicine.
-
_Before you start to use it _
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health food
shop. Please also inform your doctor if
you have asthma.
-
_Taking _
_MUCOSTOP _
_with _
_other _
_medicines _
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
HOW TO USE MUCOSTOP
-
_How much to use _
Adults:
1 effervescent tablet a day (preferably
in the evening)
-
_Whe
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SPC
MUCOSTOP 600 MG EFFERVESCENT TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each effervescent tablet contains 600mg Acetylcysteine
PRODUCT DESCRIPTION
White, round, flat-faced tablets.
Appearance of solution should be clear after dissolving in water.
PHARMACODYNAMICS
Acetylcysteine
has
strong
fluidification
activity
to
mucus
secretion
and
mucopurulent
by
depolimerization of mucoprotein acid complex and nucleic acid were as
act as viscosity agent from
mucoid component, sputum purulenta and others secretions, it acts as
anti fiogistic and increase mucosa
regeneration speed.
PHARMACOKINETICS
_Absorption _
Bioavailability
Absorbed following oral administration, with peak plasma concentration
achieved within 1 – 2 hours.
Absorbed from the pulmonary ephitelium.
_Distribution _
Extent: Crosses the placenta following oral or IV administration
Plasma protein binding: 50 – 83%
_Metabolism _
Deacetylated in the liver to cysteine
_Elimination _
Elimination route: Principally (70%) nonrenal
Half – life: 6.25 hours after oral administration
INDICATIONS
All respiratory tract diseases leading to the formation of thick
secretions difficult to be expectorated, such
as acute and chronic bronchitis, laryngitis, sinusitis, tracheitis,
influenza, bronchial asthma and (as
complementary treatment) mucoviscidosis.
RECOMMENDED DOSAGE
Adults:
1 effervescent tablet a day (preferably in the evening).
Dissolve in water before administration.
ROUTE OF ADMINISTRATION
: Oral; Dissolve the effervescent tablet in a glass of water before
consuming.
CONTRA-INDICATIONS
Patients with hypersensitivity to Acetylcysteine.
Contraindicated in children below two (2) years of age.
As Mucostop 600mg Effervescent Tablet contains aspartame, it is
contraindicated in patients suffering
from
phenylketonuria.
Active peptic ulcer.
WARNING AND PRECAUTIONS:
Unsuitable for phenylketonurics.
Patient with gastric, should be administered after food.
Several animal and human researches showed no teratogenic and
dangerous adverse effect to pregnant
and nursing patient,
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