SANBEACETIN 600 (Acetylcysteine Effervescent Tablet)

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

Acetylcysteine

Tillgänglig från:

MEDISPEC (M) SDN.BHD

INN (International namn):

Acetylcysteine

Enheter i paketet:

10tablet Tablets

Tillverkad av:

PT Caprifarmindo Laboratories

Bipacksedel

SANBEACETIN
®
600
Acetylcysteine (600 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_SANBEACETIN_
_®_
_600 _
is used
for
2.
How
_SANBEACETIN _
_®_
_600 _
works
3.
Before you use
_SANBEACETI _
_®_
_600 _
4.
How to use
_SANBEACETIN_
_®_
_600 _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_SANBEACETIN_
_®_
_600_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _SANBEACETIN_
_®_
_600 _IS USED FOR
SANBEACETIN is used for treatment of
respiratory affections characterized by a
lot of thick and viscous secretions: acute
bronchitis,
chronic
bronchitis
(inflammation of the airways that carry
air to your lungs) and its exacerbations
(worsening);
pulmonary
emphysema
(damages to the air sacs (alveoli) in your
lungs), mucoviscidosis (abnormal mucus
production in lungs) and bronchieactasis
(abnormal widening of airways).
HOW _SANBEACETIN_
_®_
_600 _WORKS
Acetylcysteine has strong fluidification
activity to mucus and pus secretion It
acts
by
reduces
inflammation
and
increase mucosa regeneration speed.
BEFORE YOU USE _SANBEACETIN_
_®_
_600 _
_When you must not use it _
•
You are allergic to
_ _
_SANBEACETIN_
_®_
_600 _
•
You are allergic to any of the
other ingredients of
_ _
_SANBEACETIN _
_®_
_600 _
•
You are children below two (2)
years of age
_ _
If any of the above applies to you, talk to
your doctor or pharmacist.
_ _
_ _
_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.
-
_Taking 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 _SANBEACETIN_
_�

Produktens egenskaper

®
SANBEACETIN 600
ACETYLCYSTEINE
Effervescent Tablet
COMPOSITION
Each effervescent tablet contains:
Acetylcysteine ………...........................….......…….
600 mg
PRODUCT DESCRIPTION
®
SANBEACETIN 600
(Acetylcysteine Effervescent
Tablet) is a round flat tablet, the colour is white with
yellow spot and has orange odour. After dissolved in
200 mL, the solution is rather turbid, colourless and has
orange odour with sweet-sour taste.
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 flogistic
and increase mucose 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
®
SANBEACETIN 600
(Acetylcysteine Effervescent
Tablet) is indicated in the treatment of respiratory
affections characterized by thick and viscous hyper-
secretions:
•
acute bronchitis
•
chronic bronchitis and its exacerbations
•
pulmonary emphysema
•
mucoviscidosis
•
bronchieactasis.
RECOMMENDED DOSAGE
Adults:
®
1 effervescent tablet of
SANBEACETIN 600
a day
(preferably in the evening).
DIRECTIONS FOR USE
Dissolve 1 effervescent tablet into a glass of water (±
200 mL).
ROUTE OF ADMINISTRATION
Oral.
CONTRA-INDICATIONS
Patients with hypersensitivity to Acetylcysteine.
Contraindicated in children below two (2) years of age.
WARNING AND PRECAUTIONS
Patient with gastric, should be administered after food.
Several animal and human researches showed no
teratogenic and dangerou