Stenac Granules 200 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Acetylcysteine

Boleh didapati daripada:

APEX PHARMACY MARKETING SDN. BHD.

INN (Nama Antarabangsa):

Acetylcysteine

Unit dalam pakej:

3 gm

Dikeluarkan oleh:

U-Liang Pharmaceutical Co., Ltd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
STENAC GRANULES
_ _
Acetylcysteine (100mg, 200mg)
1
WHAT IS IN THIS LEAFLET
1. What Stenac is used for
2. How Stenac works
3. Before you use Stenac
4. How to use Stenac
5. While you are using it
6. Side effects
7. Storage and Disposal of
Stenac
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT STENAC IS USED FOR
Stenac Granules are used:
-
to
reduce
the
thickness
of
secretions from the respiratory
tract
- as adjuvant therapy in chronic
lung disease.
HOW STENAC WORKS
Acetylcysteine belongs to a
group of medicines called
mucolytic which work by
thinning the mucus (phlegm)
so that it can be coughed up
more easily.
Before you use Stenac
_-When you must not use it _

You are allergic
(hypersensitive) to
acetylcysteine or any of
the other ingredients of
this medicine.

Your child is under 2
years of age.
_-Before you start to use it _
Talk to your doctor or
pharmacist before taking
Stenac if:

You suffer from asthma.
You may need to be
monitored closely while
taking this medication.

Risk of gastrointestinal
bleeding (eg: in
stomach/intestinal ulcer
or swollen veins of
esophagus), as oral
acetylcysteine may
induce vomiting.

Intolerance to histamine.
_-Taking other medications _
Activated charcoal should be
avoided in the treatment of
acetaminophen since they may
decrease the absorption of
orally administered
acetylcysteine.
HOW TO USE STENAC
_-How much to use _

Dissolve the content of
one sachet into a glass of
cold or warm water.

Adults & adolescents
over to 12 years of age:
600 mg daily, divided
into one or more intakes
(e.g. 200 mg 3 times
daily).

Children from 2 to 12
years of age: 100 mg 3
times daily or 200 mg
twice daily.

Long-term treatment:
400- 600 mg daily,
divided into one or more
intakes

_Mucoviscidosis _
(genetic
disorder): the same
dosage as above,
however, for children
from 6 years of age,
200mg 3 times daily or
600mg once daily.
_-When to use it _
Use as directed by your

Ciri produk

STENAC GRANULES 200 MG
FORMULATION:
Each sachet contains 200mg of Acetylcysteine.
PRODUCT DESCRIPTION:
Orange granules with orange flavor. Place 1 sachet in 100 mL of hot
water, and stir
until the granules dissolve completely. The color of solution is light
orange and
clear.
PHARMACODYNAMICS AND PHARMACOKINETICS:
The N-acetylcysteine (NAC) is the N-acetyl derivative of the naturally
occurring
amino acid I-cysteine. NAC has an intense fluidifying action, through
its free
sulfydryl
group,
on
the
mucoid
or
mucopurulent
secretions
by
cleaving
the
intramolecular and intermolecular disulfide bonds in glycoprotein
aggregates.
NAC is stable in simulated gastric and intestinal fluid, is rapidly
absorbed after oral
administration, and distributed to body tissues including the lung.
Acute toxicity, chronic toxicity, teratology and reproduction studies
support oral
NAC
safety.
Coagulation
parameters,
platelet
aggregation,
immunoglobulins
(serum
and
sputum
lgA), hematological, hepatic
and
renal
laboratory
indices
remained unchanged after oral NAC 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:
Usual posology for acute diseases
Adults: 600 mg daily, divided into one or more administrations (e.g.
200 mg sachets
3 times daily).
Adolescents over 12 years of age: 600 mg daily, divided into one or
more
administrations (e.g. 200 mg sachets 3 times daily).
Children from 2 to 12 years of age: one 100 mg sachet 3 times daily or
200 mg twice
daily.
Special posologies
Long-term treatment: 400-600 mg daily, divided into one or more
administrations,
with a maximum treatment duration of 3 - 6 months.
If the excessive mucus production and the consequent cough do not
disappear after a
two-week treatment, the diagnosis should be re-evaluated in order to
exclude a
possible malignant disease o