Acetylcysteine Sandoz Effervescent Tablet 200mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Acetylcysteine

Boleh didapati daripada:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

Acetylcysteine

Unit dalam pakej:

100sachet Sachets; 50sachet Sachets; 20sachet Sachets

Dikeluarkan oleh:

Hermes Pharma GmbH

Risalah maklumat

ACETYLCYSTEINE SANDOZ EFFERVESCENT TABLET
Acetylcysteine (200 mg and 600 mg)
1
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What is Acetylcysteine Sandoz
used for
2.
How Acetylcysteine Sandoz
works
3.
Before you use Acetylcysteine
Sandoz
4.
How to use Acetylcysteine
Sandoz
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Acetylcysteine Sandoz
8.
Product description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
WHAT IS ACETYLCYSTEINE
SANDOZ USED FOR
Acetylcysteine Sandoz is used to
reduce the thickness and secretions
from the respiratory tract.
HOW ACETYLCYSTEINE
SANDOZ WORKS
Acetylcysteine Sandoz contains
Acetylcysteine. Acetylcysteine helps
to reduce thickness of the mucus in
the respiratory tract, and has been
shown to dramatically effect in
sputum.
BEFORE YOU USE
ACETYLCYSTEINE SANDOZ
-
_When you must not use it _
•
If you are allergic (hypersensitive)
to Acetylcysteine, or to any of the
ingredients.
•
If you have inherited disorder
that causes an amino acid called
phenylalanine to build up in
your body or you are allergic to
aspartame (artificial sweetener).
•
In children under 2 years.
•
If you have severe asthma
attacks.
•
If you have chronic duodenal or
gastric ulcer disease.
-
_Before you start use it _
•
Patients with asthma should be
carefully monitored. Treatment
with acetylcysteine should be
stopped when breathing
difficulties occur. The sulfur
odour on opening the sachets
does not indicate deterioration
of the product, but is due to the
active ingredient.
•
Other medicines should not be
used with acetylcysteine
solution.
•
Caution is advised if you have
histamine intolerance.
•
Caution is advised if you need
to be on a controlled sodium
(low sodium/ low salt) diet.
•
Caution is advised to patients
who have lactose or fructose
intolerance.
•
Tell your doctor if you are
pregnant, or plan to become
pregnant or breastfeeding.
Your doctor will discuss with
you the risks and benefits
involved.
-
_Taking other me

Ciri produk

1
ACETYLCYSTEINE SANDOZ EFFERVESCENT TABLET
1.
NAME OF THE MEDICINAL PRODUCT
Acetylcysteine Sandoz Effervescent Tablet 200 mg
Acetylcysteine Sandoz Effervescent Tablet 600 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Acetylcysteine Sandoz Effervescent Tablet 200 mg
Each effervescent tablet contains 200 mg acetylcysteine.
Acetylcysteine Sandoz Effervescent Tablet 600 mg
Each effervescent tablet contains 600 mg acetylcysteine.
3.
PHARMACEUTICAL FORM
Effervescent Tablet.
Acetylcysteine Sandoz Effervescent Tablet 200 mg
White, round tablet, faultless surface, scored on one side, smell of
blackberries, with a diameter of 18 mm.
The effervescent tablet can be divided into equal doses.
Acetylcysteine Sandoz Effervescent Tablet 600 mg
White, round tablet, faultless surface, scored on one side, smell of
blackberries, with a diameter of 20 mm.
The effervescent tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTICS INDICATION
Treatment of respiratory affections characterized by thick and viscous
hypersecretions: acute or chronic bronchitis
and its exacerbations, pulmonary emphysema, mucoviscidosis and
bronchiectasis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Recommended Dosage
ACETYLCYSTEINE SANDOZ EFFERVESCENT TABLET 200 MG:
_Adult: _
_ _
_ _
200 mg three times a day
_Children >2 years: _
100 - 200 mg two times a day
ACETYLCYSTEINE SANDOZ EFFERVESCENT TABLET 600 MG:
Adult:
1 effervescent tablet daily
Duration of treatment: 5 to 10 days for acute cases.
Mode of Administration
Oral
Method of Administration
The effervescent tablets are taken dissolved in a glass of water after
meals.
4.3 CONTRAINDICATIONS
It is contraindicated
•
in patients with hypersensitivity to acetylcysteine, or any of the
excipients
•
in children under 2 years of age
•
severe asthma exacerbation
•
chronic duodenal and gastric ulcer disease
2
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The occurrence of severe skin reactions such as Stevens-Johnson
syndrome and Lyell’s syndrome has very
rarely been reported in tempo