Smecta Orange-Vanilla Flavour Powder for Oral Suspension 3g

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Diosmectite

Boleh didapati daripada:

EP PLUS GROUP SDN. BHD.

INN (Nama Antarabangsa):

Diosmectite

Unit dalam pakej:

10 Units; 12 Units; 30 Units

Dikeluarkan oleh:

BEAUFOUR IPSEN INDUSTRIE

Risalah maklumat

_ Consumer Medication Information Leaflet (RiMUP) _
SMECTA
® ORANGE-VANILLA FLAVOUR POWDER FOR ORAL
SUSPENSION 3G
DIOSMECTITE 3G
WHAT IS IN THIS LEAFLET:
•
What SMECTA
®
is used for
•
How SMECTA
®
works
•
Before you take SMECTA
®
•
How to take SMECTA
®
•
While you are taking SMECTA
®
•
Side effects
•
Storage and Disposal of SMECTA
®
•
Product description
•
Manufacturer and Product Registration
Holder
•
Date of Revision
•
Serial Number
WHAT SMECTA
® IS USED FOR
•
Treatment of acute diarrhoea in adults
and
children
above
2
years,
in
addition to oral rehydration.
•
Symptomatic
treatment
of
chronic
functional diarrhoea in adults.
•
Symptomatic
treatment
of
pain
associated
with
functional
bowel
diseases in adults
HOW SMECTA
® WORKS
The
active
substance
contained
in
SMECTA
®
is dioctaheral smectite which
belongs to a group of antidiarrheal gastro-
intestinal protectant.
The
antidiarrheal
gastro-intestinal
protectant activity is due to its powerful
coating
property
on
the
gastrointestinal
mucosa. By interacting with glycoprotein
of
mucus,
SMECTA
®
increases
the
resistance of the mucosal gel in response
to aggressive agents. SMECTA
®
is neither
absorbed nor metabolized.
BEFORE YOU TAKE SMECTA
®
_When you must not take it _
•
If
you
are
suffering
from
fructose
intolerance,
•
If you are suffering from glucose and
galactose malabsorption syndrome or
sucrose/ isomaltase deficiency.
•
In infants and children below 2 years
old, the use of SMECTA
®
should be
avoided.
•
The choric use of SMECTA
®
should
be avoided
•
SMECTA
®
is not recommended during
pregnancy and breastfeeding.
•
Hypersensitivity to diosmectite or to
one of the excipients
_ _
_Before you start to take it _
•
If you are pregnant or breast-feeding,
contact
your
doctor
before
using
SMECTA
®
.
_ _
_Taking other medicines _
It is recommended not to take any other
drugs at the same time. Please tell your
doctor or pharmacist if you are taking any
prescription
and
non-prescription
medications.
HOW TO TAKE SMEC

Ciri produk

Before you take the medicine, please read
this leaflet carefully till the end as it contains
important information. If there is anything that
you do not understand or if you need further
information or advice, you should consult your
pharmacist or doctor who will have further
details.
INFORMATION ABOUT THIS MEDICINE
Name:
SMECTA
®
Orange Vanilla Powder for oral
suspension 3 g.
Composition:
Active substance is:
Diosmectite…………………….....……3 g in each sachet.
Excipients:
Glucose monohydrate, saccharine sodium, orange-
vanilla flavor (containing sucrose).
Contains ethanol 0.00798% w/w.
Pharmaceutical Form and Pack Size
Powder for oral suspension.
Box of 10, 12 or 30 sachets.
Description
SMECTA
®
is packed in soft, flat sachet. The product
is presented as greyish-white to ochre powder,
with slightly reminiscent odour of orange when
preparing the oral suspension for use.
Pharmaco-therapeutic Classification
Antidiarrhoeal
Gastro-intestinal protectant
(A: Alimentary tract and metabolism)
Pharmacodynamic Properties
Due to its leaflet structure and its high plastic
viscosity, SMECTA
®
possesses a powerful
coating property on the gastrointestinal mucosa.
By interacting with glycoprotein of mucus,
SMECTA
®
increases the resistance of the mucosal
gel in response to aggressive agents. By its action
on the gastrointestinal mucous barrier and its
high binding capacity, SMECTA
®
protects the
gastrointestinal mucosa. SMECTA
®
is radiolucent,
does not colour the stools and, at usual doses, does
not modify the physiological intestinal transit time.
Pharmacokinetic Properties
According to structure of diosmectite (active
ingredient), SMECTA
®
is neither absorbed nor
metabolised.
WHAT IS THE MEDICINE USED FOR
• Treatment of acute diarrhoea in adults and
children above 2 years, in addition to oral
rehydration
• Symptomatic treatment of chronic functional
diarrhoea in adults
• Symptomatic treatment of pain associated with
functional bowel diseases in adults
WHAT YOU SHOULD KNOW BEFORE TAKING
THE MEDICINE