SmectaGo 3g Oral Suspension In Sachet

Country: Malaysia

Language: English

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

Active ingredient:

Diosmectite

Available from:

EP PLUS GROUP SDN. BHD.

INN (International Name):

Diosmectite

Units in package:

12 Sachets

Manufactured by:

PHARMATIS

Patient Information leaflet

Consumer Medication Information Leaflet (RiMUP) SMECTAGO
®
ORAL SUSPENSION IN SACHET DIOCTAHEDRAL SMECTITE 3G
WHAT IS IN THIS LEAFLET:
•
What SMECTAGO
®
is used for
•
How SMECTAGO
®
works
•
Before you take SMECTAGO
®
•
How to take SMECTAGO
®
•
While you are taking SMECTAGO
®
•
Side effects
•
Storage and Disposal of
SMECTAGO
®
•
Product description
•
Manufacturer and Product Registration
Holder
•
Date of Revision
WHAT SMECTAGO
® IS USED FOR
•
Treatment of acute diarrhoea in
adults
and
children
above
2
years,
in
addition
to
oral
rehydration
•
Symptomatic
treatment
of
chronic diarrhoea.
•
Symptomatic
treatment
of
pain
associated with functional bowel
disease in adults.
HOW SMECTAGO
® WORKS
The
active
substance
contained
in
SMECTAGO
®
is
dioctahedral
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,
SMECTAGO
®
increases
the
resistance of the mucosal gel in response
to
aggressive
agents.
SMECTAGO
®
is
neither absorbed nor metabolized.
BEFORE YOU TAKE SMECTAGO®
_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/ somaltase deficiency
•
In infants and children below 2 years,
the use of SMECTAGO
®
should be
avoided.
•
The chronic use of SMECTAGO
®
should be avoided.
•
SMECTAGO® is not recommended
during pregnancy and breastfeeding
_ _
_Before you start to take it _
•
Please consult your doctor.
_ _
_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 SMECTAGO
®
_How much to take_
Treatment of Acute Diarrhoea
•
In children from 2 years of age:
•
4 sachets per day for 3 days, then
2 sachets per day for 4

Summary of Product characteristics

PACKAGE INSERT
INFORMATION ABOUT THIS MEDICINE
NAME:
SMECTAGO
®
3g, oral suspension in sachet.
COMPOSITION:
Active substance is:
Diosmectite……3 g in each sachet.
EXCIPIENTS:
Caramel cocoa flavour, ascorbic acid, citric acid monohydrate, xanthan
gum,
potassium sorbate (as preservative 0.1%w/w) and sucralose.
PHARMACEUTICAL FORM AND PACK SIZE
Ready to use oral suspension.
Box of 12 sachets.
DESCRIPTION
SMECTAGO
®
is
a
beige
to
light
beige
homogeneous
suspension
with
a
characteristic odour of caramel.
PHARMACO-THERAPEUTIC CLASSIFICATION
Antidiarrheal
Gastro-intestinal protectant
(A: Alimentary tract and metabolism)
Pharmacotherapeutic class: OTHER INTESTINAL ADSORBENTS. ATC code:
A07BC05(A: Digestive tract and metabolism).
PHARMACODYNAMIC PROPERTIES:
Due to its leaflet structure and its high plastic viscosity, SMECTAGO
®
possesses
a powerful coating property on the gastrointestinal mucosa. By
interacting with
glycoprotein of mucus, SMECTAGO
®
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, SMECTAGO
®
protects the gastrointestinal
mucosa. SMECTAGO
®
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 dioctahedral smectite (active ingredient),
SMECTAGO
®
is neither absorbed nor metabolized.
INDICATIONS
•
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 disease
in adults.
CONTRAINDICATIONS
Hypersensitivity to diosmectite or to one of the excipients.
SPECIAL WARNINGS AND PRECAUTIONS
Diosmectite must be used with care in patients with a history of
severe chronic
constipation. In infants and children below 2 years, the use of
SMECTAGO
®
should
be avoided. The reference treatment in acute di