Smecta Strawberry Flavour Powder for Oral Suspension 3g

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:

BEAUFOUR IPSEN INDUSTRIE

Patient Information leaflet

_ Consumer Medication Information Leaflet (RiMUP) _
SMECTA
®
3 G STRAWBERRY, POWDER FOR ORAL
SUSPENSION IN SACHET
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/ somaltase 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 SMECT

Summary of Product characteristics

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rev2 - smecta strawberry leaflet _MAM 29/10/19