FOTAGEL SUSPENSION 3g20ml (DIOCTAHEDRAL SMECTITE)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Diosmectite

Boleh didapati daripada:

IMEKS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

Diosmectite

Unit dalam pakej:

20 ml

Dikeluarkan oleh:

DAEWON PHARM CO LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FOTAGEL SUSPENSION 3G/20ML
Dioctahedral smectite (3g/20ml)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Fotagel is used for
2.
How Fotagel works
3.
Before you use Fotagel
4.
How to use Fotagel
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Fotagel
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT FOTAGEL IS USED FOR
Fotagel is used for:
• Acute and chronic diarrhoea.
• Pain related to inflammation in digestive
system
including
oesophagitis
and
colic
disease.
HOW FOTAGEL WORKS
Diosmectite works by binding toxin, bacteria
and
viruses
and
reinforces
the
intestinal
mucus
barrier
to
shorten
duration
and
reduces frequency of diarrhoea in children
and adults. Diosmectite is not absorbed and it
is eliminated through the faeces.
BEFORE YOU USE FOTAGEL _ _
-
_When you must not use it_
• In infants and children below 2 years old.
• When constipation is worsened.
• If you are hypersensitive to diosmectite or
any other excipients of Fotagel.
-
_Before you start to use it _
Tell your doctor if you:
• Are taking any other medicine at the same
time.
• Are pregnant or breastfeeding.
_If you are not sure whether you should start _
_taking this product, consult your doctor. _
-
_Taking other medicines _
Inform your doctor or pharmacist if you are
taking or if you have recently taken any other
medicines,
including
medicines
obtained
without a prescription such as supplements or
traditional medicines.
The
absorbent
properties
of
Fotagel
may
affect the efficacy of other medicines. It is
recommended
not
to
take
any
other
medicines at the same time.
_Pregnancy and lactation_
Fotagel
is
not
recommended
to
be
used
during pregnancy or breastfeeding.
HOW TO USE FOTAGEL
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure.
-
_How much to use_
_TREATMENT OF ACUTE DIARRHOEA: _
In children >2 years old:
4 pouches a day for 3 days, then 2 pou

Ciri produk

디자인 사양(시방서)
제품명
포타겔 설명서-말레이시아
(진천)
작성자/ 신규 작성일
이규왕 / 2022.07.18
규격(장폭고)(mm)
120 x 230 (mm)
개정번호/개정일자
V.0000 / 2022.07.18
컬러
단면 1도
먹
개정내용
신규
재질/용지/원단
(단위)
모조지 70g
코팅/ 후가공
-
특이사항
코드번호 : 0099
[COMPOSITION]
Each
20mL
pouch
contains
3g
of
dioctahedral
smectite.
Other ingredients : D-sorbitol solution, Concentrated
glycerin, Melon Flavor SJ-AD (1501025), Vanilla
flavor #V-21011, Potassium dihydrogen phosphate,
Xanthan Gum, Purified water
Preservatives :
·
Methylparaben ................................... 0.001 % w/v
·
Propylparaben .................................... 0.009 % w/v
[DESCRIPTION]
Vanilla and melon-flavored light-brown suspension
contained in a Al-foil pouch.
[PHARMACODYNAMICS]
Diosmectite
(dioctahedral
smectite)
is
a
natural
aluminomagnesium silicate taking the form of layers
of
fine
sheet.
It
possesses
a
powerful
coating
property on the gastrointestinal mucosa due to its
leaflet
structure
and
its
high
plastic
viscosity.
Diosmectite increases the resistance of the mucosal
gel in response to aggressive agents, by interacting
with glycoproteins of mucus. Due to its action on
the gastrointestinal mucous barrier and its high-
binding
capacity,
diosmectite
protects
the
gastrointestinal mucosa. It is radiolucent and does
not colour the stools. At usual doses, does not
modify the physiological intestinal transit time.
[PHARMACOKINETICS]
Diosmectite is not absorbed and it is eliminated
through the faeces.
[INDICATIONS]
·
Acute and chronic diarrhoea.
·
Symptomatic treatment of pain associated with
oesogastroduodenal and colic disease.
[RECOMMENDED DOSAGE]
Treatment of Acute Diarrhoea
Children :
·
2 year and older: 4 pouches a day for 3 days,
then 2 pouches per day (up to total maximum of
7 days)
Adults :
·
An average of 3 pouches per day. In practice the
daily dosage can be doubled at the beginning of
the treatment.
Other Indications :
Childre