PROSOGAN FD

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Active ingredient:

LANSOPRAZOLE

Available from:

TAKEDA INDONESIA - Indonesia

INN (International Name):

LANSOPRAZOLE

Dosage:

15 MG

Pharmaceutical form:

TABLET

Units in package:

DUS, 1000 BLISTER @ 14 TABLET

Manufactured by:

KOKANDO Co Ltd - Japan

Authorization date:

2019-04-16

Summary of Product characteristics

PROSOGAN
® FD TABLET
LANSOPRAZOLE 15 and 30 mg
1
NAME OF THE MEDICINAL PRODUCT
PROSOGAN
®
FD Tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
Prosogan FD Tablet 15 mg
Each tablet contains 15 mg Lansoprazole.
2.2
Prosogan FD tablet 30 mg
Each tablet contains 30 mg Lansoprazole.
3
PHARMACEUTICAL FORM
3.1
Prosogan FD tablet 15 mg are white to yellowish-white uncoated tablet
speckled with red-
orange to dark brown, with “15” debossed on one side of the
tablet.
3.2
Prosogan FD tablet 30 mg are white to yellowish-white uncoated tablet
speckled with red-
orange to dark brown, with “30” debossed on one side of the
tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Duodenal ulcer.
-
Benign gastric ulcer.
-
Reflux esophagitis.
-
Treatment of NSAID-associated gastric ulcer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage :
-
Duodenal ulcer : Prosogan FD tablet 30 mg once daily for 4 weeks.
-
Benign gastric ulcer : Prosogan FD tablet 30 mg once daily for 8
weeks.
-
Reflux esophagitis : Prosogan FD tablet 30 mg once daily for 4 weeks.
-
Treatment of NSAID-associated gastric ulcer : Prosogan FD tablet 30 mg
once daily for 8
weeks.
Administration :
For oral administration
Page 1 of 7
DISETUJUI OLEH BPOM : 22/03/2021
ID REG : EREG10023512000109
Prosogan FD tablet should be placed on the tongue and gently sucked.
The tablet rapidly
disperses in the mouth, releasing the gastro-resistant microgranules
which are swallowed with
the patient’s saliva. Alternatively, the tablet can be swallowed
whole with a drink of water.
The tablets should not be crushed or chewed.
To achieve the optimal acid inhibitory effect, and hence most rapid
healing and symptom relief,
once daily should be administered in the morning before food.
Alternatively, for other patients who have difficulty swallowing
tablets, Prosogan FD tablet can
be delivered in different way :
Nasogastric tube administration
For administration via a nasogastric tube, Prosogan FD tablet can be
administered as follow :
-
Place a 15 mg tablet in a syringe a