Controloc tablets gastro-resistant film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

pantoprazole (pantoprazole sodium sesquihydrate)

Available from:

Takeda GmbH

ATC code:

A02BC02

INN (International Name):

pantoprazole (pantoprazole sodium sesquihydrate)

Dosage:

20mg

Pharmaceutical form:

tablets gastro-resistant film-coated

Units in package:

(14/1x14/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2022-05-16

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
CONTROLOC
®
TRADE NAME:
Controloc
®
INTERNATIONAL NON-PROPRIETARY NAME (INN):
pantoprazole
DOSAGE FORM:
tablets gastro-resistant film-coated
COMPOSITION
Each tablet 20 mg contains
_CORE _
_Active substance: _
pantoprazole sodium sesquihydrate 22.57 mg equivalent to pantoprazole
20
mg.
_Excipients: _
anhydrous sodium carbonate 5.00 mg; mannitol 21.33 mg; crospovidone
25.00 mg;
povidone К90 2.00 mg; calcium stearate 1.60 mg; purified water 4.50
mg;
_COATING _
Hypromellose-2910 11.88 mg; povidone К25 0.24 mg; titanium dioxide Е
171 0.21 mg; colorant
yellow iron oxide Е 172 0.02 mg; propylene glycol 2.66 mg; dispersion
of a copolymer of
methacrylic acid and ethyl acrylate [1: 1] * 8.18 mg; triethyl citrate
0.82 mg.
* Composition of 30% dispersion of a copolymer of methacrylic acid and
ethyl acrylate [1: 1]:
methacrylic acid and ethyl acrylate copolymer [1: 1] 7.94 mg;
polysorbate 80 0.18 mg; sodium
lauryl sulfate 0.06 mg;
OPACODE S-1-16530 BROWN PRINTING INK:
shellac 0,036 mg; colorant iron oxide (Е172) red
0,009 mg; colorant iron oxide (Е172) black 0,009 mg; colorant iron
oxide (Е172) yellow 0,0009
mg; ammonia solution concentrated 25% 0,001 mg.
IDENTIFICATION
Oval biconvex, yellow film-coated tablet with a white to off-white
core and with brown ink
imprinting "P20" on one side.
PHARMACOTHERAPEUTIC
GROUP:
gastric
gland
secretion
suppressing
agents
–
proton
pump
inhibitors
ATC CODE
: А02ВС02
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
Proton pump inhibitor (Н+ K+ ATPase). Blocks the terminal stage of
hydrochloric acid secretion
irrespective of the irritant nature.
Pantoprazole is a substituted benzimidazole which inhibits the
secretion of hydrochloric acid in
the stomach by specific blockade of the proton pumps of the parietal
cells.
Pantoprazole is converted to its active form in the acidic environment
in the parietal cells where
it inhibits the H+ K+ ATPase enzyme activity, i.e. blocks the final
stage in the production of
hydrochloric acid in the stomach. The inhibi