Controloc

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

pantoprazole (pantoprazole sodium sesquihydrate)

Available from:

Takeda GmbH

INN (International Name):

pantoprazole (pantoprazole sodium sesquihydrate)

Dosage:

40mg

Pharmaceutical form:

tablets gastro-resistant

Prescription type:

Prescription

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
CONTROLOC
®
REGISTRATION NUMBER:
TRADE NAME: Controloc
®
INTERNATIONAL NON-PROPRIETARY NAME (INN): pantoprazole
DOSAGE FORM: gastro-resistant tablets
COMPOSITION
Each tablet 40 mg contains
_CORE _
_Active substance: _ pantoprazole sodium sesquihydrate 45.10 mg
equivalent to pantoprazole 40
mg.
_Excipients:_ anhydrous sodium carbonate 10.00 mg; mannitol 42.70 mg;
crospovidone 50.00 mg;
povidone К90 4.00 mg; calcium stearate 3.20 mg; purified water 9.00
mg;
_COATING _
Hypromellose-2910 19.00 mg; povidone К25 0.38 mg; titanium dioxide Е
171 0.34 mg; colorant
yellow iron oxide Е 172 0.03 mg; propylene glycol 4.25 mg; Eudragit L
30D-55* 14.56 mg;
triethyl citrate 1.45 mg.
*Eudragit L 30D-55 Suspension composition: Eudragit L 30D-55
(methacrylic acid and ethyl
acrylate copolymer [1:1]) 14.13 mg; polysorbate 80 0.33 mg; sodium
lauryl sulfate 0.10 mg;
OPACODE S-1-16530 BROWN PRINTING INK FOR LABELING TABLETS: 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 tablets with a white to off-white
core and with brown ink
imprinting "P40" 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 inhibition of activity is
dose-dependent and in result both
b