Zulbex tablets gastro-resistant

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

rabeprazole (rabeprazole sodium)

Available from:

KRKA d.d.

ATC code:

A02BC04

INN (International Name):

rabeprazole (rabeprazole sodium)

Dosage:

20mg

Pharmaceutical form:

tablets gastro-resistant

Units in package:

(28/2x14/) in blister, (56/4x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-10-14

Summary of Product characteristics

Summary of product characteristics
CONFIDENTIAL
Zulbex gastro-resistant tablets 10 mg, 20 mg
MODULE 1
VOL: 1; P: 25 / 271
1.3.1
Rabeprazole sodium
SPC, Labeling and Package Leaflet
AM
SmPCPIL137288_1
05.09.2019 – Updated: 05.09.2019
Page 1 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Zulbex
®
10 mg gastro-resistant tablets
Zulbex
®
20 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zulbex 10 mg gastro-resistant tablets
Each gastro-resistant tablet contains 10 mg rabeprazole sodium
equivalent to 9.42 mg rabeprazole.
Zulbex 20 mg gastro-resistant tablets
Each gastro-resistant tablet contains 20 mg rabeprazole sodium
equivalent to 18.85 mg rabeprazole.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet
10 mg gastro-resistant tablets are round, biconvex, orange pink film
coated tablets with bevel edges.
20 mg gastro-resistant tablets are round, biconvex, slightly brownish
yellow film coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zulbex tablets are indicated for the treatment of:
Active duodenal ulcer
Active benign gastric ulcer
Symptomatic erosive or ulcerative gastro-oesophageal reflux disease
(GORD)
Gastro-oesophageal reflux disease long-term management (GORD
maintenance)
Symptomatic treatment of moderate to very severe gastro-oesophageal
reflux disease
(symptomatic GORD)
Zollinger-Ellison syndrome
In combination with appropriate antibacterial therapeutic regimens for
the eradication of
_Helicobacter pylori_ in patients with peptic ulcer disease. See
section 4.2.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults/elderly:
_Active duodenal ulcer and active benign gastric ulcer: _The
recommended oral dose for both active
duodenal ulcer and active benign gastric ulcer is 20 mg to be taken
once daily in the morning.
Most patients with active duodenal ulcer heal within four weeks.
However, a few patients may require
an additional four weeks of therapy to achieve healing. Most patients
with active benign gastric ulcer
heal wi