Rabeprazole-Asteria tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

rabeprazole (rabeprazole sodium)

Available from:

Hankook Korus Pharm Co.

ATC code:

A02BC04

INN (International Name):

rabeprazole (rabeprazole sodium)

Dosage:

20mg

Pharmaceutical form:

tablets film-coated

Units in package:

(10/1x10/), in blister and (100/10x10/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-12-17

Patient Information leaflet

To be prescribed
ATC Code : A02BC04
[COMPOSITION]
* Rabeprazole-Asteria film coated tablet 10mg
_EACH TABLET CONTAINS_
_ACTIVE INGREDIENT: _
Rabeprazole sodium
------------------------------------------------------------- 10mg
_INACTIVE INGREDIENT:_
D-mannitol, Magnesium oxide,
Magnesium stearate, Iron oxide,Hypromellose phtalate 200731,
Polyethylene glycol 6000,Talc,Hypromellose 2910,
Titanum dioxide, Sodium hydroxide, Carboxymethylcellulose calcium, Low
substituted Hydroxypropyl cellulose,
Hydroxypropylcellulose
* Rabeprazole-Asteria film coated tablet 20mg
_EACH TABLET CONTAINS_
_ACTIVE INGREDIENT: _
Rabeprazole sodium
------------------------------------------------------------- 20mg
_INACTIVE INGREDIENT:_
D-mannitol, Magnesium oxide, Hyproxypropylcellulose, Low-substituted
hydroxypropylcellulose, Magnesium stearate, Sodium
hydroxide,
Hypromellose phthalate 200731, Polyethylene glycol 6000, Talc,
Hydroxypropylmethylcellulose 2910, Titanium dioxide,
Iron oxide
[INDICATION]
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
[DOSAGE AND ADMINISTRATION]
_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 20mg 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
within six weeks. However again a few patients may require an
additional
six weeks of therapy to achieve healing.
Erosive or Ulcer

Summary of Product characteristics

Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Rabeprazole-Asteria Tab. 20mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/Tab.
Use
1
Rabeprazole sodium
20.0 mg
Active ingredient
Excipient(s)
No.
Chemical Name
Quantity/Tab.
Use
1
D-mannitol
35.0mg
Inactive
2
Magnesium oxide
62.0 mg
Inactive
3
Hydroxypropylcellulose
10.0 mg
Binder
4
Low-substituted Hydroxypropyl
cellulose
19.50mg
Dissolvent
5
Magnesium stearate
1.5 mg
Lubricant
6
Hydroxypropylcellulose
4.0 mg
Enteric agent
7
Sodium hydroxide
q.s
pH Control
8
Hypromellose phthalate 200731
16.36 mg
Enteric agent
9
Polyethylene glycol 6000
1.12 mg
Enteric agent
10
Talc
0.82 mg
Enteric agent
11
Hydroxypropyl methylcellulose
2910
3.02 mg
Enteric agent
12
Titanium dioxide
0.60 mg
Enteric agent
13
Iron oxide
q.s
Stain
3. PHARMACEUTICAL FORM
Film coated Tablets
Summary of Product Characteristics
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
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
4.2 Posology and method of administration
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 20mg 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 within six weeks. However again a few
patients may require an
additional six weeks of therapy to achieve healing.
Erosive or Ulcerative Gastro