Emanera capsules gastro-resistant

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

esomeprazole (esomeprazole magnesium)

Available from:

KRKA d.d.

ATC code:

A02BC05

INN (International Name):

esomeprazole (esomeprazole magnesium)

Dosage:

40mg

Pharmaceutical form:

capsules gastro-resistant

Units in package:

(7/1x7/) in blister, (14/2x7/) in blister, (15/3x5/) in blister, (28/4x7/) in blister, (30/3x10/) in blister, (56/8x7/) in blister, (60/6x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-02-07

Summary of Product characteristics

1.3.1
Esomeprazole
SPC, Labeling and Package Leaflet
AM
SmPCPIL152567_3
03.07.2020 – Updated: 30.11.2020
Page 1 of 15
1.
NAME OF THE MEDICINAL PRODUCT
Emanera
®
20 mg gastro-resistant capsules
Emanera
®
40 mg gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Emanera 20 mg gastro-resistant capsules
Each gastro-resistant capsule, contains 20 mg esomeprazole (as
esomeprazole magnesium).
Emanera 40 mg gastro-resistant capsules
Each gastro-resistant capsule, contains 40 mg esomeprazole (as
esomeprazole magnesium).
Excipient:
20 mg gastro-resistant
capsules
40 mg gastro-resistant
capsules
sucrose
28,464–32,556 mg
56,928–65,111 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant capsule.
20 mg:
The body and the cap of the capsule are slightly pink. The capsules
are filled with white to almost
white pellets.
40 mg:
The body and the cap of the capsule are almost pink. The capsules are
filled with white to almost
white pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Emanera capsules are indicated in adults for:
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
-
treatment of erosive reflux esophagitis
-
long-term management of patients with healed esophagitis to prevent
relapse
-
symptomatic treatment of gastroesophageal reflux disease (GERD)
IN COMBINATION WITH APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMENS FOR
THE ERADICATION OF
_HELICOBACTER PYLORI _AND
-
healing of _Helicobacter pylori _associated duodenal ulcer and
-
prevention of relapse of peptic ulcers in patients with _Helicobacter
pylori _associated ulcers
PATIENTS REQUIRING CONTINUED NSAID THERAPY
-
healing of gastric ulcers associated with NSAID therapy
-
prevention of gastric and duodenal ulcers associated with NSAID
therapy, in patients at risk
CONFIDENTIAL
Emanera gastro-resistant capsules 20 mg, 40 mg
MODULE 1
VOL: 1; P: 7 / 33
1.3.1
Esomeprazole
SPC, Labeling and Package Leaflet
AM
SmPCPIL152567_3
03.07.2020 – Updated: 30.11.2020
Page 2 of 15
PROLONGED TREATMENT AFTER IV INDUCED PREVENT