Lansoptol capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

lansoprazole

Available from:

KRKA d.d.

ATC code:

A02BC03

INN (International Name):

lansoprazole

Dosage:

30mg

Pharmaceutical form:

capsules

Units in package:

(14/2x7/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2023-05-25

Summary of Product characteristics

PI_Text051441_1
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Page 1 of 12
1.
NAME OF THE MEDICINAL PRODUCT
Lansoptol 30 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg lansoprazole.
Excipient:
30 mg capsules
sucrose
149.11 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule
White capsules containing white to slightly brown or slightly pink
pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lansoprazole is indicated in adults:
-
Treatment of duodenal and gastric ulcer.
-
Treatment and prophylaxis of reflux oesophagitis.
-
Eradication of _Helicobacter pylori_ (_H. pylori_) concurrently given
with appropriate antibiotic
therapy for treatment of _H.pylori_-associated ulcers.
-
Treatment of NSAID-associated benign gastric and duodenal ulcers in
patients requiring
continued NSAID treatment.
-
Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in
patients at risk (see
section 4.2) requiring continued NSAID treatment.
-
Symptomatic gastroesophageal reflux disease.
-
Zollinger-Ellison syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment of duodenal ulcer:
The recommended dose is 30 mg once daily for 2 weeks. In patients not
fully healed within this time,
the medication is continued at the same dose for another 2 weeks.
Treatment of gastric ulcer:
The recommended dose is 30 mg once daily for 4 weeks. The ulcer
usually heals within 4 weeks, but
in patients not fully healed within this time, the medication may be
continued at the same dose for
another 4 weeks.
Reflux oesophagitis:
CONFIDENTIAL
Lansoptol capsules 30 mg
VOL: 1; P: 7 / 29
PI_Text051441_1
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The recommended dose is 30 mg once daily for 4 weeks. In patients not
fully healed within this time,
the treatment may be continued at the same dose for another 4 weeks.
Prophylaxis of reflux oesophagitis:
15 mg once daily. The dose may be increased up to 30 mg daily as
necessary.
Eradication of _Helicobacter pylori:_
When selecting appropriate combination therapy, considerat