Ulcavis tablets film-coated

Krajina: Arménsko

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktívna zložka:

bismuth tripotassium dicitrate (bismuth oxide)

Dostupné z:

KRKA d.d.

ATC kód:

A02BX05

INN (Medzinárodný Name):

bismuth tripotassium dicitrate (bismuth oxide)

Dávkovanie:

120mg

Forma lieku:

tablets film-coated

Počet v balení:

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

Typ predpisu:

Prescription

Stav Autorizácia:

Registered

Dátum Autorizácia:

2017-05-11

Príbalový leták

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Súhrn charakteristických

1.3.1
Bismuth subcitrate
SPC, Labeling and Package Leaflet
AM
SmPCPIL150888_1
29.05.2020 – Updated: 29.05.2020
Page 1 of 4
1.
NAME OF THE MEDICINAL PRODUCT
Ulcavis
®
120 mg fim-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains tripotassium dicitratobismuthate-
303.03 mg (equivalent to 120.00
mg bismuth oxide).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to almost white, round, slightly biconvex, film coated tablets
with bevel edge.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute stomach and duodenal ulcer, including that associated with
_Helicobacter pylori_ infection.
Active chronic gastritis and gastroduodenitis, including that
associated with _Helicobacter pylori_
infection.
Irritable bowel syndrome with primarily diarrhea symptoms.
Functional dyspepsia not associated with organic gastrointestinal
diseases.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and the elderly_
The recommended dose is 1 tablet 4 times daily, 30 minutes prior to
meals and before bedtime
OR
2 tablets twice daily, 30 minutes prior to meals.
_For children_
Not recommended.
Method of administration
The tablets should be taken 30 minutes prior to meals with a small
amount of water.
The treatment course is 4 to 8 weeks. Bismuth-containing products
should not be used in the following
8 weeks.
For the eradication of _Helicobacter plyori_ Ulcavis should preferably
be used in combination with other
antibacterial agents against this microorganism.
4.3
CONTRAINDICATIONS
Severe renal insufficiency (creatinine clearance below 30 ml/min).
Period of pregnancy and breast-feeding.
CONFIDENTIAL
VOL: 1; P: 16 / 42
1.3.1
Bismuth subcitrate
SPC, Labeling and Package Leaflet
AM
SmPCPIL150888_1
29.05.2020 – Updated: 29.05.2020
Page 2 of 4
Hypersensitivity to the drug.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Treatment with Ulcavis should not exceed 8 weeks. The recommended
daily dose for the appropriate
age group should not be exceeded.
Other bismuth co