Ulkavis tab. p / o captivity. 120 mg # 56

Release form, composition and packaging

Coated tablets of white or almost white color, round, biconvex, beveled

the view at the fracture is a rough white mass with a white or almost white shell.

1 tab.

bismuth tripotassium dicitrate 303.03 mg,

- which corresponds to the content of bismuth oxide 120 mg

corn starch - 72.17 mg, povidone K30 - 18 mg, potassium polycrilin - 23.8 mg, macrogol 6000 - 6 mg, magnesium stearate - 2 mg.

The composition of the film shell: opadry II transparent - 8.5 mg (polyvinyl alcohol - 4.505 mg, macrogol 4000 - 2.295 mg, talc - 1.7 mg), titanium dioxide (E171) - 1.5 mg.

10 pieces.

- blisters (3) - cardboard packs.

10 pieces.

- blisters (4) - cardboard packs.

10 pieces.

- blisters (6) - cardboard packs.

10 pieces.

- blisters (10) - cardboard packs.

10 pieces.

- blisters (24) - cardboard packs.

14 pcs.

- blisters (2) - cardboard packs.

14 pcs.

- blisters (4) - cardboard packs.

14 pcs.

- blisters (8) - cardboard packs.

14 pcs.

- blisters (16) - cardboard packs.

15 pcs.

- blisters (2) - cardboard packs.

15 pcs.

- blisters (4) - cardboard packs.

15 pcs.

- blisters (8) - cardboard packs.

15 pcs.

- blisters (16) - cardboard packs.

pharmachologic effect

Antiulcer agent with bactericidal activity against Helicobacter pylori.

It also has anti-inflammatory and astringent properties.

In the acidic environment of the stomach, it forms insoluble bismuth oxychloride and citrate, and also chelates with a protein substrate in the form of a protective film on the surface of ulcers and erosions.

By increasing the synthesis of prostaglandin E, the formation of mucus and the secretion of bicarbonate, it stimulates the activity of cytoprotective mechanisms, increases the resistance of the gastrointestinal mucosa to the effects of pepsin, hydrochloric (hydrochloric) acid, enzymes and bile salts.

Leads to the accumulation of epidermal growth factor in the defect area.

Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics

Bismuth tripotassium dicitrate is practically not absorbed from the gastrointestinal tract.

However, a small amount of bismuth can enter the systemic circulation.

It is excreted mainly in the feces.

A small amount of bismuth entering the plasma is excreted by the kidneys.

Indications for use

Peptic ulcer and duodenal ulcer in the acute phase (including associated with Helicobacter pylori)

chronic gastritis and gastroduodenitis in the acute phase (including associated with Helicobacter pylori)

irritable bowel syndrome, which occurs predominantly with symptoms of diarrhea

functional dyspepsia not associated with organic gastrointestinal diseases.

Contraindications for use

Severe renal dysfunction, pregnancy, lactation, hypersensitivity to bismuth tripotassium dicitrate.

Dosage regimen

Adults and children over 4 years old - inside 2-4 times / day 30 minutes before meals.

The dose depends on the age of the patient.

The course of treatment is 4-8 weeks.

For the next 8 weeks, do not take bismuth-containing drugs.

For the eradication of Helicobacter pylori, it is advisable to use bismuth tripotassium dicitrate in combination with antibacterial drugs that have anti-Helicobacter activity.

Side effect

On the part of the digestive system: transient effects are possible - nausea, vomiting, increased stool frequency, constipation.

Dermatological reactions: skin rash, itching.

From the side of the central nervous system: with prolonged use in high doses - encephalopathy associated with the accumulation of bismuth in the central nervous system.

Drug interactions

With the simultaneous administration of other drugs, as well as food and liquids, in particular, antacids, milk, fruit and fruit juices, it is possible to change the effectiveness of bismuth tripotassium dicitrate.

Application during pregnancy and lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Special uk

Name ENG

ULCAVIS

Clinical and pharmacological group

A drug that has a protective effect on the mucous membrane of the stomach and duodenum.

Antiulcer drug

ATX code

Bismuth subcitrate

Dosage

120mg

Structure

Active ingredient: bismuth tripotassium dicitrate 303.03 mg (equivalent to bismuth oxide 120 mg)

Excipients: corn starch - 72.17 mg

povidone K30 - 18 mg

polycrilin potassium - 23.8 mg

macrogol 6000 - 6 mg

magnesium stearate - 2 mg.

Film shell: Opadry II transparent (polyvinyl alcohol - 4.505 mg, macrogol 4000 - 2.295 mg) - 8.5 mg

titanium dioxide (E171) - 8.5 mg

talc - 1.7 mg.

Indications

peptic ulcer of the stomach and duodenum in the acute phase, incl.

associated with Helicobacter pylori

chronic gastritis and gastroduodenitis in the acute phase, incl.

associated with Helicobacter pylori

irritable bowel syndrome, which occurs predominantly with symptoms of diarrhea

functional dyspepsia not associated with organic gastrointestinal diseases.

Storage conditions and periods

At a temperature not exceeding 25 degrees, in the original packaging.

Expiration date: 3 years

INN / Active ingredient

Bismuth tripotassium dicitrate

Contraindications

individual intolerance to the drug

severe renal failure (Cl creatinine less than 30 ml / min)

pregnancy

period of breastfeeding

children under 4 years of age.

Specifications

Category

Preparations for the gastrointestinal tract

,

Ulcer and gastritis

,

Antacids

Scope of the medicinal product

Gastrointestinal tract

Release form

Tablet

Manufacturer country

Slovenia

Package quantity, pcs

56

Minimum age from

4 years old

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

KRKA

The amount of the dosage form in the primary package

14 pcs.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antiseptic intestinal and astringent

Anatomical and therapeutic characteristics

A02BX05 Bismuth tripotassium dicitrate

Dosage form

Film-coated tablets

The target audience

Children

Expiration date in days

730

Package weight, g

thirty

Mode of application

:

Inside, 30 minutes before meals, with a little water. < br> Adults and children over 12 years of age are prescribed Ulcavis 1 tab. 4 times a day and at night or 2 tables. 2 times a day. < br> Children from 8 to 12 years old, the drug Ulcavis is prescribed for 1 table. 2 times a day from 4 to 8 years old are prescribed at a dose of 8 mg / kg / day, depending on the child's body weight, 1�2 tablets / day (respectively, in 1�2 doses per day). In this case, the daily dose should be closest to the calculated dose (8 mg / kg / day). < br> The duration of the course of treatment is 4�8 weeks. For the next 8 weeks, do not use bismuth-containing drugs. < br> < br> For the eradication of Helicobacter pylori, it is advisable to use the drug Ulcavis in combination with other antibacterial agents,possessing anti-Helicobacter activity (as recommended by a doctor).

Dosage (volume) of the substance in the preparation

:

bismuth tripotassium dicitrate 303.03 mg (equivalent to bismuth oxide 120 mg)

Information on technical characteristics, delivery set, country of manufacture