De-nol tab. p / o film. 120 mg # 56

Release form

Film-coated tablets

Packaging

56 pcs.

pharmachologic effect

De-Nol - gastroprotective, antiulcer, antibacterial.

Pharmacodynamics

Antiulcer agent with bactericidal activity against Helicobacter pylori.

It also has anti-inflammatory and astringent properties.

In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate are precipitated, chelated compounds with a protein substrate are formed in the form of a protective film on the surface of ulcers and erosions.

By increasing the synthesis of PGE, 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 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 subcitrate is practically not absorbed from the gastrointestinal tract.

It is excreted mainly in the feces.

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

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, occurring mainly with symptoms of diarrhea

functional dyspepsia not associated with organic gastrointestinal diseases.

Contraindications

individual intolerance to the drug

severe renal dysfunction

pregnancy

the period of breastfeeding.

Application during pregnancy and lactation

Contraindicated in pregnancy.

During treatment, breastfeeding should be discontinued.

special instructions

The drug should not be used for more than 8 weeks.

It is also not recommended to exceed the established daily doses for adults and children during treatment.

During the period of treatment with De-Nol, you should not use other preparations containing bismuth.

At the end of the course of treatment with the drug in the recommended doses, the concentration of the active active substance in the blood plasma does not exceed 3�58 μg / l, and intoxication is observed only at a concentration above 100 μg / l.

When using De-Nol, stool may turn dark due to the formation of bismuth sulfide.

Slight darkening of the tongue is sometimes noted.

Structure

1 tablet contains:

Active substance: bismuth tripotassium dicitrate 304.6 mg (in terms of bismuth oxide Bi2O3 - 120 mg)

Excipients: corn starch

povidone K30

potassium polyacrylate

macrogol 6000

magnesium stearate

Sheath: Opadry OY-S-7366 (hypromellose, macrogol 6000).

Method of administration and dosage

Inside with a little water.

Adults and children over 12 years old - 1 tablet 4 times a day 30 minutes before meals and at night or 2 tablets 2 times a day 30 minutes before meals.

Children from 8 to 12 years old - 1 tablet 2 times a day 30 minutes before meals.

Children from 4 to 8 years old - at a dose of 8 mg / kg / day

the daily dosage is divided into 2 doses.

Take 30 minutes before meals.

The duration of the course of treatment is 4�8 weeks.

For the next 8 weeks, do not use preparations containing bismuth.

For the eradication of Helicobacter pylori, it is advisable to use De-Nol in combination with other antibacterial agents with anti-Helicobacter activity.

Side effects

From the digestive system: nausea, vomiting, more frequent bowel movements, constipation may occur.

These phenomena are not dangerous to health and are temporary in nature.

Allergic reactions: skin rash, itching of the skin.

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

Drug interactions

Within half an hour before and after taking De-Nol, it is not recommended to use other drugs inside, as well as taking food and liquids, in particular antacids, mo

Name ENG

De-Nol

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

120 mg

Structure

1 tablet contains: Active ingredient: bismuth tripotassium dicitrate 304.6 mg (in terms of bismuth oxide Bi2O3 - 120 mg)

Excipients: corn starch

povidone K30

potassium polyacrylate

macrogol 6000

magnesium stearate

Sheath: Opadry OY-S-7366 (hypromellose, macrogol 6000).

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

The drug should be stored at temperatures between 15 В° and 25 В° C.

Shelf life 4 years.

INN / Active ingredient

bismuth tripotassium dicitrate

Contraindications

Individual intolerance to the drug

severe renal dysfunction

pregnancy

period of breastfeeding.

Specifications

Category

Preparations for the gastrointestinal tract

Scope of the drug

Gastrointestinal tract

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

56

Minimum age from

4 years old

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

ASTELLAS

The amount of the dosage form in the primary package

8 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

48

Package weight, g

45

Mode of application

:

Inside, drinking a little water. < br> < br> Adults and children over 12 years old - 1 tablet 4 times a day 30 minutes before meals and at night or 2 tablets 2 times a day 30 minutes before meals . < br> < br> Children from 8 to 12 years old - 1 tablet 2 times a day 30 minutes before meals. < br> < br> Children from 4 to 8 years old - at a dose of 8 mg / kg / day

the daily dosage is divided into 2 doses.

Take 30 minutes before meals. < br> < br> Duration of treatment - 4-8 weeks.

During the next 8 weeks, you should not use preparations containing bismuth. < br> < br> For the eradication of Helicobacter pylori, it is advisable to use De-Nol in combination with other antibacterial agents with anti-Helicobacter activity.

Dosage (volume) of the substance in the preparation

:

Bismuth tripotassium dicitrate 304.6 mg (in terms of bismuth oxide Bi2O3 - 120 mg)

Information on technical characteristics, delivery set, country of manufacture