De-nol tab. p / o captivity. 120 mg No. 112

Release form, composition and packaging

Creamy white film-coated tablets, round, biconvex, with the inscription gbr 152" squeezed out on one side, and a graphic pattern in the form of a square with discontinuous sides and rounded corners squeezed out on the other side, odorless or slightly odorless ammonia.

1 tab.

bismuth tripotassium dicitrate

304.6 mg,

which corresponds to the content of bismuth oxide

120 mg

corn starch - 70.6 mg, povidone K30 - 17.7 mg, potassium polyacrylate - 23.6 mg, macrogol 6000 - 6 mg, magnesium stearate - 2 mg.

Shell composition: opadry OY-S-7366 (hypromellose 5 mPa s - 3.2 mg, macrogol 6000 - 1.1 mg).

8 pcs.

- blisters (4) - cardboard packs.

8 pcs.

- blisters (7) - cardboard packs.

8 pcs. - blisters (14) - packs of cardboard. Pharmacological action Anti-ulcer 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. An insignificant 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 diseases of the gastrointestinal tract. Contraindications for use Severe renal dysfunction, pregnancy, lactation, hypersensitivity to bismuth tripotassium dicitrate. Dosing regimen Adults and children over 4 years of age - 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 with anti-Helicobacter activity. Side effect From 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 long-term use in high doses - encephalopathy associated with the accumulation of bismuth in the central nervous system. Drug interaction 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. Use during pregnancy and lactation. Use during pregnancy and lactation (breastfeeding) is contraindicated. Special instructions Do not use for more than 8 weeks.

During treatment, it is not recommended to exceed the established daily doses for adults and children.

At the end of the course of treatment in recommended doses, the concentration of the active substance in the blood plasma does not exceed 3-58 Ојg / l, and intoxication is observed only at a concentration of more than 100 Ојg / l.

Against the background of application, stool may turn black due to the formation of bismuth sulfide

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 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).

Indications

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.

INN / Active ingredient

bismuth tripotassium dicitrate

Contraindications

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

Storage conditions and periods

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

Shelf life 4 years.

Specifications

Category

Ulcer and gastritis

,

Antacids

Scope of the drug

Gastrointestinal tract

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

112

Scope of application

Gastroenterology

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

65

Mode of application

:

Inside, with a little water. < 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 > Children from 8 to 12 years old - 1 tablet 2 times a day 30 minutes before meals. < 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> Duration of treatment - 4-8 weeks.

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