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

Dosage form

Round biconvex film-coated tablets of a creamy white color, odorless or with a slight smell of ammonia.

Release form

Film-coated tablets, 120 mg -56 pcs per pack.

Structure

Composition for one tablet:

bismuth tripotassium dicitrate 304.6 mg, in terms of bismuth oxide Bi2O3 - 120 mg.

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

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, 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 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 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

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.

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.

If any of the side effects indicated in the instructions are aggravated or any other side effects that are not indicated in the instructions appear, inform your doctor.

Selling features

Available without a prescription

Special conditions

The use of Novobismol® is contraindicated in pregnancy.

During treatment, breastfeeding should be discontinued.

The effect of a medicinal product for medical use on the ability to drive vehicles and mechanisms

Does not affect the ability to drive a car and other mechanisms.

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

- functional dyspepsia, not associated with organic diseases of the gastrointestinal tract

- irritable bowel syndrome, occurring mainly with symptoms of diarrhea.

Contraindications

- severe renal dysfunction

- pregnancy

- lactation period

- children under 4 years old

- individual intolerance to the drug.

Drug interactions

Within half an hour before and after taking Novobismol®, it is not recommended to use other medicines (in particular, antacids) internally, as well as the consumption of food and liquids, in particular antacids, milk, fruits and fruit juices.

This is due to the fact that, when taken simultaneously, they can affect the effectiveness of Novobismol®.

Dosage

For adults and children over 12 years of age, the drug is prescribed 1 tab.

3 times a day 30 minutes before meals and 1 tab.

at night or 2 tab.

2 times a day 30 minutes before meals.

For children aged 8 to 12 years, the drug is prescribed 1 tab.

2 times a day 30 minutes before meals.

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

the daily dose is divided into 2 doses.

Take 30 minutes before meals.

The tablets should be taken with a little water.

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

Do not use drugs for the next 8 weeks

Name ENG

NOVOBISMOL

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

Composition per tablet: bismuth tripotassium dicitrate 304.6 mg, in terms of bismuth oxide Bi2O3 - 120 mg.

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

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.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 4 years

INN / Active ingredient

Bismuth tripotassium dicitrate

Contraindications

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

Specifications

Category

Preparations for the gastrointestinal tract

,

Ulcer and gastritis

,

Antacids

Scope of the drug

Gastrointestinal tract

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

56

Scope of application

Gastroenterology

Minimum age from

4 years old

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Pharmproject

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

Dosage (volume) of the substance in the preparation

for 1 tablet 304.6 mg

Expiration date in days

1461

The target audience

Children

Package weight, g

40

Mode of application

:

For adults and children over 12 years of age, the drug is prescribed 1 tab. 3 times a day 30 minutes before meals and 1 tab. at night or 2 tab. 2 times a day 30 minutes before meals. < br> For children aged 8 to 12 years, the drug is prescribed 1 tab. 2 times a day 30 minutes before meals. < br> Children aged 4 to 8 years - at a dose of 8 mg / kg / day the daily dose is divided into 2 doses. Take 30 minutes before meals. < br> The tablets should be taken with a little water. 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 bismuth tripotassium dicitrate in combination with other antibacterial agents with anti-Helicobacter activity. < br> Dosage regimen, route of administration and duration of treatment: < br> The drug should not be used for more than 8 weeks. It is not recommended to exceed the established daily doses for adults and children during treatment with Novobismol®. < br> During the treatment period, you should not use other drugs containing bismuth. < br> At the end of the course of treatment with the drug in the recommended doses, the concentration of the active substance in the blood plasma does not exceed 3-5.8 mcg / l, and intoxication is observed only at a concentration above 100 mcg / l. < br> When using Novobismol®, stool may become dark in color due to the formation of bismuth sulfide. Sometimes there is a slight darkening of the tongue.During the treatment period, do not use other preparations containing bismuth. < br> 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 3-5.8 mcg / l, and intoxication is observed only at a concentration above 100 mcg / l. < br> When using Novobismol®, stool may become dark in color due to the formation of bismuth sulfide. Slight darkening of the tongue is sometimes noted.During the treatment period, do not use other preparations containing bismuth. < br> At the end of the course of treatment with the drug in the recommended doses, the concentration of the active substance in the blood plasma does not exceed 3-5.8 mcg / l, and intoxication is observed only at a concentration above 100 mcg / l. < br> When using Novobismol®, stool may turn dark due to the formation of bismuth sulfide. Slight darkening of the tongue is sometimes noted.When using Novobismol®, feces may become dark in color due to the formation of bismuth sulfide. Slight darkening of the tongue is sometimes noted.When using Novobismol®, feces may become dark in color due to the formation of bismuth sulfide. Sometimes there is a slight darkening of the tongue.

Information on technical characteristics, delivery set, country of manufacture