Novobismol tablets 120mg, No. 112

• 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.

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. 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.

per tablet: :
Active ingredient: bismuth tripotassium dicitratobismuthate 304.6 mg, based on 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.

• severe renal dysfunction;

• pregnancy;

• lactation period;

• children under 4 years of age;

• individual intolerance to the drug.

Trade name of the drug:

Novobismol

International non-proprietary name:

bismuth tripotassium dicitrate

Dosage form:

Pills.

Composition:

per tablet: :
Active ingredient: bismuth tripotassium dicitratobismuthate 304.6 mg, based on 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.

Description:

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

Pharmacotherapeutic group:

antiseptic intestinal and astringent

ATX code:

A02BX05.

Pharmacological properties

Pharmacodynamics
Antiulcer 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 are formed 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 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.

Indications for use

• 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 of age;

• individual intolerance to the drug.

Application during pregnancy and during breastfeeding

The use of NovobismolЃ is contraindicated in pregnancy. During treatment, breastfeeding should be discontinued.

Method of administration and 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. 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.

Dosage regimen, route of administration and duration of treatment:
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 NovobismolЃ.
During the treatment period, do 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 3-5.8 ?g / l, and intoxication is observed only at a concentration above 100 ?g / l.
When using NovobismolЃ, stool may turn dark due to the formation of bismuth sulfide. Sometimes there is a slight darkening of the tongue.

Side effect

From the digestive system : nausea, vomiting, more frequent bowel movements, constipation may occur. These phenomena are not hazardous to health and are temporary.
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.

Overdose

An overdose of the drug caused by prolonged use in doses exceeding the recommended ones can lead to impaired renal function. These symptoms are completely reversible when NovobismolЃ is discontinued.
Treatment : when signs of drug poisoning appear, it is necessary to wash the stomach, apply activated charcoal and saline laxatives. In the future, symptomatic treatment is carried out. In case of impaired renal function, accompanied by a high level of bismuth in the blood plasma, you can enter complexing agents - dimercaptosuccinic and dimercaptopropanesulfonic acids. In case of severe renal dysfunction, hemodialysis is indicated.

Interaction with other medicinal products

Within half an hour before and after taking NovobismolЃ, 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 orally, they can affect the effectiveness of NovobismolЃ.

Influence on the ability to drive vehicles and use mechanisms

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

Release form

Film-coated tablets, 120 mg.
8 pcs. - contour cell packs (1, 2, 3, 4, 5, 6, 7, 14, 28) - cardboard packs.
10 pieces. - contour cell packages (1, 2, 3, 4, 5, 6, 7, 12, 24) - cardboard packs.
16 pcs. - contour cell packs (1, 2, 3, 4, 5, 6, 7, 14) - cardboard packs.
20 pcs. - contour cell packs (1, 2, 3, 4, 5, 6, 7, 12) - cardboard packs.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life

4 years
Do not use after the expiry date stated on the package.

Vacation conditions

Without recipe.