Novobismol pills 120mg №112

Antiseptic intestinal and astringent

Mechanism of action

Antiulcer agent with bactericidal activity against Helicobacter pylori. It also has anti-inflammatory and astringent effects.

In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate precipitate, chelate compounds are formed with a protein substrate in the form of a protective film on the surface of ulcers and erosions. Increasing the synthesis of prostaglandin E, the formation of mucus and the secretion of bicarbonate, stimulates the activity of cytoprotective mechanisms, increases the resistance of the mucous membrane of the gastrointestinal tract to the effects of pepsin, hydrochloric acid, enzymes and bile salts. Leads to the accumulation of epidermal growth factor in the area of ​​the defect. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics

Practically not absorbed from the digestive tract.

Excreted mainly with feces. An insignificant amount of bismuth entering the plasma is excreted by the kidneys.

Indications

- peptic ulcer of the stomach and duodenum in the acute phase, including associated with Helicobacter pylori;

- chronic gastritis and gastroduodenitis in the acute phase, including associated with Helicobacter pylori;

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

- irritable bowel syndrome, occurring predominantly with diarrhea symptoms.

Dosage and administration

Tablets should be taken with a small amount of water.

Adults and children over 12 years old the drug is prescribed on 1 tab. 3 times / day for 30 minutes before meals and 1 tab. at night or 2 tab. 2 times / day for 30 minutes before meals.

Children aged 8 to 12 years the drug is prescribed on 1 tab. 2 times / day for 30 minutes before a meal; children aged 4 to 8 years - at a dose of 8 mg / kg / day; The daily dosage is divided into 2 doses, taken 30 minutes before meals.

The duration of treatment is 4-8 weeks. For the next 8 weeks, do not use bismuth-containing products. For the eradication of Helicobacter pylori, it is advisable to use bismuth tri-potassium dicitrate in combination with other antibacterial agents with anti-helicobacter activity.

Side effect

Gastrointestinal: possible nausea, vomiting, more frequent stools, constipation. These phenomena are not dangerous to health and are temporary.

Allergic reactions: skin rash, itchy skin.

With long-term 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, the patient should be informed about this by the doctor.

Contraindications

- pronounced impaired renal function;

- pregnancy;

- lactation;

- children's age up to 4 years;

- Individual intolerance to the drug.

Use during pregnancy and lactation

Use of the drug Novobismol^® contraindicated in pregnancy.

At the time of treatment with the drug should stop breastfeeding.

Application for violations of kidney function

Use of the drug is contraindicated in cases of marked impaired renal function.

Use in children

The use of the drug is contraindicated in children under 4 years.

Special notes

Precautions for use

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

Also not recommended during treatment with Novobismol.^® exceed the prescribed daily doses for adults and children.

During the period of treatment should not use other drugs containing bismuth.

At the end of the course of treatment with the drug in recommended doses, the concentration of the active active ingredient in the blood plasma does not exceed 3-5.8 µg / l, and intoxication is observed only at a concentration above 100 µg / l.

When using the drug Novobismol^® It is possible to stain feces in a dark color due to the formation of bismuth sulphide. Sometimes there is a slight darkening of the tongue.

When disposing of unused packages of the drug special precautions are required.

Influence on ability to drive motor transport and control mechanisms

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

Overdosage

Symptoms: overdose of the drug, caused by prolonged use in doses exceeding the recommended, can lead to impaired renal function. These symptoms are completely reversible with discontinuation of the drug Novobismol.^®.

Treatment: when there is evidence of drug poisoning, it is necessary to do a gastric lavage, apply Activated carbon and saline laxatives. Further symptomatic treatment is carried out. In case of impaired renal function, accompanied by a high concentration of bismuth in the blood plasma, it is possible to introduce complexing agents — dimercaptosuccinic and dimercaptopropanesulfonic acid. In the case of pronounced renal impairment, hemodialysis is indicated.

Drug interaction

Within half an hour before and after taking the drug Novobismol^® It is not recommended to use inside other medicines, as well as the consumption of food and liquids, in particular, antacids, milk, fruits and fruit juices. This is due to the fact that they, when taken simultaneously, may have an influence on the effectiveness of the drug Novobismol.^®.

Terms and conditions of storage

The drug should be stored out of the reach of children, dry, protected from light, at a temperature not exceeding 25 ° C. Shelf life - 4 years.