De-Nol, pills 120mg, 32pcs

Composition

Cream-white film-coated tablets, round, biconvex, with the inscription” gbr 152 ” stamped on one side and a graphic drawing in the form of a square with broken sides and rounded corners stamped on the other side, odorless or with a slight smell of ammonia.

Auxiliary substances:

corn starch – 70.6 mg,

povidone K 30-17.7 mg,

potassium polyacrylate-23.6 mg,

macrogol 6000-6 mg,

magnesium stearate-2 mg.

Shell composition:

 opadray OY-S-7366 (hypromellose 5 MPa * s – 3.2 mg, macrogol 6000-1.1 mg).

Pharmacological action

of De-Nol-gastroprotective, anti-ulcer, antibacterial.

Pharmacodynamics

An anti-ulcer agent with bactericidal activity against Helicobacter pylori. It also has an anti-inflammatory and astringent effect. In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate are deposited, chelated 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 PGE, mucus formation and bicarbonate secretion, 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 mainly excreted in the faeces. A small amount of bismuth that enters the plasma is excreted from the body 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;
• irritable bowel syndrome, occurring mainly with symptoms of diarrhea;
• functional dyspepsia, not associated with organic diseases of the gastrointestinal tract.

Contraindications

• Individual intolerance to the drug;
• severe renal impairment;
• pregnancy;
• lactation

Side effects

From the digestive system:  nausea, vomiting, more frequent stools, and constipation may occur. These phenomena are not dangerous to health and are temporary in nature.

Allergic reactions:  skin rash, itchy skin.

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

Interaction

Within half an hour before and after taking De-Nol®, it is not recommended to use other drugs inside, as well as food and liquid intake, in particular antacids, milk, fruit and fruit juices. This is due to the fact that they may affect the effectiveness of De-Nol®when taken orally at the same time.

How to take, course of use and dosage

Inside, with a small amount of water.

Adults and children over 12 years of age — 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 — 1 tablet 2 times a day 30 minutes before meals.

Children from 4 to 8 years — at a dose of 8 mg / kg / day; the daily dosage is divided into 2 doses. Take 30 minutes before meals.

The duration of treatment is 4-8 weeks. Bismuth-containing medications should not be used for the next 8 weeks.

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

Overdose

Symptoms (with prolonged use of doses exceeding the recommended ones): impaired renal function. These symptoms are completely reversible when De-Nol is discontinued.

Treatment:  gastric lavage, use of activated charcoal and saline laxatives. Further treatment should be symptomatic. In the case of impaired renal function, accompanied by a high level of bismuth in the blood plasma, the use of complexing agents — dimercaptoyantaric and dimercaptopropanesulfonic acids. In case of severe renal impairment, hemodialysis is indicated.

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. Other bismuth-containing drugs should not be used during treatment with De-Nol®. At the end of the course of treatment with the drug in the recommended doses, the concentration of the active Active ingredient in the blood plasma does not exceed 3-58 mcg/l, and intoxication is observed only at concentrations above 100 mcg/l.

When using De-Nol®, feces may turn dark due to the formation of bismuth sulfide. Sometimes there is a slight darkening of the tongue.

Storage conditions

The drug should be stored at a temperature of 15° to 25°C.

Shelf

life is 4 years.

Active ingredient

Bismuth tripotassium dicitrate

Dosage form

Tablets

Description

For adults, Children as prescribed by a doctor, Children over 4 years of age

Indications

Gastritis, Gastric and Duodenal ulcers, Gastrointestinal infections caused by Helicobacter Pylori, Diarrhea, Gastroduodenitis