De-Nol 120 mg 32 coated tablets

Peptic ulcer disease of the stomach and duodenum in the acute phase, including that associated with Helicobacter pylori.
Chronic gastritis and gastroduodenitis in the acute phase, including that associated with Helicobacter pylori.
Irritable bowel syndrome predominantly presenting with diarrhea symptoms.
Functional dyspepsia not associated with organic gastrointestinal diseases.

For adults and children over 12 years of age, the medication is prescribed at a dosage of 1 tablet 4 times a day, 30 minutes before meals and at bedtime, or 2 tablets 2 times a day, 30 minutes before meals.
For children aged 8 to 12 years, the medication is prescribed at a dosage of 1 tablet 2 times a day, 30 minutes before meals.
For children aged 4 to 8 years: the dosage is 8 mg/kg/day; depending on the child's weight, 1-2 tablets per day are prescribed (correspondingly, in 1-2 doses per day). The daily dose should be as close as possible to the calculated dose (8 mg/kg/day).
Tablets should be taken 30 minutes before meals with a small amount of water. The duration of the treatment course is 4-8 weeks. During the following 8 weeks, medications containing bismuth should not be used.
For the eradication of Helicobacter pylori, the use of De-Nol in combination with other antibacterial agents that have anti-Helicobacter activity is advisable.

One film-coated tablet contains:
Active ingredient: bismuth potassium dicitrate 304.6 mg (calculated as bismuth oxide Bi2O3 - 120 mg).
Excipients:
corn starch - 70.6 mg;
povidone K30 - 17.7 mg;
potassium polyacrylate - 23.6 mg;
macrogol 6000 - 6.0 mg;
magnesium stearate - 2.0 mg.
Coating:
Opadry OY-S-7366, consists of:
hydroxypropyl methylcellulose 5 mPa·s - 3.2 mg;
macrogol 6000 - 1.1 mg.

Round biconvex tablets, coated with a film, cream-white in color, with the inscription "gbr 152" embossed on one side and a graphic design in the form of a square with dashed sides and rounded corners embossed on the other, odorless or with a slight smell of ammonia.

Decompensated renal failure, pregnancy, lactation, individual intolerance to the drug, pediatric age under 4 years.
Pregnancy and lactation:
The use of De-Nol® during pregnancy and lactation is contraindicated.

The medication 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. During the treatment with De-Nol®, other medications containing bismuth should not be used. After completing the course of treatment with the medication at the recommended doses, the concentration of the 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®, darkening of the stool may occur due to the formation of bismuth sulfide. Occasionally, slight darkening of the tongue is noted.
Effect of the medication on the ability to drive vehicles and operate machinery:
Data on the effect of De-Nol® on the ability to drive vehicles and operate machinery are absent.

Gastrointestinal system: nausea, vomiting, more frequent stools, constipation may occur. These phenomena are not harmful to health and are temporary. Allergic reactions: skin rash, itching.
With prolonged use in high doses - encephalopathy associated with bismuth accumulation in the CNS.

Overdose of the medication, caused by prolonged use of doses exceeding the recommended amount, may lead to impaired kidney function. These symptoms are completely reversible upon discontinuation of De-Nol®.

In the event of signs of poisoning with the medication, gastric lavage should be performed, activated charcoal and saline laxatives should be administered. Further treatment should be symptomatic. In cases of impaired kidney function accompanied by elevated bismuth levels in the plasma, chelating agents (D-penicillamine, unithiol) may be administered. In cases of severe kidney dysfunction, hemodialysis is indicated.

It is not recommended to take other medications, as well as food and liquids, including antacids, milk, fruits, and fruit juices, within half an hour before and after taking De-Nol®. This is due to the fact that they may affect the effectiveness of De-Nol® when taken simultaneously.
Concurrent use of De-Nol® with tetracycline reduces the absorption of the latter.

Anti-ulcer 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, forming chelate compounds with the 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, enhancing the resistance of the gastrointestinal mucosa to the effects of pepsin, hydrochloric acid, enzymes, and bile salts. It leads to the accumulation of epidermal growth factor in the area of the defect. It reduces the activity of pepsin.

Bismuth subcitrate is practically not absorbed from the gastrointestinal tract. It is primarily excreted with feces. A small amount of bismuth that enters the plasma is eliminated from the body by the kidneys.