Vysmuta trykalyya dytsytrat | De-Nol tablets 120 mg, 56 pcs.

release form

film-coated tablets

Packing

56 pcs.

Pharmacological action

De-Nol - gastroprotective, antiulcer, antibacterial.

Pharmacodynamics

An antiulcer with bactericidal activity against Helicobacter pylori. It also has anti-inflammatory and astringent effects. In the acidic environment of the stomach insoluble bismuth precipitate oxychloride and citrate, chelating compounds are formed with a protein substrate in the form of a protective film on the surface of ulcers and erosion. Increasing the synthesis of PGE, the formation of mucus and the secretion of bicarbonate, stimulates the activity of cytoprotective mechanisms, increases 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 defect zone. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics of

Bismuth subcitrate is practically not absorbed from the digestive tract. It is excreted mainly with feces. A small amount of bismuth received in the plasma is excreted from the body by the kidneys.

Indications

peptic ulcer of the stomach and duodenum in the exacerbation phase, incl. chronic gastritis and gastroduodenitis associated with Helicobacter pylori

in the exacerbation phase, including associated with Helicobacter pylori

irritable bowel syndrome, occurring mainly with symptoms of diarrhea

functional dyspepsia, not associated with organic diseases of the digestive tract.

Contraindications

individual intolerance to the drug

severe impaired renal function

pregnancy

period of breastfeeding.

Use during pregnancy and lactation

Contraindicated in pregnancy.

Breastfeeding should be discontinued during treatment.

Composition

1 tablet contains:

Active ingredient:

bismuth tripotassium dicitrate 304.6 mg (in terms of bismuth oxide Bi2O3 - 120 mg)

Excipients:

corn starch

povidone K30

potassium polyacrylate

macrogol 6000

magnesium stearate

Shell:

Opadry OY-S-7366 (hypromellose, macrogol 6000).

Dosage and administration

Inside, with a little 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.

For children from 8 to 12 years old - 1 tablet 2 times a day 30 minutes before meals.

For children from 4 to 8 years old - at a dose of 8 mg / kg / day, the daily dosage is divided into 2 doses. Take 30 minutes before meals.

Duration of treatment - 4-8 weeks. Over the next 8 weeks, preparations containing bismuth should not be used.

To eradicate Helicobacter pylori, it is advisable to use De-Nol® in combination with other antibacterial agents with anti-Helicobacter pylori activity.

Side effects

From the digestive system: the appearance of nausea, vomiting, more frequent stools, constipation.

These phenomena are not hazardous 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.

Drug Interaction

Within half an hour before and after taking De-Nol®, it is not recommended to use other medicines inside, as well as to eat food and liquids, in particular antacids, milk, fruits and fruit juices.

This is due to the fact that they can, when taken internally, affect the effectiveness of De-Nol®.

overdose

Symptoms (with prolonged doses in excess of recommended doses): impaired renal function. These symptoms are completely reversible upon de-Nol® withdrawal.

Treatment: gastric lavage, administration of activated charcoal and salt laxatives. In the future, treatment should be symptomatic. In the case of impaired renal function, accompanied by high levels of bismuth in the blood plasma, the use of complexing agents - dimercaptoantaric and dimercaptopropanesulfonic acids. Hemodialysis is indicated in case of severe renal dysfunction.

Storage conditions

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

Expiration

4 years.

Deystvuyuschee substances

Vysmuta trykalyya dytsytrat

Pharmacy terms of delivery

OTC

dosage form

dosage form

tablets

Astellas Pharm Europe BV, Netherlands , Russia