De-Nol^® (Tablets) Instructions for Use

Marketing Authorization Holder

Cheplapharm Arzneimittel, GmbH (Germany)

Manufactured By

Astellas Pharma Europe B.V. (Netherlands)

Or

R-Pharm JSC (Russia)

Or

ZiO-Health CJSC (Russia)

Packaging and Quality Control Release

ASTELLAS PHARMA EUROPE, B.V. (Netherlands)

Or

R-Pharm, JSC (Russia)

Or

ZiO-Health, CJSC (Russia)

Or

ORTAT, JSC (Russia)

ATC Code

A02BX05 (Bismuthate, tripotassium dicitrato)

Active Substance

Bismuthate, tripotassium dicitrato (BP British Pharmacopoeia)

Dosage Form

De-Nol®

Film-coated tablets, 304.6 mg: 32, 56, or 112 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets are cream-white, round, biconvex, 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 side.

Excipients: corn starch – 70.6 mg, povidone K30 – 17.7 mg, potassium polyacrylate – 23.6 mg, macrogol 6000 – 6 mg, magnesium stearate – 2 mg.

Shell composition opadry OY-S-7366 (hypromellose 5 mPa·s – 3.2 mg, macrogol 6000 – 0.5 mg; macrogol 6000 – 0.6 mg).

8 pcs. – blisters (4) – cardboard packs.
8 pcs. – blisters (7) – cardboard packs.
8 pcs. – blisters (14) – cardboard packs.

Clinical-Pharmacological Group

A drug that exerts a protective effect on the gastric and duodenal mucosa. Antiulcer drug

Pharmacotherapeutic Group

Intestinal antiseptic and astringent

Pharmacological Action

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

In the acidic environment of the stomach, it forms insoluble bismuth oxychloride and citrate, and also forms 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 and 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 area. It reduces the activity of pepsin and pepsinogen.

Pharmacokinetics

Bismuthate, tripotassium dicitrato is practically not absorbed from the gastrointestinal tract. However, a small amount of bismuth may enter the systemic circulation. It is excreted mainly with feces. The small amount of bismuth that enters the plasma is excreted by the kidneys.

Indications

Gastric and duodenal ulcer 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 predominantly with symptoms of diarrhea; functional dyspepsia not associated with organic diseases of the gastrointestinal tract.

ICD codes

Dosage Regimen

Adults and children over 4 years old – orally 2-4 times/day 30 minutes before meals. The dose depends on the patient’s age.

The course of treatment is 4-8 weeks. For the next 8 weeks, preparations containing bismuth should not be taken.

For the eradication of Helicobacter pylori, it is advisable to use bismuth tripotassium dicitrate in combination with antibacterial drugs that have anti-Helicobacter activity.

Adverse Reactions

From the digestive system, transient effects are possible – nausea, vomiting, increased stool frequency, constipation.

Dermatological reactions: skin rash, itching.

From the central nervous system: with long-term use in high doses – encephalopathy associated with the accumulation of bismuth in the central nervous system.

Contraindications

Severe renal impairment, pregnancy, lactation period, hypersensitivity to bismuth tripotassium dicitrate.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation (breastfeeding) period.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

Used in children over 4 years of age according to the dosage regimen.

Special Precautions

Should not be used for more than 8 weeks.

During treatment, it is not recommended to exceed the established daily doses for adults and children.

After completing the course of treatment at recommended doses, the concentration of the active substance in the blood plasma does not exceed 3-58 µg/l, and intoxication is observed only at concentrations above 100 µg/l.

During use, stool may turn black due to the formation of bismuth sulfide. Sometimes a slight darkening of the tongue is noted.

Drug Interactions

When taken simultaneously with other medicines, as well as food and liquids, in particular, antacids, milk, fruits, and fruit juices, the effectiveness of bismuth tripotassium dicitrate may change.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.