Novobismol^® (Tablets) Instructions for Use

Marketing Authorization Holder

Aliym, JSC (Russia)

Contact Information

ALIUM JSC (Russia)

ATC Code

A02BX05 (Bismuthate, tripotassium dicitrato)

Active Substance

Bismuthate, tripotassium dicitrato (BP British Pharmacopoeia)

Dosage Form

Novobismol®

Film-coated tablets 120 mg: 8, 10, 14, 16, 20, 24, 28, 30, 32, 40, 42, 48, 50, 56, 60, 64, 70, 80, 84, 96, 98, 100, 112, 120, 140, 224, or 240 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets creamy-white in color, round, biconvex, odorless or with a slight smell of ammonia.

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

Coating composition Opadry OY-S-7366 consists of hypromellose 5 mPa×s – 3.2 mg and macrogol 6000 – 1.1 mg.

8 pcs. – blister packs (1, 2, 3, 4, 5, 6, 7, 14, 28) – cardboard cartons.
10 pcs. – blister packs (1, 2, 3, 4, 5, 6, 7, 12, 24) – cardboard cartons.
16 pcs. – blister packs (1, 2, 3, 4, 5, 6, 7, 14) – cardboard cartons.
20 pcs. – blister packs (1, 2, 3, 4, 5, 6, 7, 12) – cardboard cartons.

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, insoluble bismuth oxychloride and citrate precipitate, forming chelate compounds with the protein substrate as 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. Leads to the accumulation of epidermal growth factor in the area of the defect. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics

It is practically not absorbed from the gastrointestinal tract.

It is excreted mainly with feces. A small amount of bismuth that enters the plasma is excreted from the body by the kidneys.

Indications

• Gastric and duodenal ulcer in the acute phase, including that associated with Helicobacter pylori;
• Chronic gastritis and gastroduodenitis in the acute phase, including that associated with Helicobacter pylori;
• Functional dyspepsia not associated with organic diseases of the gastrointestinal tract;
• Irritable bowel syndrome occurring predominantly with symptoms of diarrhea.

ICD codes

Dosage Regimen

The tablets should be taken with a small amount of water.

For adults and children over 12 years of age, the drug is prescribed 1 tablet 3 times/day 30 minutes before meals and 1 tablet at night, or 2 tablets 2 times/day 30 minutes before meals.

For children aged 8 to 12 years, the drug is prescribed 1 tablet 2 times/day 30 minutes before meals; for children aged 4 to 8 years – at a dose of 8 mg/kg/day; the daily dose is divided into 2 doses, taken 30 minutes before meals.

The duration of the treatment course is 4-8 weeks. For the next 8 weeks, drugs containing bismuth should not be used. For the eradication of Helicobacter pylori, it is advisable to use bismuth tripotassium dicitrate in combination with other antibacterial agents that have anti-Helicobacter activity.

Adverse Reactions

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

Allergic reactions: skin rash, skin itching.

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 mentioned in the instructions worsen or any other side effects not listed in the instructions appear, the patient should inform the doctor.

Contraindications

• Severe renal impairment;
• Pregnancy;
• Lactation;
• Children under 4 years of age;
• Individual intolerance to the drug.

Use in Pregnancy and Lactation

The use of Novobismol^® is contraindicated during pregnancy.

Breastfeeding should be discontinued during treatment with the drug.

Use in Renal Impairment

The use of the drug is contraindicated in severe renal impairment.

Pediatric Use

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

Special Precautions

Precautionary measures for use

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 with Novobismol^®.

During the treatment period, other drugs containing bismuth should not be used.

After completing the course of treatment with the drug at the recommended doses, the concentration of the active substance in the blood plasma does not exceed 3-5.8 µg/L, and intoxication is observed only at concentrations above 100 µg/L.

When using Novobismol^®, stool may turn dark in color due to the formation of bismuth sulfide. Sometimes a slight darkening of the tongue is noted.

No special precautions are required when disposing of unused drug packages.

Effect on the ability to drive vehicles and mechanisms

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

Overdose

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

Treatment: if signs of drug poisoning appear, gastric lavage should be performed, and activated charcoal and saline laxatives should be used. Subsequently, symptomatic treatment is carried out. In case of impaired renal function accompanied by a high concentration of bismuth in the blood plasma, complexing agents – dimercaptosuccinic acid and dimercaptopropanesulfonic acid – can be administered. In case of severe renal impairment, hemodialysis is indicated.

Drug Interactions

Within half an hour before and after taking Novobismol^®, the oral use of other medicines, as well as the consumption of food and liquids, in particular, antacids, milk, fruits, and fruit juices, is not recommended. This is because they, when taken orally simultaneously, may affect the effectiveness of Novobismol^®.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 4 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.