De-Nol tablets p / o 120mg, No. 112

• Peptic ulcer and duodenal ulcer in the acute phase, including those associated with Helicobacter pylori.

• Chronic gastritis and gastroduodenitis in the acute phase, including those associated with Helicobacter pylori.

• Irritable bowel syndrome, which occurs predominantly with symptoms of diarrhea.

• Functional dyspepsia not associated with organic diseases of the gastrointestinal tract.

For adults and children over 12 years of age, the drug is prescribed 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, the drug is prescribed 1 tablet 2 times a day 30 minutes before meals.

Children from 4 to 8 years old are prescribed at a dose of 8 mg / kg / day; depending on the child's body weight, 1-2 tablets are prescribed per day (respectively, in 1-2 doses per day). In this case, the daily dose should be closest to the calculated dose (8 mg / kg / day).

The tablets are taken 30 minutes before meals with a little water.

The duration of the course of treatment is 4-8 weeks. For the next 8 weeks, do not use preparations containing bismuth.

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

One film-coated tablet contains:

Active ingredient: bismuth tripotassium dicitrate 304.6 mg (in terms of 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.

Sheath: Opadray OY-S-7366: hypromellose 5 mPa s - 3.2 mg, macrogol 6000 - 0.5 mg; macrogol 6000 - 0.6 mg.

• Decompensated renal failure

• pregnancy, lactation,

• individual intolerance to the drug,

• children under 4 years of age.

Trade name:

De-Nol

International non-proprietary or group name:

Bismuth tripotassium dicitrate

Dosage form:

Film-coated tablets

Composition:

One film-coated tablet contains:

Active ingredient: bismuth tripotassium dicitrate 304.6 mg (in terms of 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.

Sheath: Opadray OY-S-7366: hypromellose 5 mPa s - 3.2 mg, macrogol 6000 - 0.5 mg; macrogol 6000 - 0.6 mg.

Description

Round biconvex, creamy white film-coated tablets with the inscription 'gbr 152' extruded on one side and a graphic pattern in the form of a square with discontinuous sides and rounded corners extruded on the other.

Pharmacotherapeutic group:

antiseptic intestinal and astringent.

ATX code:

A02VX05

Pharmacological properties

Pharmacodynamics

Antiulcer agent with bactericidal activity against Helicobacter pylori. It also has anti-inflammatory and astringent properties. In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate are precipitated, chelated compounds are formed with a 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, increases the resistance of the mucous membrane of the gastrointestinal tract 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.

Pharmacokinetics

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

Indications for use

• Peptic ulcer and duodenal ulcer in the acute phase, including those associated with Helicobacter pylori.

• Chronic gastritis and gastroduodenitis in the acute phase, including those associated with Helicobacter pylori.

• Irritable bowel syndrome, which occurs predominantly with symptoms of diarrhea.

• Functional dyspepsia not associated with organic diseases of the gastrointestinal tract.

Contraindications

• Decompensated renal failure

• pregnancy, lactation,

• individual intolerance to the drug,

• children under 4 years of age.

Pregnancy and lactation

The use of the drug De-NolЃ during pregnancy and lactation is contraindicated.

Method of administration and dosage

For adults and children over 12 years of age, the drug is prescribed 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, the drug is prescribed 1 tablet 2 times a day 30 minutes before meals.

Children from 4 to 8 years old are prescribed at a dose of 8 mg / kg / day; depending on the child's body weight, 1-2 tablets are prescribed per day (respectively, in 1-2 doses per day). In this case, the daily dose should be closest to the calculated dose (8 mg / kg / day).

The tablets are taken 30 minutes before meals with a little water.

The duration of the course of treatment is 4-8 weeks. For the next 8 weeks, do not use preparations containing bismuth.

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

Side effect

From the digestive system: nausea, vomiting, more frequent bowel movements, constipation may occur. These phenomena are not hazardous to health and are temporary.
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.

Overdose of the drug

An overdose of the drug caused by prolonged use of doses exceeding the recommended ones can lead to impaired renal function. These symptoms are completely reversible when De-Nol is canceled.

When signs of drug poisoning appear, it is necessary to wash the stomach, apply activated charcoal and saline laxatives. Further treatment should be symptomatic. In case of impaired renal function, accompanied by a high level of bismuth in the blood plasma, chelating agents (D-penicillamine, unitiol) can be administered. In case of severe renal dysfunction, hemodialysis is indicated.

Interaction with other medicinal products

Within half an hour before and after taking De-Nol, it is not recommended to use other medicines inside, as well as the intake of food and liquids, in particular, antacids, milk, fruits and fruit juices. This is due to the fact that, when taken simultaneously orally, they can affect the effectiveness of De-Nol.
The combined use of De-Nol with tetracycline reduces the absorption of the latter.

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. During the period of treatment with De-Nol, other preparations containing bismuth should not be used. At the end of the course of treatment with the drug in recommended doses, the concentration of the active active substance in the blood plasma does not exceed 3-5 8 ?g / l, and intoxication is observed only at a concentration above 100 ?g / l.

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

Influence on the ability to drive vehicles and mechanisms

There are no data on the effect of De-NolЃ on the ability to drive vehicles and mechanisms.

Release form

During production at JSC 'R-Pharm', Russia, the instructions for medical use indicate the following information:
8 tablets each in a blister made of aluminum foil and PVC laminated with aluminum foil.

During production at ZiO-Zdorovye, Russia, the instructions for medical use indicate the following information:
8 tablets in a blister of aluminum foil and laminated aluminum foil.

When packaged at JSC 'ORTAT', Russia, the instructions for medical use indicate the following information:
8 tablets each in a blister made of aluminum foil and PVC laminated with aluminum foil.

For all manufacturers carrying out secondary packaging, the instructions for medical use indicate:
4, 7 or 14 blisters, together with instructions for use, in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life

4 years. Do not use after the expiration date printed on the package

Conditions of dispensing from pharmacies

Without recipe