Bismuth tripotassium dicitrate tablets p / o 120mg, No. 112

• functional dyspepsia not associated with organic diseases of the gastrointestinal tract;

• chronic gastritis and gastroduodenitis in the acute phase, including those associated with Helicobacter pylori;

• peptic ulcer and duodenal ulcer in the acute phase, including those associated with Helicobacter pylori;

• irritable bowel syndrome, occurring mainly with symptoms of diarrhea.

Inside. The duration of the course of treatment and the dose of the drug are determined by the attending physician individually for each patient, depending on the nature of the disease.

For adults and children over 12 years of age, the drug is prescribed 1 tablet 4 times a day, 30 minutes before meals (breakfast, lunch, dinner) and at night, or 2 tablets 2 times a day 30 minutes before meals (breakfast, dinner).

Children aged 8 to 12 years are prescribed 1 tablet 2 times a day, 30 minutes before meals (breakfast, dinner).

Children aged 4 to 8 years are prescribed at a dose of 8 mg / kg / day; depending on the body weight of the child, 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 small amount of water.

It is recommended to swallow the tablet whole, without chewing or crushing, drinking plenty of water.

It is not recommended to drink the tablets with milk.

The duration of the course of treatment is usually 4 to 8 weeks.

After the end of taking the drug, it is not recommended to take medicines containing bismuth (for example, Vikalin, Vikair) for 2 months.

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

If there is no improvement during treatment, you should consult a doctor. Use the drug only according to the method of administration and in the doses indicated in the instructions. If necessary, please consult your doctor before using this medication.

for 1 tablet:

Active substance : bismuth tripotassium dicitrate - 304.6 mg, in terms of bismuth oxide - 120.0 mg.

Excipients : corn starch - 71.1 mg; potassium polyacrylate - 23.6 mg; povidone-K25 - 17.7 mg; macrogol-6000 - 6.0 mg; magnesium stearate - 2.0 mg.

Shell composition : hypromellose - 5.5 mg; titanium dioxide - 3.0 mg; macrogol-4000 - 1.5 mg.

Х increased individual sensitivity to the components of the drug;

Х pregnancy;

Х period of breastfeeding;

Х taking medications containing bismuth;

Х chronic renal failure;

Х children under 4 years of age.

Trade name of the drug:

Bismuth tripotassium dicitrate

International non-proprietary name:

bismuth tripotassium dicitrate

Dosage form:

film-coated tablets

Composition:

for 1 tablet:

Active substance: bismuth tripotassium dicitrate - 304.6 mg, in terms of bismuth oxide - 120.0 mg.

Excipients : corn starch - 71.1 mg; potassium polyacrylate - 23.6 mg; povidone-K25 - 17.7 mg; macrogol-6000 - 6.0 mg; magnesium stearate - 2.0 mg.

Shell composition : hypromellose - 5.5 mg; titanium dioxide - 3.0 mg; macrogol-4000 - 1.5 mg.

Description:

round biconvex film-coated tablets of white or almost white color; odorless or with a weak characteristic odor. The cross section shows two layers: a core of white or white with a yellowish tinge and a film shell.

Pharmacotherapeutic group:

antiulcer, antiseptic intestinal and astringent.

ATX code:

A02VX05

Pharmacological properties

Pharmacodynamics

Gastroprotective and 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. Thus, the drug forms a protective layer, which for a long period of time protects the affected areas of the mucous membrane from the influence of aggressive factors. 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 fact 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 and pepsinogen.

Pharmacokinetics

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

• functional dyspepsia not associated with organic diseases of the gastrointestinal tract;

• chronic gastritis and gastroduodenitis in the acute phase, including those associated with Helicobacter pylori;

• peptic ulcer and duodenal ulcer in the acute phase, including those associated with Helicobacter pylori;

• irritable bowel syndrome, occurring mainly with symptoms of diarrhea.

Contraindications

• increased individual sensitivity to the components of the drug;

• pregnancy;

• breastfeeding period;

• taking drugs containing bismuth;

• chronic renal failure;

• children under 4 years of age.

Application during pregnancy and during breastfeeding

Bismuth tripotassium dicitrate is contraindicated in pregnant women. If necessary, the use of the drug during lactation should stop breastfeeding.

Method of administration and dosage

Inside. The duration of the course of treatment and the dose of the drug are determined by the attending physician individually for each patient, depending on the nature of the disease.

For adults and children over 12 years of age, the drug is prescribed 1 tablet 4 times a day, 30 minutes before meals (breakfast, lunch, dinner) and at night, or 2 tablets 2 times a day 30 minutes before meals (breakfast, dinner).

Children aged 8 to 12 years are prescribed 1 tablet 2 times a day, 30 minutes before meals (breakfast, dinner).

Children aged 4 to 8 years are prescribed at a dose of 8 mg / kg / day; depending on the body weight of the child, 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 small amount of water.

It is recommended to swallow the tablet whole, without chewing or crushing, drinking plenty of water.

It is not recommended to drink the tablets with milk.

The duration of the course of treatment is usually 4 to 8 weeks.

After the end of taking the drug, it is not recommended to take medicines containing bismuth (for example, Vikalin, Vikair) for 2 months.

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

If there is no improvement during treatment, you should consult a doctor. Use the drug only according to the method of administration and in the doses indicated in the instructions. If necessary, please consult your doctor before using this medication.

Side effect

The undesirable effects listed below, noted with the use of bismuth tripotassium dicitrate, are distributed according to the frequency of occurrence in accordance with the following gradation: very often ( > 1/10); often ( > 1/100, <1/10); infrequently ( > 1/1000, <1/100); rarely ( > 1/10 000, <1/1 000); very rare (<1/10 000).
From the gastrointestinal tract : very often - stool staining black; infrequently - nausea, vomiting, diarrhea, or constipation.
Allergic reactions : infrequently - skin rash, itching; very rarely - anaphylactic reactions.
From the nervous system : very rarely - with prolonged use in high doses - encephalopathy associated with the accumulation of bismuth in the central nervous system.
Side effects are reversible and quickly disappear after discontinuation of the drug.
If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose

When using the drug in doses dozens of times higher than the recommended ones, or with prolonged use of overestimated doses of the drug, bismuth poisoning may develop.
Symptoms : indigestion, rash, inflammation of the oral mucosa, characteristic darkening in the form of blue lines on the gums; with prolonged use in doses exceeding the recommended ones, renal dysfunction is possible.
These symptoms are completely reversible when the drug is discontinued.
Treatment: no specific antidote. In case of an overdose of the drug, gastric lavage, the intake of enterosorbents and symptomatic therapy aimed at maintaining the function of the nights are indicated. In case of overdose, the appointment of saline laxatives is also indicated. Further treatment should be symptomatic. In case of impaired renal function, accompanied by a high level of bismuth in the blood plasma, you can enter complexing agents - dimercaptosuccinic and dimercaptopropanesulfonic acids. With the development of severe renal dysfunction, hemodialysis is indicated.

Interaction with other medicinal products

Within half an hour before and half an hour after taking the drug, 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, they can affect the effectiveness of bismuth tripotassium dicitrate.
The drug reduces the absorption of tetracyclines.
The drug is not used concurrently with other drugs containing bismuth, since the simultaneous use of several bismuth drugs increases the risk of side effects, including the risk of encephalopathy.

special instructions

The drug should not be used for more than 8 weeks. It is not recommended to exceed the established daily doses for adults and children during treatment. During the period of drug treatment, you should not use other drugs containing bismuth (see section 'Interaction with other drugs'). At the end of the course of treatment with the drug in the recommended doses, the concentration of the active active substance in the blood plasma does not exceed 3-58 ?g / l, and intoxication is observed only at a concentration above 100 ?g / l.
When using bismuth tripotassium dicitrate, feces may become dark in color due to the formation of bismuth sulfide.
Sometimes there is a slight darkening of the tongue.
Alcohol intake is not recommended during therapy.

Influence on the ability to drive vehicles and mechanisms

There are no data on the effect of the drug Bismuth tripotassium dicitrate on the ability to drive vehicles and mechanisms.

Release form

Film-coated tablets 120 mg.
On 7, 10, 14, 28, 30 tablets in a blister strip packaging from a film of polyvinyl chloride and printed aluminum foil varnished.
7, 10, 14, 20, 28, 30, 50, 56, 60, 100, 112, 160 or 240 tablets in jars made of polyethylene terephthalate for medicines or polypropylene for medicines, sealed with high-pressure polyethylene lids with first opening control , or polypropylene caps with a 'push-turn' system or low-pressure polyethylene caps with first opening control.
One can or 1, 2, 3, 4, 5, 6, 7, 8, 10 or 16 blisters together with instructions for use are placed in a cardboard package (pack).

Storage conditions

At a temperature not higher than 25 ? C.
Keep out of the reach of children.

Shelf life

3 years. Do not use after the expiration date.

Vacation conditions

Available without a prescription.