Escape pills 120mg, 112pcs

Composition

Active ingredient:

Bismuth tripotassium dicitrate — 300.00 mg, in terms of bismuth oxide-120.00 mg.

Auxiliary substances:  

corn starch — 54.22 mg,

povidone (polyvinylpyrrolidone medium molecular weight, povidone K 25) – 42.00 mg,

polacrylin (potassium polacrylin) – 20.00 mg,

magnesium stearate-3.78 mg.

Shell:  

AquaPolish® P white 019,49 MS [hydroxypropylmethyl cellulose (E 464) — 7,80 mg; hydroxypropyl cellulose (E 463) and 1.30 mg, stearic acid (E 570) — 0,91 mg; talc (E 553b) and 1.30 mg; polyethylene glycol — 0,39 mg; titanium dioxide (E 171) and 1.30 mg] — 13,00 mg.

Pharmacological action

Gastroprotective and anti-ulcer agent with bactericidal activity against Helicobacter pylori. It also has an anti-inflammatory and astringent effect.

In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate are deposited, 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 that protects the affected areas of the mucous membrane from the influence of aggressive factors for a long period of time. Increasing the synthesis of prostaglandin E, mucus formation and bicarbonate secretion, it stimulates the activity of cytoprotective mechanisms, 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 defect area. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics

It is practically not absorbed from the gastrointestinal tract. It is mainly excreted in the faeces. A small amount of bismuth that enters the plasma is excreted from the body by the kidneys.

Indications

– Functional dyspepsia not associated with organic diseases of the gastrointestinal tract;

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

– stomach ulcer and duodenal ulcer in acute phase, including associated with Helicobacter pylori;

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

Use during pregnancy and lactation

Bismuth tripotassium dicitrate is contraindicated for use in pregnant women. If it is necessary to use the drug during lactation, stop breastfeeding.

Contraindications

• Increased individual sensitivity to the components of the drug;
• pregnancy; breast-feeding;
• taking drugs containing bismuth;
• chronic renal failure;
• children under 4 years of age.

Side effects

The following adverse events observed with the use of Bismuth tripotassium dicitrate are distributed according to the frequency of occurrence in accordance with the following gradation: very common (≥ 1/10); common (≥ 1/100, < 1/10); infrequent (≥ 1/1000, < 1/100); rare (≥ 1/10 000, < 1/1 000); very rare (

From the gastrointestinal tract: very often-staining of feces in black color; infrequently-nausea, vomiting, diarrhea or constipation.

Allergic reactions: infrequently – skin rash, pruritus; 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.

Interaction

Within half an hour before and half an hour after taking the drug, it is not recommended to use other medications inside, as well as food and liquids, in particular antacids, milk, fruit and fruit juices. This is due to the fact that they can affect the effectiveness of Bismuth tripotassium dicitrate when taken orally at the same time.

The drug reduces the absorption of tetracyclines.

The drug is not used simultaneously with other medications containing bismuth, since the simultaneous use of several bismuth preparations increases the risk of side effects, including the risk of developing encephalopathy.

How to take, course of use and dosage

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

Adults and children over 12 years of age are 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 8-12 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 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 as close as possible to the calculated dose (8 mg / kg / day).

Tablets are taken 30 minutes before meals, washed down with a small amount of water.

It is recommended to swallow the tablet whole, without chewing or grinding, with a sufficient amount of water. It is not recommended to drink tablets with milk. The duration of treatment is usually from 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 that have anti-helicobacter activity.

Overdose

When using the drug in doses ten times higher than recommended, or with prolonged use of excessive doses of the drug, bismuth poisoning may develop.

Symptoms:  dyspepsia, 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 function may be impaired.

These symptoms are completely reversible when the drug is discontinued.

Treatment:  there is no specific antidote. In case of overdose of the drug, gastric lavage, use of enterosorbents and symptomatic therapy aimed at maintaining kidney function 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, complexing agents — dimercaptoyantaric and dimercaptopropanesulfonic acids-can be administered. With the development of severe renal impairment, hemodialysis is indicated.

Special instructions

The drug should not be used for more than 8 weeks. It is not recommended to exceed the prescribed daily doses for adults and children during treatment. During treatment with the drug, other drugs containing bismuth should not be used (see the 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 ingredient in the blood plasma does not exceed 3-58 mcg/l, and intoxication is observed only at concentrations above 100 mcg/l.

When using Bismuth tripotassium dicitrate, feces may turn dark

due to the formation of bismuth sulfide.

Sometimes there is a slight darkening of the tongue.

Alcohol intake is not recommended during therapy.

Effects on the ability to drive vehicles and mechanisms

There are no data on the effect of Escape® film-coated tablets on the ability to drive vehicles and mechanisms.

Form of production

Film-coated tablets

Storage conditions

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

Shelf

life is 2 years.

Active ingredient

Bismuth tripotassium dicitrate

Dosage form

Tablets

Description

Children as prescribed by a doctor, Children over 4 years of age, For adults

Indications

Gastroduodenitis, Irritable Bowel syndrome, Diarrhea, Gastric and Duodenal Ulcers, Gastrointestinal infections caused by Helicobacter Pylori, Gastritis