Escape - instructions for use, dose, side effects, contraindications

Excipients: corn starch - 54.22 mg, povidone (medium molecular weight polyvinylpyrrolidone, povidone K 25) - 42.00 mg, polacrilin (potassium polacrilin) - 20.00 mg, magnesium stearate - 3.78 mg.

Sheath: AquaPoIish® R white 019,49 MS [Hydroxypropyl cellulose (E 464): 7.80 mg; hydroxypropyl cellulose (E 463) -1.30 mg; stearic acid (E570) - 0.91 mg; talc (E 553b) - 1.30 mg; polyethylene glycol 0.39 mg; titanium dioxide (E171) -1.30 mg] - 13.00 mg.

Description:Round biconvex tablets covered with a film coating of white or almost white color, with a faint smell of ammonia, on a fracture of white or almost white color.

Pharmacotherapeutic group:Antiulcer, antiseptic intestinal and astringent

ATX: & nbsp

A.02.B.X.05 Bismuth tricalcium dicitrate

Pharmacodynamics:

Gastroprotective and antiulcer with antibacterial 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 precipitate, chelate compounds are formed with a protein substrate in the form of a protective film on the surface of ulcers and erosions. Thus, the preparation forms a protective layer, which for a long period of time protects the affected parts of the mucosa from the influence of aggressive factors. By increasing the synthesis of prostaglandin E, the formation of mucus and the secretion of bicarbonate, stimulates activity cytoprotective mechanisms, increases the stability of the mucous membrane of the gastrointestinal tract to the effects of pepsin, hydrochloric acid, enzymes and bile salts. It leads to the accumulation of the epidermal growth factor in the defect area. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics:

Practically is not absorbed from the gastrointestinal tract. Displayed mainly with feces.An insignificant amount of bismuth, which 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 phase of exacerbation, including associated with Helicobacter pylori;

- peptic ulcer of the stomach and duodenum in the phase of exacerbation, including associated with Helicobacter pylori;

- irritable bowel syndrome, mainly with symptoms of diarrhea.

Contraindications:

- Increased individual sensitivity to the components of the drug;

- pregnancy;

- the period of breastfeeding;

- taking drugs containing bismuth;

- chronic renal failure;

- children under 4 years.

Pregnancy and lactation:

Bismuth tricalcium dicitrate is contraindicated in pregnant women. If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

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 The drug is prescribed 1 tablet 4 times a day, 30 minutes before meals (breakfast, lunch, dinner) and at night, or 2 tablets twice a day for 30 minutes before meals (breakfast, dinner).

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

Children aged 4 to 8 years appoint a dose of 8 mg / kg / day; depending on the weight of the child's appoint 1-2 tablets per day (respectively, in 1-2 hours per day). In this case, the daily dose should be closest to the calculated dose (8 mg / kg / day). Tablets are taken 30 minutes before meals, washed down with a small amount of water.

The tablet is recommended to swallow whole, without chewing and grinding, with plenty of water. It is not recommended to take the tablets with milk. The duration of treatment usually ranges from 4 to 8 weeks. After the end of the drug is not recommended to take medicines containing bismuth (for example, Vikalin, Vicair) for 2 months.

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

Side effects:

The following undesirable phenomena noted with the use of bismuth titrate dicitrate are distributed according to the frequency of occurrence according to the following gradation: very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1 000, <1/100); rarely (≥ 1/10 000, <1/1 000); very rarely (<1/10 000).

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

Allergic reactions: infrequent - skin rash, itching; very rarely - anaphylactic reactions.

From the side of 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 pass after drug withdrawal.

Overdose:

When using the drug in doses that are tens of times higher than recommended, or with prolonged use of excessive doses of the drug, the development of poisoning bismuth.

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, there may be a violation of kidney function.

These symptoms are completely reversible when the drug is withdrawn.

Treatment: there is no specific antidote.When an overdose of the drug is shown gastric lavage, the reception of enterosorbents and symptomatic therapy aimed at maintaining the function of the nights. In the case of an overdose, the appointment of salt laxatives is also indicated. In the future, treatment should be symptomatic. In the case of impaired renal function, accompanied by a high level of bismuth in the blood plasma, it is possible to introduce complexing agents - dimercaptosuccinic and dimercaptopropanesulfonic acids. With the development of severe renal dysfunction, hemodialysis is indicated.

Interaction:

Within half an hour before and half an hour after taking the drug, the use of other medicines inside, as well as the intake of food and liquids, in particular antacids, milk, fruits and fruit juices, is not recommended. This is due to the fact that they can affect the efficiency of bismuth tricalium dicitrate when administered concomitantly.

The drug reduces the absorption of tetracyclines.

The drug is not used concomitantly with other medicines 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 during treatment to exceed the established daily doses for adults and children. During drug treatment, other preparations containing bismuth should not be used (see section "Interaction with other drugs"). At the end of the course treatment with the drug in the recommended doses, the concentration of active active substance in the blood plasma does not exceed 3-58 μg / l, and intoxication is observed only at concentrations above 100 μg / l.

When using bismuth tricalium dicitrate, it is possible to stain the stool in a dark color due to the formation of bismuth sulphide.

Sometimes there is a slight darkening of the tongue.

During therapy, alcohol intake is not recommended.

Effect on the ability to drive transp. cf. and fur:

Data on the effect of the preparation Eskeyp® tablets coated with film coating on the ability to control vehicles and mechanisms are absent.

Form release / dosage:

Tablets, film-coated, 120 mg.

Packaging:

For 10 or 14 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

4 or 8 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:Store at a temperature not higher than 25 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003299

Date of registration:10.11.2015

Expiration Date:10.11.2020

The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp15.03.2017

Illustrated instructions

Instructions

Escape® (Escape)