Vitridinol pills 120mg, 112pcs

Composition

Active ingredient: Bismuth tripotassium dicitrate – 304.6 mg, in terms of bismuth oxide Bi2O3-120 mg. Auxiliary substances: corn starch-70.6 mg, povidone K 30-17.7 mg, potassium polyacrylate-23.6 mg, macrogol 6000-6.0 mg, magnesium stearate-2.0 mg. Shell:  Opadray 11 85F38077 – 4.3 mg, consists of polyvinyl alcohol, polyethylene glycol / macrogol 3350, yellow quinoline (E 104), talc, titanium dioxide, indigo carmine (E 132).

Pharmacological action

Pharmacotherapeutic group: Antiseptic intestinal and astringent sredstvo Kod ATX: A02BX05 Pharmacodynamics : An 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, and chelated compounds are formed with a protein substrate in the form of a protective film on the surface of ulcers and erosions. Increasing prostaglandin synthesis, mucus formation and bicarbonate secretion 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: Bismuth tripotassium dicitrate is practically not absorbed from the gastrointestinal tract. It is mainly excreted in the faeces. A small amount of bismuth entering the plasma is excreted from the body by the kidneys.

Indications

Peptic ulcer of the stomach and duodenum in the acute phase, including associated with Helicobacter pylori. Chronic gastritis and gastroduodenitis in the acute phase (including those associated with Helicobacter pylori). Functional dyspepsia not associated with organic diseases of the gastrointestinal tract. Irritable bowel syndrome occurs mainly with symptoms of diarrhea.

Use during pregnancy and lactation

Contraindicated in pregnancy. Stop breastfeeding for the duration of treatment.

Contraindications

Increased individual sensitivity to the components of the drug;

pregnancy;breast-feeding;

taking medications containing bismuth;

severe renal impairment (severe renal failure (creatinine clearance less than 30 ml / min) and chronic renal failure);

children under 4 years of age.

Side effects

The following adverse events reported 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 (≥ 1/10000, < 1/1000); 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. If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Within half an hour before and 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 juice. This is due to the fact that they can affect the effectiveness of the drug when taken orally at the same time. The combined use of the drug with tetracyclines reduces the absorption of the latter. Do not drink alcohol during treatment with the drug.

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.

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

Overdose

Prolonged use of the drug in doses higher than recommended may cause bismuth poisoning. Symptoms of poisoning: dyspepsia, rash, inflammation of the oral mucosa, characteristic darkening in the form of blue lines on the gums; kidney 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.

Description

Round biconvex film-coated tablets, light yellow in color

Special instructions

The drug should not be used for more than 8 weeks. During treatment, it is not recommended to exceed the established daily doses for adults and children. During treatment with Vitridinol, other drugs containing bismuth should not be used, as the risk of developing systemic side effects increases due to an increase in the concentration of bismuth in the blood. When using Vitridinol, feces 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 the drug Vitridinol on the ability to drive a car and work with mechanisms.

Storage conditions

In a dry place protected from light at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Bismuth tripotassium dicitrate

Dosage form

Tablets