Ulcavis, pills 120mg 56pcs

Composition

for 1 tablet:

Active ingredient:

Bismuth tripotassium dicitrate 303.03 mg, equivalent to bismuth oxide 120.00 mg

Auxiliary substances:

Corn starch, povidone K-30, potassium polycrylin, macrogol-6000, magnesium stearate

Film shell:

Opadray II transparent*, titanium dioxide (E 171)

* Opadray II transparent:

Polyvinyl alcohol, macrogol-4000, talc

Pharmacological action

antiseptic intestinal and astringent agent

Clinical Pharmacology

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, chelated compounds are formed with a protein substrate in the form of a protective film on the surface of ulcers and erosions. 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.

Pharmacokinetics

Bismuth subcitrate is practically not absorbed from the gastrointestinal tract. It is excreted mainly through the intestines. A small amount of bismuth that has entered the blood 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 associated with Helicobacter pylori.
• Irritable bowel syndrome, which occurs mainly with symptoms of diarrhea.
• Functional dyspepsia that is not associated with organic diseases of the gastrointestinal tract.

Use during pregnancy and lactation

The use of Ulkavis® during pregnancy and lactation is contraindicated.

Contraindications

Severe renal insufficiency (creatinine clearance less than 30 ml / min), pregnancy, breast-feeding, individual intolerance to the drug, children under 4 years of age.

Side effects

From the digestive system: nausea, vomiting, more frequent stools, and constipation may occur. These phenomena are not dangerous to health and are temporary in nature.

Allergic reactions: skin rash, itchy skin.

With prolonged use in high doses, encephalopathy associated with the accumulation of bismuth in the central nervous system may develop

Interaction

Within half an hour before and after taking Ulkavis®, 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 the drug Ulkavis®when taken orally at the sametime.

Concomitant use ofUlcavis with tetracycline reduces the absorption of tetracycline.

How to take, course of use and dosage

Adults and children over 12 years of age are prescribed Ulkavis® 1 tablet 4 times a day 30 minutes before meals and at night or 2 tablets 2 times a day 30 minutes before meals.

Children from 8 to 12 years of age are prescribed Ulkavis® 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 as close as possible to the calculated dose (8 mg / kg / day).

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

The duration of treatment is 4-8 weeks. For the next 8 weeks, you should not use medications containing bismuth.

For the eradication of Helicobacter pylori, it is advisable to use Ulkavis® in combination with other antibacterial agents that have anti-helicobacter activity (on the recommendation of a doctor).

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, skin rash, inflammation of the oral mucosa, characteristic darkening in the form of blue lines on the gums. An overdose ofUlcavis®caused by prolonged use of doses exceeding the recommended dose may lead to impaired renal function. These symptoms are completely reversible with discontinuation ofUlcavis.

Treatment: if signs of poisoning appear, it is necessary to wash the stomach, take activated charcoal and salt laxatives. Further treatment should be symptomatic. In case of impaired renal function, which is accompanied by a high concentration of bismuth in the blood plasma, chelating agents (penicillamine, sodium dimercaptopropanesulfonate) can be prescribed. In case of severe renal impairment, hemodialysis is indicated.

Description

Round slightly biconvex tablets, white or almost white film-coated tablets, odorless or slightly odorless with ammonia, chamfered.

View at the break: a rough mass of white color.

Special instructions

Contraindicated in children under 4 years of age.

For children over 12 years of age, Ulkavis® 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.

Children from 8 to 12 years of age are prescribed Ulkavis® 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 as close as possible to the calculated dose (8 mg / kg / day).

It is contraindicated in patients with severe renal insufficiency (creatinine clearance less than 30 ml / min),

Ulcavis® 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 treatment with Ulkavis®, other medications containing bismuth should not be used. At the end of the course of treatment withUlkavis® in the recommended doses, the concentration of the Active ingredient in the blood plasma does not exceed 3-58 mcg/l, and intoxication is observed only when the concentration in the blood plasma is higher than 100 mcg/l.

When using the drug Ulkavis®, feces may turn dark due to the formation of bismuth sulfide. Sometimes there is a slight darkening of the tongue.

There are no data on the effect ofUlkavis® on the ability to drive vehicles and mechanisms.

Form of production

Film-coated tablets,120 mg.

10 or 14 or 15 tablets in a blister of combined OPA/Al/PVC material and aluminum foil.

2,4,8 or 16 blisters (a blister of 14 tablets), or 3,4,6,10 or 24 blisters (a blister of 10 tablets), or 2,4,8 or 16 blisters (a blister of 15 tablets) together with the instructions for use are placed in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 °C, in the original packaging.

Keep out of reach of children.

Shelf

life is 3 years.

Do not use the drug after the expiration date.

Active ingredient

Bismuth tripotassium dicitrate

Dosage form

Tablets

Description

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

Indications

Irritable Bowel syndrome, Gastritis, Gastroduodenitis, Diarrhea, Gastrointestinal infections caused by Helicobacter Pylori, Stomach and Duodenal ulcer