Ulcavis, 120 mg 112 pcs

Gastroduodenitis, GI infections caused by Helicobacter pylori, Scrotal pain, Diarrhea, Irritable bowel syndrome, Gastritis, Peptic ulcer

• Gastric and duodenal ulcers in the acute phase, including those associated with Helicobacter pylori.
• Cronic gastritis and gastroduodenitis in the acute phase, including associated with Helicobacter pylori.
• Irritable bowel syndrome with predominantly diarrheal symptoms.
• Functional dyspepsia not associated with organic gastrointestinal diseases.

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Indications

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

Pharmacological effect

intestinal antiseptic and astringent

Special instructions

Contraindicated in children under 4 years of age.

For children over 12 years of age, Ulcavis® 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.

For children from 8 to 12 years old, Ulcavis® is prescribed 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 per day are prescribed (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)

Contraindicated in patients with severe renal impairment (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 Ulcavis®, other medications containing bismuth should not be used. At the end of a course of treatment with Ulcavis® in recommended doses, the concentration of the active substance in the blood plasma does not exceed 3-58 mcg/l, and intoxication is observed only when the concentration in the blood plasma is above 100 mcg/l.

When using the drug Ulcavis®, stool 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 of Ulcavis® on the ability to drive vehicles and operate machinery.

Active ingredient

Bismuth tripotassium dicitrate

Composition

for 1 tablet:

Active ingredient:

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

Excipients:

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

Film shell:

Opadry II transparent*, titanium dioxide (E171)

*Opadray II transparent:

Polyvinyl alcohol, macrogol-4000, talc

Pregnancy

The use of Ulcavis® during pregnancy and breastfeeding is contraindicated.

Contraindications

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

Side Effects

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

Allergic reactions: skin rash, itching.

With long-term use in high doses, the development of encephalopathy associated with the accumulation of bismuth in the central nervous system is possible.

Interaction

For half an hour before and after taking Ulcavis®, it is not recommended to take other medications internally, as well as take food and liquids, in particular antacids, milk, fruits and fruit juices. This is due to the fact that when taken orally simultaneously, they can affect the effectiveness of the drug Ulcavis®.

The simultaneous use of Ulcavis® with tetracycline reduces the absorption of the latter.

Overdose

When using the drug in doses tens of 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 of Ulcavis®, caused by long-term use of doses exceeding the recommended ones, can lead to impaired renal function. These symptoms are completely reversible when Ulcavis® is discontinued.

Treatment: if signs of poisoning appear, it is necessary to rinse the stomach, take activated charcoal and saline 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 dysfunction, hemodialysis is indicated.

Clinical pharmacology

Pharmacodynamics

Antiulcer agent with bactericidal activity against Helicobacter pylori. It also has anti-inflammatory and astringent effects. In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate are precipitated, and chelate compounds are formed with the protein substrate in the form of a protective film on the surface of ulcers and erosions. By 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 pepsin activity.

Pharmacokinetics

Bismuth subcitrate is practically not absorbed from the gastrointestinal tract. It is excreted primarily through the intestines. A small amount of bismuth entering the blood plasma is excreted from the body by the kidneys.

Storage conditions

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

Keep out of the reach of children.

Shelf life

3 years.

Do not use the drug after the expiration date.

Manufacturer

KRKA dd Novo Mesto, Slovenia