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Instructions for use Ulcavis

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINE Ulcavis® Ulcavis®

Registration number:

Trade name: Ulcavis®

International nonproprietary or generic name: bismuth tripotassium dicitrate

Dosage form: film-coated tablets

Composition per 1 tablet: Active ingredient: Tripotassium bismuth dicitrate 303.03 mg (equivalent to bismuth oxide 120.00 mg) Excipients: Corn starch, povidone K-30, potassium polykrilin, macrogol-6000, magnesium stearate Film coating: Opadry II transparent *, titanium dioxide (E171) *Opadray II transparent: polyvinyl alcohol, macrogol-4000, talc

Description Round, slightly biconvex, film-coated tablets of white or almost white color, odorless or with a faint odor of ammonia, with a bevel.

On the fracture there is a rough white mass.

Pharmacotherapeutic group: antiseptic intestinal and astringent ATC code: A02BX05

Pharmacological properties 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.

Indications for use

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.

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

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

Method of administration and dosage: For adults and 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). The tablets are taken 30 minutes before meals with a small amount of water. The duration of treatment is 4-8 weeks. You should not use medications containing bismuth for the next 8 weeks. To eradicate Helicobacter pylori, it is advisable to use the drug Ulcavis® in combination with other antibacterial agents that have anti-Helicobacter pylori activity (as recommended by a doctor).

Side effects From the digestive system: nausea, vomiting, more frequent bowel movements, 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.

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 the drug Ulcavis ® . 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.

Interaction with other drugs For half an hour before and after taking Ulcavis ® , it is not recommended to take other drugs orally, 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.

Special instructions 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.

Effect on the ability to drive vehicles and machinery data on the effect of the drug Ulcavis ® on the ability to drive vehicles and machinery.

Release form: Film-coated tablets, 120 mg. 10 or 14 or 15 tablets in a blister made of combined material OPA/Al/PVC and aluminum foil. 2, 4, 8 and 16 blisters (blister of 14 tablets) or 3, 4, 6, 10 and 24 blisters (blister of 10 tablets), or 2, 4, 8 and 16 blisters (blister of 15 tablets) together with instructions for use are placed in a cardboard box.

Storage conditions At a temperature not exceeding 25 ºС, in the original packaging. Keep out of the reach of children.

Shelf life: 3 years. Do not use the drug after the expiration date.

Conditions of release Dispensed without a prescription.

Name and address of the holder (owner) of the registration certificate JSC "KRKA, d.d., Novo mesto", Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer (All stages of production) JSC "KRKA, d.d., Novo mesto", Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Name and address of the organization receiving consumer complaints LLC KRKA-RUS, 125212, Moscow, Golovinskoe highway, building 5, building 1 Tel., fax

Ulcavis 120 mg No. 112 tablet p.p.o.

APPROVED by the Order of the Chairman of the Pharmacy Committee of the Ministry of Health of the Republic of Kazakhstan Instructions for the medical use of the drug Ulcavis® Trade name Ulcavis® International nonproprietary name No Dosage form Film-coated tablets, 120 mg Composition One tablet contains the active substance: bismuth tripotassium dicitrate 303.03 mg ( equivalent to bismuth oxide 120 mg), excipients: corn starch, povidone K-30, potassium polyacryline, macrogol 6000, magnesium stearate, shell: Opadry II clear (composition: polyvinyl alcohol, macrogol 4000, talc), titanium dioxide (E171) Description Film-coated tablets, white or almost white, round, slightly biconvex, chamfered, odorless or with a faint odor of ammonia Pharmacotherapeutic group Other antiulcer drugs and drugs for the treatment of gastroesophageal reflux (GORD). Bismuth tripotassium dicitrate. ATC code A02BX05 Pharmacological properties Pharmacokinetics Absorption Ulcavis® is a surface-active agent, negligible amounts of bismuth, derivatives of bismuth subcitrate, are absorbed during treatment (less than 0.2% of the dose). Distribution Bismuth is mainly deposited in the kidneys; other organs also contain traces of bismuth. Biotransformation Ulcavis® is deposited in the stomach into insoluble bismuth complex compounds, possibly into bismuth oxychloride and bismuth citrate. Excretion The bulk of bismuth taken orally is excreted in the feces. Urine clearance with small amounts of absorbed bismuth is approximately 50 ml/min. However, most of the absorbed bismuth is excreted within a half-life of 5-11 days. Pharmacodynamics Ulcavis® is an 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 prostaglandins 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. Indications for use - peptic ulcer of the stomach and duodenum - chronic gastritis and gastroduodenitis in the acute phase, including those associated with Helicobacter pylori Method of administration and dosage Orally For adults, 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. The tablets should be taken 30 minutes before meals and washed down 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. To eradicate Helicobacter pylori, it is advisable to use Ulcavis® in combination with other antibacterial agents that have anti-Helicobacter activity and proton pump inhibitors, the so-called quadruple therapy. Side effects Very common (≥ 1/10) - dark coloration of stool due to the formation of bismuth sulfide, but it can be easily distinguished from melena Uncommon (≥ 1/1000, <1/100) - nausea, vomiting, diarrhea or constipation - allergic reactions: skin rash, itching Very rare (<1/10000) - anaphylactic reactions - with long-term use in high doses - encephalopathy associated with the accumulation of bismuth in the central nervous system Contraindications - hypersensitivity to any component of the drug - chronic renal failure - hypokalemia - pregnancy and lactation - children under 18 years of age Drug interactions Within half an hour 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 Ulcavis®. Ulcavis® reduces the absorption of tetracycline. Special instructions The drug should not be used for more than 8 weeks; it is also not recommended to exceed the established daily doses for adults during treatment. During treatment with the drug, you should not use other drugs containing bismuth, as the risk of side effects increases. At the end of a course of treatment with the drug 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 at concentrations above 100 mg/l. Prolonged use of large doses of bismuth-containing compounds is not recommended, since in some cases it can lead to reversible encephalopathy. The risk of encephalopathy, however, is minimal when Ulcavis is used in recommended doses. When using Ulcavis, stool may turn dark due to the formation of bismuth sulfide. Sometimes there is a darkening of the tongue. Alcohol intake is not recommended during Ulcavis therapy. Peculiarities of the drug's influence on the ability to drive a vehicle or operate potentially dangerous mechanisms. No effect. Overdose Symptoms: dyspepsia, rash, inflammation of the mucous membranes of the mouth, characteristic darkening in the form of blue lines on the gums, impaired renal function. Treatment: discontinuation of the drug, gastric lavage, taking activated charcoal, saline laxatives. Monitoring of kidney function and bismuth concentrations in the blood and urine is indicated. Subsequently, symptomatic therapy is carried out. In case of impaired renal function, accompanied by a high level of bismuth in the blood plasma, complexing agents - dimercaptosuccinic and dimercaptopropanesulfonic acids - can be administered. In severe renal failure, hemodialysis is indicated. Release form and packaging 14 tablets are placed in a blister pack made of laminated polyamide/aluminum/polyvinyl chloride film and aluminum foil. 2, 4 or 8 blister packs together with instructions for medical use in the state and Russian languages are placed in a cardboard pack. Storage conditions In original packaging at a temperature not exceeding 25 ºС. Keep out of the reach of children! Shelf life 2 years Do not use after expiration date Conditions for dispensing from pharmacies Without a prescription Manufacturer KRKA, d.d. Novo mesto, Slovenia Šmarješka cesta 6, 8501 Novo mesto, Slovenia Registration certificate holder KRKA, d.d. Novo mesto, Slovenia Address of the organization on the territory of the Republic of Kazakhstan that accepts claims (suggestions) on the quality of medicines from consumers and is responsible for post-registration monitoring of the safety of the medicine: KRKA Kazakhstan LLP, RK, 050059, Almaty, Al-Ave. Farabi 19, building 1 b, 2nd floor, office 207 tel.: +7 (727) 311 08 09 fax