Heli-Stop® tablets 120 mg

Instructions for use Heli-Stop® tablets 120 mg

Registration number: LP-005904

Trade name of the drug: Heli-Stop

International nonproprietary name or grouping name: Bismuthate tripotassium dicitrate

Dosage form: film-coated tablets

Composition per one tablet:

Active substance: Bismuthate tripotassium dicitrate - 300.0 mg, calculated as bismuth oxide - 120.0 mg;

Excipients: povidone K-17 – 17.7 mg, macrogol – 6.0 mg, magnesium stearate – 2.0 mg, crospovidone – 1.5 mg, corn starch – up to a core tablet weight of 430.0 mg.

Film coating excipients: Mixture for film coating "VIVACOAT®" (hypromellose – 35.0 %, methacrylic acid - ethyl acrylate copolymer (1:1) – 30.0 %, talc – 18.0 %, titanium dioxide – 10.0 %, triacetin – 7.0 %).

Description:

Round, biconvex, film-coated tablets, white or almost white in color. The core on cross-section is from white to almost white with a brownish tint. Inclusions from grey to brown are allowed. Marbling and a rough tablet surface are allowed.

Pharmacotherapeutic group: Antiulcer agent, intestinal antiseptic and astringent.

ATC Code: A02BX05

Pharmacological properties

Pharmacodynamics:

A gastroprotective and anti-ulcer agent with bactericidal activity against Helicobacter pylori. It also possesses anti-inflammatory and astringent effects.

In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate precipitate, forming chelate compounds with the protein substrate as a protective film on the surface of ulcers and erosions. Thus, the drug forms a protective layer that, for an extended period, protects the affected areas of the mucous membrane from the influence of aggressive factors. By increasing the synthesis of prostaglandin E, the formation of mucus, and the secretion of bicarbonate, 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.

Pharmacokinetics:

Practically not absorbed from the gastrointestinal tract. Excreted primarily in feces. A small amount of bismuth that enters the plasma is excreted by the kidneys.

Indications for use:

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

Contraindications:

• Hypersensitivity to the components of the drug;
• Pregnancy;      
• Breastfeeding period;
• Concomitant use of drugs containing bismuth;
• Chronic renal failure;
• Severe renal impairment (severe renal failure (creatinine clearance less than 30 ml/min) and chronic renal failure);
• Children under 4 years of age.

Use during pregnancy and breastfeeding:

Heli-Stop is contraindicated in pregnant women. If use during lactation is necessary, breastfeeding should be discontinued.

Dosage and administration:

Orally. The duration of the treatment course and drug dosage is determined individually for each patient by the treating physician, depending on the nature of the disease.

Adults and children over 12 years: The drug is prescribed as 1 tablet four times daily 30 minutes before meals (breakfast, lunch, dinner) and at bedtime, OR as 2 tablets
twice daily 30 minutes before meals (breakfast, dinner).

Children aged 8 to 12 years: Prescribed 1 tablet twice daily
30 minutes before meals (breakfast, dinner).

Children aged 4 to 8 years: Prescribed at a dose of 8 mg/kg/day; depending on the child's body weight, 1-2 tablets per day are prescribed (accordingly, in 1-2 doses per day). 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 tablet should be swallowed whole, without chewing or crushing, with a sufficient amount of water. It is not recommended to take the tablets with milk. The duration of the treatment course is usually from 4 to 8 weeks. After finishing the course, it is not recommended to take medicines containing bismuth (e.g., Vikalin, Vikair) for 2 months.

For the eradication of Helicobacter pylori it is advisable to use Bismuthate Tripotassium Dicitrate in combination with antibacterial drugs possessing anti-Helicobacter activity.

If no improvement occurs during treatment, consult a doctor. Use the drug only according to the dosage and administration instructions provided. If necessary, please consult your doctor before using the medicine.

Adverse reactions:

The adverse events listed below, observed with the use of Bismuthate Tripotassium Dicitrate, are categorized by frequency as follows: Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100); Rare (≥ 1/10,000, <1/1,000); Very rare (< 1/10,000).

Gastrointestinal disorders: Very common - black discoloration of stools; Uncommon - nausea, vomiting, diarrhea, or constipation.

Allergic reactions: Uncommon - skin rash, itching; Very rare - anaphylactic reactions.

Nervous system disorders: Very rare - with long-term use in high doses - encephalopathy associated with the accumulation of bismuth in the CNS.

Adverse effects are reversible and resolve quickly after discontinuation of the drug. If any of the adverse effects mentioned in the instructions worsen, or if you notice any other adverse effects not listed, inform your doctor.

Overdose:

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

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 recommendations, impaired renal function is possible.

These symptoms are completely reversible upon discontinuation of the drug.

Treatment: There is no specific antidote. In case of overdose, gastric lavage, administration of enterosorbents, and symptomatic therapy aimed at maintaining kidney function are indicated. Administration of saline laxatives is also indicated in case of overdose. Further treatment should be symptomatic. In case of impaired renal function accompanied by high plasma bismuth levels, chelating agents – dimercaptosuccinic acid and dimercaptopropanesulfonic acid – can be administered. If severe renal impairment develops, hemodialysis is indicated.

Drug interactions:

Within half an hour before and half an hour after taking the drug, the oral use of other medicines, as well as consumption of food and liquids, particularly antacids, milk, fruits, and fruit juices, is not recommended. This is because they may affect the effectiveness of Bismuthate Tripotassium Dicitrate when taken concomitantly.

The drug reduces the absorption of tetracyclines.

The drug should not be used concurrently with other medicines containing bismuth, as the simultaneous use of several bismuth preparations increases the risk of adverse effects, including the risk of encephalopathy.

Special warnings and precautions:

The drug should not be used for more than 8 weeks. It is not recommended to exceed the established daily doses for adults and children during treatment. During treatment with the drug, other preparations containing bismuth should not be used (see section "Drug Interactions"). Upon completion of the course of treatment with the drug at recommended doses, the concentration of the active substance in the blood plasma does not exceed 3-58 µg/L, while intoxication is observed only at concentrations above 100 µg/L.

When using Heli-Stop, black discoloration of stools is possible due to the formation of bismuth sulfide.

Slight darkening of the tongue is sometimes noted.

Alcohol consumption is not recommended during therapy.

Effect on ability to drive and operate machinery:

Data on the effect of Bismuthate Tripotassium Dicitrate on the ability to drive vehicles and operate machinery are not available.

Dosage form:

Film-coated tablets, 120 mg.

8, 10, or 14 tablets in a blister strip made of polyvinyl chloride/polyvinylidene chloride film or multilayer aluminum foil and printed lacquered aluminum foil.

4, 7, 10, or 14 blister packs of 8 tablets, or 4, 6, 8, 10, or 12 blister packs of 10 tablets, or 4 or 8 blister packs of 14 tablets, together with the instructions for use, are placed in a cardboard carton for consumer packaging.

Storage conditions:

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

Shelf life:

2 years. Do not use after the expiration date.

Prescription status:

Available without a prescription.

Name and address of the legal entity in whose name the registration certificate is issued / Organization accepting claims:

JSC "AVVA RUS", Russia, 121614, Moscow, Krylatskie Kholmy st., 30, building 9.

Tel.: +7 (495) 956-75-54.

avva.com.ru

Manufacturer:

JSC "AVVA RUS", Russia, 610044, Kirov region, Kirov, Luganskaya st., 53a.

Tel.: +7 (8332) 25-12-29.