Vikanol Life - instructions for use, dose, side effects, contraindications

Excipients: corn starch - 70,60 mg, potassium polyacrylate - 23.60 mg, magnesium stearate - 2.00 mg, povidone K30 - 1.70 mg, macrogol 6000 - 2.13 mg.

Sheath:

Gipromellose 5 mPas - 3.20 mg, macrogol 6000 - 1.10 mg.

Description:

Round biconvex tablets covered with a creamy-white coating, odorless or with a slight odor of ammonia. On the break the tablets are white or almost white in color.

Pharmacotherapeutic group:Antiulcer, antiseptic intestinal and astringent

ATX: & nbsp

A.02.B.X.05 Bismuth tricalcium dicitrate

Pharmacodynamics:

Antiulcer 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 precipitate, chelate 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, the formation of mucus and the secretion of bicarbonate, stimulates the activity of cytoprotective mechanisms, increases resistance mucous membrane of the gastrointestinal tract to the effects of pepsin, hydrochloric acid, enzymes and bile salts. It leads to the accumulation of the epidermal growth factor in the defect area. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics:

Bismuth subcitrate is practically not absorbed from the gastrointestinal tract. It is excreted mainly with feces. An insignificant amount of bismuth, which enters the plasma, is excreted from the body by the kidneys.

Indications:

- Chronic gastritis and gastroduodenitis in the phase of exacerbation, including associated with Helicobacter pylori.

- Peptic ulcer of the stomach and duodenum in the phase of exacerbation, including associated with Helicobacter pylori.

- Functional dyspepsia, not associated with organic diseases of the gastrointestinal tract.

- Irritable bowel syndrome, which occurs mainly with symptoms of diarrhea.

Contraindications:

Severe renal impairment (severe renal failure (creatinine clearance less than 30 ml / min) and chronic renal failure), pregnancy, breastfeeding period, individual drug intolerance, children under 4 years old, taking medications containing bismuth.

Pregnancy and lactation:

The use of the drug Vikanol Life during pregnancy and during breastfeeding is contraindicated.

Dosing and Administration:

The drug is taken orally.

Adults and children over 12 years of age the drug is prescribed 1 tablet 4 times a day for 30 minutes before meals (breakfast, lunch and dinner) and for the night or 2 tablets 2 times a day for 30 minutes before meals (breakfast, dinner).

Children from 8 to 12 years old the drug is prescribed 1 tablet 2 times a day for 30 minutes before meals (breakfast, dinner).

Children from 4 to 8 years appoint a dose of 8 mg / kg / day; depending on the body weight of the child appoint 1-2 tablets per day (respectively, in 1-2 hours per day). In this case, the daily dose should be closest to the calculated dose (8 mg / kg / day).

The drug is taken 30 minutes before meals, squeezed with a small amount of water. The tablet should be swallowed whole, not chewing and grinding, with enough water. It is not recommended to take the tablets with milk.

Duration of treatment 4-8 weeks. For the next 8 weeks, do not use drugs containing bismuth (for example, Vicair, Vikalin).

For eradication Helicobacter pylori it is advisable to use the drug in combination with other antibacterial agents with anti-Helicobacter activity (as recommended by the doctor).

Side effects:

The frequency of side effects of the drug is assessed as follows:

Very frequent: ≥ 1/10, frequent: ≥ 1/100, <1/10, infrequent: ≥ 1/1000, <1/100, rare: ≥ 1/10 000, <1/1000, very rare: <1 / 10 000.

From the gastrointestinal tract: very often - staining the feces in black; infrequently - nausea, vomiting, diarrhea, or constipation.

Allergic reactions: infrequently - skin rash, itching; very rarely - anaphylactic reactions.

From the nervous system: very rarely - with prolonged use in high doses, the development of encephalopathy associated with the accumulation of bismuth in the central nervous system (CNS) is possible.

Side effects are reversible and quickly pass after drug withdrawal.

Overdose:

When using the drug in doses that are dozens of times higher than recommended, or if the doses of the drug are longer than recommended, a development of bismuth poisoning is possible.

Symptoms: inflammation of the mucous membrane of the mouth, rash, indigestion, darkening in the form of blue lines on the gums; with prolonged use of inflated doses of the drug may impair renal function.

These symptoms are completely reversible when the drug is withdrawn.

Treatment: there is no specific antidote. When an overdose of the drug shows gastric lavage, the reception of enterosorbents (for example, Activated carbon) and symptomatic therapy aimed at maintaining kidney function. Also, in case of an overdose, the appointment of salt laxatives is indicated. In the future, treatment should be symptomatic.In the case of impaired renal function, accompanied by a high level of bismuth in the blood plasma, you can enter complexing agents - dimercaptosuccinic and dimercaptopropanesulfonic acids. In the case of development of severe renal dysfunction, hemodialysis is indicated.

Interaction:

Within half an hour before and after taking the drug, it is not recommended to use other medicines inside, as well as food and liquid intake, in particular antacids, milk, fruits and fruit juices. This is due to the fact that they can affect the effectiveness of the drug while taking it inside.

The drug reduces the absorption of tetracyclines.

The drug should not be used concomitantly with other medicines containing bismuth, since the simultaneous administration of several bismuth preparations may lead to the risk of side effects, including the risk of encephalopathy.

Special instructions:

The drug should not be used for more than 8 weeks. Also it is not recommended during treatment to exceed the established daily doses for adults and children. During the treatment with the drug should not use other drugs containing bismuth.At the end of the course treatment with the drug at recommended doses, the active substance concentration in the blood plasma does not exceed 3 - 5 8 μg / l, and intoxication is observed only at concentrations above 100 μg / l.

When applying the drug, it is possible to stain the stool in a dark color due to the formation of bismuth sulphide. Sometimes there is a slight darkening of the tongue. During therapy, alcohol intake is not recommended.

Effect on the ability to drive transp. cf. and fur:

There are no data on the effect of the drug on the ability to drive vehicles and mechanisms.

Form release / dosage:

Tablets, film-coated, 120 mg.

Packaging:

By 8, 10, 15, 20 tablets into the contour cell package from the film polyvinylchloride and aluminum foil.

By 3, 4, 6, 7, 8, 10, 12, 14, 24 contour mesh packages along with the instruction for use are placed in a pack of cardboard.

By 30, 60, 120, 240 tablets in cans of polymeric polyethylene for storage of medicines and vitamins complete with polymeric polyethylene capsules or in cans of polymeric polyethylene with the control of the first opening and shock absorber.

1 bank together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004459

Date of registration:12.09.2017

Expiration Date:12.09.2022

The owner of the registration certificate:NGO Farmvilar, OOO NGO Farmvilar, OOO Russia

Manufacturer: & nbsp

NGO Farmvilar, OOO Russia

Information update date: & nbsp06.10.2017

Illustrated instructions

Instructions

Vikanol® Life (Vikanol Life)