Bismuth tripotassium dicitratobismuthate pi n / v 120mg film 112 pcs

Description

Composition
Active substance:
bismuth tripotassium dicitratobismuthate – 304.6 mg, based on bismuth oxide – 120.0 mg.
Excipients:
Corn starch – 71.1 mg; potassium polyacrylate – 23.6 mg; povidone K25 – 17.7 mg; macrogol-6000 – 6.0 mg; Magnesium stearate – 2.0 mg.
Composition of the shell; Valium – 5.5 mg; titanium dioxide – 3.0 mg; macrogol-4000 – 1.5 mg.
Description:
Round biconvex tablets, film-coated white or almost white, odorless or with a faint characteristic odor. The cross section shows two layers: the nucleus of the white or white to yellowish white color and a film coating.
Product form:
Tablets, film-coated 120 mg.
For 112 tablets in polyethylene jars for medicines or polypropylene for medicines, caps of the capped high-pressure polyethylene having a first opening control or polypropylene lids with a system “push-turn” or caps of high density polyethylene with a first control opening.
One jar together with instructions for use placed in a cardboard box (pack).
Equipment is allowed to 2 or 3 cartons (packs) in multipacks (transportation) of paperboard for consumer packaging or imported.
Contraindications
• increased individual sensitivity to the drug;
• pregnancy;
• breastfeeding;
• reception of preparations containing bismuth;
• chronic renal failure;
• Children under 4 years old.
Indications
• functional dyspepsia not associated with organic disease of the gastrointestinal tract;
• chronic gastritis and gastroduodenitis in the acute phase, including those associated with Helicobacter pylori;
• gastric ulcer and duodenal ulcer in the acute phase, including those associated with Helicobacter pylori;
• Irritable bowel syndrome occurs predominantly with symptoms of diarrhea.
Interaction with other drugs
Within half an hour before and after drug administration is not suitable for use within other drugs, as well as meal and liquid, in particular antacids, milk, fruit and fruit juices. This is due to the fact that they, while ingestion may affect the efficiency of bismuth tripotassium dicitrate.
The drug reduces the absorption of tetracyclines.
Preparation is not used in conjunction with other pharmaceutical preparations containing bismuth, as bismuth simultaneous use of several drugs increases the risk of side effects, including the risk of encephalopathy.
Overdose
In applying the drug in doses tens of times higher than recommended, or long-term use of excessive doses of the drug may develop poisoning bismuth.
Symptoms: dyspepsia, rash, inflammation of the oral mucosa, in the form of darkening characteristic blue lines on the gums; during prolonged use at doses exceeding recommended possibly kidney function.
These symptoms are completely reversible remove the drug.
Treatment: No specific antidote. If overdose shown gastric lavage, ehnterosorbentov and symptomatic therapy aimed at maintaining renal function. In case of overdose, also shows the assignment of laxatives. IN
further treatment should be symptomatic. In the case of impaired renal function, accompanied by high levels of bismuth in plasma, it is possible to enter the complexing agents – dimerkaptoyantarnuyu and dimerkaptopropansulfonovuyu acid. With the development of severe renal impairment indicated hemodialysis.
pharmachologic effect
Pharmacological group:
antiulcer agent, an antiseptic and astringent intestines.
Pharmacodynamics:
Gastroprotective and antiulcer agent with antibacterial activity against Helicobacter pylori.
Also has anti-inflammatory and astringent.
In the acidic environment of the stomach precipitated insoluble bismuth oxychloride and citrate chelated compound formed from a proteinaceous substrate a protective film on the surface of ulcers and erosions. Thus preparation forms a protective layer, which for a long period of time protects the affected areas of the mucosa from the effects of aggressive factors.
By increasing the synthesis of prostaglandin E, mucus secretion and bicarbonate, stimulates activity of cytoprotective mechanisms increases the resistance of the gastrointestinal mucosa to the fact exposed 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 pepsipogena.
Pharmacokinetics:
Practically not absorbed from the gastrointestinal tract. It appears mainly faeces. A minor amount of bismuth, received by the plasma is excreted by the kidneys.
Pregnancy and breast-feeding
Bismuth tripotassium dicitratobismuthate contraindicated for use in pregnant women. If necessary, use during lactation should stop breastfeeding.
Conditions of supply of pharmacies
Without a prescription.
side effects
The following adverse events reported during the application of bismuth tripotassium dicitrate, distributed over occurrence frequency according to the following gradation: very often (> 1/10); common (> 1/100, 000 1/1, 1/10, 000,
Gastro-intestinal tract: often – fecal staining black; infrequently – nausea, vomiting, diarrhea or constipation.
Allergic reactions: seldom – skin rash, itching; very rarely – anaphylactic reactions.
From the nervous system: very rarely – long-term use at high doses -entsefalopatiya associated with the accumulation of bismuth in the CNS.
Side effects are reversible and quickly disappear after drug withdrawal.
If any of these instructions side effects are compounded, or if you notice any other side effects not mentioned in the instructions, inform your doctor /
special instructions
The drug should not be used more than 8 weeks. It is not recommended during treatment exceed the daily dose for adults and children. The period of treatment should not be applied other preparations containing bismuth (see. See “The interaction with other drugs”). Upon completion of a course of treatment at the recommended doses of active principle concentration in blood plasma does not exceed 3-58 g / l, and the toxicity is observed only at concentrations above 100 g / l.
In applying bismuth tripotassium dicitrate possible staining of feces in a dark color due to the formation of bismuth sulphide.
Sometimes there is a slight darkening of the tongue.
During treatment is not recommended alcohol intake.
Effect on the ability to drive mechanisms and
Data on the effect of the drug Bismuth tripotassium dicitratobismuthate on ability to drive and there are no mechanisms.
Storage conditions
At temperatures above 25 ° C.
Keep out of the reach of children
Dosing and Administration
Inside. The duration of treatment and the dose determined by the physician individually for each patient, depending on the nature of the disease.
Adults and children over 12 years of drug prescribed 1 tablet 4 times a day for 30 minutes before a meal (breakfast, lunch, dinner) and at night, or 2 tablets 2 times a day 30 minutes before meals (breakfast, dinner).
Children aged 8 to 12 years: 1 tablet 2 times a day for 30 minutes before a meal (breakfast and dinner).
Children aged from 4 to 8 years administered in a dose of 8 mg / kg / day; depending on the body weight of the child prescribed 1-2 tablets a day (or in 1-2 daily administration). Thus, the daily dose should be closest to the calculated dose (8 mg / kg / day). Tablets are taken 30 minutes before eating, with a small amount of water.
Tablet is recommended to swallow whole without chewing or crushing, drinking plenty of water. Not recommended drink milk tablets.
The duration of treatment typically is from 4 to 8 weeks. After receiving the drug is not recommended to take medicines containing bismuth (e.g., Vikalin, Vikair) for 2 months.
For eradication of Helicobacter pylori appropriate to use bismuth tripotassium dicitrate in combination with antibacterial agents having Helicobacter activity.
If during the treatment did not improve, you should consult your doctor. Use drug only according to the application and in those doses which are specified in the instruction. If necessary, please consult your physician before using the drug.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist