Новобисмол®

General characteristics. Structure:

Active agent: bismuth a trikaliya dicitrate – 304,6 mg, in terms of Bi2O3 bismuth oxide – 120,0 mg.
Excipients: corn starch – 70,6 mg, povidone To 30 – 17,7 mg, potassium polyacrylate – 23,6 mg, a macrogoal of 6000 - 6,0 mg, magnesium stearate – 2,0 mg.
Cover: опадрай OY-S-7366 consists from: gipromelloza of 5 MPas ∙ with – 3,2 mg and a macrogoal of 6000 - 1,1 mg.

Description. Round biconvex tablets, film coated cream-white color, inodorous or with a light smell of ammonia.

Pharmacological properties:

Pharmacodynamics. Antiulcerous means with bactericidal activity concerning Helicobacter pylori. Possesses also antiinflammatory and knitting action. In acid medium of a stomach insoluble oxychloride of bismuth and citrate are besieged, chelate connections with proteinaceous substrate in the form of a protective film on a surface of ulcers and erosion are formed. Increasing prostaglandin E synthesis, a myxopoiesis and secretion of a hydrocarbonate, stimulates activity of cytoprotective mechanisms, increases resistance of a mucous membrane of digestive tract to influence of pepsin, hydrochloric acid, enzymes and salts of bile acids. Leads to accumulation of an epidermal growth factor in a defect zone. Reduces activity of pepsin and a pepsinogen.

Pharmacokinetics. Practically it is not soaked up from digestive tract. It is removed preferential with a stake. The insignificant amount of bismuth which came to plasma is brought out of an organism by kidneys.

Indications to use:

The peptic ulcer of a stomach and duodenum in an aggravation phase including associated with Helicobacter pylori. Chronic gastritis also gastroduodenit in an aggravation phase, including associated with Helicobacter pylori. The functional dyspepsia which is not connected with organic diseases of digestive tract.

Route of administration and doses:

To adults and children drug is more senior than 12 years appoint on 1 tablet 3 times a day in 30 minutes prior to meal and 1 tablet to night or 2 tablets 2 times a day in 30 minutes prior to meal.
To children from 8 to 12 years drug is appointed on 1 tablet by 2 times a day in 30 minutes prior to food.
To children from 4 to 8 years: appoint 8 mg/kg/days in a dose; the daily dosage is divided into 2 receptions. Accept in 30 minutes prior to food.
Tablets need to be washed down with a small amount of water. Duration of a course of treatment is 4-8 weeks. Within the next 8 weeks it is not necessary to use the drugs containing bismuth. For an eradikation of Helicobacter pylori bismuth use a dicitrate trikaliya in a combination with other antibacterial agents having antikhelikobakterny activity is reasonable.
Precautionary measures at use
It is not necessary to use drug more than 8 weeks. Also it is not recommended by the drug Novobismol® to exceed during treatment the established daily doses for adults and children. During treatment it is not necessary to use other drugs containing bismuth. Upon termination of course treatment by drug in the recommended doses concentration of active active ingredient in a blood plasma does not exceed 3-5,8 mkg/l, and intoxication is observed only at concentration higher than 100 mkg/l. At use of the drug Novobismol® coloring a calla in dark color owing to formation of bismuth sulfide is possible. Insignificant darkening of language is sometimes noted.

Features of use:

Features of a medical use of medicine pregnant women, women during breastfeeding, the children, adults having chronic diseases
Use of the drug Novobismol® is contraindicated at pregnancy. For the period of treatment it is necessary to stop breastfeeding.
Influence of medicine for a medical use on ability to manage vehicles and mechanisms
Does not exert impact on ability to driving and other mechanisms.

Side effects:

From the alimentary system: emergence of nausea, vomiting, more frequent chair, locks is possible. These phenomena are not hazardous to health and are temporary.
Allergic reactions: skin rash, skin itch. At prolonged use in high doses – the encephalopathy connected with accumulation of bismuth in TsNS.
If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.

Interaction with other medicines:

Within half an hour before administration of drug of Novobismol® use in other medicines, and also meal and liquids, in particular, of antacids, milk, fruit and fruit juice is not recommended. It is connected with the fact that they at a concomitant use inside can exert impact on efficiency of the drug Novobismol®.

Contraindications:

The expressed renal failure, pregnancy, lactation, individual intolerance of drug, children's age up to 4 years.

Overdose:

The drug overdose caused by long reception of the doses exceeding recommended can lead to a renal failure. These symptoms are completely reversible at drug withdrawal of Novobismol®. At emergence of symptoms of poisoning with drug it is necessary to make a gastric lavage, to apply absorbent carbon and salt laxatives. Further treatment has to be symptomatic. In case of the renal failure which is followed by the high level of bismuth in a blood plasma it is possible to enter kompleksoobrazovatel – dimercaptoamber and dimercaptopro-pan-sulfonic acids. In case of the expressed renal failure the hemodialysis is shown.

Storage conditions:

Period of validity 4 years. Not to apply after the period of validity specified on packaging. To store in the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

Tablets, film coated, 120 mg.
On 8 tablets in a blister strip packaging. On 7, 14 or 28 blister strip packagings together with the application instruction place in a pack from a cardboard.
On 10 tablets in a blister strip packaging. On 6, 12 or 24 blister strip packagings together with the application instruction place in a pack from a cardboard.
On 16 tablets in a blister strip packaging. On 7 or 14 blister strip packagings together with the application instruction place in a pack from a cardboard.
On 20 tablets in a blister strip packaging. On 3, 6 or 12 blister strip packagings together with the application instruction place in a pack from a cardboard.