? The tablets covered with a creamy-white film cover are round, biconcave, with the inscription "gbr 152" squeezed out on one side, and a graphic pattern in the form of a square with interrupted sides and rounded corners squeezed out on the other side, odorless or with a slight odor ammonia.
1 tab.
bismuth tricalcium dicitrate 304.6 mg,
which corresponds to the content of bismuth oxide 120 mg
Excipients: corn starch - 70.6 mg, povidone K30 - 17.7 mg, potassium polyacrylate - 23.6 mg, macrogol 6000 - 6 mg, magnesium stearate - 2 mg.
Sheath composition: opadrai OY-S-7366 (hypromellose 5 mPas В· s - 3.2 mg, macrogol 6000 - 1.1 mg).
8 pcs. - blisters (4) - packs of cardboard.
8 pcs. - blisters (7) - packs of cardboard.
8 pcs. - blisters (14) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Antiulcer drug 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 are precipitated, and chelate compounds are also formed with the protein substrate as 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 the resistance of the gastrointestinal mucosa 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
Suction and distribution
Bismuth tricalcium dicitrate is practically not absorbed from the digestive tract.
Excretion
It is excreted mainly with feces. An insignificant amount of bismuth, which enters the plasma, is excreted by the kidneys.
INDICATIONS
- Stomach ulcer and duodenal ulcer in the phase of exacerbation (including associated with Helicobacter pylori);
- chronic gastritis and gastroduodenitis in the phase of exacerbation (including associated with Helicobacter pylori);
- irritable bowel syndrome, which proceeds mainly with symptoms of diarrhea;
- Functional dyspepsia, not associated with organic gastrointestinal diseases.
DOSING MODE
Adults and children over 12 years of age, the drug is prescribed 1 tablet. 4 times / day for 30 minutes before meals and at night or 2 tab. 2 times / day for 30 minutes before meals.
Children aged 8 to 12 years are prescribed 1 tab. 2 times / day for 30 minutes before meals.
Children aged 4 to 8 years are prescribed at a dose of 8 mg / kg / day; depending on the weight of the child's appoint 1-2 tables / 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).
Tablets are taken 30 minutes before meals, washed down with a small amount of water.
The duration of the course of treatment is 4-8 weeks. For the next 8 weeks, do not take drugs containing bismuth.
For the eradication of Helicobacter pylori, it is advisable to use De-Nol in combination with antibacterial drugs possessing anti-Helicobacter pylori activity.
SIDE EFFECT
On the part of the digestive system: nausea, vomiting, frequent stools, constipation. These effects are not hazardous to health and are temporary.
Allergic reactions: skin rash, skin itching.
From the side of the central nervous system: with prolonged use in high doses - encephalopathy associated with the accumulation of bismuth in the central nervous system.
CONTRAINDICATIONS
Decompensated renal failure;
- Pregnancy;
- lactation period;
- Children's age up to 4 years;
- Hypersensitivity to the drug.
PREGNANCY AND LACTATION
De-Nol В® is contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in decompensated renal failure.
APPLICATION FOR CHILDREN
Contraindicated in children under 4 years.
SPECIAL INSTRUCTIONS
The drug should not be used for more than 8 weeks.
During treatment it is not recommended to exceed the established daily doses for adults and children.
During the period of De-Nol В® treatment, other preparations containing bismuth should not be used.
At the end of the course treatment with the drug at recommended doses, the concentration of the active substance in the blood plasma does not exceed 3-58 Ојg / l, and intoxication is observed only at a concentration of more than 100 Ојg / l.
With De-Nol В®, it is possible to stain the stool black due to the formation of bismuth sulphide. Sometimes there is a slight darkening of the tongue.
Impact on the ability to drive vehicles and manage mechanisms
Data on the effect of De-nol В® on the ability to control vehicles and mechanisms are not available.
OVERDOSE
Symptoms: with prolonged use in doses exceeding the recommended, there may be a violation of kidney function (completely reversible when the drug is withdrawn).
Treatment: gastric lavage, the appointment of activated charcoal and saline laxatives. In the future, symptomatic therapy is performed. When violations of kidney function, accompanied by a high level of bismuth in blood plasma, it is possible to introduce chelating agents (D-penicillamine, unitiol). In the case of pronounced impaired renal function, hemodialysis is indicated.
DRUG INTERACTION
With the simultaneous administration of other drugs, as well as food and liquids, particularly antacids, milk, fruits and fruit juices, it is possible to change the effectiveness of the drug De-Nol В® (it is not recommended to take inside for 30 min before and after taking De-Nol В® ).
The combined use of the drug De-nol В® with tetracycline reduces the absorption of the latter.
TERMS OF RELEASE FROM PHARMACY
The drug is dispensed without a prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 4 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.
