De-Nol 120mg 112 tablets — Made in Netherlands — Free Delivery

De-Nol

A medicinal product consisting of colloidal bismuth subcitrate. The mechanism of action consists in the formation of chelated compounds in the form of a protective film on the surface of ulcers and erosions of the gastrointestinal mucosa. Stimulates the synthesis of protective prostaglandin E. Participates in the restoration of epidermal growth factor in the zone of violations of the integrity of the epithelium, stimulating the regeneration of the mucosa. It breaks the adhesion of pathogenic microorganisms to the mucous membrane, simultaneously disrupting the production of ATP in the bacterial cell.

Indications for use

Peptic ulcer and duodenal ulcer, chronic gastritis, including those caused by Helicobacter pylori. The preparation is included in the protocols for the complex treatment of these pathologies.

The active substance is not absorbed in the gastrointestinal tract, the bioavailability of the preparation is low. Although the compound has the characteristics of a heavy metal, bismuth subcitrate is non-toxic.

De-Nol is well tolerated; darkening of the stool due to the formation of bismuth sulfide is the most common side effect.

Features:

In the acidic environment of the stomach, the preparation forms a protective film on the surface of ulcers and erosions, which promotes scarring and protects against the effects of gastric juice; increases the synthesis of prostaglandin E2, which stimulates the formation of mucus and bicarbonates, leads to the accumulation of epidermal growth factor in the defect area, reduces the activity of pepsin and pepsinogen. The preparation has bactericidal activity against Helicobacter pylori.

Pharmacokinetics.

The preparation is practically not absorbed from the gastrointestinal tract; only a small amount of the active substance enters the bloodstream and is excreted in the urine, while the concentration of bismuth in the plasma rapidly decreases after the end of treatment. It is excreted mainly in the feces.

Indications

Peptic ulcer and duodenal ulcer, chronic gastritis, including those caused by Helicobacter pylori (as part of anti-Helicobacter pylori therapy regimens).

Contraindications

Hypersensitivity to the active substance or to an excipient. Severe renal failure.

Method of administration and dosage

Adults and children over 14 years of age are prescribed 1 tablet 4 times a day 30 minutes before meals and at night, or 2 tablets 2 times a day.

For children aged 8 to 14 years, take 1 tablet 2 times a day 30 minutes before meals.

Children aged 4 to 8 years should be prescribed at a dose of 8 mg / kg / day; the daily dosage is divided into 2 doses, but not more than 2 tablets per day.

Take the tablets with a little water. The duration of the course of treatment is 4-8 weeks. For the next 8 weeks, do not take bismuth-containing preparations.

If Helicobacter pylori is present, use in treatment regimens according to national guidelines.

Overdose

Intoxication symptoms.

Acute massive overdose can lead to renal failure with a delayed onset up to 10 days.

Intoxication treatment.

After a single dose of a very high dose, treatment consists of gastric lavage followed by doses of activated charcoal and osmotic laxatives. This therapy usually decreases the absorption of bismuth, so additional measures are not necessary.

The concentration of bismuth in the blood and urine should be determined in acute and chronic intoxication in order to identify the connection of any symptoms with an increased effect of bismuth.

Chelation therapy with dimercaptosuccinic acid (DMSA) and dimercaptopropanosulfonic acid (DMSA) is used if symptoms are caused by acute or chronic bismuth overdose.

In the case of severe renal failure, hemodialysis should be followed by chelation therapy.

Application features

It is possible that the color of the stool changes to black, in which case you need to consult a doctor. You should not take antacids and drink milk half an hour before and half an hour after taking the preparation, since the available gastric juice is needed to form a protective layer.

Long-term use of high doses of bismuth compounds is not recommended due to the rare occurrence of reverse encephalopathy. Subject to the recommended dosage regimen, the risk of this side effect is very small, however, it is not recommended to take other bismuth-containing preparations while taking this preparation.

Composition

Active ingredient in 1 tablet: colloidal bismuth subcitrate - 120 mg (Ві2О3, which is contained in a solution of dry bismuth subcitrate).

Excipients: corn starch, povidone, potassium polacrilin, macrogol 6000, magnesium stearate, hypromellose.

Storage conditions

Store at a temperature not exceeding 25 ° C out of reach of children.

Shelf life is 4 years.

Do not use after the expiration date printed on the package.

Instructions For the use of medicine DE-NOL

Ingredients:

Active ingredients: Bismuth Tripotassium Dicitrate

1 tablet contains 120 mg Bismuth Dicitrate Bi2O2 contained in solution of dry Bismuth Dicitrate.

Inactive ingredients: corn starch, polyvinylpyrrolidone, potassium polacryline, macrogol 6000, magnesium stearate, gypromelosis

Medication form: coated tablets

Manufacturer: Astellas Pharma Europe B.V. Hogemaat 2, 7942 JG Meppel, the Netherlands

Pharmaceutical group: laxative Other drugs for peptic ulcer and gastro oesophageal reflux disease GORD

Stimulation of the biosynthesis of prostaglandin E2, under the influence of which the mucus  increases and bicarbonate ions  form a protective mucous-bicarbonate barrier. It improves the microcirculation in the antral part of the stomach and duodenum, which contributes to the improvement of metabolism at the cellular level, which leads to acceleration of regeneration of cells and helps to restore the microstructure of the mucous membranes. Reducing the amount of hydrochloric acid by reducing its secretion fundic cells of the stomach, which decreases gastric juice acidity. Due to the formation of complex compounds of pepsin with bismuth subcitrate inactivation of pepsin, which results in a decreased peptic activity of gastric juice.

After oral administration only a small part of the bismuth subcitrate  absorbed into the circulation. The concentration of drug in the blood increases with prolonged use. The drug is excreted in the feces.

Uses:

Gastric ulcer and duodenal ulcers caused by Helicobacter pylori, including peptic ulcer of the stomach and duodenum.  Acute and chronic gastritis and gastro, including associated with Helicobacter pylori

Contraindications:

Active and inactive ingredients hypersensitivity, severe kidney disease.

Warnings:

Consult your healthcare provider  if stool color changes to black. Do not take antacid drugs or milk 30 minutes before and 30 minutes after De-Nol administration because existing stomach juice is necessary to form protective layer.  Prolonged use of the drug is not recommended  due to rare cases of encephalopathy. If used according to recommendations the chances of side effects are very low, however prolonged use or the use of other drugs containing bismuth is not recommended.

Special warnings:

Usage during pregnancy and lactation:

Not recommended

Usage while driving and operating machinery:

There was no clinical research conducted to determine influence of De-Nol  while driving or operating machinery. However the risk of side effects is very low.

Children:

De-Nol may be used for children over 4 years.

Usage and Dosage:

Adults and children over 14 years:  1 tablet 4 times a day 30 minutes before meal and at bed time or 2 tablets twice a day.

Children 8-14 years: 1 tablet twice a day 30 minutes before meal.

Children 4-8 years:  8 mg per kilogram of weight a day, daily dose should be split into 2 sets, but not to exceed 2 tablets a day.

Tablets should be taken with water. Course duration is 4-8 weeks.  Do not take drugs containing bismuth for 8 weeks following De-Nol course.

In case of Helicobacter pylori follow the scheme:

For quadrature therapy:

De-Nol – 120 mg times a day

Tetracycline - at 500mg 4 times a day;

Metronidazole - at 500mg 3 times a day; Preparations of proton pump inhibitors (omeprazole, lansoprazole, etc.) in the standard dosage. Duration of treatment 10-14 days.

Treatment with De-Nol is possible to  accelerate regeneration of the mucous membrane of the stomach and duodenum: 1 tablet 4 times a day 30 minutes before breakfast, lunch and supper and at bed time. Total duration of treatment should not exceed 6 weeks (8 weeks maximum).

Overdose:

Using the drug in doses many times higher than recommended, or with prolonged use of excessive doses of the drug may develop bismuth poisoning. Symptoms of poisoning are the development of reversible renal failure and increase the level of bismuth in the blood.

No specific antidote. If overdose is shown gastric lavage, enterosorbents and symptomatic therapy aimed at maintaining renal function. In case of overdose, also shows the assignment of saline laxatives. With the development of severe renal impairment shown hemodialysis.

Side effects:

The drug is usually well tolerated, but some patients had such side effects when using the drug De-Nol:

Very frequent: black stool.

Not frequent: The gastro-intestinal tract: nausea, vomiting, upset stomach ( constipation and diarrhea)

Skin: itching

Occasional : anaphylactic reaction

Interaction with other drugs:

Milk, food and antacids reduce the effectiveness of the drug De-Nol. Recommended observe interval of at least 30 minutes between doses of bismuth subcitrate and antacids. It is recommended to take the drug at least 30 minutes before or after meal.

The drug is not used concurrently with other medicinal preparations containing bismuth, since simultaneous use of several drugs bismuth increases the risk of side effects, including the risk of encephalopathy.

Pharmaceutical characteristics:

Round tablets white to cream color with “gbr152” imprint on one side and company logo on another.

Shelf life - 4 years.

Storage:

Store in dry place at room temperature. Keep away from children

Packaging: 8 tablets per blister. 7 or 14 blisters in a box.

No prescription needed.