Nolpaza, 20 mg 28 pcs.

Indications

For a dosage of 20 mg:

Adults and adolescents from 12 years of age and older

– symptomatic gastroesophageal reflux disease

– for long-term treatment and prevention of recurrent reflux esophagitis.

Adults

– prevention of erosive ulcerative lesions of the stomach and duodenum caused by taking non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients with high risk and needing continuous treatment with NSAIDs (See.Special Indications)

For dosage 40 mg

Adults and adolescents 12 years and older

– reflux esophagitis

Adults

– eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with peptic ulcer disease associated with H.pylori

-gastric and duodenal ulcer

– Zollinger-Ellison syndrome and other pathological hypersecretory conditions

Active ingredient

Composition

One tablet contains

the active ingredient pantoprazole sodium sesquihydrate 22.55 mg or 45.10 mg

(equivalent to pantoprazole 20 mg or 40 mg respectively),

auxiliary substances: Mannitol, crospovidone (type B), anhydrous sodium carbonate, sorbitol (E420), calcium stearate,

The composition of the enteric coating: Hypromellose (2.4-3.6 mPas), povidone (K25), titanium dioxide (E171), iron oxide yellow (E172), propylene glycol, *methacrylic-ethyl acrylate copolymer (1:1) 30% dispersion, macrogol 6000, talcum

The 30% dispersion contains sodium lauryl sulfate (0.7% solids in the dispersion and polysorbate 80 (2.3% solids in the dispersion) as emulsifiers.

How to take, the dosage

Nolpaza® Tablets enteric soluble should not be chewed or crushed and should be swallowed whole before meals with a small amount of fluid.

Adults and adolescents 12 years and older

Symptomatic gastroesophageal reflux disease: The recommended dose for oral administration is one 20 mg tablet daily. Relief of symptoms usually occurs within 2-4 weeks. If this time is not long enough, recovery usually occurs in an additional 4 weeks of therapy. After relief of symptoms, if they reappear it is sufficient to take a dose of 20 mg once a day on demand. Long-term maintenance therapy is prescribed if the desired relief of symptoms is not achieved with on-demand dosing.

Reflux esophagitis: The recommended dose for oral administration is one tablet of 40 mg daily. In individual cases, the dose may be doubled (increased to 2 tablets of 40 mg per day), especially when there is no clinical improvement in response to other treatment. For treatment of reflux esophagitis a 4-week course of treatment is necessary; if necessary, therapy is continued for 4 more weeks.

Long-term treatment and prevention of recurrence of reflux esophagitis: For long-term treatment, a maintenance dose of 20 mg per day is recommended, with an increase to 40 mg per day for exacerbations. After symptoms of exacerbation have disappeared, the dose may be reduced again to 20 mg pantoprazole.

Adults

.Prevention of erosive ulcerative lesions of the stomach and duodenum caused by taking non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at high risk andneeding ongoing treatment with NSAIDs: The recommended dose for oral administration is 20 mg of pantoprazole per day.

Eradication of H.pylori in combination with two appropriate antibiotics: In patients with gastric and duodenal ulcers associated with H.pylori, eradication of the bacterium should be performed with combination therapy. Official local guidelines (e.g., national guidelines) regarding bacterial resistance and appropriate use and prescribing of antibacterial agents should be considered. Depending on resistance, the following combinations may be recommended for eradication of H.pylori:

a) Nolpaza® 40 mg 2 times daily + amoxicillin 1000 mg 2 times daily

+ clarithromycin 500 mg 2 times daily

p> b) Nolpaza® 40 mg 2 times daily + metronidazole 400 – 500 mg 2 times daily (or 500 mg of tinidazole) + clarithromycin 250- 500 mg 2 times daily

/p>

c) Nolpase® 40 mg 2 times daily + amoxicillin 1000 mg 2 times daily

+ metronidazole 400 to 500 mg 2 times daily (or 500 mg of tinidazole).

In combination therapy of eradication of bacterium H. pylori, the second tablet of Nolpaza® should be taken 1 hour before dinner.

The combination therapy is carried out for 7 days and may be prolonged for another 7 days (total duration up to 2 weeks). Further treatment is indicated to ensure healing of ulcers after consideration of recommendations for dosing of the drug for gastric and duodenal ulcers.

In patients who are negative for H. pylori in monotherapy with Nolpase® may be guided by the following dosing guidelines:

Treatment of peptic ulcer disease: the recommended dose is 1 tablet 40 mg.

In individual cases, the dose may be doubled (increasing to 2 Nolpaz® 40 mg tablets daily), especially when there is no clinical improvement in response to other treatment. A 4-week course of treatment is usually needed for gastric ulcer, in some cases for the next 4 weeks.

Treatment of duodenal ulcer: Recommended dose is 1 tablet 40 mg. If ineffective, the dose can be doubled to 80 mg (2 tablets Nolpaz® of 40 mg) per day. Healing of duodenal ulcer usually occurs within 2 weeks, in some cases, within the next 4 weeks.

Sollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion: For long-term treatment of patients with Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion, treatment should be started with a daily dose of 80 mg (2 40 mg tablets). Thereafter, the dose may be increased or decreased as needed, depending on the level of hydrochloric acid secretion. At doses over 80 mg per day, the dose should be divided into two doses per day. A temporary increase in the daily dose of pantoprazole over 160 mg is possible, but should not be used longer than necessary for a period of adequate control of gastric secretion.

The duration of treatment of Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion is not limited and should be adapted according to clinical need.

Special patient categories

In patients with severe hepatic impairment, the daily dose of pantoprazole should not exceed 20 mg.

Nolpaza® should not be used in combination treatment with antibiotics to eradicate the bacterium H. pylori in patients with moderate to severe hepatic dysfunction and in patients with impaired renal function

.p> Dose adjustment is not required in older patients and patients with ndisordered renal function

Dose adjustment is not required.

Interaction

Because of its profound and prolonged inhibition of gastric juice secretion, pantoprazole may reduce absorption of drugs whose bioavailability depends on the pH of the gastric environment, e.g. some antifungaldrugs from the azolegroup,

Special Instructions

Hepatic impairment

In patients with severely impaired liver function during treatment with pantoprazole, especially with long-term use, the liver enzymes should be monitored regularly. If liver enzyme levels increase, treatment should be discontinued.

Simultaneous use of NSAIDs

. The use of 20 mg should be limited for the prevention of gastroduodenal ulcers in patients requiring long-term treatment with nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs) and who are at increased risk of gastrointestinal complications.

The increased risk should be evaluated according to individual risk factors, such as: older age (> 65 years), gastric or duodenal ulcer, or a history of upper gastrointestinal bleeding.

Combined treatment

In combination therapy of eradication H. pylori, a brief characterization of the medications involved must be considered.

In the presence of alarming symptoms

. If any alarming symptoms are present (e.g., significant unintentional weight loss, recurrent bouts of vomiting, dysphagia, vomiting blood, anemia, or melena) and if gastric ulcer is present or suspected, malignancy should be excluded, as taking pantoprazole may relieve symptoms and delay diagnosis. The possibility of malignancy should be ruled out before starting treatment.

Combined treatment with atazanavir

The use of atazanavir with proton pump inhibitors is contraindicated.

Influence on vitamin absorptionB12

Pantoprazole, like all drugs that block the production of hydrochloric acid, may decrease the absorption of vitamin B12 (cyanocobalamin) due to hypo- and achlorhydria. This should be considered during long-term therapy in patients with low body weight or with increased risk of decreased absorption of vitamin B12 or if corresponding clinical symptoms are observed.

Long-term treatment

Patients should be monitored regularly during long-term treatment, especially when treated for more than 1 year.

Gastrointestinal infections caused by bacteria

Pantoprazole, like all proton pump inhibitors, increases bacteria normally present in the upper gastrointestinal tract. Treatment with Nolpase® may increase the risk of gastrointestinal infections caused by bacteria such as Salmonella and Campilobacter.

Hypomagnesemia

There have been cases of severe hypomagnesemia in patients treated with proton pump inhibitors (PPIs) such as pantoprazole for at least three months and, in most cases, for up to a year. Serious manifestations of hypomagnesemia such as fatigue, tetany, delirium, seizures, dizziness, and ventricular arrhythmias may occur, but may occur without obvious symptoms and unnoticed. In most patients, hypomagnesemia resolves after magnesium deficiency is corrected and PPI treatment is discontinued.

In patients on long-term treatment or patients taking PPIs with digoxin or other drugs that may cause hypomagnesemia (e.g., diuretics), magnesium levels should be measured before starting PPI treatment and periodically during treatment.

Hip fracture of the wrist and spine

The use of proton pump inhibitors, especially at high doses and for a long time (> 1 year), may slightly increase the risk of hip, wrist, and spine fractures, primarily in the elderly or in the presence of other recognized risk factors. Observational studies show that proton pump inhibitors can increase overall fracture risk by 10-40%. Some of this increase may be due to other risk factors. Patients at risk for osteoporosis should receive care according to current clinical guidelines and should take sufficient vitamin D and calcium.

Associates

Nolpaza® contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Pediatric use

Because of insufficient safety and efficacy data, pantoprazole is not recommended for use in children younger than 12 years of age with reflux esophagitis, symptomatic gastroesophageal reflux disease.

The data on the use of pantoprazole in children and adolescents under 18 years of age for gastric and duodenal ulcer disease, eradication of Helicobacter pylori, Zollinger-Ellison syndrome, for prevention of erosive ulcerative lesions of the stomach and duodenum caused by non-selective NSAIDs are not available.

Pregnancy and lactation

Animal studies suggest reproductive toxicity of pantoprazole.

Nolpaza® should not be used during pregnancy unless necessary.

Pantoprazole is excreted in breast milk. Breastfeeding should be stopped during treatment with the drug.

Particular effects of the drug on driving or potentially dangerous machinery

An adverse adverse reaction such as dizziness and visual disturbances may occur during treatment. In such cases, patients should not drive vehicles or operate machinery.

Synopsis

Contraindications

– hypersensitivity to pantoprazole, substituted benzimidazoles

or excipients of the drug

– co-administration with atazanavir

Side effects

Infrequent (≥ 1/1, 000 to < 1/100)

sleep disturbances

headache, dizziness

diarrhea, nausea, vomiting, abdominal bloating and flatulence, constipation, dryness

Overdose

Similarities