Nolpaza, 40 mg 56 pcs.

Interaction

The simultaneous use of other proton pump inhibitors or H₂-histamine receptor blockers without medical advice is not recommended.

The simultaneous use of Nolpase^® may decrease the absorption of drugs whose bioavailability is dependent on the pH of the stomach (e.g. ketoconazole, itraconazole, posaconazole and other drugs such as erlotinib).

During drug interaction studies, no clinically significant interactions were identified when pantoprazole was used in the following cases:

• Patients with cardiovascular diseases taking cardiac glycosides (digoxin), slow calcium channel blockers (nifedipine), beta-adrenoblockers (metoprolol);
• patients with gastrointestinal diseases taking antacids, antibiotics (amoxicillin, clarithromycin);
• patients taking oral contraceptives containing levonorgestrel and ethinylestradiol;
• patients taking non-steroidal anti-inflammatory drugs (diclofenac, naproxen, piroxicam);
• patients with endocrine disorders taking glibenclamide, levothyroxine;
• patients with anxiety and sleep disorders taking diazepam;
• patients with epilepsy taking carbamazepine and phenytoin;
• Patients taking indirect anticoagulants such as warfarin and phenprocoumon, with monitoring of prothrombin time and international normalized ratio (INR) at the beginning and at the end of treatment, as well as during irregular pantoprazole administration. At the same time, it should be noted that there are known cases of increased INR and prothrombin time in patients treated with IPN together with warfarin or with phenprocoumon. Increased INR and prothrombin time may lead to life-threatening pathological bleeding. In this regard, these patients should be monitored for an increase in INR and prothrombin time.

It is also noted that there is no clinically significant drug interaction with caffeine, ethanol, theophylline.

There are reports of elevated blood levels of methotrexate in some patients when it is used together in high doses (e.g., 300 mg) with IPN. Therefore, when using high doses of methotrexate, such as in cancer or psoriasis, it may be necessary to consider temporarily withdrawing pantoprazole.

CYP2C19 isoenzyme activity inhibitors such as fluvoxamine may increase the systemic exposure of pantoprazole. Dose reduction may be necessary in patients receiving long-term treatment with high doses of pantoprazole or in patients with hepatic impairment.

Inducers of CYP2C19 and CYP3A4 isoenzyme activity such as rifampicin and Hypericum (Hypericum. perforatum), can decrease the plasma concentration of IPNs metabolized by these enzyme systems.

HIV protease inhibitors

Pantoprazole is not recommended for use with HIV protease inhibitors whose absorption depends on the pH of the gastric environment (e.g., atazanavir) because of a significant decrease in their bioavailability.

If co-administration of HIV protease inhibitors and IPNs is still necessary, careful clinical monitoring (e.g., viral load determination) is recommended. The dose of pantoprazole should not exceed 20 mg daily. Adjustment of HIV protease inhibitor dosage may also be necessary.

Special Instructions

Hepatic failure, risk factors for cyanocobalamin (vitamin B₁₂ deficiency (especially in the background of hypo- and achlorhydria).

It is contraindicated in persons under 18 years of age.

In patients with significant liver dysfunction the daily dose of pantoprazole should not exceed 20 mg per day (1 tablet of Nolpaza^® 20 mg). In this regard, the use of pantoprazole in 40 mg dosage is not recommended in this group of patients. Hepatic enzyme activity should be monitored regularly during treatment with pantoprazole, especially during long-term use. In case of increased liver enzyme activity the treatment should be discontinued.

No dose adjustment is required in elderly patients and patients with renal failure.

Due to the lack of data on the use of Nolpase^® as part of combination antimicrobial therapy against Helicobacter pylori in patients with impaired renal function as well as in patients with moderate to severe hepatic impairment, the drug should not be used.

Before treatment with Nolpase^®, the possibility of malignancy should be excluded because the drug may mask symptoms and delay correct diagnosis.

Patients should consult a physician if they are to have an endoscopy or urea breath test.

Patients should consult a physician if the following are present:

• unintentional weight loss, anemia, gastrointestinal bleeding, impaired swallowing, persistent vomiting or vomiting blood. In these cases, taking the drug may partially relieve symptoms and delay proper diagnosis;
• past gastrointestinal surgery or peptic ulcer;
• continuous symptomatic treatment of dyspepsia and heartburn for 4 weeks or more;
• liver disease, including jaundice and liver failure;
• other serious conditions that worsen overall health.

Patients over 55 should consult a physician if there are new or recently changed symptoms.

Taking drugs that reduce the acidity of gastric juice slightly increases the risk of gastrointestinal infections, the causative agents being bacteria of the genus Salmonella spp., Campylobacter spp. or C. difficile.

In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions that require long-term treatment, pantoprazole, like other drugs that block gastric juice secretion, may decrease vitamin B₁₂ (cyanocobalamin) absorption due to hypo- and achlorhydria. This should be considered when treating patients with reduced stores of this vitamin in the body, or when treating patients with risk factors for vitamin B₁₂ deficiency for a long time, as well as when observing corresponding clinical symptoms.

The conduct of long-term therapy, especially over 1 year, requires regular monitoring of patients.

Pantoprazole is not recommended together with HIV protease inhibitors whose absorption depends on pH of the stomach (eg, atazanavir), because of a significant decrease in their bioavailability.

There are reports of severe hypomagnesemia in patients who have received IPNs for at least 3 months, and in most cases for up to a year. Serious manifestations of hypomagnesemia such as increased fatigue, tetany, delirium, seizures, dizziness and ventricular arrhythmia can occur, but hypomagnesemia can develop unnoticed and not recognized in time. In most patients with hypomagnesemia it decreases after magnesium replacement therapy and IPN withdrawal. Patients who are planned for long-term treatment or patients receiving IPN together with digoxin or with other drugs which may cause hypomagnesemia (e.g., diuretics) should have serum magnesium content determined before the beginning of IPN treatment and periodically during the treatment.

Proton pump inhibitors, especially when used at high doses and for long periods of time (> 1 year), may slightly increase the risk of femoral, carpal, and spinal fractures, primarily in elderly patients or in the presence of other recognized risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fractures by 10-40%. Some of these fractures may be due to the presence of other risk factors. Patients at risk for osteoporosis should be treated according to current clinical guidelines and receive adequate amounts of vitamin D and calcium.

The development of subacute cutaneous lupus erythematosus is very rare with IPN treatment. If skin lesions occur, especially in sun-exposed areas, and if there is concomitant arthralgia, the patient should seek medical attention immediately, and the health care provider should assess whether Nolpase treatment should be discontinued^®. The occurrence of PKCV after prior PPI treatment may increase the risk of PKCV when treated with other proton pump inhibitors.

When performing laboratory tests, it should be considered that elevated serum CgA levels may distort the results of diagnostic tests to detect neuroendocrine tumors. In this connection the use of Nolpaz®® should be discontinued at least 5 days before CgA investigation. If CgA and gastrin levels do not return to normal values after the first determination, the study should be repeated 14 days after proton pump inhibitor discontinuation.

Effect on ability to operate vehicles, machinery

A refrain from driving vehicles and other mechanisms requiring increased attention due to the possibility of dizziness and visual disturbances.

A refrain from driving vehicles and other mechanisms requiring high attention because of the possibility of dizziness and visual impairment.