active substance:1 gastroresistant tablet contains 20 mg pantoprazole as pantoprazole sodium sesquihydrate;
excipients: mannitol (E 421), crospovidone, sodium carbonate anhydrous, sorbitol (E 420), calcium stearate, hypromellose, povidone, titanium dioxide (E 171), iron oxide yellow (E 172), propylene glycol, methacrylate copolymer dispersion, sodium lauryl sulfate, Polysorbate 80, talc, macrogol 6000.The
proton pump Inhibitors. Code ATC a02b C02.
Adults and children over 12 years of age.The
Symptomatic treatment of gastroesophageal reflux disease.
Hypersensitivity to pantoprazole, a benzimidazole derivatives or any other substance that is included in the preparation. Pantoprazole, like other proton pump inhibitors, is contraindicated for use with atazanavir.
Nolpaza, gastroresistant tablets 20 mg, take 1:00 to food whole without chewing but not grind with water.
Adults and children over 12 years of age.
Symptomatic treatment of gastroesophageal reflux disease.
the recommended dose is 20 mg (1 tablet) drug Nolpazaper day. Usually, the symptoms of heartburn occur within 2-4 weeks. If this period is not enough, the treatment continues for the next 4 weeks. After the symptoms disappear, its recurrence can be controlled using 20 mg, depending on the need.
Long-term treatment and prevention of relapse reflux esophagitis.
for long-term treatment, the maintenance dose is 20 mg (1 tablet) of Nolpazaper day, with an exacerbation of the disease, the dose may increase to 40 mg per day. In this case, we recommend taking the pills Nolpaza40 mg. After elimination of the relapse the dose can be reduced again to 20 mg per day.
Prevention of gastric ulcers and duodenal ulcers caused by taking non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk need to take NSAIDs for a long time.
the recommended dose is 20 mg (1 tablet) drug Nolpazaper day.
liver dysfunction. Patients with severely impaired liver function should not exceed a dose of 20 mg (1 tablet) per day.
impairment of renal function.patients with impaired renal function do not require dose adjustment.
elderly Patientsdose adjustment is not required.
the Occurrence of adverse reactions was observed in about 5% of patients. The most frequent adverse reactions are diarrhea and headache (about 1%).
Adverse effects frequency of occurrence klassificeret in categories: very common (? 1/10), often (? 1/100 and<1/10), infrequently (? 1/1000 and<1/100), rare (? 1/10,000 and<1/1000), very rare
(<1/10000), unknown (frequency not determined by available data).
by the blood and lymphatic system.
very rarely leukopenia, thrombocytopenia, pancytopenia.
by the immune system.
hypersensitivity reactions are Rare (including anaphylactic reactions, anaphylactic shock).
Metabolism and metabolic disorders.
Rarely hyperlipidemia and an increase in lipid levels (triglycerides, cholesterol), changes in body weight.
not known: hyponatremia, hypomagnesemia (see Section "Peculiarities of use"), hypocalcemia1, hypokalemia.
a Mental disorder.
Uncommon: sleep disturbances.
Rarely, depression (including exacerbation).
disorientation (including exacerbations) is Very rare.
Unknown: hallucination, confusion (especially in patients with a predisposition to these disorders, as well as exacerbation of these symptoms if they exist).
from the nervous system.
Infrequently: headache, dizziness.
Rare: disorders of taste.
on the part of the organ of vision.
Rare: visual impairment/blurred vision.
from the digestive tract.
infrequently diarrhea, nausea, vomiting, bloating, constipation, dry mouth, abdominal pain and discomfort.
from the digestive system.
Uncommon: increase in liver enzymes (transaminases, g-GT).
Rare: increased levels of bilirubin.
Unknown: lesions of hepatocytes, hepatitis, hepatocellular insufficiency.
on the part of the skin and subcutaneous tissue.
Infrequently: skin rash, exanthema, itching.
Rare: urticaria, angioedema.
it is not known Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, photosensitivity.
on the part of the musculoskeletal system and connective tissue.
Rarely, fractures of the hip, wrist, spine (see Section "Peculiarities of use").
Rare: arthralgia, myalgia.
not known: muscle spasm2.
from the kidneys and urinary system.
Unknown: interstitial nephritis (with possible development of renal failure).
on the part of the reproductive system and mammary glands.
gynecomastia is Rare.
infrequently asthenia, fatigue, malaise.
Rare: fever, peripheral edema.
1.at the same time hypocalcemia with hypomagnesemia.
2.muscle Spasm as a consequence of electrolyte imbalance.
the Symptoms of an overdose are unknown.
Doses up to 240 mg when administered intravenously within 2 minutes was well tolerated. As pantoprazole is extensively protein bound, it does not apply to drugs that can be easily displayed with the help of dialysis.
in the case of an overdose with the appearance of clinical signs of intoxication, symptomatic and supportive therapy is used. There are no recommendations for specific therapy.
use during pregnancy or lactation.
the experience of the drug is limited to pregnant women. In studies of reproductive function in animals, there was a slight embryotoxicity in doses of more than 5 mg/kg.the Potential risk to humans is unknown. The drug is used during pregnancy only in case of emergency.
There is data on the excretion of pantoprazole in breast milk. The decision on the use of the drug during breastfeeding should be taken after a thorough evaluation of the benefit/risk ratio.The
Drug should not be used for children up to 12 years.
patients with hepatic impairment
in severe hepatic disorders during treatment, especially with prolonged use, requires regular monitoring of the level of liver enzymes. In case of increase in level of liver enzymes the treatment should be stopped.
the co-administration of atazanavir
the co-administration of atazanavir with proton pump inhibitors is not recommended. If the combination of atazanavir with proton pump inhibitors is inevitable, careful clinical monitoring (e.g. measuring viral load) should be carried out in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir. The dose of pantoprazole is 20 mg per day should not be exceeded.
effect on the adsorption of vitamin12
in patients with Zollinger-Ellison syndrome and other hypersecretory conditions requiring long - term treatment, pantoprazole, like other drugs that block the release of gastric juice, may reduce the absorption of vitamin b12(cyanocobalamin) due to the occurrence of Hypo-or ahlorgidrii. This should be taken into account in patients with reduced body weight or risk factors for reduced absorption of vitamin b12(cyanocobalamin), especially in long-term treatment or the presence of appropriate clinical symptoms.
the duration of treatment more than 1 year, the patient should be kept under constant surveillance.
in the presence of anxiety symptoms.
malignant diseases of the esophagus or stomach should be excluded before treatment, as pantoprazole treatment can mask the symptoms of malignant disease and thus prevents the establishment of a correct diagnosis.
Hypomagnesemia.there have been cases of severe hypomagnesemia in patients treated with PPIS like pantoprazole for at least three months, and in most cases during the year. Can occur first to quietly develop the next major clinical manifestations of hypomagnesaemia include fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia. In the case of hypomagnesemia in most cases, the condition of patients improved after replacement corrective therapy with magnesium and discontinuation of IPP.
Patients who require long-term therapeutics, or patients who take STIs simultaneously with digoxin or drugs that may cause hypomagnesemia (such as diuretics), need to determine the level of magnesium before starting treatment of STIs and periodically during treatment.
fractures of bones.Long-term treatment (more than 1 year) with high doses of proton pump inhibitors may slightly increase the risk of fracture of hip, wrist and spine, especially in the elderly or in the presence of other risk factors. Observational studies indicate that the use of proton pump inhibitors may increase the overall risk of fractures by 10-40%. Some of them may be due to other risk factors. Patients at risk of osteoporosis should receive treatment in accordance with the current clinical guidelines and consume sufficient vitamin d and calcium.
Gastrointestinal infections caused by bacteria
Pantoprazole, like other proton pump inhibitors, can increase the number of bacteria that are usually present in the upper gastrointestinal tract. Treatment with the drug may slightly increase the risk of gastrointestinal infections caused by bacteria such asSalmonellaandCampylobacterorC. Diff.
the Drug Nolpaza contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not use the drug.
Ability to influence the reaction rate when driving motor transport or operating other mechanisms:.
in the event of adverse reactions such as dizziness and visual impairment, the handling of vehicles and handling of potentially dangerous machinery should be avoided.The
the effect of pantoprazole on the absorption of other drugs
as a result of complete and long-term inhibition of hydrochloric acid secretion, pantoprazole may reduce the absorption of drugs whose bioavailability depends on the pH of gastric juice, such as certain azoles, antifungal drugs such as ketoconazole, Itraconazole, Posaconazole and other drugs such as erlotinib.
drugs for the treatment of HIV (atazanavir)
Co-administration of atazanavir and other drugs for the treatment of HIV, the adsorption of which depends on pH, with proton pump inhibitors, can lead to a significant reduction in bioavailability of the latter and affect their effectiveness. Therefore, the joint appointment of proton pump inhibitors with atazanavir is not recommended.
Indirect anticoagulants (warfarin or phenprocoumon)
Despite the lack of interaction in concurrent use with warfarin or phenprocoumon during clinical trials have been registered single cases of changes in International normalizing index (PIM) in post-marketing period. Thus, patients who use anticoagulants (for example phenprocoumon or warfarin) is recommended to monitor the prothrombin time or the PIM after the beginning, the end or the irregular employment of pantoprazole.
Methotrexate.concomitant use of high doses of methotrexate (e.g. 300 mg) and proton pump inhibitors has been Reported to increase blood methotrexate levels in some patients. Patients taking high doses of methotrexate, such as cancer patients or psoriasis, are recommended to temporarily discontinue treatment with pantoprazole.
Pantoprazole is largely metabolized in the liver through the cytochrome P450 enzyme system. The main pathway is demethylation through CYP2C19 and other metabolic pathways, including oxidation by the enzyme CYP3A4.
Studies with drugs also metabolised with these pathways, like carbamazepine, diazepam, glibenclamide, nifedipine, phenprocoumon and oral contraceptives containing levonorgestrel and ethinyl estradiol, did not reveal clinically significant interactions.
the Results of studies on possible interactions indicate that pantoprazole does not affect the metabolism of active substances metabolised via CYP1A2 (such as caffeine and theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol) or does not affect p-glycoprotein, which ensures the absorption of digoxin.
there was No interaction simultaneously with the prescribed antacids.
special researches of interaction of pantoprazole with certain antibiotics (clarithromycin, metronidazole, amoxicillin) at simultaneous application of preparations are Carried out. Clinically significant interactions between these drugs have not been revealed.
Pantoprazole is a substituted benzimidazole that blocks the secretion of hydrochloric acid in the stomach through a specific effect on the proton pump of parietal cells.
Pantoprazole is transformed into an active form in an acidic environment, namely in parietal cells, where the enzyme inhibits H+-K+-ATPase, that is, blocks the final stage of hydrochloric acid production in the stomach. The inhibition is dose-dependent and inhibits both basal and stimulated acid secretion.
Treatment with pantoprazole, like other proton pump inhibitors and inhibitors of the H2receptors reduces the acidity in the stomach and thereby increases gastrin secretion is proportional to the decrease of acidity. Increasing gastrin secretion is reversible. Since pantoprazole binds to the enzyme distal relative to the cell receptor, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrinomas). The effectiveness of the drug is the same in oral administration or intravenous.
the use of pantoprazole increased fasting gastrin. With short-term use, in most cases, they do not exceed the upper limit of the norm. With long - term treatment of gastrin levels in most cases grow twice. Excessive increase, however, occurs only in rare cases. As a result, a small number of cases with long-term treatment observed slight or moderate increase in the number enterochromaffin cells (ECL-cells) of the stomach (adenomatoid hyperplasia). However, according to current research, the formation of precursor cells of neuroendocrine tumors of the stomach, which were found in experiments with animals, was not observed in humans. But with long-term (more than 1 year) treatment can not exclude the influence of pantoprazole on the endocrine parameters of the thyroid gland.
Pantoprazole is rapidly absorbed, the maximum concentration in blood plasma is achieved even after taking one dose of 40 mg.on average, the maximum concentration in plasma 2-3 mg/ml is achieved within 2.5 hours after administration and remains constant also after repeated administration. The volume of distribution is about 0.15 l/kg, and clearance - about 0.1 l/h/kg.
the half-life is approximately 1:00. In cases of withdrawal has been extended. Due to the specific binding of pantoprazole with proton pump of parietal cells, the half-life period does not correlate with a longer duration of action.
Pharmacokinetics does not change after a single or multiple administration. At doses of
10 to 80 mg of the kinetics of pantoprazole in plasma is linear both after oral and intravenous administration.
the Binding of pantoprazole to plasma proteins is 98%. The drug is almost completely metabolized in the liver. The main route of excretion of the kidney - about 80% of the metabolites of pantoprazole; the rest is excreted in the feces. The main metabolite in both plasma and urine desmethyldonepezil that connects with the sulfate. The half-life of the main metabolite (approximately 1.5 hours) is slightly longer than pantoprazole.
Bioavailability.after oral administration pantoprazole is absorbed completely. The bioavailability of the tablet is about 77%. Eating has no effect on the value of the area under the pharmacokinetic curve concentration-time (AUC), the maximum concentration in plasma and bioavailability; there is only a change in the beginning of the action.
Characteristics of special groups of patients
no dose reduction is required for patients with impaired renal function (including hemodialysis patients). As in healthy people, the half-life of pantoprazole is short. Only very small amounts of pantoprazole are dialyzed. Despite the fact that the half-life of the main metabolite increases slightly (2-3 hours), it is quickly excreted and therefore does not accumulate.
in patients with liver cirrhosis (classes a and B according to child-Pugh) the half-life period increases to 7-9 hours and accordingly the AUC value increases by 5-7 times and the maximum concentration of pantoprazole in plasma increases by 1.5 in comparison with healthy people.
a Slight increase in AUC and the maximum concentration of pantoprazole in plasma in elderly volunteers compared to young also is not clinically significant.
Children.After a single oral dose of 20 or 40 mg oral pantoprazole, the AUC and Cmaxin children aged 5 to 16 years were in the range of those in adults. After a single administration of pantoprazole at a dose of 0.8 or 1.6 mg/kg in children from 2 to 16 years, there was no significant relationship between the clearance of pantoprazole and the age or body weight. AUC and the volume of distribution with data obtained in adult studies.
tablets are light yellow-brown, oval, slightly biconvex, film-coated.The
Store at a temperature not exceeding 30 ° Coin its original packaging to protect against moisture. Keep out of reach of children.The
14 tablets in a blister, 1 or 2 or 4 blisters in a box.The
According to the recipe.The
the KRKA D. D., Novo mesto, Slovenia.
KRKA, dd, Novo mesto, Slovenia.The
Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
Nolpaza is a special preparation that acts as an inhibitor for the pump. Is a enteric coated tablets. The dragee contains 20 mg of active ingredient-pantoprazole. He is responsible for inhibiting the production of hydrochloric acid in the digestive tract, thereby provoking a decrease in acidity and increased secretion of gastrin. The drug is used to treat gastrointestinal diseases, including ulcers. Pantoprazole is perfectly absorbed by the systemic blood flow. The maximum level of concentration of the substance in the stomach occurs 2 hours after taking the pill. Metabolism of the substance occurs in the liver, residues are removed from the body through the kidneys. The drug has side effects.
the pill should be only oral, not crushing and not liquid. Drink plenty of water. Adults should take the drug before meals. Per day take 20 mg (1 tablet) activitiesthese substances. Take the drug should not be less than 2 weeks.