Pulcet 40 mg 14 tablets — Made in Turkey — Free Delivery

(Pulcet 40 mg)
Pulcet 40 mg 14 tablets — Made in Turkey — Free Delivery
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Nobel Ilac San. Ve Tic. A.S. Brand: Nobel Ilac San. Ve Tic. A.S.
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Description Pulcet 40 mg 14 tablets — Made in Turkey — Free Delivery

Pharmacological properties

Pharmacodynamics. Pantoprazole is a blocker of gastric secretion, inhibits the activity of n + -c + -atphase in parietal cells of the stomach and thus blocks the last phase of hydrochloric acid secretion. this leads to a decrease in the level of basal secretion, regardless of the nature of the irritation. possesses antibacterial activity against Helicobacter pylori and contributes to the manifestation of the anti-Helicobacter effect of other preparations. the therapeutic effect after the application of a single dose comes quickly and lasts for 24 hours.
Pharmacokinetics. It is rapidly and completely absorbed after oral administration. Absolute bioavailability - 77%. Cmax in blood plasma is achieved in 2–4 hours. Plasma protein binding - 98%; T1 / 2 - 1 hour Very weakly penetrates the BBB. Metabolized in the liver. It is excreted mainly in the urine (82%) in the form of metabolites, in small quantities in the feces. Not cumulative. T1 / 2 in patients with liver cirrhosis increases to 7-9 hours, with hepatic failure - slightly, but T1 / 2 of the main metabolite reaches 2-3 hours.

Indications

Reflux esophagitis; eradication h. pylori in patients with peptic ulcers caused by this microorganism, in combination with certain antibiotics (see application); duodenal ulcer; stomach ulcer; Zollinger-Ellison syndrome and other pathological hypersecretory conditions.

Application

Pulcet, tablets resistant to gastric juice, should be taken 1 hour before meals whole, without chewing or crushing, washed down with water.
Reflux esophagitis treatment. The recommended dose of Pulcet for children aged 12 years and adults is 1 tablet of the preparation 40 mg once a day. In some cases, the dose can be doubled (2 tablets of the preparation 40 mg / day), especially if there is no effect from the use of other preparations.
Reflux esophagitis usually takes 4 weeks to treat. If this is not enough, a cure can be expected within the next 4 weeks.
Eradication of H. pylori in combination with two antibiotics. In patients with gastric and duodenal ulcers and who test positive for H. pylori, it is necessary to achieve eradication of the microorganism using combination therapy. Depending on the sensitivity of microorganisms for the eradication of H. pylori in adults, the following therapeutic combinations can be prescribed:
a) 1 tablet Pulcet 40 mg 2 times a day
+ 1000 mg amoxicillin 2 times a day
+ 500 mg clarithromycin 2 times a day;
b) 1 tablet Pulcet 40 mg 2 times a day
+ 400-500 mg metronidazole (or 500 mg tinidazole) 2 times a day
+ 500 mg clarithromycin 2 times a day;
c) 1 tablet Pulcet 40 mg 2 times a day
+ 1000 mg amoxicillin 2 times a day
+ 400-500 mg of metronidazole (or 500 mg of tinidazole) 2 times a day.
When using combination therapy for the eradication of H. pylori, the second tablet of the preparation Pulcet should be taken in the evening 1 hour before meals. The duration of treatment is 7 days and can be extended for another 7 days with a total duration of treatment of no more than 2 weeks.
If combination therapy is not indicated, for example, in patients with a negative result for H. pylori, the following dose is prescribed for monotherapy.
Stomach ulcer treatment. 1 pill Pulcet per day. In some cases, the dose can be doubled (2 Pulcet tablets per day), especially if there is no effect from the use of other preparations.
Stomach ulcers usually take 4 weeks to treat. If this is not enough, a cure can be expected within the next 4 weeks.
Treatment of duodenal ulcers. 1 pill Pulcet per day. In some cases, the dose can be doubled (2 Pulcet tablets per day), especially if there is no effect from the use of other preparations.
Duodenal ulcers usually take 2 weeks to treat. If this is not enough, a cure can be expected within the next 2 weeks.
Treatment of Zollinger-Ellison syndrome and other hypersecretory pathological conditions. For long-term treatment of Zollinger-Ellison syndrome and other pathological hypersecretory conditions, the initial daily dose is 80 mg (2 Pulcet tablets, 40 mg each). If necessary, then the dose can be titrated, increasing or decreasing, depending on the rate of acid secretion in the stomach. If the dose exceeds 80 mg / day, it must be divided into 2 doses. A temporary increase in the dose to more than 160 mg of pantoprazole is possible, but the duration of use should be limited only by the period necessary for adequate control of acid secretion.
The duration of treatment for Zollinger-Ellison syndrome and other pathological conditions is not limited and depends on the clinical need.
Patients with severely impaired liver function should not exceed a daily dose of 20 mg (1 tablet Pulcet 20 mg). Patients with moderate to severe hepatic dysfunction should not use the preparation Pulcet  for the eradication of H. pylori in combination therapy, since there is currently no data on the efficacy and safety of such use in this category of patients.
No dose adjustment is required for patients with impaired renal function. Patients with impaired renal function should not use the preparation Pulcet for the eradication of H. pylori in combination therapy, since there is currently no data on the efficacy and safety of such use for this category of patients.
Elderly patients do not need dose adjustment.

Contraindications

Hypersensitivity to pantoprazole or any component of the preparation.

Side effects

The occurrence of adverse reactions was noted in about 5% of patients. the most common adverse reactions are diarrhea and headache (about 1%).
On the part of the blood and lymphatic system: agranulocytosis, leukopenia, thrombocytopenia, pancytopenia.
From the immune system: hypersensitivity reactions (including anaphylactic reactions, anaphylactic shock).
Metabolism and metabolic disorders: hyperlipidemia and increased lipid levels (TG, CS), changes in body weight, hyponatremia, hypomagnesemia.
Mental disorders: sleep disturbances, depression (with complications), disorientation (with complications), hallucinations; confusion (especially in patients with a tendency to these disorders, as well as exacerbation of these symptoms, if any).
From the nervous system: headache, dizziness, taste disorders.
From the side of the organ of vision: visual impairment / blurredness.
From the digestive tract: diarrhea, nausea, vomiting, bloating, constipation, dry mouth, abdominal pain and discomfort.
From the hepatobiliary system: an increase in the level of liver enzymes (transaminases, gamma-glutamyltransferase), an increase in the level of bilirubin, damage to hepatocytes, jaundice, hepatocellular insufficiency.
Skin and subcutaneous tissue disorders: skin rash, exanthema, pruritus, urticaria, angioedema, Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, photosensitivity.
From the musculoskeletal system and connective tissue: arthralgia, myalgia.
On the part of the kidneys and urinary system: interstitial nephritis.
On the part of the reproductive system and mammary glands: gynecomastia.
General disorders: asthenia, fatigue, malaise, fever, peripheral edema.

special instructions

Patients with severely impaired liver function should regularly monitor the level of liver enzymes, especially during long-term treatment. in case of an increase in the level of liver enzymes, treatment should be discontinued.
In combination therapy, the instructions for use of the respective medicinal products must be followed.
In the presence of alarming symptoms (for example, in the case of a significant decrease in body weight, intermittent vomiting, dysphagia, vomiting of blood, anemia, melena), as well as if a stomach ulcer is suspected or present, it is necessary to exclude malignancy, since pantoprazole treatment can mask the symptoms of a malignant ulcer and delay the establishment diagnosis. If symptoms persist with further adequate treatment, further research is needed.
Concomitant use of atazanavir with proton pump inhibitors is not recommended (see INTERACTIONS). If the combination of Pulcet with atazanavir is necessary, close clinical monitoring (for example, measurement of viral load) should be carried out in combination with increasing the dose of atazanavir to 400 mg using 100 mg ritonavir. The dose of pantoprazole 20 mg should not be exceeded.
In patients with Zollinger-Ellison syndrome and other hypersecretory pathological conditions that require long-term treatment, pantoprazole, like all antacids, can reduce the absorption of vitamin B12 (cyanocobalamin) due to the occurrence of hypo- and achlorhydria. This should be taken into account when patients are underweight or have risk factors for reduced absorption of vitamin B12 with long-term treatment, or the presence of appropriate clinical symptoms.
With long-term treatment, especially for more than 1 year, patients should be under regular medical supervision.
Pantoprazole, like other proton pump inhibitors, can increase the number of bacteria that are commonly found in the upper GI tract. Treatment with the preparation  may mildly increase the risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.
Use during pregnancy and lactation. The experience of using the preparation in pregnant women is limited. The preparation is used during pregnancy only if absolutely necessary.
There are data on the excretion of pantoprazole in breast milk. The decision to use the preparation during lactation should be made after a careful assessment of the benefit / risk ratio.
Children. The preparation is not recommended for use in children under 12 years of age, as data on the safety and efficacy of the preparation for this age group are limited.
The ability to influence the reaction rate when driving or operating other mechanisms. It is necessary to take into account the possible development of adverse reactions, such as dizziness and visual impairment.

Interactions

Pantoprazole may reduce the absorption of preparations whose bioavailability depends on the pH of gastric juice (for example, some antifungal preparations such as ketoconazole, itraconazole, posaconazole, or other preparations such as erlotinib).
The simultaneous use of proton pump inhibitors with atazanavir and other anti-HIV preparations, the adsorption of which depends on pH, can lead to a significant decrease in the bioavailability of the latter and affect their effectiveness. Therefore, the combined use of proton pump inhibitors with atazanavir is not recommended.
Despite the lack of interaction with the simultaneous appointment with phenprocoumon and warfarin during clinical trials, isolated cases of changes in INR (international normalized ratio) have been reported in the post-marketing period. Thus, in patients who are using indirect anticoagulants (for example, phenprocoumon and warfarin), it is recommended to monitor the prothrombin time / INR after initiation, discontinuation or irregular administration of pantoprazole.
Pantoprazole is largely metabolized in the liver through the cytochrome P450 system. The main metabolic pathway is demethylation by CYP 2C19 and other metabolic pathways, including oxidation by the CYP 3A4 enzyme. With preparations that are also metabolized by these pathways, such as carbamazepine, diazepam, glibenclamide, nifedipine, phenprocoumon, and oral contraceptives containing levonorgestrel and ethinyl estradiol, no clinically significant interactions have been identified.
Pantoprazole does not affect the metabolism of active substances that are metabolized by CYP 1A2 (eg caffeine, theophylline), CYP 2C9 (eg piroxicam, diclofenac, naproxen), CYP 2D6 (eg metoprolol), CYP 2E1 (eg ethanol), does not affect p -glycoprotein, which ensures the absorption of digoxin.

Overdose

Overdose symptoms in humans are unknown. an increase in the severity of adverse reactions is possible.
Doses of up to 240 mg when administered intravenously for 2 minutes were well tolerated.
In case of an overdose with signs of intoxication, symptomatic treatment is carried out.

Storage conditions

In a dry, dark place at a temperature not exceeding 25 ° C.

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