Instructions for use PANTASUN tablets

Instructions for use

Each pack contains a small receipt - this is an instruction with important data. They relate to the method of administration, the moments at which the drug is taken, its interaction with other drugs, side effects, contraindications, conditions of use during pregnancy or breastfeeding, storage conditions, pharmacology, and composition.

It is best to carefully study all this data so that no negative reactions arise in the future.

This drug is manufactured in the UK.

Pharmacology

Enteric tablets 40 mg No. 28 (7x4) Ulsepan is an antiulcer agent that works due to the antisecretory effect of lantprazor. Due to this, the process of pump inhibition occurs. The pharmacodynamics of the drug suggests the accumulation of lantoprazole among the tubules of parietal cells. At this moment, a combination with hydrogen ions occurs. After this, the drug transforms sulfenamide reactions, and covalent bonds are formed with the proton pump.

After these processes, the last phase of hydrochloric acid secretion is blocked, as well as a decrease in the level of acid in the human stomach.

After administration, the medicine enters the stomach, Ulsepan is absorbed in the intestines within a few minutes. The bioavailability of the product is 80%. The maximum concentration of the drug is observed after four hours. The first half-life is one hour.

The pharmacokinetics of the drug does not change under the influence of antacids.

In what cases can the remedy be prescribed?

If you ask yourself what exactly this medicine helps with, you can identify a number of pathologies, which include conditions such as:

• Zollinger-Ellison syndrome;
• Any form of ulcer;
• Reflux esophagitis.

In case of any pathologies (whether they are related to the heart, stomach, liver, etc.), you should under no circumstances show independence. Only a qualified specialist can select the right medicine.

How exactly should you take the drug?

If suddenly, for some reason, the doctor has not prescribed to you exactly how to take the drug Ulsepan, the instructions contain detailed instructions for use.

For all pathologies, the tablets should be taken orally with plenty of water. The dosage may vary slightly depending on the disease.

Pills.

• For ulcers, the medicine should be taken in a dosage of 1-2 tablets per day. For intestinal ulcers, treatment lasts 2 weeks, and for stomach ulcers, treatment is extended to two months;
• If there is reflux esophagitis, the drug should be taken in a tablet dosage for two months. If there is still no positive result, then the course of treatment can be extended;
• If you have been diagnosed with Zollinger-Ellison, the dose of the medicine is selected individually. You should start with two tablets a day. In the future, this dose can be increased to 6 tablets per day, and the duration of treatment is about a year;
• To eradicate Helicobacter, you need to take the medicine in a dosage of one tablet. The drug should be taken together with other means for a speedy recovery.

Injections.

Lyophilized powder for the preparation of solution for injection. The instructions for use say that this form of the drug can be taken only when a person for some reason cannot take tablets. The dosage also directly depends on the type of disease.

• For the treatment of erosive reflux esophagitis, the drug should be taken at a dosage of 40 mg of the active substance per day. The total duration of treatment is 2-3 weeks;
• If there is Zollinger-Ellison syndrome, then the dosage can be 80 mg. The medicine should be taken twice.

In order to prepare the solution, you need to take the powder in a bottle and break it with 10 ml of saline solution. The result is a primary solution, which should be mixed with 100 ml of sodium chloride to obtain 0.4 mg/ml. The resulting solution cannot be stored in the refrigerator; it must be used immediately for its intended purpose.

What is the composition of the product?

In pharmacies you can find the drug in several forms:

• Pills. They contain the active substance pantoprazole. Additional components include povidone, calcium carbonate, mannitol, calcium stearate, crospovidone, sucrose stearate, calcium stearate. All tablets are coated with white opadry, titanium dioxide, talc, silicon dioxide, yellow iron oxide, calcium stearate, sodium bicarbonate, sodium lauryl sulfate
• Lyophilized powder, which is used for the preparation of injections. One bottle contains the active substance - pantoprazole, as well as an additional substance - sodium hydroxide.

Interaction of means

The simultaneous combination of the drug with other drugs, the bioavailability of which depends on the pH of the stomach, may reduce the effectiveness of such drugs.

No significant interaction of the drug with nifedipine, amoxicillin, digoxin, glibenglamide, phenazone, diazepam, warfarin, tacrolimus, antacids, caffeine, ethanol, clarithromycin, metoprolol was not detected.

All gastroenterology clinics and medical centers in your city. Tests and ultrasound. Consultation with a gastroenterologist. Diseases of the digestive system. Find out more: - In Kiev (Hertz, Ilaya, Euromed) - In St. Petersburg (SM-Clinic, Longevity, Allergomed, Doctor +, BaltZdrav, Professor) - In Moscow (SM-Clinic, Medlux, Onmed) - In Kharkov ( TsMEI, Olympic, Victoria, Fortis, Ecomed) - In Minsk (Belgirudo, Art-Med-Company, Sinlab, Mikosha, GrandMedica, MedClinic) - in Odessa (Medea, On Clinic, Into Sano, Venus) - In Razyan (Trust + , Polyclinic-Pesochnya, Evrikas +) - in Nizhny Novgorod (Only Clinic, Alpha Center, EuroClinic, SOLO, Altea) - gastroenterological clinics of Tyumen (Doctor A+, Clinic "Vera", Avicenna, Medis, Sibirina, Your Doctor)

Pharmachologic effect:

The drug Controloc is a proton pump inhibitor.
The active ingredient of Controloc - pantoprazole - has the ability to inhibit the secretion of HCl in the stomach as a result of a specific effect on the proton pumps of parietal cells. Pantoprazole in an acidic environment in parietal cells is transformed into its active form and inhibits the final phase of hydrochloric acid release, regardless of the origin of the stimulus, that is, H+/K+-ATPase. Inhibition of H+/K+-ATPase is dose-dependent and affects stimulated and basal secretion of gastric juice. Pantoprazole has the ability to reduce stomach acidity, which leads to increased gastrin secretion.

In most cases, with a short course of treatment with pantoprazole, gastrin levels do not exceed the upper limit of normal. With long-term therapy, gastrin levels may double. In extremely rare cases, during long-term drug therapy, a moderate or slight increase in the number of endocrine cells of the stomach (development of adenomatoid hyperplasia) was observed.

Pantoprazole is absorbed quickly from the digestive tract, reaching maximum concentration even after a single dose of the drug. In most cases, 2 - 2.5 hours after taking Controloc, the maximum concentration of pantoprazole is 1 - 1.5 mcg/ml. After repeated administration of the drug, these concentration levels remain constant. The clearance of pantoprazole is about 0.1 l/h/kg, the volume of distribution is 0.15 l/kg. The half-life of pantoprazole is 60 minutes. The half-life of pantoprazole due to specific activation in parietal cells does not correlate with the duration of action.

After repeated or single administration of the drug, the pharmacokinetics do not change. It remains linear both after intravenous administration and after oral administration of the drug.

The binding ability of pantoprazole to blood proteins is about 98%. Metabolization of the drug occurs in the liver. 80% of pantoprazole is excreted by the kidneys, 20% is excreted in feces. The main metabolite of pantoprazole in plasma and urine is dismethylpantoprazole bound to sulfate. The main metabolite has a slightly longer half-life (1.5 - 2 hours) than pantoprazole.

After oral administration, pantoprazole is completely absorbed. Food intake does not affect the bioavailability of the drug and the maximum concentration. The absolute bioavailability of pantoprazole for the tablet form of the drug, resistant to gastric juice, is approximately 77%.

When Controloc is taken orally at a dose of 20 mg, the antisecretory effect is observed after 1 hour, and reaches a maximum after 2 - 4 hours. Controloc has no effect on gastrointestinal motility. A decrease in gastric secretion in duodenal ulcer associated with Helicobacter pyl. leads to an increase in the sensitivity of microorganisms to antibacterial drugs. After finishing taking the drug, secretory activity normalizes within 3-4 days.

Controloc, compared to other proton pump inhibitors at neutral pH, is characterized by greater chemical stability and a lower potential for interaction with the hepatic oxidase system, which depends on cytochrome P450. In this regard, Controloc does not interact with most other common drugs.

When treating patients with impaired renal function (including patients on hemodialysis), a reduction in pantoprazole dosage is not required. In such patients, the half-life is short, as in healthy individuals. A small amount of pantoprazole is dialyzed. The main metabolite does not accumulate and is rapidly eliminated, although it has a slightly longer half-life.

The half-life of the drug in patients with liver cirrhosis (class A and B) increases to 4 - 6 hours, the maximum concentration in the blood (plasma) increases by 1.3 times compared to Cmax in healthy individuals.

In elderly patients, there is a slight increase in the maximum concentration of pantoprazole, which is not clinically significant.

When can a negative reaction appear in the form of side symptoms?

Adverse reactions include:

• Headache, sleep disturbance, dry mouth, flatulence, stomach discomfort, increased fatigue, eczema, constipation, asthenia;
• Changes in body weight, myalgia, peripheral edema, urticaria, fever, gynecomastia;
• Leukopenia, spatial disorientation, thrombocytopenia, arthralgia;
• Depression, complete apathy towards everything,
• visual impairment,
• Any skin rashes

If you experience at least one of these conditions, then you should stop taking the drug. Next, you need to go to the hospital to get medical help.

Overdose data

To date, no cases of overdose have been reported. However, doctors advise not to exclude the possibility of this condition. If any symptoms of an overdose do appear, then therapy should be carried out based on the existing symptoms.

Symptoms of Ulsepan overdose: increased side effects

What contraindications does the product have?

The drug should not be taken if you are hypersensitive to the active substance of the drug, as well as to any other components that are also included in the composition. Before you start taking the drug, you must notify your doctor about taking any medication . This must be done to prevent the possibility of allergies in the future.

In addition, contraindications to taking the drug are hepatitis, as well as cirrhosis of the liver, which may be accompanied by acute renal failure.

During pregnancy

Taking this medication during pregnancy is not advisable. Treatment is possible only if the benefit to the woman is several times greater than the risk to the child.

Considering that the active substance of the drug has the ability to penetrate into breast milk, it is best to refuse breastfeeding or refrain from treatment for a while while taking it.

• If you have any symptoms of the disease, you should immediately consult a doctor. You can view a list of gastroenterology clinics on our website
• You will be interested! The article describes symptoms that make it possible to suspect the presence of liver disease in the early stages
• You will also be interested in learning more about the treatment of various diseases of the gastrointestinal tract

Ulsepan 40 mg No. 14 tablet p.o. solution/intestinal

Instructions for medical use of the drug ULSEPAN Trade name Ulsepan International nonproprietary name Pantoprazole Dosage form Enteric-coated tablets, 40 mg Composition One tablet contains the active substance - pantoprazole 40 mg (in the form of sodium pantoprazole sesquihydrate 45.10 mg), excipients: mannitol , calcium carbonate, crospovidone, povidone VA 64, sucrose stearate, calcium stearate, film coating composition: Opadry White (YS-1-7027)*, purified water, enteric coating composition: Acryl-Eze yellow (93092157) **, purified water. * — HPMC 2910/Hypromellose 6Ср, titanium dioxide (E171), triacetin/glycerol triacetate. ** — methacrylic acid copolymer Type C, talc, titanium dioxide (E171), triethyl citrate, colloidal anhydrous silicon dioxide, sodium bicarbonate, yellow iron oxide (E172), sodium lauryl sulfate. Description Tablets are oval in shape, with a biconvex surface, coated with a yellow enteric coating. Pharmacotherapeutic group Drugs for the treatment of diseases associated with acidity disorders. Antiulcer drugs and drugs for the treatment of gastroesophageal reflux (GORD). Proton pump inhibitors. Pantoprazole. ATC code A02BC02 Pharmacological properties Pharmacokinetics Absorption. After oral administration, pantoprazole is quickly and completely absorbed from the gastrointestinal tract. Peak plasma concentrations of 2.5 mcg/ml are observed after 2-3 hours. Pantoprazole is subject to little first-pass effect and its bioavailability is 70-80%. Absorption of pantoprazole is not affected by food intake or antacids. Distribution. The volume of distribution is approximately 11-23.6 L. Pantoprazole is 98% bound to plasma proteins (albumin). Metabolism. Pantoprazole is metabolized in the liver by the cytochrome P450 system. The main metabolic pathway is demethylation reactions. Excretion. Approximately 71% of the dose taken is excreted by the kidneys and 18% by biliary excretion. The half-life of pantoprazole is approximately 1 hour. Slightly penetrates the blood-brain barrier. Pharmacodynamics Ulsepan belongs to the group of antiulcer drugs, the action of which is due to the antisecretory effect of pantoprazole due to inhibition of the proton pump - H+-K+-ATPase. Being a weak base, pantoprazole accumulates in the tubules of parietal cells, interacts with hydrogen ions, and is transformed into sulfenamide derivatives, which form covalent bonds with the SH group of the proton pump on the surface of the apical membrane. As a result, the last phase of hydrochloric acid secretion is blocked, which leads to a decrease in the level of basal and stimulated acid secretion in the stomach. Ulsepan has antibacterial activity against Helicobacter pylori and promotes the anti-Helicobacter effect of other drugs. Indications for use - peptic ulcer of the stomach or duodenum - reflux esophagitis - pathological hypersecretory conditions, including Zollinger-Ellison syndrome - eradication of Helicobacter pylori (in combination with antibacterial therapy) Method of administration and dosage Ulsepan is taken orally before meals, without chewing, with a glass water. Peptic ulcer of the stomach and duodenum: 40 mg/day is prescribed, in some cases, including when therapy is ineffective, 80 mg/day can be prescribed. The course of treatment for exacerbation of duodenal ulcer is 2-4 weeks, and for gastric ulcer: 4-8 weeks. Gastroesophageal reflux disease, erosive and ulcerative reflux esophagitis: prescribed 40 mg/day. The course of therapy is 4 weeks. If healing does not occur, an additional 4-week course of treatment is recommended. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome: the dose is selected individually depending on the clinical indication. The recommended starting dose is 40 mg 2 times/day. The dose can be increased to 240 mg/day, and the course of treatment can be extended to 2 years. Eradication of Helicobacter pylori: take 40 mg 2 times a day in combination with antimicrobial agents for 7 days and can be continued for another 7 days. In patients with liver diseases, the daily dose of the drug should not exceed 20 mg. Side effects Uncommon - headache, dizziness - dry mouth, nausea, vomiting, bloating, upper abdominal pain and discomfort, diarrhea, constipation - skin rash, itching, exanthema - asthenia, fatigue and malaise - increased activity of liver enzymes (transaminases) , γ – GT) - sleep disturbance Rarely - agranulocytosis - visual disturbances, blurred vision (blurred vision) - urticaria, angioedema - arthralgia, myalgia - hyperlipidemia and increased levels of triglycerides, cholesterol, changes in body weight, taste disturbances - increased body temperature , peripheral edema - increased sensitivity to the active and auxiliary components of the drug (including anaphylactic reactions and anaphylactic shock) - increased bilirubin levels - depression (and all associated deteriorations) - gynecomastia Very rarely - thrombocytopenia, leukopenia, pancytopenia - disorientation (and all associated deteriorations) Unknown - interstitial nephritis - Stevens-Johnson syndrome, Lyell's syndrome, exudative erythema multiforme, photosensitivity - hyponatremia, hypomagnesemia - hepatocellular damage, jaundice, hepatocellular failure - hallucinations, confusion (especially in patients predisposed to these conditions, as well as worsening of these symptoms, if they existed before the start of treatment) Contraindications - hypersensitivity to pantoprazole and auxiliary components of the drug - hepatitis or cirrhosis of the liver, accompanied by severe liver failure - combined use with atazanavir - severe renal dysfunction Drug interactions With simultaneous use of drugs whose bioavailability depends on the pH of the stomach (eg ketoconazole), Ulsepan may alter their absorption. Due to the fact that pantoprazole is metabolized in the liver by the cytochrome P450 enzyme system, the possibility of drug interactions with drugs metabolized by the same enzyme system cannot be excluded. Special instructions Before starting therapy, the possibility of a malignant neoplasm of the stomach and esophagus should be excluded, since the use of Ulsepan can reduce the severity of symptoms and delay the establishment of the correct diagnosis. The diagnosis of reflux esophagitis requires mandatory endoscopic confirmation. Patients should not simultaneously take other proton pump inhibitor or H2 antagonist drugs. When used in patients with impaired liver function, the activity of liver enzymes in the blood plasma should be regularly monitored and, if they increase, Ulsepan should be discontinued. Decreasing stomach acid increases the number of stomach bacteria that are normally present in the gastrointestinal tract. Treatment with acid-lowering drugs increases the risk of developing gastrointestinal infections caused by microorganisms such as Salmonella, Campylobacter or C. difficie. Use in pediatrics Due to insufficient data on safety and effectiveness, the use of the drug in the treatment of children and adolescents under 18 years of age is not recommended. Pregnancy and lactation The use of the drug during pregnancy is possible if the expected benefit to the mother outweighs the potential risk to the fetus or child. Lactation should be stopped during treatment with the drug. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Considering the side effects of the drug, care should be taken when driving vehicles and working with potentially dangerous mechanisms. Overdose Symptoms: increased side effects. Treatment: symptomatic, it is necessary to carry out regular detoxification measures. Release form and packaging 7 tablets are packed in a blister pack. 2 or 4 blister packs with instructions for medical use in the state and Russian languages ​​are placed in a cardboard box. Storage conditions Store in a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children! Shelf life: 3 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription (Akpinar Mahallesi Fatih Caddesi, No.: 17, 34885 Samandira-Sanjak Tepe - Istanbul / Turkey). “Biofarma ilaç San. Ve Tic. AS" (Akpmar Mah. Fatih Cad. No: 17, 34885 Samandira - Sancaktepe - Istanbul / Turkey). The owner of the trademark and registration certificate is, Great Britain The owner of the registration certificate "World Medicine", Great Britain Address of the organization that accepts claims from consumers on the quality of products (products) in the territory of the Republic of Kazakhstan WM Pharma Alliance LLP (VM Pharma Alliance) RK, Almaty, st. Suyunbaya 222 B Tel/fax: 8(7272)529090

Reviews

Before reading the “Reviews” section, we would like to remind you that every review is important to us. After all, it is on the basis of your feedback that we can fully highlight the positive and negative qualities of the product. That is why, if you suddenly encountered taking this drug, then please leave your review about it.

Before purchasing or using the drug, you should consult your doctor and read the original manufacturer's instructions. Taking any drug is accompanied by both positive and negative opinions of people. If a patient is suddenly prescribed any medicine, then the first thing he studies after the instructions is the reviews, because What matters to him is how effective the product is.

It is important to note that after taking the medicine, many people have positive opinions. Most note a decrease in symptoms. If the remedy was prescribed for gastritis, then the person experienced attacks of pain much less frequently.

When taken together with other medications, Ulsepan was very well tolerated.

Negative reviews are usually associated with the lack of product in pharmacies, as well as with improper use, resulting in negative reactions.

It is worth remembering that any remedy that your acquaintances and friends speak very highly of may not help, and sometimes even harm you. This is due to the fact that each person has a different body, which may perceive the medicine completely differently, and everyone’s disease always progresses individually.

Indications for use:

Controloc is used to treat peptic ulcers of the duodenum, gastric ulcers, Zollinger-Ellison syndrome and other pathological hypersecretory conditions, severe and moderate reflux esophagitis.

Controloc tablets 20 mg are prescribed for the treatment of mild reflux disease and its symptoms (pain when swallowing, reflux of acidic contents, heartburn), prevention of relapse and long-term treatment of reflux esophagitis, prevention of duodenal and stomach ulcers caused by taking drugs NSAID group in patients at risk who have been taking NSAIDs for a long time.

Controloc in 40 mg tablets is prescribed for the treatment of stomach ulcers, duodenal ulcers, severe and moderate reflux esophagitis, Zollinger-Ellison syndrome and other hypersecretory conditions, for complex treatment with antibacterial drugs for the eradication of Helicobacter pyl. in patients with peptic ulcers caused by this bacterium, to reduce the number of relapses of duodenal and gastric ulcers