Controloc enteric-coated tablets 20 mg 14 pcs. in Smolensk

Compound

Pharmacodynamics

Proton pump inhibitor (H+-K+-ATPase). Blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus.

Antisecretory activity. After the first oral administration of 20 mg of the drug Controloc®, a decrease in gastric juice secretion by 24% occurs after 2.5–3.5 hours and by 26% after 24.5–25.5 hours. After oral administration once a day for 7 days, antisecretory activity increases to 56% after 2.5–3.5 hours and to 50% after 24.5–25.5 hours. In case of duodenal ulcer associated with Helicobacter pylori, a decrease in gastric secretion increases the sensitivity of microorganisms to antibiotics . Does not affect gastrointestinal motility. Secretory activity returns to normal 3–4 days after the end of administration.

Compared to other proton pump inhibitors, Controloc® has greater chemical stability at neutral pH and a lower potential for interaction with the cytochrome P450-dependent oxidase system of the liver. Therefore, no clinically significant interactions have been observed between Controloc® and many other drugs.

Controloc Control 20 mg No. 14 tablet p.o. solution/intestinal

Instructions for medical use of the drug Controloc Control Trade name Controloc Control International nonproprietary name Pantoprazole Dosage form Enteric-coated tablets, 20 mg Composition One tablet contains the active substance - pantoprazole sodium sesquihydrate 22.57 mg (equivalent to pantoprazole 20.0 mg), excipients: anhydrous sodium carbonate, mannitol, crospovidone, povidone K90, calcium stearate, purified water*** shell composition: hypromellose 2910, povidone K25, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol enteric coating composition: copolymer methacrylic acid and ethacrylate (1:1) 30% dispersion**, triethyl citrate, purified water*** composition of brown ink Opacode S-1-16530: shellac glaze 45%, iron (III) oxide red (E172), iron (III ) black oxide (E172), iron (III) yellow oxide (E172), concentrated ammonia solution. * - current edition; ** - dispersion composition: copolymer of methacrylic acid and ethyl acrylate - 14.13 mg, sodium lauryl sulfate - 0.10 mg, polysorbate 80 - 0.33 mg; *** - removed during production. Description Oval, biconvex, yellow film-coated tablets with a white to almost white core. “P20” is printed on one side of the tablet in brown ink. Pharmacotherapeutic group Drugs for the treatment of diseases associated with acidity disorders. Antiulcer drugs and drugs for the treatment of gastroesophageal reflux. Proton pump inhibitors. Pantoprazole. ATC code A02BC02 Pharmacological properties Pharmacokinetics Pantoprazole is rapidly absorbed from the gastrointestinal tract. Absolute bioavailability is 77%. The maximum concentration in blood plasma after taking a dose of 20 mg - 2 - 3 μg / ml is achieved after 2.5 hours and remains constant after repeated use. Volume of distribution is approximately 0.15 l/h/kg, clearance is approximately 0.1 l/h/kg. Plasma protein binding is approximately 98%. Pantoprazole is almost completely metabolized in the liver. The main metabolite detected in blood serum and urine is desmethylpantoprazole, which is combined with sulfate. The half-life is approximately 1 hour. Approximately 80% of the drug is eliminated by the kidneys, the remaining 20% ​​with feces. Pharmacodynamics Pantoprazole is a substituted benzimidazole that slows the secretion of hydrochloric acid in the stomach by specifically affecting the proton pump of parietal cells. In the acidic environment of parietal cells, pantoprazole is converted into its active form, cyclic sulfenamide, where it inhibits the enzyme H+, K+-ATPase. By blocking the proton pump, pantoprazole interferes with the process of acid formation at the level of the final stage of hydrochloric acid synthesis in the stomach. The inhibitory effect is dose-dependent and affects the level of basal and stimulated secretion of hydrochloric acid (regardless of the type of stimulus). In gastric and duodenal ulcers associated with Helicobacter pylori, such a decrease in gastric secretion increases the sensitivity of the microorganism to antibiotics. After oral administration of 20 mg of Controloc Control, the antisecretory effect occurs within 1 hour and reaches a maximum after 2 to 4 hours. Does not affect gastrointestinal motility. Secretory activity returns to the original level 3 to 4 days after the end of administration. Pantoprazole has greater chemical stability at neutral pH, and less potential for interaction with other drugs. Indications for use - short-term treatment of reflux symptoms such as heartburn, sour belching. Method of administration and dosage. Enteric tablets Controloc Control 20 mg should not be chewed or bitten; they should be swallowed whole and washed down with sufficient liquid. The drug must be taken before meals. When prescribing a double dose of the drug, the second tablet should be taken before the evening meal. Symptomatic improvement in patients may begin after approximately one day of treatment with Controloc Control, but may require 7 days to achieve complete resolution of symptoms. Short-term treatment of reflux symptoms (heartburn, sour belching) Adults are prescribed 20 mg per day. To relieve symptoms, it may be necessary to take the drug for 2 to 3 days. Once the symptoms have disappeared, treatment can be stopped. If improvement is not observed within 2 weeks of continuous treatment, the patient should consult a doctor. Side effects The observed side reactions with their frequency of occurrence are listed below: very often (³ 1/10); often (from ³ 1/00 ​​to < 1/10); uncommon (from ³ 1/1000 to < 1/100); rare (from ³ 1/10000 to < 1/1000); very rare (< 1/10000); unknown (cannot be estimated from available data). Uncommon - headache, dizziness - dry mouth, nausea, vomiting, bloating, abdominal pain and discomfort, diarrhea, constipation - skin rash, itching, exanthema - asthenia, fatigue and malaise - increased activity of liver enzymes (transaminases, g-GT ) - sleep disturbance Rarely - agranulocytosis - hypersensitivity to the active and auxiliary components of the drug (including anaphylactic reactions and anaphylactic shock) - hyperlipidemia, increased levels of triglycerides, cholesterol - increased bilirubin levels - weight change, taste disturbance - depression (and all associated deteriorations) - blurred vision / blurred vision - urticaria, angioedema - arthralgia, myalgia - gynecomastia - increased body temperature, peripheral edema Very rare - thrombocytopenia, leukopenia, pancytopenia - disorientation (and all associated impairments) Not known - hyponatremia, hypomagnesemia - hallucinations, confusion (especially in patients predisposed to these conditions, as well as worsening of these symptoms if they existed before treatment) - hepatocellular damage, jaundice, hepatocellular failure - Stevens-Johnson syndrome, Lyell's syndrome, exudative erythema multiforme, photosensitivity - interstitial nephritis Contraindications - hypersensitivity to components of the drug, other substituted benzimidazoles - combined use of pantoprazole with atazanavir Drug interactions Pay attention to simultaneous use with drugs whose absorption is pH-dependent, for example ketoconazole, itraconazole, posaconazole, erlotinib, including drugs prescribed shortly before the course treatment with Controloc Control, due to changes in the absorption of these drugs. Concomitant use of Controloc Control and atazanavir significantly reduces the effectiveness of the latter. When phenprocoumon or warfarin were used together, several isolated cases of changes in the International Normalization Ratio (INR) were observed. Therefore, for patients undergoing treatment with coumarin anticoagulants (for example, phenprocoumon or warfarin), it is recommended to monitor the prothrombin time/INR after starting, stopping, or during irregular use of Controloc Control. Controloc Control has a low potential for interaction with the cytochrome P450 system. Therefore, the risk of adverse reactions caused by the interaction of Controloc Control with other drugs metabolized by the cytochrome P450 system can be considered minimal. Special studies have not revealed clinically significant interactions of the drug Controloc Control with caffeine, carbamazepine, diazepam, ethanol, diclofenac, glibenclamide, naproxen, metoprolol, nifedipine, phenytoin, piroxicam, theophylline, oral contraceptives containing levonorgestrel and ethinyl estradiol. When taken simultaneously with antibiotics such as clarithromycin, amoxicillin, and metronidazole, no interaction was detected. No interaction with antacids when taken concomitantly was detected. Special instructions In patients with severe liver dysfunction when taking the drug Controloc Control, especially over a long period, it is recommended to regularly monitor the level of liver enzymes. If the level of liver enzymes increases, the use of the drug should be discontinued. For patients who require long-term treatment with non-specific non-steroidal anti-inflammatory (NSAID) drugs and are at increased risk of developing gastrointestinal complications, the use of Controloc Control 20 mg as a preventive measure for the formation of gastric and duodenal ulcers caused by the use of NSAIDs should be limited. A risk assessment should be made based on individual risk factors, including age (over 65 years), history of gastric or duodenal ulcers, and gastrointestinal bleeding. Patients should consult a doctor in the following cases: - if symptoms have not resolved within 2 weeks after continuous therapy - involuntary weight loss, anemia, gastrointestinal bleeding, dysphagia, persistent vomiting or vomiting with blood, in these cases, should rule out the presence of a malignant process - previous stomach ulcer or previous gastric surgery - indigestion or heartburn for 4 weeks or more - jaundice, dysfunction or liver disease - any other serious illness affecting general health - patients over 55 years of age if you have new or recently changed symptoms. Controloc Control, like all drugs that block acid secretion in the stomach, can reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlogria. This should be taken into account in the presence of corresponding clinical symptoms. With a long period of taking the drug, especially over 1 year, patients should be under regular supervision. Decreasing stomach acid increases the number of stomach bacteria that are normally present in the gastrointestinal tract. Treatment with drugs that reduce acidity leads to an increased risk of developing gastrointestinal infections caused by microorganisms such as Salmonella, Campylobacter. Use in pediatrics Due to insufficient data on safety and effectiveness, the use of Controloc Control in children and adolescents under 18 years of age is not recommended. Pregnancy and lactation There are no adequate data on the use of pantoprazole during pregnancy. Animal studies indicate reproductive toxicity of the drug. The potential risk to humans is unknown. Controloc Control should not be used during pregnancy unless clearly necessary. Lactation is stopped for the period of treatment with the drug. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms. You should refrain from driving vehicles and other mechanisms that require increased attention due to the likelihood of dizziness and visual impairment. Overdose Symptoms: unknown Treatment: if an overdose is suspected, supportive and symptomatic therapy is recommended. The drug is not excreted by hemodialysis. Release form and packaging. 14 tablets are placed in a blister pack made of polyvinyl chloride film and aluminum foil. 1 or 2 contour packages together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard pack. Storage conditions Store 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 Without a prescription Manufacturer Takeda GmbH, Oranienburg, Germany Name and country of the owner of the registration certificate Takeda GmbH, Germany Name and country of the packaging organization Takeda GmbH, Oranienburg, Germany Address of the organization that accepts claims from consumers regarding product quality in the territory of the Republic of Kazakhstan ( goods) Representative office (Austria) in Kazakhstan, Almaty, st. Begalina 136 a Phone number (727) 2444004 Fax number (727) 2444005 Email address

Pharmacokinetics

Pantoprazole is rapidly absorbed after oral administration. Cmax in blood plasma when administered orally is achieved after the first dose of 20 or 40 mg.

For 20 mg: an average Cmax of 1–1.5 mcg/ml is achieved in 2–2.5 hours for a dosage of 20 mg. This indicator remains constant after repeated use of this drug.

Vd is 0.15 l/kg, clearance is 0.1 l/h/kg. T1/2 - 1 hour.

For 40 mg: an average Cmax of 2-3 mcg/ml is achieved after 2.5 hours for a dosage of 40 mg. This indicator remains constant after repeated use of this drug.

Vd is 0.15 l/kg, clearance is 0.1 l/h/kg. T1/2 - 1 hour.

Pharmacokinetics are the same after both single and repeated use of the drug.

The binding of pantoprazole to plasma proteins is 98%. Metabolized in the liver. The main route of excretion is through the kidneys (about 80%) in the form of pantoprazole metabolites; a small amount is excreted through the intestines. The main metabolite in blood plasma and urine is desmethylpantoprazole, which is conjugated with sulfate.

The absolute bioavailability of pantoprazole tablets is 77%. Their simultaneous use with food does not affect AUC and Cmax.

When using pantoprazole in patients with limited renal function (including patients on hemodialysis), no dose reduction is required. As in healthy patients, T1/2 of pantoprazole is short. Only a very small portion of the drug is dialyzed. Does not accumulate.

In patients with liver cirrhosis (classes A and B according to the Child-Pugh classification), the T1/2 value increases to 3-6 hours when using pantoprazole at a dosage of 20 mg and to 7-9 hours when using pantoprazole at a dosage of 40 mg. AUC increases by 3–5 times (for a dosage of 20 mg) and by 5–7 times (for a dosage of 40 mg). Cmax increases by 1.3 times (for a dosage of 20 mg) and 1.5 times (for a dosage of 40 mg) compared with healthy patients. The slight increase in AUC and Cmax in older adults is not clinically significant.

Controloc enteric-coated tablets 20 mg 14 pcs. in Smolensk

Pharmacological action: Accumulates in the tubules of parietal cells of the stomach and is transformed into the active form - cyclic sulfenamide, which selectively interacts (forms a covalent bond) with H+-K+-ATPase. Inhibits the H+-K+-ATPase of parietal cells, disrupts the transfer of hydrogen ions from the parietal cell into the lumen of the stomach and blocks the final stage of hydrophilic secretion of hydrochloric acid. Dose-dependently suppresses basal and stimulated (regardless of the type of stimulus - acetylcholine, histamine, gastrin) secretion of hydrochloric acid for a long time. Mean effective dose values ​​for in vivo

vary between 0.2–2.4 mg/kg. The maximum effect appears only in a strongly acidic (pH 3) environment (at higher pH values ​​it remains practically inactive).

Has antibacterial activity against Helicobacter pylori

and contributes to the manifestation of the anti-Helicobacter effect of other drugs. The MIC is 128 mg/l. The therapeutic effect after a single dose occurs quickly and persists for 24 hours. Provides rapid reduction of symptoms and healing of duodenal ulcers. When taken at a dose of 40 mg, pH values ​​>3 remain for more than 19 hours. After 2 weeks of treatment (40 mg daily), complete healing of the duodenal ulcer is observed in 89% of patients. After 4 weeks of treatment (40 mg), 88% of patients experienced complete healing of the gastric ulcer. The recurrence rate of peptic ulcers after treatment is 55%. Within 4 weeks of treatment at a dose of 40 mg/day provides complete remission in 82% of patients with stage II-III gastroesophageal reflux disease (according to Savary - Miller), after 8 weeks - in 92%. Complete endoscopic remission in 57% of children 6–13 years old with stage Ic/II gastroesophageal reflux disease (according to Vandeplas) is achieved after 4 weeks of therapy at a dose of 20 mg/day. Over the course of 4–8 weeks of treatment, plasma gastrin levels increase 1.5 times. Maintenance therapy (40–80 mg daily for more than 3 years) in patients with peptic ulcer disease was accompanied by a slight increase in the number of enterochromaffin-like (ECL-) cells.

Experimental carcinogenicity studies indicate that long-term use of pantoprazole is associated with an increased risk of ECL cell hyperplasia and the occurrence of gastric carcinoid, liver adenoma and carcinoma, and neoplastic processes in the thyroid gland.

Quickly and completely absorbed after oral administration. Absolute bioavailability 70–80% (average 77%). Cmax - achieved after 2–4 hours (on average, after 2.7 hours). Plasma protein binding is 98%. T1/2 - 0.9–1.9 hours, volume of distribution - 0.15 l/kg, Cl - 0.1 l/h/kg. It penetrates very poorly through the BBB and is secreted into breast milk. Taking antacids or food does not affect AUC, Cmax or bioavailability. Pharmacokinetics are linear in the dose range of 10–80 mg (AUC and Cmax increase in proportion to increasing doses). The T1/2 and Cl values ​​are dose-independent. Metabolized in the liver (oxidation, dealkylation, conjugation). It has low affinity for the cytochrome P450 system; the metabolism mainly involves the isoenzymes CYP3A4 and CYP2C19. The main metabolites are demethylpantoprazole (T1/2 - 1.5 hours) and 2 sulfated conjugates. It is excreted mainly in the urine (82%) in the form of metabolites, and is found in small quantities in feces. Does not accumulate. T1/2 in patients with liver cirrhosis increases to 7–9 hours, in case of renal failure it increases slightly, but T1/2 of the main metabolite reaches 2–3 hours. AUC and Cmax are slightly higher in the older age group.

Side effects

When taking the drug Controloc® in accordance with the indications and in recommended doses, side effects occur extremely rarely. The most common unwanted side effects are diarrhea and headache - observed in approximately 1% of patients.

Below are data on undesirable side reactions depending on the frequency of their occurrence: very often (≥1/10); often (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (<1/10000, including isolated cases); frequency unknown (cannot be estimated from available data).

From the circulatory and lymphatic system: rarely - agranulocytosis; very rarely - thrombocytopenia, leukopenia, pancytopenia.

From the nervous system: infrequently - headache, dizziness; rarely - dysgeusia.

From the side of the organ of vision: rarely - blurred vision (blurred).

From the gastrointestinal tract: uncommon - diarrhea, nausea/vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain.

From the kidneys and urinary tract: frequency unknown - interstitial nephritis.

From the skin and subcutaneous tissues: infrequently - exanthema/rash, itching; rarely - urticaria, angioedema; frequency unknown - malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, toxic epidermal necrolysis, photosensitivity.

From the musculoskeletal system and connective tissue: rarely - arthralgia, myalgia.

From the side of metabolism: rarely - hyperlipidemia and increased concentration of lipids (triglycerides, cholesterol), changes in body weight; frequency unknown - hyponatremia, hypomagnesemia.

General disorders: infrequently - weakness, fatigue and malaise; rarely - increased body temperature, peripheral edema.

From the immune system: rarely - hypersensitivity (including anaphylactic reactions and anaphylactic shock).

From the liver and biliary tract: infrequently - increased activity of liver enzymes (AST, GGT); rarely - increased bilirubin levels; frequency unknown - hepatocellular damage, jaundice.

From the genital organs and breast: rarely - gynecomastia.

From the mental side: infrequently - sleep disturbance; rarely - depression (including exacerbation of existing disorders); very rarely - disorientation (including exacerbation of existing disorders); frequency unknown - hallucinations, confusion (especially in predisposed patients), as well as possible exacerbation of symptoms if they existed before the start of therapy.

Controloc, 14 pcs., 40 mg, enteric-coated tablets

When taking the drug Controloc® in accordance with the indications and in recommended doses, side effects occur extremely rarely. The most common unwanted side effects are diarrhea and headache - observed in approximately 1% of patients.

Below are data on undesirable side reactions depending on the frequency of their occurrence: very often (≥1/10); often (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (<1/10000, including isolated cases); frequency unknown (cannot be estimated from available data).

From the circulatory and lymphatic system:

rarely - agranulocytosis; very rarely - thrombocytopenia, leukopenia, pancytopenia.

From the nervous system:

infrequently - headache, dizziness; rarely - dysgeusia.

From the side of the organ of vision:

rarely - blurred vision (blurred).

From the gastrointestinal tract:

uncommon - diarrhea, nausea/vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain.

From the kidneys and urinary tract:

frequency unknown - interstitial nephritis.

For the skin and subcutaneous tissues:

uncommon - exanthema/rash, itching; rarely - urticaria, angioedema; frequency unknown - malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, toxic epidermal necrolysis, photosensitivity.

From the musculoskeletal system and connective tissue:

rarely - arthralgia, myalgia.

From the side of metabolism:

rarely - hyperlipidemia and increased concentration of lipids (triglycerides, cholesterol), changes in body weight; frequency unknown - hyponatremia, hypomagnesemia.

Common disorders:

infrequently - weakness, fatigue and malaise; rarely - increased body temperature, peripheral edema.

From the immune system:

rarely - hypersensitivity (including anaphylactic reactions and anaphylactic shock).

From the liver and biliary tract:

infrequently - increased activity of liver enzymes (AST, GGT); rarely - increased bilirubin levels; frequency unknown - hepatocellular damage, jaundice.

From the genital organs and breast:

rarely - gynecomastia.

From the mental side:

infrequently - sleep disturbance; rarely - depression (including exacerbation of existing disorders); very rarely - disorientation (including exacerbation of existing disorders); frequency unknown - hallucinations, confusion (especially in predisposed patients), as well as possible exacerbation of symptoms if they existed before the start of therapy.

Interaction

The simultaneous use of other proton pump inhibitors or histamine H1 receptor blockers is not recommended without consulting a doctor.

The simultaneous use of Controloc® may reduce the absorption of drugs whose bioavailability depends on the pH of the stomach (for example, iron salts, ketoconazole).

Controloc® can be prescribed without the risk of drug interactions to patients:

- with cardiovascular diseases, taking cardiac glycosides (digoxin), CCB (nifedipine), beta-blockers (metoprolol);

- with gastrointestinal diseases, taking antacids, antibiotics (amoxicillin, clarithromycin);

- taking oral contraceptives containing levonorgestrel and ethinyl estradiol;

- taking NSAIDs (diclofenac, phenazone, naproxen, piroxicam);

- with diseases of the endocrine system, taking glibenclamide, levothyroxine;

- with anxiety and sleep disorders, taking diazepam;

- with epilepsy taking carbamazepine and phenytoin;

- those taking indirect anticoagulants, such as warfarin and phenprocoumon, under the control of PT and INR at the beginning and at the end of treatment, as well as during irregular use of pantoprazole;

- those who have undergone transplantation and are taking cyclosporine or tacrolimus.

The absence of clinically significant drug interactions with caffeine, ethanol, and theophylline was also noted.

Possible interaction with atazanavir and ritonavir (tablets).

Directions for use and doses

Orally, before meals, without chewing or crushing, with a sufficient amount of liquid.

For 40 mg

Peptic ulcer of the stomach and duodenum, erosive gastritis (including those associated with taking NSAIDs): 40–80 mg/day. The course of treatment is 2 weeks for exacerbation of duodenal ulcer and 4–8 weeks for exacerbation of gastric ulcer. Anti-relapse treatment of gastric and duodenal ulcers - 20 mg/day.

Eradication of Helicobacter pylori. The following combinations are recommended:

1) Controloc® 20–40 mg 2 times a day + amoxicillin 1000 mg 2 times a day + clarithromycin 500 mg 2 times a day;

2) Controloc® 20–40 mg 2 times a day + metronidazole 500 mg 2 times a day + clarithromycin 500 mg 2 times a day;

3) Controloc® 20–40 mg 2 times a day + amoxicillin 1000 mg 2 times a day + metronidazole 500 mg 2 times a day.

The course of treatment is 7–14 days.

Zollinger-Ellison syndrome: 40–80 mg/day. In patients with severe liver dysfunction, the dose should be reduced to 40 mg once every 2 days. In this case, it is necessary to monitor biochemical blood parameters. If the level of liver enzymes increases, the use of the drug should be discontinued.

No dose adjustment is required in elderly patients, as well as in patients with impaired renal and hepatic function, but the daily dose should not exceed 40 mg. An exception is the use of combination antimicrobial therapy against Helicobacter pylori, when elderly patients should also use the drug Controloc® 40 mg 2 times a day.

Controloc® should not be taken for prophylactic purposes.

For 20 mg

To achieve positive dynamics in eliminating symptoms, it may be necessary to take the drug 20 mg per day for 2-3 days, however, to completely eliminate symptoms, it may be necessary to take the drug for 7 days. If the condition worsens during the first 3 days of treatment, consultation with a specialist is recommended. The drug should be stopped immediately after symptoms disappear.

If there is no positive dynamics within 2 weeks of continuous use of the drug, you should consult your doctor.

Controloc® should not be taken for prophylactic purposes.

Controloc®

When using the drug Controloc® in accordance with the indications and in recommended doses, adverse reactions occur extremely rarely. Most common (about 1%)

diarrhea and headache are observed.

Determination of the frequency of adverse reactions: very often (≥1/10), often (≥1/100 and <1/10), infrequently (≥1/1000 and <1/100), rarely (≥1/10,000 and <1 /1000), very rare (< 1/10,000, including isolated cases), frequency unknown (cannot be estimated from available data).

From the digestive system:

uncommon - diarrhea, nausea/vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain.

From the liver and biliary tract:

infrequently - increased activity of liver enzymes (AST, GGT); rarely - increased bilirubin levels; frequency unknown - hepatocellular damage, jaundice.

From the hematopoietic system:

rarely - agranulocytosis; very rarely - thrombocytopenia, leukopenia, pancytopenia.

From the nervous system:

infrequently - headache, dizziness; rarely - dysgeusia.

From the side of the organ of vision:

rarely - blurred vision (blurred).

From the mental side:

infrequently - sleep disturbance; rarely - depression (including exacerbations of existing disorders); very rarely - disorientation (including exacerbations of existing disorders); frequency unknown - hallucinations, confusion (especially in predisposed patients), as well as possible exacerbation of symptoms if they existed before the start of therapy.

From the urinary system:

frequency unknown - interstitial nephritis.

For the skin and subcutaneous tissues:

uncommon - exanthema/rash, itching; frequency unknown - malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, toxic epidermal necrolysis, photosensitivity.

From the musculoskeletal system:

rarely - arthralgia, myalgia.

From the side of metabolism:

rarely - hyperlipidemia and increased concentration of lipids (triglycerides, cholesterol), changes in body weight; frequency unknown - hyponatremia, hypomagnesemia.

Allergic reactions:

rarely - urticaria, angioedema.

From the immune system:

rarely - hypersensitivity (including anaphylactic reactions and anaphylactic shock).

From the endocrine system:

rarely - gynecomastia.

General reactions:

infrequently - weakness, fatigue and malaise; rarely - increased body temperature, peripheral edema.

special instructions

Before starting treatment with Controloc®, the presence of a malignant neoplasm should be excluded, since the drug may mask symptoms and delay the correct diagnosis.

Patients should consult their physician if they are undergoing an endoscopy or urea breath test.

Patients should consult a doctor if the following occur:

- unintentional weight loss, anemia, gastrointestinal bleeding, difficulty swallowing, persistent vomiting or vomiting blood. In these cases, taking the drug may partially relieve symptoms and delay correct diagnosis;

- previous surgery on the gastrointestinal tract or gastric ulcer;

- continuous symptomatic treatment of dyspepsia and heartburn for 4 weeks or more;

- liver diseases, incl. jaundice and liver failure;

- other serious diseases that worsen general health.

Patients over 55 years of age who have new or recently changed symptoms should consult a doctor. When taking drugs that reduce the acidity of gastric juice, the risk of gastrointestinal infections caused by bacteria of the genus Salmonella spp., Campylobacter spp. slightly increases. or C. difficile.

Impact on the ability to drive vehicles/machines. You should refrain from driving vehicles and other mechanisms that require increased attention due to the likelihood of dizziness and visual impairment.

Controloc, 40 mg, lyophilisate for the preparation of solution for intravenous administration, 1 pc.

When taking the drug Controloc® in accordance with the indications and in recommended doses, side effects occur extremely rarely. The most common undesirable side reaction is thrombophlebitis at the injection site. Diarrhea and headache occur in approximately 1% of patients.

Below are data on undesirable side reactions depending on the frequency of their occurrence: very often (≥1/10); often (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (<1/10000, including isolated cases); frequency unknown (cannot be estimated from available data).

From the circulatory and lymphatic system:

rarely - agranulocytosis; very rarely - thrombocytopenia, leukopenia, pancytopenia.

From the nervous system:

infrequently - headache, dizziness; rarely - dysgeusia.

From the side of the organ of vision:

rarely - blurred vision (blurred).

From the gastrointestinal tract:

uncommon - diarrhea, nausea/vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain.

From the kidneys and urinary tract:

frequency unknown - interstitial nephritis.

For the skin and subcutaneous tissues:

uncommon - exanthema/rash, itching; rarely - urticaria, angioedema; frequency unknown - malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, toxic epidermal necrolysis, photosensitivity.

From the musculoskeletal system and connective tissue:

rarely - arthralgia, myalgia.

From the side of metabolism:

rarely - hyperlipidemia and increased concentration of lipids (triglycerides, cholesterol), changes in body weight; frequency unknown - hyponatremia, hypomagnesemia.

Common disorders:

often - thrombophlebitis at the injection site; infrequently - weakness, fatigue and malaise; rarely - increased body temperature, peripheral edema.

From the immune system:

rarely - hypersensitivity (including anaphylactic reactions and anaphylactic shock).

From the liver and biliary tract:

infrequently - increased activity of liver enzymes (AST, GGT); rarely - increased bilirubin levels; frequency unknown - hepatocellular damage, jaundice.

From the genital organs and breast:

rarely - gynecomastia.

From the mental side:

infrequently - sleep disturbance; rarely - depression (including exacerbation of existing disorders); very rarely - disorientation (including exacerbation of existing disorders); frequency unknown - hallucinations, confusion (especially in predisposed patients), as well as possible exacerbation of symptoms if they existed before the start of therapy.

Release form

Enteric-coated tablets, 20 mg: 14 tablets each. in a blister of Aluminum PVC/Aluminium PVC; 1 blister in a cardboard pack. 7 tablets each in a blister inserted into a folding cardboard cover; in a cardboard box, 1 cardboard cover.

Enteric-coated tablets, 40 mg: 14 tablets each. in a blister of Aluminum PVC/Aluminum PVC; in a cardboard pack 1 or 2 blisters. 7 tablets each in a blister inserted into a folding cardboard cover; in a cardboard pack of 1 or 4 cardboard covers.

Manufacturer

Manufacturer/Marketing Authorization Holder: Takeda GmbH, Germany, Takeda GmbH, Germany.

Byk-Gulden-Strasse 2, D-78467 Konstanz, Germany, Byk-Gulden-Strasse 2, D-78467 Konstanz, Germany.

Address of the production site. Takeda GmbH, Germany, Takeda GmbH, Germany.

Lehnitzstraße, 70-98, 16515, Oranienburg, Germany, Lehnitzstraβe, 70-98, 16515, Oranienburg, Germany.

Consumer complaints should be sent to: Takeda Pharmaceuticals LLC. 119048, Moscow, st. Usacheva, 2, building 1.

Tel.; Fax.

www.takeda.com.ru;