Kontrolok 14s Control 20 mg coated tablets
- $15.30
The instruction for medical use
of Controlok Control medicine
the Trade name
Controlok Control
Mezhdunarodnoye the unlicensed
name Pantoprazol Lekarstvennaya
the Tablet form, covered with a kishechnorastvorimy cover, 20 mg
Structure
One tablet contains
active agent - a pantoprazol of sodium sexivihydrat of 22.57 mg, (it is equivalent to a pantoprazol of 20.0 mg),
excipients: sodium a carbonate anhydrous, Mannitolum, krospovidon, K90 povidone, calcium stearate, water purified ***
structure of a cover: gipromelloza 2910, K25 povidone, titan dioxide (E171), ferrous oxide yellow (E172), propylene glycol
structure of a kishechnorastvorimy covering: copolymer of methacrylic acid and etakrilat (1:1) 30 of % dispersion **, triethyl citrate, water purified ***
composition of brown Opacode S-1-16530 ink: shellac glaze of 45%, iron (III) oxide red (E172), gland (III) oxide black (E172), gland (III) oxide yellow (E172), ammonia the solution concentrated.
* - the existing edition,
** - structure of dispersion: copolymer of methacrylic acid and ethyl acrylate - 14.13 mg, sodium lauryl sulfate – 0.10 mg, polysorbate of 80 - 0.33 mg,
*** - is removed in the course of production.
The description
Oval biconvex tablets, film coated yellow color with a kernel from white till almost white color. On one party of a tablet, brown ink printed P20
Pharmacotherapeutic group
Drugs for treatment of the diseases connected with disturbance of acidity. Antiulcerous drugs and drugs for treatment of a gastroezofagalny reflux. Inhibitors of the protonew pump. Pantoprazol.
The ATX A02BC02 code
the Pharmacological
Pantoprazol Pharmacokinetics properties is quickly absorbed from digestive tract. The absolute bioavailability is 77%. The maximum concentration in blood plasma after reception of a dose of 20 mg - 2 – 3mkg/ml is reached in 2.5 hours and remains constant after repeated use. Distribution volume – about 0.15 l/h/kg, clearance – about 0.1 l/h/kg.
Linking with proteins of blood plasma – about 98%. Pantoprazol is almost completely metabolized in a liver. The main metabolite defined in blood serum and urine - desmetilpantoprazol which connects sulfate. Elimination half-life makes about 1 hour. About 80% of drug eliminirutsya by kidneys, other 20% with excrements.
The pharmacodynamics
Pantoprazol is the substituted benzimidazole which is slowing down secretion of hydrochloric acid in a stomach by specific impact on a proton pomp of covering cells.
In acidic environment of covering cells pantoprazol turns into the active form – cyclic sulphenamide where it suppresses enzyme H+, K+-ATFazu.
Blocking the proton pump, pantoprazol interferes with process of a kislotoobrazovaniye at the level of a final stage of synthesis of hydrochloric acid in a stomach. Inhibiting effect dozozavisimo also influences the level of basal and stimulated secretion of hydrochloric acid (irrespective of a type of an irritant). In a peptic ulcer of a stomach and the duodenum associated with Helicobacter pylori, such decrease in gastric secretion increases sensitivity of a microorganism to antibiotics.
After oral administration of 20 mg of the drug Controlok Control the anti-secretory effect occurs in 1 hour and reaches a maximum in 2 – 4 hours. Does not affect motility of digestive tract. The secretory activity is restored to initial level in 3 – 4 days after the end of reception.
Pantoprazol has big chemical stability at a neutral rn, and the smaller potential of interaction with other medicines.
Indications
- acid
the Route of administration and doses
the Kishechnorastvorimy tablets Controlok Control of 20 mg it is not necessary to chew or get to the core of short-term treatment of reflux symptoms, such as heartburn, an eructation, they have to be swallowed entirely and be washed down with enough liquid. Administration of drug needs to be carried out before food.
When assigning double administration of drug, the second tablet has to be used before evening meal.
Symptomatic improvement at patients can begin approximately in one day of treatment of Controlok Control, but 7 days for achievement of total disappearance of symptoms can be required.
Short-term treatment of reflux symptoms (heartburn, an eructation acid)
the Adult is appointed on 20 mg a day.
It can be necessary for stopping of symptoms, to take the drug within 2 – 3 days. After symptoms disappeared, the carried-out treatment can be stopped. If improvement is not observed within 2 weeks of continuous treatment, the patient needs to see a doctor.
Side effects
are listed below the observed side reactions with a frequency of their occurrence: very often (³ 1/10), it is frequent (from ³ 1/00 to & lt, 1/10), infrequently (from ³ 1/1000 to & lt, 1/100), is rare (from ³ 1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000), it is unknown (it is impossible to estimate on the available data).
Infrequently
- a headache, dizziness
- dryness in a mouth, nausea, vomiting, an abdominal distension, abdominal pain and discomfort, diarrhea, a constipation
- skin rash, an itching, a dieback
- an asthenia, fatigue and an indisposition
- increase in activity of liver enzymes (transaminases, g-GT)
- the sleep disorder
Is rare
- an agranulocytosis
- hypersensitivity to active and to auxiliary components of drug (including anaphylactic reactions and an acute anaphylaxis)
- a lipidemia, increase in level of triglycerides, cholesterol
- increase in content of bilirubin
- change of weight, disturbance of taste
- a depression (and all accompanying deteriorations)
- disorder of vision / illegibility of sight
- urticaria, a Quincke's disease
- an arthralgia, myalgia
- a gynecomastia
- fervescence, peripheral hypostases
Very seldom
- thrombocytopenia, a leukopenia, a pancytopenia
- a disorientation (and all accompanying deteriorations)
It is unknown
- a hyponatremia, a hypomagnesiemia
- hallucinations, confusion of consciousness (especially at the patients predisposed to these states and also deterioration in these symptoms if they existed prior to treatment)
- hepatocellular damages, jaundice, hepatocellular insufficiency
- Stephens-Johnson's syndrome, a Lyell's disease, an exudative mnogoformny erythema, photosensitivity
- interstitial nephrite
of the Contraindication
- hypersensitivity to drug components, other substituted benzimidazoles
- combined use of a pantoprazol with atazanaviry
Medicinal interactions
It is necessary to pay attention to a concomitant use with drugs which absorption is rn-dependent, for example ketokonazoly, itrakonazoly, pozakonazoly, erlotiniby, including with the drugs appointed shortly before Controlok Control course of treatment in view of change of absorption of these drugs.
The concomitant use of Controlok Control and an atazanavir considerably reduces efficiency of the last.
At combined use of a fenprokumon or warfarin, several isolated cases of change of the International normalizing relation were celebrated (MNO or INR). Therefore for the patients undergoing treatment by coumarinic anticoagulants (for example, fenprokumony or warfarin), it is recommended to watch a prothrombin time / MNO after the beginning, the termination or during irregular use of Controlok Control.
Controlok Control has the low potential of interaction with the system of P450 cytochrome. Therefore the risk of the side reactions caused by Controlok Control's interaction with other drugs which is metabolized a system P450 cytochrome can be considered as minimum. Special researches did not reveal clinically significant interaction of the drug Controlok Control with caffeine, carbamazepine, diazepam, ethanol, diclofenac, glibenclamide, Naproxenum, metoprololy, nifedipine, Phenytoinum, piroxicam, theophylline, the oral contraceptives containing levonorgestrel and ethinylestradiol.
At a concomitant use with antibiotics, such as klaritromitsin, amoxicillin, with metronidazole, interactions it is not revealed.
Interaction with antacids at a concomitant use is not revealed.
Special instructions
At patients with heavy abnormal liver functions at administration of drug Controlok Control, especially during the long period, is recommended to carry out regular control of level of enzymes of a liver. At increase in level of liver enzymes it is necessary to stop drug use.
To the patients needing long treatment by nonspecific nonsteroid anti-inflammatory (NPVP) drugs and being in group of the increased risk of development of gastrointestinal complications, Controlok Control of 20 mg as the preventive measure of ulceration of a stomach and a duodenum caused by use of NPVP it is necessary to limit administration of drug.
It is necessary to carry out the risk level assessment taking into account individual risk factors, including age (65 years are more senior), the anamnesis of ulceration of a stomach or duodenum and also gastrointestinal bleedings.
Patients have to consult with the doctor in the following cases:
- if the symptomatology did not pass within 2 weeks after continuous therapy
- involuntary weight reduction of a body, anemia, gastrointestinal bleeding, a dysphagy, persistent vomiting or vomiting with blood, in these cases, it is necessary to exclude existence of malignant process
- earlier there was stomach ulcer, or the undergone surgery on a stomach
- disturbances of digestion or heartburn within 4 or more weeks
- jaundice, dysfunctions or diseases of a liver
- any other serious disease influencing overall health
- patients is more senior than 55 years in the presence of the new or recently changed symptoms.
Controlok Control as all drugs blocking secretion of acid in a stomach can reduce absorption of B12 vitamin (cyanocobalamine) owing to hypo - or akhlogidriya. It should be considered in the presence of the corresponding clinical symptoms.
At the long period of administration of drug, especially over 1 year, patients have to be under regular observation.
Lowering of acidity of a stomach increases quantity of gastric bacteria which usually are present at digestive tract. Treatment by the drugs lowering acidity leads to increase in risk of developing the gastrointestinal infections caused by such microorganisms as Salmonella, Campylobacter.
Use in pediatrics
Because of insufficient amount of data on safety and efficiency, is not recommended use of the drug Controlok Control for children and teenagers up to 18 years.
Pregnancy and a lactation
of Adequate data on use of a pantoprazol at pregnancy are not present. Researches on animals demonstrate reproductive toxicity of drug. The potential risk for the person is unknown. Controlok Control should not be applied during pregnancy if in it there is no obvious need.
The lactation for drug treatment is stopped.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms.
It is necessary to refrain from control of the vehicles and other mechanisms requiring special attention because of the probability of dizzinesses and a disorder of vision
Overdose
Symptoms: are unknown
Treatment: at suspicion on overdose performing the supporting and symptomatic therapy is recommended. Drug is not removed by means of a hemodialysis
the Form of release and packing
On 14 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1 or 2 planimetric packs together with the instruction for medical use in the state and Russian languages put in a pack cardboard.
To Store storage conditions at a temperature not above 25 °C.
To store out of children's reach!
3 years
not to use a period of storage after an expiration date.
Prescription status
Without prescription
of Proizvoditel Takeda GmbH, Oraniyenburg, Germany
the Name and the country of the owner of the registration certificate
of Takeda GmbH, Germany
the Name and the country
of the organization packer Takeda GmbH, Oraniyenburg, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office Takeda Osteuropa Holding GmbH (Austria) in Kazakhstan Almaty, Begalin St. 136 an anomer of phone number (727) 2444004 Fax number (727) 2444005
To Develop the e-mail address of DSO-KZ@takeda.com
of Controlok Control medicine
the Trade name
Controlok Control
Mezhdunarodnoye the unlicensed
name Pantoprazol Lekarstvennaya
the Tablet form, covered with a kishechnorastvorimy cover, 20 mg
Structure
One tablet contains
active agent - a pantoprazol of sodium sexivihydrat of 22.57 mg, (it is equivalent to a pantoprazol of 20.0 mg),
excipients: sodium a carbonate anhydrous, Mannitolum, krospovidon, K90 povidone, calcium stearate, water purified ***
structure of a cover: gipromelloza 2910, K25 povidone, titan dioxide (E171), ferrous oxide yellow (E172), propylene glycol
structure of a kishechnorastvorimy covering: copolymer of methacrylic acid and etakrilat (1:1) 30 of % dispersion **, triethyl citrate, water purified ***
composition of brown Opacode S-1-16530 ink: shellac glaze of 45%, iron (III) oxide red (E172), gland (III) oxide black (E172), gland (III) oxide yellow (E172), ammonia the solution concentrated.
* - the existing edition,
** - structure of dispersion: copolymer of methacrylic acid and ethyl acrylate - 14.13 mg, sodium lauryl sulfate – 0.10 mg, polysorbate of 80 - 0.33 mg,
*** - is removed in the course of production.
The description
Oval biconvex tablets, film coated yellow color with a kernel from white till almost white color. On one party of a tablet, brown ink printed P20
Pharmacotherapeutic group
Drugs for treatment of the diseases connected with disturbance of acidity. Antiulcerous drugs and drugs for treatment of a gastroezofagalny reflux. Inhibitors of the protonew pump. Pantoprazol.
The ATX A02BC02 code
the Pharmacological
Pantoprazol Pharmacokinetics properties is quickly absorbed from digestive tract. The absolute bioavailability is 77%. The maximum concentration in blood plasma after reception of a dose of 20 mg - 2 – 3mkg/ml is reached in 2.5 hours and remains constant after repeated use. Distribution volume – about 0.15 l/h/kg, clearance – about 0.1 l/h/kg.
Linking with proteins of blood plasma – about 98%. Pantoprazol is almost completely metabolized in a liver. The main metabolite defined in blood serum and urine - desmetilpantoprazol which connects sulfate. Elimination half-life makes about 1 hour. About 80% of drug eliminirutsya by kidneys, other 20% with excrements.
The pharmacodynamics
Pantoprazol is the substituted benzimidazole which is slowing down secretion of hydrochloric acid in a stomach by specific impact on a proton pomp of covering cells.
In acidic environment of covering cells pantoprazol turns into the active form – cyclic sulphenamide where it suppresses enzyme H+, K+-ATFazu.
Blocking the proton pump, pantoprazol interferes with process of a kislotoobrazovaniye at the level of a final stage of synthesis of hydrochloric acid in a stomach. Inhibiting effect dozozavisimo also influences the level of basal and stimulated secretion of hydrochloric acid (irrespective of a type of an irritant). In a peptic ulcer of a stomach and the duodenum associated with Helicobacter pylori, such decrease in gastric secretion increases sensitivity of a microorganism to antibiotics.
After oral administration of 20 mg of the drug Controlok Control the anti-secretory effect occurs in 1 hour and reaches a maximum in 2 – 4 hours. Does not affect motility of digestive tract. The secretory activity is restored to initial level in 3 – 4 days after the end of reception.
Pantoprazol has big chemical stability at a neutral rn, and the smaller potential of interaction with other medicines.
Indications
- acid
the Route of administration and doses
the Kishechnorastvorimy tablets Controlok Control of 20 mg it is not necessary to chew or get to the core of short-term treatment of reflux symptoms, such as heartburn, an eructation, they have to be swallowed entirely and be washed down with enough liquid. Administration of drug needs to be carried out before food.
When assigning double administration of drug, the second tablet has to be used before evening meal.
Symptomatic improvement at patients can begin approximately in one day of treatment of Controlok Control, but 7 days for achievement of total disappearance of symptoms can be required.
Short-term treatment of reflux symptoms (heartburn, an eructation acid)
the Adult is appointed on 20 mg a day.
It can be necessary for stopping of symptoms, to take the drug within 2 – 3 days. After symptoms disappeared, the carried-out treatment can be stopped. If improvement is not observed within 2 weeks of continuous treatment, the patient needs to see a doctor.
Side effects
are listed below the observed side reactions with a frequency of their occurrence: very often (³ 1/10), it is frequent (from ³ 1/00 to & lt, 1/10), infrequently (from ³ 1/1000 to & lt, 1/100), is rare (from ³ 1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000), it is unknown (it is impossible to estimate on the available data).
Infrequently
- a headache, dizziness
- dryness in a mouth, nausea, vomiting, an abdominal distension, abdominal pain and discomfort, diarrhea, a constipation
- skin rash, an itching, a dieback
- an asthenia, fatigue and an indisposition
- increase in activity of liver enzymes (transaminases, g-GT)
- the sleep disorder
Is rare
- an agranulocytosis
- hypersensitivity to active and to auxiliary components of drug (including anaphylactic reactions and an acute anaphylaxis)
- a lipidemia, increase in level of triglycerides, cholesterol
- increase in content of bilirubin
- change of weight, disturbance of taste
- a depression (and all accompanying deteriorations)
- disorder of vision / illegibility of sight
- urticaria, a Quincke's disease
- an arthralgia, myalgia
- a gynecomastia
- fervescence, peripheral hypostases
Very seldom
- thrombocytopenia, a leukopenia, a pancytopenia
- a disorientation (and all accompanying deteriorations)
It is unknown
- a hyponatremia, a hypomagnesiemia
- hallucinations, confusion of consciousness (especially at the patients predisposed to these states and also deterioration in these symptoms if they existed prior to treatment)
- hepatocellular damages, jaundice, hepatocellular insufficiency
- Stephens-Johnson's syndrome, a Lyell's disease, an exudative mnogoformny erythema, photosensitivity
- interstitial nephrite
of the Contraindication
- hypersensitivity to drug components, other substituted benzimidazoles
- combined use of a pantoprazol with atazanaviry
Medicinal interactions
It is necessary to pay attention to a concomitant use with drugs which absorption is rn-dependent, for example ketokonazoly, itrakonazoly, pozakonazoly, erlotiniby, including with the drugs appointed shortly before Controlok Control course of treatment in view of change of absorption of these drugs.
The concomitant use of Controlok Control and an atazanavir considerably reduces efficiency of the last.
At combined use of a fenprokumon or warfarin, several isolated cases of change of the International normalizing relation were celebrated (MNO or INR). Therefore for the patients undergoing treatment by coumarinic anticoagulants (for example, fenprokumony or warfarin), it is recommended to watch a prothrombin time / MNO after the beginning, the termination or during irregular use of Controlok Control.
Controlok Control has the low potential of interaction with the system of P450 cytochrome. Therefore the risk of the side reactions caused by Controlok Control's interaction with other drugs which is metabolized a system P450 cytochrome can be considered as minimum. Special researches did not reveal clinically significant interaction of the drug Controlok Control with caffeine, carbamazepine, diazepam, ethanol, diclofenac, glibenclamide, Naproxenum, metoprololy, nifedipine, Phenytoinum, piroxicam, theophylline, the oral contraceptives containing levonorgestrel and ethinylestradiol.
At a concomitant use with antibiotics, such as klaritromitsin, amoxicillin, with metronidazole, interactions it is not revealed.
Interaction with antacids at a concomitant use is not revealed.
Special instructions
At patients with heavy abnormal liver functions at administration of drug Controlok Control, especially during the long period, is recommended to carry out regular control of level of enzymes of a liver. At increase in level of liver enzymes it is necessary to stop drug use.
To the patients needing long treatment by nonspecific nonsteroid anti-inflammatory (NPVP) drugs and being in group of the increased risk of development of gastrointestinal complications, Controlok Control of 20 mg as the preventive measure of ulceration of a stomach and a duodenum caused by use of NPVP it is necessary to limit administration of drug.
It is necessary to carry out the risk level assessment taking into account individual risk factors, including age (65 years are more senior), the anamnesis of ulceration of a stomach or duodenum and also gastrointestinal bleedings.
Patients have to consult with the doctor in the following cases:
- if the symptomatology did not pass within 2 weeks after continuous therapy
- involuntary weight reduction of a body, anemia, gastrointestinal bleeding, a dysphagy, persistent vomiting or vomiting with blood, in these cases, it is necessary to exclude existence of malignant process
- earlier there was stomach ulcer, or the undergone surgery on a stomach
- disturbances of digestion or heartburn within 4 or more weeks
- jaundice, dysfunctions or diseases of a liver
- any other serious disease influencing overall health
- patients is more senior than 55 years in the presence of the new or recently changed symptoms.
Controlok Control as all drugs blocking secretion of acid in a stomach can reduce absorption of B12 vitamin (cyanocobalamine) owing to hypo - or akhlogidriya. It should be considered in the presence of the corresponding clinical symptoms.
At the long period of administration of drug, especially over 1 year, patients have to be under regular observation.
Lowering of acidity of a stomach increases quantity of gastric bacteria which usually are present at digestive tract. Treatment by the drugs lowering acidity leads to increase in risk of developing the gastrointestinal infections caused by such microorganisms as Salmonella, Campylobacter.
Use in pediatrics
Because of insufficient amount of data on safety and efficiency, is not recommended use of the drug Controlok Control for children and teenagers up to 18 years.
Pregnancy and a lactation
of Adequate data on use of a pantoprazol at pregnancy are not present. Researches on animals demonstrate reproductive toxicity of drug. The potential risk for the person is unknown. Controlok Control should not be applied during pregnancy if in it there is no obvious need.
The lactation for drug treatment is stopped.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms.
It is necessary to refrain from control of the vehicles and other mechanisms requiring special attention because of the probability of dizzinesses and a disorder of vision
Overdose
Symptoms: are unknown
Treatment: at suspicion on overdose performing the supporting and symptomatic therapy is recommended. Drug is not removed by means of a hemodialysis
the Form of release and packing
On 14 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1 or 2 planimetric packs together with the instruction for medical use in the state and Russian languages put in a pack cardboard.
To Store storage conditions at a temperature not above 25 °C.
To store out of children's reach!
3 years
not to use a period of storage after an expiration date.
Prescription status
Without prescription
of Proizvoditel Takeda GmbH, Oraniyenburg, Germany
the Name and the country of the owner of the registration certificate
of Takeda GmbH, Germany
the Name and the country
of the organization packer Takeda GmbH, Oraniyenburg, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office Takeda Osteuropa Holding GmbH (Austria) in Kazakhstan Almaty, Begalin St. 136 an anomer of phone number (727) 2444004 Fax number (727) 2444005
To Develop the e-mail address of DSO-KZ@takeda.com
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