Gastritis and Ulcer / Gastrointestinal tract and Liver

Kontrolok 14s 40 mg coated tablets

Brands: Takeda (Germany)

$23.00

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Kontrolok 14s 40 mg coated tablets quantity

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16003b3648f8

Brands:: Takeda (Germany)

Description

The instruction for medical use

of Controlok Torgovoye medicine a name
Controlok

Mezhdunarodnoye the unlicensed

name Pantoprazol Lekarstvennaya
the Tablet form, 40 mg covered with a kishechnorastvorimy cover

Structure
One tablet contains
active agent – a pantoprazol of sodium sexivihydrat of 45.10 mg (it is equivalent to a pantoprazol of 40.00 mg),
excipients: sodium a carbonate anhydrous, Mannitolum, krospovidon, K90 povidone, calcium stearate, water purified ***
structure of a cover: a gipromelloza 2910, K25 povidone, the titan dioxide (E171), gland (III) oxide yellow (E 172), propylene glycol, water purified ***
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: isopropyl alcohol ***, shellac glaze of 45%, iron (III) oxide red (E172), gland (III) oxide black (E172), gland (III) oxide yellow (E172), propylene glycol, alcohol n-butyl ***, 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 P40.

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 40 mg – 2-3μг/мл is reached in 2.5 hours and remains constant after repeated use. Distribution volume – about 0.15 I/h/kg, clearance – about 0.1 I/h/kg.
Linking with proteins of blood plasma – approximately for 98%. Pantoprazol is almost completely metabolized in a liver. The main metabolite defined in blood serum and urine – desmetilpantoprazol, being connection with sulfate. Elimination half-life makes about 1.5 hours. 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 Controlok 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
– a reflux esophagitis
– a peptic ulcer of a stomach and duodenum
– Helicobacter pylori eradikation in a combination with antibacterial drugs
–

the Kishechnorastvorimy tablets Controlok of 40 mg it is not necessary to chew or get to the core of Zollingera-Ellison’s syndrome or other states which are characterized by pathological gastric hypersecretion the Route of administration and doses, they have to be swallowed entirely and be washed down with enough liquid. Administration of drug needs to be carried out before food.
Symptomatic improvement at patients can begin approximately in one day of treatment by Controlok, but 7 days for achievement of total disappearance of symptoms can be required.
The reflux esophagitis
to Adults and teenagers is more senior than 12 years appoint on 1 tablet a day, if necessary it is possible to increase a dose to 2 tablets a day. The recommended course of treatment 4 weeks, if necessary treatment it is possible to prolong up to 4 weeks.
The adult
the Peptic ulcer of a stomach and duodenum
On 40 mg a day, in certain cases, including at inefficiency of therapy, it is possible to appoint 80 mg of Controlok a day. Course of treatment: 2 weeks at exacerbation of a peptic ulcer of a duodenum, in certain cases within the next 2 weeks of therapy, 4 weeks at exacerbation of a peptic ulcer of a stomach, in certain cases within the next 4 weeks of therapy. The recommended dose at antirecurrent treatment of a peptic ulcer of a stomach and a 12-perstny gut – on 20 mg a day.
Eradikation Helicobacter pylori
Recomendovana following combinations:
1. Controlok on 40 mg 2 times a day + amoxicillin on 1000 mg 2 times a day + klaritromitsin on 500 mg 2 times a day
2. Controlok on 40 mg 2 times a day + metronidazole on 400 – 500 mg 2 times a day (or 500 mg of Tinidazolum) + klaritromitsin on 250 – 500 mg 2 times a day
3. Controlok on 40 mg 2 times a day + amoxicillin on 1000 mg 2 times a day + metronidazole on 400 – 500 mg 2 times a day (or 500 mg of Tinidazolum).
In case of combination therapy for an eradikation of H. pylori, the second tablet has to be used in 1 hour prior to evening meal.
Combination therapy is carried out within 7 days and 7 more days can be continued (the general duration of treatment up to 2 weeks). Further treatment is possible after consideration of recommendations about drug dosing in an ulcer of a duodenum and stomach.
At monotherapy by Controlok at patients with negative take on H. pylori the following dosages can be used.
Zollingera-Ellison’s syndrome or other states which are characterized by pathological hypersecretion. Treatment is begun with 80 mg a day. In need of further the dose can be titrated, raising or reducing, depending on indicators of gastric secretion. The doses exceeding 80 mg a day need to be distributed on two receptions. Perhaps temporary increase in a dose over 160 mg, but only for adequate control of gastric secretion. The course of treatment is not limited, and depends on clinical need.
Special groups of patients
At patients with the profound abnormal liver functions the daily dose of drug should not exceed 20 mg. It is not necessary to apply Controlok in combination therapy to Helicobacter pylori eradikation at patients with moderate and heavy abnormal liver functions.
Dose adjustment is not required to patients of advanced age and patients with renal failures

Side effects
Below the observed side reactions with a frequency of their occurrence are listed: 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 ketokonazol, itrakonazol, pozakonazol, erlotinib, including with the drugs appointed shortly before a course of treatment Controlok in view of change of absorption of these drugs.
The concomitant use of Controlok 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.
Controlok has the low potential of interaction with the system of P450 cytochrome. Therefore the risk of the side reactions caused by Controlok’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 Controlok 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 and amoxicillin, with metronidazole, interactions it is not revealed.
Interaction with antacids at a concomitant use is not revealed.

At patients with heavy abnormal liver functions at Controlok’s reception, especially during the long period, regular control of level of enzymes of a liver is recommended to carry out special instructions. At increase in level of liver enzymes it is necessary to stop drug use.
At combination therapy it is necessary to consider in general all characteristics of the used drugs.
At treatment by Controlok the expressiveness of symptoms of malignant diseases can decrease that can delay establishment of the correct diagnosis, in communication with what before an initiation of treatment it is necessary to exclude a possibility of a malignant new growth.
Patients have to consult with the doctor in the following cases:
– if symptoms did not pass within 2 weeks,
– 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.
Patients at whom long-term recurrent symptoms of disturbance of digestion or heartburn are observed have to see a doctor.
At patients with Zollingera-Ellison’s syndrome and other morbid hyper secretory conditions which treatment demands long reception of Controlok as the drug blocking secretion of acid in a stomach reduction of absorption of B12 vitamin (cyanocobalamine) owing to hypo – or achlorhydrias is possible. 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 for children 12 years at a reflux esophagitis are younger.
Data on use of the drug Controlok for children and teenagers up to 18 years in a peptic ulcer of a stomach and duodenum, an eradikation of Helicobacter pylori and Zollingera-Ellison’s syndrome are not available.
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 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
According to the 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 E-mail address:
To Develop DSO-KZ@takeda.com

Additional information