Îá¡¿¡¿½® 1,75/3,5/5

General characteristics. Structure:

Îá¡¿¡¿½® 1,75

Active agent: Glibenclamidum (a mikroiizirovaiiy form) - 1.75 mg.

Excipients: lactoses monohydrate, potato starch, methylhydroxyethylcellulose, silicon the dioxide besieged magnesium stearate, the cochineal insect red And (E124 dye).

Îá¡¿¡¿½® 3,5

Active agent: Glibenclamidum (the micronized form) - 3,5 mg.

Excipients: lactoses monohydrate. potato starch, methylhydroxyethylcellulose, silicon the dioxide besieged magnesium stearate, the cochineal insect red And (E124 dye).

Îá¡¿¡¿½® 5

Active ingredient: гдибенкламид - 5 mg;

Excipients: lactoses monohydrate, potato starch, magnesium stearate, talc, gelatin, dye crimson (Ponso 4R).

Pharmacological properties:

Stimulates secretion of insulin due to linkng with specific receptors of a membrane of a b-cell of a pancreas, reduces a threshold of stimulation glucose of b-cells of a pancreas, increases sensitivity to insulin and extent of its linkng with target cells, increases insulin release, strengthens effect of insulin on glucose absorption by muscles and a liver, thereby reduces concentration of glucose in blood. Works in the second stage of secretion of insulin. Brakes a lipolysis in fatty tissue. Has hypolipidemic effect, reduces thrombogenic properties of blood.

Манинил® in the micronized form represents the hi-tech, in a special way crushed Glibenclamidum form allowing drug to be absorbed quicker from digestive tract. Due to earlier achievement of the maximum concentration of Glibenclamidum in plasma, the hypoglycemic effect practically corresponds on time to rise in concentration of glucose in blood after food that does effect of drug softer and physiologic.

Pharmacokinetics. Îá¡¿¡¿½® 1,75/3,5

At intake bystry and almost full absorption from digestive tract is observed. Full release of the micronized active agent happens within 5 minutes. Communication with proteins of plasma makes more than 98%. Almost another is completely metabolized in a liver with formation of two inactive metabolites, one of which is brought by kidneys, and - with bile. Plasma elimination half-life of-1,5-3,5 h.

Îá¡¿¡¿½® 5

At intake absorption makes of digestive tract 48-84%, Time of achievement of the maximum concentration of 1-2 h, distribution volume - 9-10 l. Communication with proteins of plasma makes 95%. Absolute bioavailability at intake makes about 54 (49-59) %. Almost another is completely metabolized in a liver with formation of two inactive metabolites, one of which is brought by kidneys, and - with bile. Elimination half-life from 3 to 16 h.

Indications to use:

Diabetes mellitus of type 2 at inefficiency of strict observance of a diet, body degrowth at obesity and sufficient physical activity.

Route of administration and doses:

The doctor establishes a drug dose individually, depending on age, weight of a course of diabetes, the maintenance of a glycemia on an empty stomach and in 2 h after food.

Îá¡¿¡¿½® 1,75

The initial dose of the drug Манинил® 1,75 makes 1/2 tablets once a day. At insufficient efficiency under control of the doctor the drug dose is gradually raised to achievement of a daily dose necessary for stabilization of carbohydrate metabolism. The average daily dose makes 2 tablets (3,5 mg). The maximum daily dose - 3 (in exceptional cases - 4) tablets. In need of reception of higher doses of drug (to 14 mg/days) pass to administration of drug Манинил® 3,5.

Îá¡¿¡¿½® 3,5

The initial dose of the drug Манинил® 3,5 makes 1/2 - 1 tablets once a day. At insufficient efficiency under control of the doctor the drug dose is gradually raised to achievement of a daily dose necessary for stabilization of carbohydrate metabolism. The average daily dose makes 3 tablets (10,5 mg). The maximum daily dose - 4 tablets (14 mg).

Îá¡¿¡¿½® 1,75/3,5 it is necessary to accept before food, without chewing and washing down with a small amount of liquid. The daily doses of drug making up to 2 tablets usually should be accepted once a day in the morning, before a breakfast. Higher doses divide into morning and evening reception. At the admission of one administration of drug, the following pill should be taken in usual time, at the same time it is not allowed to accept higher dose.

Îá¡¿¡¿½® 5

The initial dose of the drug Манинил® 5 makes 2,5 mg once a day. At insufficient efficiency under control of the doctor the drug dose is gradually raised on 2,5 mg a day at an interval of 3-5 days to achievement of a daily dose necessary for stabilization of carbohydrate metabolism. The average daily dose fluctuates from 2,5 to 15 mg. Doses more than 15 mg/days do not increase expressiveness of hypoglycemic effect of drug.

Patients of advanced age have a danger of development of a hypoglycemia therefore the initial dose of drug at them makes 1 mg/days, and the maintenance dose has to be selected under careful observation of the doctor.

Pill should be taken with a small amount of liquid in 20-30 min. prior to food. Frequency rate of administration of drug - 1-3 times a day.

Transfer from other hypoglycemic means on Манинил® 5:

Upon transition from other hypoglycemic means with the similar chip of action Манинил® 5 is appointed according to the scheme which is stated above, and the previous drug is cancelled at once. Upon transition from guanyl guanidines the initial daily dose makes 2,5 mg, if necessary the daily dose increases each 5-6 days by 2,5 mg before achievement of compensation. In the absence of compensation during 4-6 weeks, it is necessary to resolve an issue of carrying out a combination therapy with insulin.

Features of use:

It is regularly necessary to control concentration of glucose in blood on an empty stomach and after meal. It is necessary to warn patients about the increased risk of emergence of a hypoglycemia in ethanol reception cases (including development of a disulfiramopodobny syndrome is possible: abdominal pains, nausea, vomiting, headache) and at starvation. The doctor has to consider carefully a question of purpose of the drug Maninil® the patient with an abnormal liver function and kidneys, and also at hypofunction of a thyroid gland, a front share of a hypophysis or bark of adrenal glands. Dose adjustment of the drug Maninil® at a physical and emotional overstrain, change of a diet is necessary. During treatment it is not recommended to be engaged in the activity demanding concentration of attention and speed of psychomotor reactions; it is long to stay in the sun. At each change of the doctor (for example, at hospitalization in hospital, a disease on issue) the patient shall report to the attending physician that he suffers from a diabetes mellitus.

Influence on ability to driving of motor transport and to control of mechanisms

During the period before establishment of an optimum dose or when changing drug, and also at irregular administration of drug of Maninil® decline in the ability to driving of the car or control of various mechanisms, and also occupations other potentially dangerous types of activity requiring special attention and speed of mental and motor reactions is possible.

Side effects:

The most frequent undesirable action at treatment by the drug Maninil® is the hypoglycemia (low content of glucose in blood). This state can accept long character and promote development of serious conditions up to the coma, life-threatening patient or coming to an end letalno. At slow process of diabetic polyneuropathy or at the accompanying treatment by sympatholytics (see the section "Interaction with Other Medicines") typical harbingers of a hypoglycemia can be slight or be absent absolutely.

Can be the reasons of development of a hypoglycemia: drug overdose; wrong indication; irregular meal; advanced age of patients; vomiting, diarrhea; big exercise stresses; the diseases reducing the need for insulin (an abnormal liver function and kidneys, hypofunction of bark of adrenal glands, a hypophysis or thyroid gland): an alcohol abuse, and also interaction with other medicines (see this section).

Symptoms of a hypoglycemia are: strong feeling of hunger, sudden plentiful sweating, heartbeat, pallor of integuments, paresthesia in oral cavities, a shiver, the general concern, a headache, pathological drowsiness, frustration of a dream, sensation of fear, a lack of coordination of movements, temporary neurologic frustration (for example, visual disturbances and speeches, displays of paresis or paralyzes or the changed perceptions of feelings). When progressing a hypoglycemia loss by the patient of self-checking and consciousness is possible. Often such patient has a wet cold skin and predisposition to spasms. Along with a hypoglycemia frustration from system of digestive organs are possible: seldom arising nausea, an eructation, vomiting, metal taste in a mouth, feeling of weight and completeness in a stomach, an abdominal pain and diarrhea. Were in some cases described temporary increase in activity of "hepatic" enzymes (GShchT, GPT, an alkaline phosphatase) in blood serum; medicinal hepatitis and jaundice.

Seldom there are skin allergic reactions: rash, a skin itch, a small tortoiseshell, erubescence, a Quincke's edema, dot hemorrhages in skin, the shelled rash on the big surfaces of skin and the raised photosensitization. Very seldom skin reactions can serve as the beginning of development of the serious conditions accompanied with short wind and a lowering of arterial pressure up to approach of shock, the life-threatening patient. Separate cases of heavy generalized allergic reactions with skin rash, joint pains, fever, emergence of protein in urine and jaundice are described. Changes from system of bodies of a hemopoiesis: thrombocytopenia, an erythropenia or very seldom a leykotsitopeniya, an agranulocytosis is seldom noted. In isolated cases hemolitic anemia or a pancytopenia develops. Treat other side effects observed in isolated cases: weak diuretic effect, temporary emergence of protein in urine, vision disorders and accommodations, and also the acute reaction of intolerance of alcohol after its use which is expressed complications from bodies of blood circulation and breath (similar reactions to Disulfiramum: vomiting, feeling of heat in the person and an upper part of a trunk, tachycardia, dizziness, a headache).

Interaction with other medicines:

Strengthening of hypoglycemic effect of the drug Maninil® should be expected when treatment by blockers of an angiotensin-converting enzyme, anabolic means, other peroral hypoglycemic drugs (for example, acarbose, guanyl guanidines) and insulin, azapropazony, the beta adrenoblockers, quinine derivative of a hinolon, chloramphenicol, Clofibratum and analogs, coumarin derivatives, Disopyramidum, fenfluraminy, feniramidoly, fluoxetine, monoamine oxidase inhibitors, Miconazolum, p-aminosalicylic acid, pentoksifilliny (in the high doses entered parenterally is at the same time carried out), pergeksiliny, derivatives of pyrazyl ketones, phenylbutazones, phosphamides (for example, cyclophosphamide, ifosfamidy, trofosfamidy), probenetsidy, salicylates, Sulfinpyrazonum, streptocides, tetracyclines and tritokvaliny. The same concerns an alcohol abuse. The means acidifying urine (ammonium chloride, Calcii chloridum) strengthen effect of the drug Maninil® due to reduction of extent of its dissociation and increase in its reabsorption.

Along with strengthening of hypoglycemic action beta adrenoblockers, a clonidine, гуанетидин and Reserpinum, and also medicines with the central mechanism of action can weaken feeling of harbingers of a hypoglycemia.

Hypoglycemic effect of the drug Maninil® can decrease at simultaneous use of barbiturates, an isoniazid, cyclosporine, diazoxide, glyukortikosteroid, a glucagon, nikotinat (in high doses), Phenytoinum, fenotiazin, rifampicin, saluretics, acetazoleamide, sex hormones (for example, hormonal contraceptives), drugs of hormones of a thyroid gland, sympathomimetic means, indometacin and salts of lithium.

The chronic alcohol abuse and purgatives can aggravate disturbance of carbohydrate metabolism.

Antagonists of H2 receptors can weaken on the one hand, and with another to strengthen hypoglycemic effect of the drug Maninil®. Pentamidine in isolated cases can cause strong decrease or increase in concentration of glucose in blood. Action of derivatives of coumarin can amplify or weaken.

The medicines oppressing a marrowy hemopoiesis increase risk of a miyelosupressiya.

At such number of possible interactions with other medicines, in need of reception together with the drug Maninil® of other drug, the patient has to find out from the doctor whether the concomitant use of these drugs influences concentration of glucose in blood.

Contraindications:

• the hypersensitivity, known from the anamnesis, to Glibenclamidum and/or other derivatives of sulphonylurea, streptocides, diuretic (diuretic) means containing sulphonamide group, and a probenetsida since there can be cross-reactions in a molecule;
• diabetes mellitus of type 1;
• diabetic ketoacidosis, diabetic prekoma and coma;
• a state after a pancreatectomy;
• heavy abnormal liver functions;
• heavy renal failures (the clearance of creatinine is lower than 30 ml/min.);
• some acute states (for example, a decompensation of carbohydrate metabolism at infectious diseases, burns, injuries or after big surgeries when performing insulin therapy is shown);
• leukopenia;
• intestinal impassability, stomach paresis;
• the states which are followed by disturbance of absorption of food and development of a hypoglycemia;
• period of pregnancy and feeding by a breast.

With care of Maninil® it is necessary to apply at:
• feverish syndrome;
• diseases of a thyroid gland (with dysfunction);
• hypofunctions of a front share of a hypophysis or bark of adrenal glands;
• alcoholism;
• at patients of advanced age because of probability of development of a hypoglycemia.

Overdose:

The acute overdose of Maninila® as well as prolonged use of drug in the raised doses, can call heavy, "long" a hypoglycemia, in rare instances life-threatening the patient. Easy conditions of a hypoglycemia, namely its first harbingers, the patient can eliminate: having immediately eaten a sugar piece, jam, honey, having drunk a glass of sweet tea or solution of glucose. Therefore it is always very important to patient to have at itself several pieces of refining sugar or confectionery (candies). The confectionery made especially for patients with a diabetes mellitus do not help with such situations. If the patient is not able to eliminate hypoglycemia symptoms at once, then he needs to call the doctor immediately. At disorder of consciousness - intravenously to enter 40% solution of a dextrose, 1-2 mg of a glucagon intramusculary. After consciousness recovery the patient needs to give the food rich with digestible carbohydrates (in order to avoid repeated development of a hypoglycemia).

Storage conditions:

List B. At a temperature not above 30 °C. To store in the place, unavailable to children! Period of validity 3 years. Not to apply after the expiration specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Îá¡¿¡¿½® 1,75: 120 tablets on 1,75 mg of the micronized Glibenclamidum - in a glass bottle and a cardboard box.

Îá¡¿¡¿½® 3,5: 120 tablets on 3,5 mg of the micronized Glibenclamidum - in a glass bottle and a cardboard box.

Îá¡¿¡¿½® 5: 120 tablets on 5 mg of Glibenclamidum - in a glass bottle and a cardboard box.