Maninil 3,5 - instructions for use, dose, side effects, contraindications

Excipients; lactose monohydrate - 63.9967 mg, potato starch - 27.7500 mg, gimetellose - 11,0000 mg, silicon dioxide colloid - 3,5000 mg, magnesium stearate - 0,2500 mg, dye crimson [Ponso 4R] (E 124) 0.0033 mg.

Description:

Pink planocylindrical tablets with chamfer and risk on one side of the tablet.

Pharmacotherapeutic group:Hypoglycemic agent for oral use of the second-generation sulfonylurea group

ATX: & nbsp

A.10.B.B.01 Glibenclamide

Pharmacodynamics:

Glibenclamide stimulates insulin secretion by lowering the threshold for stimulation of pancreatic beta cells by glucose, increases insulin sensitivity and its binding to target cells, increases insulin release, enhances insulin action on glucose uptake by muscles and liver, inhibits lipolysis in adipose tissue. It operates in the second stage of insulin secretion. Has hypolipidemic action, reduces thrombogenic properties of blood.

Maninil®3.5 in micronized form is a high-tech, specially crushed form of glibenclamide that allows the drug to be absorbed faster from the gastrointestinal tract. In connection with the earlier achievement of the maximum concentration of glibenclamide in blood plasma, the hypoglycemic effect practically corresponds to the rise in the concentration of glucose in the blood plasma after eating, which makes the action of the drug milder and physiological. The duration of the hypoglycemic effect of glibenclamide envy of the dose and can last up to 24 hours.

Pharmacokinetics:

Ingestion glibenclamide quickly and almost completely absorbed.Simultaneous food intake has no significant effect on the absorption of glibenclamide. The complete release of the micronized active substance occurs within 5 minutes. The time to reach the maximum concentration is 1-2 hours. The connection with plasma proteins is 98%. Glibenclamide completely metabolized in the liver with the formation of two inactive metabolites, one of which is excreted by the kidneys, the other - with bile. The half-life after oral administration is 2-5 hours.

In patients with impaired hepatic function, the elimination of the active substance from the plasma is slowed down. In patients with renal insufficiency, excretion of metabolites with bile is compensatory. With creatinine clearance> 30 ml / min, the total elimination remains unchanged, with severe renal failure, cumulation of glibenclamide in the body is possible.

Indications:

Type 2 diabetes mellitus as a monotherapy or as part of a combination therapy with other oral hypoglycemic drugs, in addition to the derivatives of sulfonylurea and clay.

Contraindications:

Hypersensitivity to glibenclamide and / or other components included in the preparation;
hypersensitivity to other sulfonylurea derivatives, sulfonamides, diuretic drugs containing a sulfonamide group in the molecule, and probenecid, since there may be cross reactions;
type 1 diabetes mellitus;
diabetic ketoacidosis, diabetic precoma and coma;
condition after resection of the pancreas;
severe hepatic impairment;
severe renal failure (creatinine clearance <30 mL / min);
decompensation of carbohydrate metabolism in infectious diseases, burns, trauma or after major surgical operations, when insulin therapy is indicated;
leukopenia;
intestinal obstruction, paresis of the stomach;
hereditary lactose intolerance, lactase deficiency or glucose malabsorption syndrome and lactose.
deficiency of glucose-6-phosphate dehydrogenase;
pregnancy and lactation;
children under 18 years of age (efficacy and safety not studied).

Carefully:

Diseases of the thyroid gland (with impaired function);
febrile syndrome;
cerebral atherosclerosis;
hypofunction of the anterior lobe of the pituitary gland or adrenal cortex;
chronic alcoholism; acute alcohol intoxication;
conditions, accompanied by a violation of food intake and development of hypoglycemia;
older age (over 70 years) because of the risk of developing hypoglycemia.

Pregnancy and lactation:

The use of Maninil® 3,5 during pregnancy and during breastfeeding is contraindicated. At the onset of pregnancy, the drug should be stopped.

Dosing and Administration:

The dose of the drug depends on the age, the severity of the course of diabetes, the concentration of glucose in the blood on an empty stomach and 2 hours after eating.

The initial dose of Maninil® 3,5 is 1/2 - 1 tablet (1.75 mg-3 mg) once a day day. If the initial dose does not lead to the achievement of adequate metabolic control, the dose of Maninil® 3.5 should be increased in stages and increased under medical supervision. Increase the dose should be made at intervals of several days to one week, until the required therapeutic dose, which should not exceed the maximum. The maximum daily dose of Maninil® is 3.5 - 3 tablets (10.5 mg).

The drug should be taken before eating, without chewing and washing down with a small amount of liquid.Daily doses of the drug, up to 2 tablets, should be taken 1 time per day - in the morning, just before breakfast. Higher doses are divided into morning and evening reception in a ratio of 2: 1.

If you miss one dose of the drug, the next dose of the drug should be taken at the usual time, while not allowed to take a higher dose.

Elderly, debilitated patients or patients with reduced diet, as well as those suffering from severe renal or hepatic impairment the initial and maintenance dose should be reduced because of the risk of developing hypoglycemia.

Translation from other hypoglycemic agents;

The transition from other hypoglycemic drugs to the preparation Maninil® 3,5 should be started under the supervision of a doctor with 1/2 - 1 tablets of Maninil® 3.5 per day (1.75 mg-3.5 mg), gradually increasing the dose to the required therapeutic .

Side effects:

Possible side effects with Maninil® 3.5 are given below in the descending incidence frequency: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10000 , <1/1000), very rarely (<1/10000), including individual messages.

Disorders from the metabolism and nutrition:

Often: hypoglycemia (hunger, hyperthermia, tachycardia, drowsiness, weakness, skin moisture, movement coordination disorder, tremor, general anxiety, fear, headache, transient neurological disorders (eg, visual and speech disorders, paresis or paralysis, or altered perceptions sensations), weight gain;

Disorders from the gastrointestinal tract:

Infrequently: nausea, a feeling of heaviness in the stomach, belching, vomiting, abdominal pain, diarrhea, a "metallic" taste in the mouth;

Violation of the liver and biliary tract:

Rarely: a temporary increase in the activity of "hepatic" enzymes, intrahepatic cholestasis, hepatitis;

Immune system disorders:

Infrequently: itching, hives, purpura, petechiae, increased photosensitivity.

Rarely: generalized allergic reactions accompanied by skin rashes, arthralgia, fever, proteinuria and jaundice; allergic vasculitis; anaphylactic shock.

Violations from the blood and lymphatic system:

Rarely: thrombocytopenia;

Rarely: leukopenia, erythropenia, agranulocytosis;

In a few cases: pancytopenia, hemolytic anemia.

Other:

Rarely: impaired vision and accommodation disorders, increased diuresis, transient proteinuria, hyponatremia, "antabuse effect" (disulfiramoid-like reaction) with alcohol intake (the most common signs of the effect: nausea, vomiting, abdominal pain, fever of the face and upper body, tachycardia, dizziness, headache). Cross-allergy to probenecid, sulfonylureas, sulfonamides, diuretic agents containing a sulfonamide group in the molecule.

Overdose:

Symptoms: hypoglycemia (hunger, hyperthermia, tachycardia, drowsiness, weakness, skin moisture, movement coordination disorder, tremor, general anxiety, fear, headache, transient neurological disorders (eg, visual and speech disorders, paresis or paralysis, or altered perception Sensations.) With the progression of hypoglycemia, it is possible for the patients to lose self-control and consciousness, the development of hypoglycemic coma.

Treatment: In mild hypoglycemia, you should take a piece of sugar, food or drinks high in sugar (jam, honey, a glass of sweet tea) inside.

If you lose consciousness, you need to inject glucose intravenously (40-80 ml 40% solution of dextrose (glucose), then infuse 5-10% dextrose solution.) Then you can additionally administer 1 mg glucagon intravenously (intramuscularly or subcutaneously) .If the patient does not regain consciousness, then this measure can be repeated, and further intensive therapy may be required.

Interaction:

An increase in the hypoglycemic effect of Maninil® 3,5 is possible with concurrent administration with angiotensin-converting enzyme inhibitors, anabolic agents and male sex hormones, other oral hypoglycemic agents (eg, acarbose, biguanides) and insulin, azaprope, non-steroidal anti-inflammatory drugs (NSAIDs), beta- adrenoblockers, quinolone derivatives, chloramphenicol, clofibrate and its analogues, coumarin derivatives, disopyramide, fenfluramine, antifungal and drugs (miconazole, fluconazole), fluoxetine, monoamine oxidase inhibitors, para-aminosalicylic acid, pentoxifylline (at high doses administered parenterally), perhexylline, pyrazolone derivatives, phosphamides (for example,cyclophosphamide, ifosfamide, trophosphamide), probenecid, salicylates, sulfonamides, tetracyclines, and grossoqualin.

Urine acidifying agents (ammonium chloride, calcium chloride) increase the effect of Maninil® 3,5 by reducing the degree of its dissociation and increasing its reabsorption.

The hypoglycemic effect of the drug Maninil® 3,5 may decrease with simultaneous use with barbiturates, isoniazid, diazoxide, glucocorticosteroids, glucagon, nicotinates (in large doses), phenytoin, phenothiazines, rifampicin, thiazide diuretics, acetazolamide, oral contraceptives and estrogens, iodine-containing thyroid hormone preparations, sympathomimetic agents, slow calcium channel blockers, lithium salts.

H2-receptor antagonists may on one side weaken, and on the other - enhance the hypoglycemic effect of the drug Maninil® 3.5. Pentamidine in a few cases can cause a strong decrease or increase in the concentration of glucose in the blood. The effect of coumarin derivatives may be enhanced or weakened.

Along with the increase in hypoglycemic action, beta-blockers, clonidine, guanethidine and reserpine, as well as drugs with a central mechanism of action, can ease the feeling of harbingers of symptoms of hypoglycemia.

Special instructions:

During treatment with Maninil® 3,5, you must strictly follow the doctor's recommendations for diet and self-monitoring of blood glucose.

Long-term abstinence from eating, insufficient provision of carbohydrates, intense physical activity, diarrhea or vomiting are a risk of developing hypoglycemia.

Simultaneous administration of drugs that have an effect on the central nervous system, lowering blood pressure (including beta-blockers), as well as autonomic neuropathy can mask symptoms of hypoglycemia.

In elderly patients, the risk of developing hypoglycemia is slightly higher, so a more careful selection of the dose of the drug and regular monitoring of the concentration of glucose in the blood on an empty stomach and after meals, especially at the beginning of treatment.

Alcohol can provoke the development of hypoglycemia, as well as the development of an antabuse effect (nausea, vomiting, abdominal pain, a feeling of fever in the face and upper body, tachycardia, dizziness, headache),so you should refrain from drinking alcohol during treatment with Maninil® 3,5.

Large surgical interventions and trauma, extensive burns, infectious diseases with febrile syndrome may require the abolition of oral hypoglycemic drugs and the administration of insulin.

During treatment, prolonged exposure to the sun is not recommended.

Effect on the ability to drive transp. cf. and fur:

During treatment, care must be taken when driving vehicles and other potentially hazardous activities requiring concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets 3,5 mg.

Packaging:

For 120 tablets in a bottle of colorless glass, sealed with a plug of polyethylene.

One bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep the medicine out of the reach of children!

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012253 / 01

Date of registration:02.03.2012 / 14.02.2018

Expiration Date:Unlimited

The owner of the registration certificate:Berlin-Chemie / Menarini Pharma, GmbH Berlin-Chemie / Menarini Pharma, GmbH Germany

Manufacturer: & nbsp

BERLIN-CHEMIE, AG Germany

MENARINI-VON HEYDEN, GmbH Germany

Information update date: & nbsp27.03.2018

Illustrated instructions

Instructions

Maninil® 3,5 (Maninil® 3,5)