Universal reference book for medicines
Product name: MANINIL® 5 (MANINIL® 5)

Active substance: glibenclamide

Type: Oral hypoglycemic drug

Manufacturer: BERLIN-CHEMIE / MENARINI PHARMA (Germany) manufactured by MENARINI-VON HEYDEN (Germany)
Composition, form of production and packaging
Maninil® 1.75

Tablets are pale pink in color, flat-cylindrical, with a facet and a risk on one side.

1 tab.

glibenclamide (in micronized form) 1.75 mg

Excipients: lactose monohydrate - 68.99967 mg, potato starch - 26 mg, gimetellose - 11 mg, silicon dioxide colloid - 2 mg, magnesium stearate - 0.25 mg, dye crimson (Ponso 4R) (E124) - 0.00033 mg.

120 pcs.
- bottles of colorless glass (1) - packs of cardboard.
Maninil® 3.5

Tablets are pink in color, flat-cylindrical, with a facet and a risk on one side.

1 tab.

glibenclamide (in micronized form) 3.5 mg

Auxiliary substances: lactose monohydrate - 63.9967 mg, potato starch - 27.75 mg, gimetellose - 11 mg, silicon dioxide colloid - 3.5 mg, magnesium stearate - 0.25 mg, dye crimson (Ponso 4R) (E124) - 0.0033 mg.

120 pcs.
- bottles of colorless glass (1) - packs of cardboard.
Maninil® 5

Tablets are pink in color, flat-cylindrical, with a facet and a risk on one side.

1 tab.

glibenclamide 5 mg

Auxiliary substances: lactose monohydrate - 90 mg, potato starch - 48.697 mg, magnesium stearate - 1.5 mg, talc - 2.25 mg, gelatin - 2.55 mg, dye crimson (Ponso 4R) (E124) - 0.003 mg.

120 pcs.
- bottles of colorless glass (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Oral hypoglycemic drug from the group of derivatives of sulfonylureas of the second generation.

Stimulates the secretion of insulin by binding to specific receptors of the membrane of the pancreatic gland, reduces the threshold for stimulation of glucose in the pancreatic glands, increases insulin sensitivity and the degree of its binding to target cells, increases the release of insulin, enhances the action of insulin on the absorption of glucose by muscles and the liver, thereby reducing the concentration of glucose in the blood.
It operates in the second stage of insulin secretion. It inhibits lipolysis in adipose tissue. Has hypolipidemic action, reduces thrombogenic properties of blood.
Maninil ® 1.5 and Maninil ® 3.5 in micronized form is a high-tech, specially crushed form of glibenclamide that allows the drug to be absorbed more quickly from the digestive tract.
Due to the earlier achievement of Cmax glibenclamide in plasma, the hypoglycemic effect almost corresponds to a time increase in the concentration of glucose in the blood after a meal, which makes the action of the drug milder and physiological. The duration of hypoglycemic action is 20-24 hours.
The hypoglycemic effect of the preparation Maninil ® 5 develops after 2 hours and lasts for 12 hours.

PHARMACOKINETICS

Suction

After ingestion of Maninil 1.75 and Maninil 3.5, rapid and almost complete absorption from the gastrointestinal tract is observed.
The complete release of the microionized active substance occurs within 5 minutes.
After ingestion of Maninil 5, absorption from the gastrointestinal tract is 48-84%.
T max is 1-2 hours. Absolute bioavailability is 49-59%.
Distribution

The binding to plasma proteins is more than 98% for Maninil 1.75 and Maninil 3.5, 95% for Maninil 5.

Metabolism and excretion

Almost completely metabolized in the liver with the formation of two inactive metabolites, one of which is excreted by the kidneys, and the other - with bile.

T 1/2 for Maninil 1.75 and Maninil 3.5 is 1.5-3.5 h, for Maninil 5 - 3-16 hours.

INDICATIONS

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

DOSING MODE

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 ® 1.75 is 1-2 tablets.
(1.75-3.5 mg) 1 time / day. With insufficient effectiveness under the supervision of a doctor, the dose of the drug is gradually increased to the daily dose necessary to stabilize the carbohydrate metabolism. Increase the dose should be made at intervals of several days to 1 week, until the required therapeutic dose, which should not exceed the maximum. The maximum daily dose of Maninil ® 1.75 is 6 tablets. (10.5 mg).
If the daily dose of glibenclamide exceeds 3 tab.
preparation Maninil ® 1.75, it is recommended to use the preparation Maninil ® 3.5.
Transition from other hypoglycemic drugs to Maninil ® 1.75 should be started under the supervision of a doctor with 1-2 tablets.
of Maninil ® 1.75 per day (1.75-3.5 mg), gradually increasing the dose to the required therapeutic dose.
The initial dose of Maninil ® 3.5 is 1 / 2-1 tab.
(1.75-3 mg) 1 time / day. With insufficient effectiveness under the supervision of a doctor, the dose of the drug is gradually increased to the daily dose necessary to stabilize the carbohydrate metabolism. Increase the dose should be made at intervals of several days to 1 week, until the required therapeutic dose, which should not exceed the maximum. The maximum daily dose of Maninil ® 3.5 is 3 tab. (10.5 mg).
Transition from other hypoglycemic drugs to Maninil ® 3.5 should be started under the supervision of a doctor with 1 / 2-1 tab.
preparation Maninil ® 3.5 per day (1.75-3.5 mg), gradually increasing the dose to the required therapeutic.
The initial dose of Maninil ® 5 is 1 / 2-1 tab.
(2.5-5 mg) 1 time / day. With insufficient effectiveness under the supervision of a doctor, the dose of the drug is gradually increased to the daily dose necessary to stabilize the carbohydrate metabolism. Increase the dose should be made at intervals of several days to 1 week, until the required therapeutic dose, which should not exceed the maximum. The maximum daily dose of Maninil ® 5 is 3 tab. (15 mg).
Transition from other hypoglycemic drugs to Maninil ® 5 should be started under the supervision of a doctor with 1 / 2-1 tab.
drug Maninil ® 5 per day (2.5-5 mg), gradually increasing the dose to the required therapeutic.
In elderly patients, impaired patients, patients with reduced diet, in patients with severe renal or hepatic impairment, the initial and maintenance dose of Maninil ®should be reduced because of the risk of developing hypoglycemia.

Maninil ® should be taken before meals, without chewing and washing down with a small amount of liquid.
Daily doses of the drug, up to 2 tab., Usually should be taken 1 time / day - in the morning, just before breakfast. Higher doses are divided into morning and evening reception.
If you skip one dose of the drug, the next pill should be taken at the usual time, while a higher dose is not allowed.

SIDE EFFECT

Determination of the frequency of side effects: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10 000, <1/1000), very rarely (<1 / 10 000), including individual messages.

On the part of the metabolism: often - hypoglycemia (hunger, hyperthermia, tachycardia, drowsiness, weakness, moisture of the skin, impaired coordination of movements, tremor, general anxiety, fear, headache, transient neurological disorders, including vision disorders and speech, the appearance of paresis or paralysis, or altered perceptions of sensations);
increase in body weight;
From the digestive system: infrequently - nausea, a feeling of heaviness in the stomach, belching, vomiting, abdominal pain, diarrhea, metallic taste in the mouth.

From the liver and bile ducts: very rarely - a temporary increase in liver enzymes, intrahepatic cholestasis, hepatitis.

From the immune system: infrequently - itching, hives, purpura, petechiae, increased photosensitivity;
very rarely - generalized allergic reactions accompanied by skin rashes, arthralgia, fever, proteinuria and jaundice; allergic vasculitis; anaphylactic shock.
From the hemopoietic system: rarely - thrombocytopenia;
Very rarely: leukopenia, erythropenia, agranulocytosis; in isolated cases - pancytopenia, hemolytic anemia.
Other: very rare - visual impairment and accommodation disorders, increased diuresis, transient proteinuria, hyponatremia, disulfiramoid reaction with alcohol intake (the most common signs of the effect: nausea, vomiting, abdominal pain, sensation of fever of the face and upper body, tachycardia, dizziness , headache), cross-allergy to probenecid, sulfonylurea derivatives, sulfonamides, diuretic drugs containing a sulfonamide group in the molecule.

CONTRAINDICATIONS

- hypersensitivity to glibenclamide and / or components included in the preparation;

- hypersensitivity to other sulfonylurea derivatives, sulfonamides, diuretic drugs containing a sulfonamide group in the molecule, and to 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;

- renal failure of severe degree (QC less than 30 ml / min);

- decompensation of carbohydrate metabolism in infectious diseases, burns, injuries or after major surgical operations, when insulin therapy is indicated;

- Lakopenia;

- intestinal obstruction, paresis of the stomach;

- hereditary lactose intolerance, lactase deficiency or glucose malabsorption syndrome and lactose;

- deficiency of glucose-6-phosphate dehydrogenase;

- Pregnancy;

- the period of lactation (breastfeeding);

- Children's and adolescents under 18 years of age (efficacy and safety not studied).

With caution should prescribe the drug for thyroid disease (with impaired function), febrile syndrome, hypofunction of the anterior lobe of the pituitary or adrenal cortex, chronic alcoholism, acute alcohol intoxication, in elderly patients (over 70 years) because of the risk of hypoglycemia.

PREGNANCY AND LACTATION

The drug is contraindicated for use during pregnancy and during breastfeeding.

At the onset of pregnancy, the drug should be discontinued.

APPLICATION FOR FUNCTIONS OF THE LIVER

The drug is contraindicated in patients with severe renal insufficiency (CC less than 30 ml / min).

In patients with severe impairment of renal function, the initial and maintenance dose of Maninil ® should be reduced because of the risk of developing hypoglycemia.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The drug is contraindicated in severe hepatic insufficiency.

In patients with severe impairment of liver function, the initial and maintenance dose of Maninil ® should be reduced because of the risk of developing hypoglycemia.

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

APPLICATION IN ELDERLY PATIENTS

In elderly patients, the initial and maintenance dose of Maninil ® should be reduced because of the risk of developing hypoglycemia.

SPECIAL INSTRUCTIONS

During treatment with Maninil ® it is necessary to strictly follow the doctor's recommendations for diet compliance and self-monitoring of blood glucose concentration.

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 peripheral 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 fasting blood glucose and post-prandial blood glucose, especially at the beginning of treatment, are necessary.

Alcohol can trigger the development of hypoglycemia, as well as the development of a disulfiram-like reaction (nausea, vomiting, abdominal pain, a fever sensation of the face and upper body, tachycardia, dizziness, headache), so you should refrain from alcohol during treatment with Maninil ® .

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.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, patients should be careful when driving vehicles and other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

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, manifestations of paresis or paralysis or altered perception of sensations.) With the progression of hypoglycemia, it is possible for the patients to lose self-control and consciousness, the development of hypoglycemic coma.

Treatment: for mild hypoglycemia, the patient should take a piece of sugar, food or drinks high in sugar (jam, honey, a glass of sweet tea) inside.
In case of unconsciousness, 40-80 ml of 40% dextrose (glucose) solution should be injected into / from glucose, then infusion of 5-10% dextrose solution. Then you can additionally enter 1 mg glucagon IV, IM or SC. If the patient does not regain consciousness, then this measure can be repeated; further intensive care may be required.
DRUG INTERACTION

An increase in the hypoglycemic effect of Maninil ® is possible with concurrent administration with ACE inhibitors, anabolic agents and male sex hormones, other oral hypoglycemic agents (eg, acarbose, biguanides) and insulin, azaprozone, NSAIDs, beta-blockers, quinolone derivatives, chloramphenicol, clofibrate and its analogues, coumarin derivatives, disopyramide, fenfluramine, antifungal drugs (miconazole, fluconazole), fluoxetine, MAO inhibitors, P
CK, pentoxifylline (high dose when administered parenterally), perhexiline, pyrazolone derivatives, phosphamide (e.g., cyclophosphamide, ifosfamide, trofosfamide), probenecid, salicylates, sulfonamides, tetracyclines and tritokvalinom.
Urine acidifying agents (ammonium chloride, calcium chloride) enhance the effect of Maninil ® by reducing the degree of its dissociation and increasing its reabsorption.

The hypoglycemic effect of Maninil ® can decrease with the simultaneous use of barbiturates, isoniazid, diazoxide, GCS, glucagon, nicotinate (high doses), phenytoin, phenothiazines, rifampicin, thiazide diuretics, acetazolamide, oral contraceptives and estrogens, thyroid hormone drugs, sympathomimetic drugs , blockers of slow calcium channels, lithium salts.

H 2 -receptor antagonists may on one side weaken, and on the other, enhance the hypoglycemic effect of Maninil ® .

Pentamidine in a few cases can cause a strong decrease or increase in the concentration of glucose in the blood.

When applied simultaneously with the drug, Maninil ® may exacerbate or weaken the effects of coumarin derivatives.

Along with the increase in hypoglycemic effect, beta-adrenoblockers, clonidine, guanethidine and reserpine, as well as drugs with a central mechanism of action, can weaken the sensation of precursors of symptoms of hypoglycemia.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children.
Tablets 1.75 mg and 3.5 mg should be stored at a temperature not higher than 30 ° C, tablets 5 mg - not higher than 25 ° C. Shelf life - 3 years.
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