Active substanceMetforminMetformin
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  • Dosage form: & nbspfilm coated tablets
    Composition:

    1 tablet contains:

    Active substance: metformin hydrochloride 500 mg

    Excipients: sodium carboxymethyl starch, corn starch, silicon dioxide colloid, povidone (K-30), magnesium stearate, hypromellose (5 CPS), macrogol 6000, titanium dioxide, talc, propylene glycol.

    Description:Round tablets of white color, covered with a film shell, practically odorless.
    Pharmacotherapeutic group:Hypoglycemic agent for oral administration of the biguanide group
    ATX: & nbsp

    A.10.B.A.02   Metformin

    Pharmacodynamics:Metgogamma® 500 inhibits glknoneogenesis in the liver, reduces absorption of glucose from the intestine, enhances peripheral utilization of glucose, and also increases the sensitivity of tissues to insulin. In this case, it has no effect on the secretion of insulin by beta cells of the pancreas. Reduces the level of triglycerides and low density lipoproteins in the blood. Stabilizes or reduces body weight. Has a fibrinolytic effect due to inhibition of the inhibitor of tissue-type plasminogen activator.
    Pharmacokinetics:After oral administration metformin is absorbed from the gastrointestinal tract. Bioavailability after taking a standard dose is -50-60%. The maximum concentration in the blood plasma is reached after 2 hours after ingestion. Virtually does not bind to plasma proteins. It accumulates in the salivary glands, muscles, liver and kidneys. It is allocated in an invariable kind by kidneys. The elimination half-life is 1.5-4.5 hours. In cases of kidney dysfunction, cumulation of the drug is possible.
    Indications:Diabetes mellitus type 2, without a tendency to ketoacidosis (especially in patients with obesity) with ineffectiveness of diet therapy.
    Contraindications:

    - Hypersensitivity to metformin or to any auxiliary substance;

    - diabetic ketoacidosis, diabetic precoma, coma;

    - renal failure or impaired renal function (creatinine clearance less than 60 ml / min);

    - acute conditions that occur with a risk of developing renal dysfunction:

    - Dehydration (with diarrhea, vomiting), severe infectious diseases,

    - clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including cardiac or respiratory failure, acute myocardial infarction);

    - extensive surgery and trauma, when insulin therapy is indicated (see section "Special instructions");

    - liver failure, a violation of liver function;

    - chronic alcoholism, acute alcohol poisoning;

    - lactic acidosis (including in the anamnesis);

    - Pregnancy;

    - use less than 48 hours before and within 48 hours after radioisotope or X-ray studies with the introduction of an iodine-containing contrast medium (see section "Interaction with other drugs");

    - compliance with the hypocaloric diet (less than 1000 kcal / day);

    - Children under 18 years.

    Carefully:In the period of breastfeeding; in patients older than 60 years, performing heavy physical work (increased risk of lactic acidosis).
    Pregnancy and lactation:The drug is contraindicated for use in pregnancy. When planning or in the event of pregnancy, Metfogamma® 500 should be discontinued and insulin therapy should be prescribed. The patient should be warned about the need to inform the doctor if a pregnancy occurs. Mother and child should be monitored. A limited amount of data on the use of metformin in pregnant women does not indicate an increased risk of developing congenital malformations in children. Metformin penetrates into breast milk. Side effects in newborns with breastfeeding against metformin were not observed. However, due to the limited amount of data, the use of the drug during breastfeeding is not recommended. The decision to stop breastfeeding should be taken in consideration of the benefits of breastfeeding and the potential risk of side effects in the child.
    Dosing and Administration:

    The dose of Metofamma® 500 is determined individually, taking into account the level of glucose in the blood. The initial dose is usually 500-1000 mg (1-2 tablets) per day, perhaps a further gradual increase in dose, depending on the effect of therapy.

    The maintenance daily dose of the drug is 1000-2000 mg (2-4 tablets) per day. The maximum daily dose - 3 g (6 tablets), the appointment of higher doses does not contribute to an increase in the effect of the treatment.

    Tablets Metfogamma® 500 should be taken with food, wholly, with a small amount of liquid (a glass of water).

    The course of treatment with the drug is long.

    Due to the increased risk of lactic acidosis, the dose of the drug should be reduced in case of severe metabolic disorders.

    Side effects:

    From the gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea, lack of appetite, "metallic" taste in the mouth. In these cases, it is usually not necessary to stop treatment, and the symptoms go away without changing the dose of the drug. The frequency and severity of GI side effects may decrease with a gradual increase in the dose of metformin.In rare cases - abnormal abnormalities of liver samples or hepatitis, transient after drug withdrawal.

    Allergic reactions: skin rash.

    From the endocrine system: hypoglycemia (mainly when used in inadequate doses).

    From the side of metabolism: in rare cases - lactic acidosis (requires discontinuation of treatment), with prolonged treatment - hypovitaminosis B12 (impaired absorption).

    On the part of the hematopoiesis system: in some cases - megaloblastic anemia.

    Overdose:In case of an overdose of Methofogma® 500, lactoacidosis can develop with a fatal outcome. The cause of the development of lactic acidosis may also be cumulation of the drug due to impaired renal function. The early symptoms of lactic acidosis are nausea, vomiting, diarrhea, lower body temperature, abdominal pain, muscle pain, there may be more rapid breathing, dizziness, impaired consciousness and coma development. In case of signs of lactic acidosis, treatment with Methofamma® 500 should be stopped immediately, the patient should immediately hospitalize and, after determining the concentration of lactate, confirm the diagnosis.The most effective measure for excretion from the body of lactate and metformin is hemodialysis. Conduct also symptomatic treatment. With combined therapy with Metgammam® 500 with sulfonylureas, hypoglycemia may develop.
    Interaction:

    With simultaneous use with sulfonylurea derivatives, acarbose, insulin, non-steroidal anti-inflammatory agents, monoamine oxidase inhibitors, oxytetracycline, angiotensin converting enzyme inhibitors, clofibrate derivatives, cyclophosphamide, 6-adrenoblockers, hypoglycemic effect of metformin may be enhanced. When used simultaneously with glucocorticosteroids, oral contraceptives, epinephrine, sympathomimetics, glucagon, thyroid hormones, thiazide and loop diuretics, phenothiazine derivatives, nicotinic acid derivatives, a decrease in the hypoglycemic effect of metformin is possible.

    Cimetidine slows the excretion of metformin, which increases the risk of developing lactic acidosis.

    Metformin can weaken the effect of indirect anticoagulants (coumarin derivatives).With the simultaneous use of alcohol may develop lactic acidosis.

    Nifedipine increases absorption, Cmax, slows down the excretion.

    Incompatible with ethanol (lactoacidosis).

    Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, vancomycin), secreted in the tubules, compete for the canalic transport systems and, with prolonged therapy, can increase Cmax by 60%.

    Special instructions:

    During the treatment with Metfogamma 500, it is necessary to regularly monitor the concentration of glucose in the blood on an empty stomach and after eating.

    The patient should be warned about the need to stop taking the drug and see a doctor if there is vomiting, abdominal pain, muscle cramps, general weakness and severe malaise. Obtuse symptoms can be a sign of beginning lactic acidosis.

    Lactoacidosis is characterized by severe weakness, acidotic dyspnea, abdominal pain and hypothermia, followed by the development of coma.

    Diagnostic laboratory indicators for lactic acidosis: a decrease in blood pH, an increase in plasma lactate concentration above 5 mmol / l, an increase in the anion interval and an increase in the lactate / pyruvate ratio.If metabolic acidosis is suspected, metformin should be discontinued and the patient should be immediately hospitalized.

    Lactic acidosis is a rare but serious metabolic complication that may occur in connection with the cumulation of metformin. The cases of lactic acidosis were noted mainly in patients with diabetes mellitus with severe renal insufficiency. Risk factors are uncompensated diabetes mellitus, ketosis, prolonged fasting, excessive alcohol consumption, liver failure and other conditions accompanied by hypoxia. If there is a suspicion of the development of metabolic lactic acidosis metformin must be canceled and the patient should be immediately hospitalized.

    Kidney function

    Because the metformin is excreted by the kidneys before the beginning of treatment, and regularly afterwards, creatinine clearance in serum should be determined at least 1 time per year in patients with normal renal function, and less than 2-4 times per year in patients with reduced creatinine clearance and elderly patients.

    Particular caution should be exercised in cases of impaired renal function, for example, during the initial period of concomitant therapy with antihypertensive drugs, diuretics, and NSAIDs.

    Carrying out X-ray study (urography, intravenous angiography) with the use of iodine-containing rasgenocontrast agents can lead to renal failure. Preparation Metfogamma® 500 should be discontinued 48 hours before the radiographic examination, and resume the drug no earlier than 48 hours after it.

    When conducting surgical interventions under general anesthesia, spinal or epidural anesthesia, Metfogamma® 500 should be discontinued 48 hours before surgery. Resume the drug is recommended not earlier than 48 hours after the operation.

    When treating Metfogamma® 500, you should follow a diet with a uniform distribution of carbohydrates throughout the day. Patients with excessive body weight should follow a diet with calorie restriction.

    Standard laboratory tests should be routinely performed to monitor diabetes mellitus, especially at the beginning of treatment with Metfogamma® 500.

    Metformin with monotherapy does not cause hypoglycemia, but caution should be exercised when using the drug together with insulin or other hypoglycemic drugs (for example, sulfonylurea derivatives or repaglinide).In this case, a particularly careful control of the concentration of glucose in the blood is necessary.

    It is necessary to inform the patient about the need to consult a doctor if symptoms of bronchopulmonary infection or infectious disease of the genito-urinary organs appear.

    Against the background of the use of Metfogamma® 500, you should refrain from taking alcohol because of the increased risk of hypoglycemia and disulfiram-like effect.

    Hypovitaminosis B12 when taking the drug due to a violation of absorption and has a reversible nature - the content of vitamin B12 quickly restored when the drug is withdrawn. Decreased vitamin B content12 should be taken into account in patients with megaloblastic anemia.

    Effect on the ability to drive transp. cf. and fur:Preparation Metfogamma® 500 with monotherapy does not cause hypoglycemia, therefore does not affect the ability to drive vehicles and work with mechanisms. When combined metformin with other hypoglycemic agents (insulin, repaglinide and others), it is possible to develop hypoglycemic conditions, in which the ability to drive vehicles and engage in other potentially dangerous activities deteriorates,require increased attention and rapid psychomotor reactions.
    Form release / dosage:Film coated tablets 500 mg.
    Packaging:

    10 tablets per blister, made of polyvinylchloride film and aluminum foil.

    For 3, 12 blisters together with the instructions for use are placed in a cardboard box (when packaged on Dragogenopharm Apotheker Piushl GmbH and Co. KG, Germany);

    For 6 blisters together with instructions for use are placed in a cardboard box (when packaged at ZiO-ZAO, Russia).

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:П N014463 / 01
    Date of registration:24.04.2008 / 14.08.2013
    Expiration Date:Unlimited
    Date of cancellation:2018-03-22
    The owner of the registration certificate:Wörwag Pharma GmbH & Co. KG. KGWörwag Pharma GmbH & Co. KG. KG Germany
    Manufacturer: & nbsp
    Information update date: & nbsp11.05.2018
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