Pharmacy No. 84. Delivery of medicines to your home and office.

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Glucophage 1000 mg No. 60 tablet p.o.

Instructions for medical use of the drug GLUCOPHAGE® Trade name Glucophage® International nonproprietary name Metformin Dosage form Film-coated tablets 500 mg, 850 mg and 1000 mg Composition One tablet contains the active substance - metformin hydrochloride 500 mg, 850 mg or 1000 mg, auxiliary substances: povidone, magnesium stearate, film shell composition - hydroxypropyl methylcellulose, in tablets 1000 mg - pure opadry YS-1-7472 (hydroxypropyl methylcellulose, macrogol 400, macrogol 8000). Description Glucophage 500 mg and 850 mg: round, biconvex, white film-coated tablets Glucophage 1000 mg: oval, biconvex, white film-coated tablets, with a break mark on both sides and “1000” marking on one side of the tablet Pharmacotherapeutic group Drugs for the treatment of diabetes mellitus. Oral hypoglycemic drugs. Biguanides. Metformin. ATC code A10BA02 Pharmacological properties Pharmacokinetics After oral administration of metformin tablets, the maximum plasma concentration (Cmax) is reached after approximately 2.5 hours (Tmax). Absolute bioavailability in healthy individuals is 50-60%. After oral administration, 20-30% of metformin is excreted unchanged through the gastrointestinal tract. When metformin is used in normal doses and dosage regimens, a constant plasma concentration is achieved within 24-48 hours and is generally less than 1 mcg/ml. The degree of binding of metformin to plasma proteins is insignificant. Metformin is distributed in red blood cells. The maximum level in the blood is lower than in the plasma and is reached at approximately the same time. The average volume of distribution (Vd) is 63–276 l. Metformin is excreted unchanged in the urine. No metabolites of metformin have been identified in humans. The renal clearance of metformin is more than 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion. After oral administration, the half-life is approximately 6.5 hours. If renal function is impaired, renal clearance decreases in proportion to creatinine clearance, and thus the half-life increases, resulting in increased plasma levels of metformin. Pharmacodynamics Metformin is a biguanide with an antihyperglycemic effect, reducing both basal and postprandial plasma glucose levels. It does not stimulate insulin secretion and therefore does not cause hypoglycemia. Metformin has 3 mechanisms of action: (1) reduces hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis; (2) improves the uptake and utilization of peripheral glucose in muscles by increasing insulin sensitivity; (3) delays the absorption of glucose in the intestine. Metformin stimulates the synthesis of intracellular glycogen by acting on glycogen synthase. It also improves the capacity of all types of membrane glucose transporters (GLUTs). In clinical studies, taking metformin had no effect on body weight or slightly reduced it. Regardless of its effect on glycemia, metformin has a positive effect on lipid metabolism. In controlled clinical studies using therapeutic doses, metformin was found to reduce total cholesterol, low-density lipoprotein cholesterol and triglycerides. Indications for use Glucophage is indicated for the treatment of type 2 diabetes mellitus, especially in overweight patients when diet therapy and exercise alone do not provide sufficient glycemic control. - in adults, Glucophage can be used as monotherapy, in combination with other oral antidiabetic agents or with insulin; − in children over 10 years of age, Glucophage can be used as monotherapy or in combination with insulin. Dosage and administration Adults: Monotherapy and combination therapy with other oral antidiabetic agents: The usual starting dose is 500 or 850 mg of Glucophage 2-3 times daily during or after meals. After 10-15 days from the start of therapy, it is necessary to adjust the dose of the drug based on the results of measuring blood glucose. Slowly increasing the dose may improve gastrointestinal tolerance. In patients receiving a high dose of metformin hydrochloride (2-3 g per day), two Glucophage 500 mg tablets can be replaced by one Glucophage 1000 mg tablet. The maximum recommended dose is 3 g per day (divided into three doses). If you are planning to switch from another antidiabetic drug: you must stop taking the other drug and start taking Glucophage at the dose indicated above. Combination with insulin: To achieve better blood glucose control, Glucophage and insulin can be used in combination therapy. The usual starting dose of Glucophage is 500 mg or 850 mg 2-3 times a day, while the dose of insulin is adjusted based on the results of blood glucose measurements. Children and adolescents: In children over 10 years of age, Glucophage can be used both as monotherapy and in combination with insulin. The usual starting dose is 500 mg or 850 mg once daily during or after meals. After 10-15 days of therapy, it is necessary to adjust the dose of the drug based on the results of blood glucose measurements. Slowly increasing the dose may improve gastrointestinal tolerability. The maximum recommended dose is 2 g of Glucophage per day, divided into 2-3 doses. Elderly patients: Due to the possible decrease in renal function in the elderly, the dose of Glucophage should be adjusted based on renal function parameters. Renal function should be assessed regularly. Patients with Renal Impairment: Metformin may be used in patients with moderate renal impairment - stage 3a chronic kidney disease (creatinine clearance [CrCl] 45-59 mL/min or estimated glomerular filtration rate [eGFR] 45-59 mL/min/1 .73 m2) - only in the absence of other conditions that may increase the risk of developing lactic acidosis, and with the following dose adjustment: the initial dose of metformin hydrochloride is 500 mg or 850 mg 1 time per day. The maximum dose is 1000 mg per day, divided into 2 doses. It is necessary to carefully monitor kidney function (every 3-6 months). If ClCr or eGFR values decrease to <45 mL/min or <45 mL/min/1.73 m2, respectively, metformin should be discontinued immediately. Side effects At the beginning of treatment, the most common adverse reactions are nausea, vomiting, diarrhea, abdominal pain and loss of appetite, which in most cases resolve spontaneously. To prevent the development of these symptoms, it is recommended to take Glucophage in 2 or 3 doses with a gradual increase in dose. During treatment with Glucophage, the following adverse reactions may occur. The frequency of such reactions is classified as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000 , <1/1,000), very rare (<1/10,000). Side effects for each frequency group are presented in order of decreasing severity. Metabolic and nutritional disorders Very rare: - lactic acidosis - with prolonged use of metformin, the absorption of vitamin B12 may decrease, which is accompanied by a decrease in its level in the serum. When megaloblastic anemia is detected, the possibility of such an etiology must be taken into account. Nervous system disorders Common: − taste disturbances Gastrointestinal tract disorders Very common: − gastrointestinal disorders such as nausea, vomiting, diarrhea, abdominal pain, lack of appetite. Most often, these adverse reactions occur at the beginning of treatment and, as a rule, resolve spontaneously. To prevent the development of these symptoms, it is recommended to take Glucophage in 2 or 3 doses before or after meals with a slow increase in dose Disorders of the liver and biliary tract Very rarely: - there have been isolated cases of abnormalities in liver function tests or hepatitis, which disappeared after stopping the use of metformin Skin and subcutaneous tissue disorders: Very rare: - skin reactions such as erythema, itching, urticaria Pediatric patients: Side effects in children were similar in nature and severity to those observed in adults. After starting treatment with Glucophage, any suspected adverse events should be reported. This will allow continuous monitoring of the benefit/risk profile of the drug. Contraindications - hypersensitivity to metformin or to any excipient; - diabetic ketoacidosis, diabetic precoma; — chronic kidney disease (stages 3b, 4 and 5) or kidney dysfunction (ClCr <45 ml/min or eGFR <45 ml/min/1.73 m2); - acute conditions that can lead to impaired renal function: dehydration, severe infection, shock; - acute or chronic diseases that are accompanied by tissue hypoxia: decompensated heart failure, respiratory failure, recent myocardial infarction, shock; - liver failure; - acute alcohol intoxication, alcoholism. Drug interactions Not recommended combinations Alcohol: The risk of developing lactic acidosis increases with acute alcohol intoxication, especially in cases of fasting or malnutrition and liver failure. During treatment with Glucophage®, you should avoid drinking alcohol and medications containing alcohol. Iodinated contrast media: Intravascular administration of iodinated contrast media may cause renal failure. This may lead to accumulation of metformin and cause lactic acidosis. In patients with an eGFR >60 mL/min/1.73 m2, metformin should be discontinued before or during an iodinated contrast media study, not restarted until 48 hours after the study, and only after re-evaluation of renal function has shown that normal results provided that it does not worsen subsequently. In patients with moderate renal impairment (eGFR 45-60 ml/min/1.73 m2), metformin should be discontinued 48 hours before the use of iodinated contrast media and not resumed until 48 hours after the study and only after repeated use. assessment of renal function, which showed normal results and provided that it will not deteriorate subsequently. Combinations requiring caution Drugs with hyperglycemic effects (glucocorticoids (systemic and local) and sympotomimetics): More frequent blood glucose determinations may be required, especially at the beginning of treatment. If necessary, the dosage of metformin should be adjusted with the appropriate drug until the latter is discontinued. Diuretics, especially loop diuretics, may increase the risk of lactic acidosis due to their potential negative effects on renal function. Special instructions Lactic acidosis Lactic acidosis is a very rare but serious metabolic complication with high mortality in the absence of immediate treatment, which can develop due to the accumulation of metformin. Reported cases of lactic acidosis in patients receiving metformin occurred primarily in patients with diabetes mellitus and severe renal failure or acute deterioration of renal function. Caution should be exercised in situations where renal function may be impaired, such as in cases of dehydration (severe diarrhea, vomiting) or the administration of antihypertensive, diuretic, or nonsteroidal anti-inflammatory drug (NSAID) therapy. In these acute conditions, metformin therapy should be temporarily suspended. Other associated risk factors must be considered, such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol consumption, liver failure, and any condition associated with hypoxia (such as decompensated heart failure, acute myocardial infarction). The diagnosis of lactic acidosis should be considered if nonspecific symptoms such as muscle cramps, abdominal pain, and/or severe asthenia occur. Patients should be advised that they should report the occurrence of these symptoms to their healthcare provider, especially if patients have previously tolerated metformin. If lactic acidosis is suspected, treatment with Glucophage should be discontinued. Resumption of use of Glucophage should be considered on an individual basis only after taking into account the benefit/risk ratio and renal function. Diagnosis Lactic acidosis is characterized by the appearance of acidotic shortness of breath, abdominal pain and hypothermia followed by coma. Diagnostic laboratory parameters are a decrease in blood pH, plasma lactate levels above 5 mmol/l, an increase in the anion gap and the lactate/pyruvate ratio. If lactic acidosis is suspected, the patient should be hospitalized immediately. Doctors should notify patients about the risks and symptoms of lactic acidosis. Renal function Since metformin is excreted by the kidneys, creatinine clearance should be checked before starting and regularly during treatment with Glucophage (by determining the serum creatinine level using the Cockcroft-Gault formula): at least once a year in patients with normal function kidney; · at least 2-4 times a year in elderly patients, as well as in patients with creatinine clearance at the lower limit of normal. If ClCr <45 ml/min (eGFR <45 ml/min/1.73 m2), the use of metformin is contraindicated. Decreased renal function in elderly patients is common and asymptomatic. Particular caution is recommended in cases where renal function may be impaired, for example, when starting antihypertensive therapy, diuretics or non-steroidal anti-inflammatory drugs. In these cases, it is also recommended to check kidney function before starting treatment with metformin. Cardiac Function Patients with heart failure are more susceptible to the risk of hypoxia and renal failure. In patients with stable chronic heart failure, metformin should only be used with regular monitoring of cardiac and renal function. Glucophage is contraindicated in patients with acute and unstable heart failure. Surgical interventions Taking Glucophage should be discontinued 48 hours before planned surgical interventions performed under general, spinal or epidural anesthesia. In general, treatment with Glucophage should not be restarted until 48 hours after surgery or after resumption of food intake, or after renal function has been reassessed and found to be normal. Other precautions Patients are required to follow a diet with proper distribution of carbohydrate intake throughout the day. People who are overweight should follow a low-calorie diet. Laboratory tests should be performed regularly to monitor the progress of the disease. The use of Glucophage cannot cause hypoglycemia, but patients should be advised to exercise caution when taking it in combination with insulin or sulfonylurea derivatives. Pediatric patients Before starting treatment with Glucophage, it is necessary to confirm the diagnosis of type 2 diabetes mellitus. In controlled clinical studies over a one-year period, there was no effect of metformin on the growth and sexual development of children, but data over a longer period of time are not available. Therefore, it is recommended to monitor the effect of metformin on these indicators in children and, especially, in the prepubertal period. Children aged 10 to 12 years The controlled clinical trials included only 15 children aged 10-12 years. Although the effectiveness and safety of metformin in children younger than 12 years of age is similar to that in older children and adolescents, caution should still be exercised when prescribing metformin to children aged 10 to 12 years. Pregnancy and lactation Pregnancy Uncontrolled diabetes during pregnancy (including gestational diabetes) is associated with an increased risk of congenital pathologies and perinatal mortality. Limited data on the use of metformin in pregnant women does not indicate an increased risk of congenital disorders. When planning and during pregnancy, it is not recommended to use metformin. To maintain blood glucose levels, insulin should be used as close as possible to the norm as possible to reduce the risk of fetal development. The lactation period metformin penetrates into breast milk. No unwanted effects in newborn/babies, fed by breast milk, was observed. However, due to a limited amount of data, it is not recommended to breastfeed during treatment with glucofa It is necessary to make a decision on breastfeeding, taking into account the benefits of breastfeeding and the potential risk of adverse reactions for the baby. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms monotherapy with glucophage does not cause hypoglycemia and therefore does not affect the ability to drive a car and work with mechanisms. However, patients should remember the possibility of hypoglycemia when using the glucophage drug in combination with other antidiabetic drugs (derivatives of sulfonylumrevine, insulin or meglitinides). An overdose when using the glucophage drug at a dose of 85 g, the development of hypoglycemia was not observed. However, in this case, the development of lactacidosis was observed. A significant overdose of metformin or related risks can lead to the development of lactacidosis. Lactacidosis is an emergency medical condition that requires hospitalization. Treatment: The most effective event to remove lactate and metformin is hemodialysis from the body. The output form and packaging of 15 tablets are placed in contour cell packages from the polyvinyl chloride film and aluminum foil. 4 contour packages along with the instructions for medical use in the state and Russian languages are invested in a pack of cardboard. Storage conditions Store at a temperature not exceeding 25 °C. Keep out of the reach of children! The shelf life of 3 years does not use the drug after the expiration of the shelf life. Conditions of vacation from pharmacies according to the recipe manufacturer Merk C.L., Spain Poligono Merck, Mollet del Valles, 08100 Barcelona/ Polygon Merk, Sllet del Valles, 08100 Barcelona Owner Obroier's Certificate Merk Sante Sante Sante Sante, France Accepting the Organization Administration On the territory of the Republic of Kazakhstan, claims from consumers on the quality of products (goods) representation of the company “TaKeda Osteuropa Holding GmbH” (Austria) in Kazakhstan of Almaty, ul. Shashkin 44 phone number (727) 2444004 Fax number (727) 2444005 Email address