Glucophage pills p/o 1000mg №15×4

Name:
Glucophage tab. 1000mg per blister. in pack. No. 15×4 Main active ingredient Metformin hydrochloride
Description:
Film-coated tablets 1000 mg: White film-coated tablets, oval, biconvex, scored on both sides and engraved “1000” on one side; on the transverse section – a homogeneous white mass. 15 tablets in a PVC / aluminum foil blister, 4 blisters, together with instructions for use, are placed in a cardboard box. Dosage 1000 mg Pharmacological action Pharmacodynamics Glucophage® reduces hyperglycemia without leading to the development of hypoglycemia. Unlike sulfonylurea derivatives, it does not stimulate insulin secretion and does not have a hypoglycemic effect in healthy individuals. Increases the sensitivity of peripheral receptors to insulin and the utilization of glucose by cells. Reduces the production of glucose by the liver by inhibiting gluconeogenesis and glycogenolysis. Delays the absorption of glucose in the intestine. Metformin stimulates glycogen synthesis by acting on glycogen synthase. Increases the transport capacity of all types of membrane glucose carriers. In addition, it has a beneficial effect on lipid metabolism: it reduces the content of total cholesterol, low-density lipoprotein and triglycerides. While taking metformin, the patient’s body weight either remains stable or moderately decreases. Pharmacokinetics: Metformin is rapidly absorbed from the gastrointestinal tract after oral administration. Absolute bioavailability is 50-60%. The maximum concentration (Cmax) (approximately 5 μg / ml) in plasma is reached after 2.5 hours. With simultaneous ingestion of food, the absorption of metformin decreases and lingers. Metformin is rapidly distributed in tissues, practically does not bind to plasma proteins. It is metabolized to a very low degree and excreted by the kidneys. Metformin clearance in healthy patients is 400 ml / min (4 times greater than creatinine clearance), indicating the presence of active tubular secretion. The half-life is approximately 6.5 hours. With renal failure, it increases, there is a risk of cumulation of the drug. Indications for use Type 2 diabetes mellitus, especially in patients with obesity, with the ineffectiveness of diet therapy and physical activity: in adults as monotherapy or in combination with other oral hypoglycemic agents, or with insulin; in children from 10 years of age as monotherapy or in combination with insulin. Reducing the severity of complications of diabetes in adult patients with type II diabetes mellitus and overweight as a first-line drug in case of ineffective diet therapy. Use during pregnancy and lactation Decompensated diabetes mellitus during pregnancy is associated with an increased risk of congenital malformations and perinatal mortality. Limited data suggest that taking metformin in pregnant women does not increase the risk of birth defects in children. When planning pregnancy, as well as in the event of pregnancy while taking metformin, the drug should be canceled and insulin therapy prescribed. Plasma glucose levels should be maintained as close to normal as possible to reduce the risk of fetal malformations. Metformin is excreted in breast milk. Side effects in newborns during breastfeeding while taking metformin were not observed. However, due to the limited amount of data, the use of the drug during lactation is not recommended. The decision to stop breastfeeding should be made taking into account the benefits of breastfeeding and the potential risk of side effects in the baby. Precautions Lactic acidosis Lactic acidosis is a very rare but serious metabolic complication that most often occurs with acute deterioration of kidney function, cardiorespiratory disease, or sepsis. Accumulation of metformin occurs with acute deterioration of kidney function and increases the risk of developing lactic acidosis. In case of dehydration (severe diarrhea or vomiting, fever or reduced fluid intake), metformin should be temporarily discontinued and a doctor should be contacted. Patients taking metformin should be wary of starting medications that can dramatically impair kidney function (eg, antihypertensives, diuretics, and NSAIDs). Other risk factors for lactic acidosis: excessive alcohol consumption, liver failure, poorly controlled diabetes mellitus, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as the concomitant use of drugs that can cause lactic acidosis (see sections “Contraindications” and ” Interaction with other medicinal products). Patients and/or caregivers should be informed of the risk of developing lactic acidosis. Lactic acidosis is characterized by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia, and hypothermia followed by coma. If suspicious symptoms develop, the patient should stop taking Metformin and consult a doctor immediately. Laboratory examination reveals a decrease in blood pH (< 7.35), an increase in plasma lactate levels more than (> 5 mmol / l), an increase in the anion gap and the lactate / pyruvate ratio. Surgery Metformin should be discontinued during surgery under general, spinal, or epidural anesthesia. Therapy may be resumed no earlier than 48 hours after surgery or resumption of oral nutrition and subject to assessment and recognition of stable renal function. Renal function GFR should be assessed prior to treatment and then regularly (see section “Method of administration and doses”). Metformin is contraindicated in patients with GFR < 30 ml/min and should be temporarily discontinued in the presence of conditions affecting renal function (see Contraindications section). Cardiac function Patients with heart failure are at greater risk of developing hypoxia and renal failure. In patients with stable chronic heart failure, metformin should only be used with regular monitoring of cardiac and renal function. Metformin treatment is contraindicated in patients with acute and unstable heart failure (see section "Contraindications"). Use of iodine-containing contrast agents Intravenous administration of iodine-containing contrast agents can lead to contrast-induced nephropathy, which can lead to accumulation of metformin and an increased risk of lactic acidosis. Metformin should be discontinued before or during the imaging procedure and not resumed for at least 48 hours after the procedure, provided that renal function has been reassessed and found to be stable, see sections "Dosage and administration" and "Interaction with other medicinal products". Children and adolescents Diagnosis of type 2 diabetes mellitus must be confirmed before starting treatment with metformin. In clinical studies lasting 1 year, it was shown that metformin does not affect growth and puberty. However, in view of the lack of long-term data, careful monitoring of the subsequent effect of metformin on these parameters in children is recommended, especially during puberty. The most careful monitoring is necessary for children aged 10-12 years. Other Precautions: Patients are advised to continue to follow a diet of even carbohydrate intake throughout the day. Overweight patients are advised to continue to follow a low-calorie diet (but not less than 1000 kcal / day). It is recommended to regularly conduct standard laboratory tests to control diabetes. Metformin does not cause hypoglycemia when used alone, but caution is recommended when it is used in combination with insulin or other hypoglycemic agents (for example, sulfonylurea derivatives, repaglinide, etc.). Interactions with other drugs Contraindicated combinations re-evaluated and found to be stable, see sections "Method of application and doses" and "Special instructions". Combinations that are not recommended Alcohol: alcohol intoxication is associated with an increased risk of lactic acidosis, especially in case of starvation, malnutrition or liver failure. Combinations requiring caution Some drugs may adversely affect kidney function, which may increase the risk of developing lactic acidosis, for example, NSAIDs, including selective cyclooxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics. At the beginning of the use of these drugs or when they are used in combination with metformin, it is necessary to carefully monitor renal function. Danazol: concomitant use of danazol is not recommended in order to avoid the hyperglycemic effect of the latter. If treatment with danazol is necessary and after discontinuation of the latter, a dose adjustment of the drug Glucofage® is required under the control of blood glucose concentration. Chlorpromazine: when taken in high doses (100 mg per day), it increases the concentration of glucose in the blood, reducing the release of insulin. In the treatment of neuroleptics and after discontinuation of the latter, a dose adjustment of the drug is required under the control of the concentration of glucose in the blood. Glucocorticosteroids (GCS) of systemic and local action reduce glucose tolerance, increase the concentration of glucose in the blood, sometimes causing ketosis. In the treatment of corticosteroids and after discontinuation of the latter, a dose adjustment of the drug Glucophage® is required under the control of the concentration of glucose in the blood. Assigned in the form of injections of beta2-agonists: increase the concentration of glucose in the blood due to stimulation of beta2-adrenergic receptors. In this case, it is necessary to control the concentration of glucose in the blood. If necessary, the appointment of insulin is recommended. With the simultaneous use of the above drugs, more frequent monitoring of blood glucose levels may be required, especially at the beginning of treatment. If necessary, the dose of metformin can be adjusted during treatment and after its termination. Angiotensin-converting enzyme inhibitors and other antihypertensive drugs may lower blood glucose levels. If necessary, the dose of metformin should be adjusted. With the simultaneous use of the drug Glucophage® with sulfonylurea derivatives, insulin, acarbose, salicylates, hypoglycemia may develop. Nifedipine increases the absorption and Cmax of metformin. Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin) secreted in the renal tubules compete with metformin for tubular transport systems and may increase its Cmax. Organic cation transporters (OCTs) Metformin is a substrate for both TOC1 and TOC2. Simultaneous administration of metformin with drugs such as: TOK1 inhibitors (verapamil) may lead to a decrease in its effectiveness. TOK1 inducers (rifampicin) may increase the absorption of metformin in the gastrointestinal tract and its effectiveness. TOK2 inhibitors (cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib , isavuconazole), may reduce the renal excretion of metformin and thus increase its plasma concentration. TOK1 and TOK2 inhibitors (such as crizotinib, olaparib) may alter the efficacy and excretion of metformin by the kidneys. Therefore, caution is advised, especially in patients with impaired function kidneys when these drugs are co-administered with metformin, as plasma metformin concentrations may increase. Dosage adjustment of metformin may be considered, if necessary, as TOC inhibitors/inducers may alter the efficacy of metformin. Contraindications hypersensitivity to metformin or any excipient; acute metabolic acidosis of any type (eg lactic acidosis, diabetic ketoacidosis); diabetic coma; severe renal failure (GFR < 30 ml/min); acute conditions with a risk of developing impaired renal function: dehydration (with diarrhea, vomiting), severe infectious diseases, shock; a condition (especially an acute illness or a chronic illness in the acute stage) that can lead to the development of tissue hypoxia, including unstable congestive heart failure, respiratory failure, recent myocardial infarction, shock; extensive surgical operations and injuries when insulin therapy is indicated (see section "Special Instructions"); liver failure, acute alcohol intoxication, alcoholism; pregnancy; lactic acidosis (including history); use in less than 48 hours before and within 48 hours after the radio isotope or X-ray studies with the introduction of an iodine-containing contrast agent (see. section "Interaction with other drugs"); compliance with a hypocaloric diet (less than 1000 kcal / day). Use the drug with caution in people over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis; during the period of breastfeeding. Composition One film-coated tablet contains: Core: Active ingredient: metformin hydrochloride - 1000 mg; Auxiliary ingredients: povidone K30 40 mg, magnesium stearate 10.0 mg. Film shell: Dosage 1000 mg: pure opadry 21 mg (hypromellose K100M 90.90%, macrogol 400 4.550%, macrogol 8000 4.550%). Dosage and administration Apply inside. Adult patients with normal renal function (GFR ? 90 ml / min): Monotherapy and combination therapy in combination with other oral hypoglycemic agents: the usual initial dose is 500 mg or 850 mg 2-3 times a day after or during meals. maximum the dose is 3000 mg / day, divided into three doses. After 10-15 days, it is recommended to adjust the dose of the drug in accordance with the results of measuring blood glucose levels. Slowly increasing the dose may help reduce gastrointestinal side effects. Patients taking metformin at doses of 2000-3000 mg / day can be transferred to taking Glucofage® 1000 mg. The maximum recommended dose is 3000 mg / day, divided into 3 doses. If you plan to switch from taking another hypoglycemic agent: you must stop taking the other agent and start taking Glucophage® at the dose indicated above. Combination with insulin: To achieve better blood glucose control, metformin and insulin can be used as a combination therapy. The usual initial dose of Glucophage® is 500 mg or 850 mg 2-3 times a day, while the dose of insulin is selected based on the concentration of glucose in the blood. 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 a day after or during a meal. After 10-15 days, the dose must be adjusted based on the concentration of glucose in the blood. The maximum daily dose is 2000 mg divided into 2-3 doses. Elderly patients: due to a possible decrease in renal function, the dose of metformin should be selected under regular monitoring of renal function indicators (to determine the concentration of creatinine in the blood serum at least 2-4 times a year). Renal insufficiency: GFR should be assessed prior to initiation of metformin-containing products and then at least annually thereafter. In patients with an increased risk of further development of impaired renal function and in the elderly, renal function should be monitored more frequently, for example, every 3-6 months. GFR (ml/min) 60-89 - 3000 mg (maximum daily dose (divided into 2-3 daily doses) - Dose reduction should be considered due to decreased renal function. GFR (ml/min) 45-59 - 2000 mg ( Maximum daily dose (divided into 2-3 daily doses) - Before starting metformin, factors that may increase the risk of developing lactic acidosis should be studied (see section "Special Instructions"). The initial dose is half the maximum daily dose. GFR (ml / min ) 30-44 - 1000 mg (Maximum daily dose (divided into 2-3 daily doses) - Before starting metformin, you should study factors that may increase the risk of developing lactic acidosis (see section "Special Instructions"). The initial dose is half the maximum GFR (ml / min) <30 - Metformin is contraindicated Duration of treatment Glucophage® should be taken daily, without interruption. by our means"). Overdose When using metformin at a dose of 85 g (42.5 times the maximum daily dose), no hypoglycemia was observed. However, in this case, the development of lactic acidosis was observed. A significant overdose or associated risk factors can lead to the development of lactic acidosis (see "Special Instructions"). Treatment: in case of signs of lactic acidosis, treatment with the drug should be stopped immediately, the patient should be urgently hospitalized and, having determined the concentration of lactate, clarify the diagnosis. The most effective measure for removing lactate and metformin from the body is hemodialysis. Symptomatic treatment is also carried out. 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 disappear on their own. In order to avoid the development of these adverse reactions, it is recommended to take the daily dose of Glucovance® in 2 or 3 doses during the day and gradually increase the dose. At the beginning of treatment, transient visual impairment may occur due to a decrease in blood glucose. During treatment with Glucovance®, the following adverse reactions may occur. The frequency of adverse reactions is regarded as follows: very often: ?1/10; often: ?1/100, <1/10; infrequently: ?1/1000, <1/100; rarely: ?1/10000, <1/1000; very rarely: <1/10000. Blood and lymphatic system disorders: These adverse reactions disappear after discontinuation of the drug. Rare: leukopenia, thrombocytopenia. Very rare: agranulocytosis, hemolytic anemia, bone marrow aplasia and pancytopenia. Metabolic and nutritional disorders: Hypoglycemia (see Precautions section). Uncommon: attacks of hepatic porphyria and cutaneous porphyria. Very rare: lactic acidosis (see Precautions section); a decrease in the absorption of vitamin B12, accompanied by a decrease in its concentration in the blood serum with prolonged use of metformin (if megaloblastic anemia is detected, the possibility of such an etiology must be taken into account); disulfiram-like reaction when drinking alcohol. Nervous system disorders: Often: taste disturbance. Visual disturbances: At the beginning of treatment, transient visual impairment may occur due to a decrease in blood glucose. Gastrointestinal disorders: Very common: gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These symptoms are more common at the beginning of treatment and in most cases go away on their own. To prevent the development of these symptoms, it is recommended to take the drug in 2 or 3 doses; slowly increasing the dose of the drug also improves its tolerability. Skin and subcutaneous tissue disorders: Cross-reactivity to sulfonamides and their derivatives may occur. Rare: skin reactions such as pruritus, urticaria, maculopapular rash. Very rare: cutaneous or visceral allergic vasculitis, erythema multiforme, exfoliative dermatitis, photosensitivity, urticaria up to the development of shock. Liver and biliary tract disorders: Very rare: abnormal liver function tests or hepatitis requiring discontinuation of treatment. Influence on the results of laboratory and instrumental studies: Infrequently: a moderate or moderate increase in serum urea and creatinine concentrations. Very rare: hyponatremia. Reporting Suspected Adverse Reactions It is important to report suspected adverse reactions after drug registration. This will allow continuous monitoring of the benefit-risk ratio of the medicinal product. If an adverse reaction occurs that is indicated in this package leaflet or not mentioned in it, patients are advised to contact their doctor. Medical professionals are encouraged to report any suspected adverse drug reactions to the Republican Unitary Enterprise "Center for Expertise and Testing in Health Care" (see section "Send information about adverse reactions to the address"). Storage conditions At a temperature not higher than 25 °C. Keep out of the reach of children. 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