Metformin Pharmland tablets p/o 1000mg №10×3

Name Metformin tab 1000mg №30 Pharmland shell roughness is allowed. The main active substance Metformin Form of release: film-coated tablets Dosage 1 g Indications for use Type II diabetes mellitus (insulin-independent), especially in patients with obesity, with ineffective diet therapy and physical activity. As monotherapy or combination therapy with other oral hypoglycemic agents or with insulin for the treatment of adults. As monotherapy or combination therapy with insulin for the treatment of children over 10 years of age. Metformin appears as a first-line drug to reduce the complications of diabetes in overweight adults with type 2 diabetes mellitus with diet failure. Dosage and administration Apply inside. Adults Monotherapy or combination therapy in combination with other oral glycoglycemic agents: The usual starting dose is 500 mg (Metformin Pharmland, 500 mg tablets) 2-3 times a day after or during meals. Perhaps a further gradual increase in dose depending on the level of glucose in the blood. The maintenance dose of the drug is usually 1500-2000 mg per day. To reduce side effects from the gastrointestinal tract, the daily dose should be divided into 2-3 doses. The maximum daily dose is 3000 mg / day, divided into three doses. Slow dose escalation may improve gastrointestinal tolerance. Patients taking metformin at doses of 2000-3000 mg/day may be switched to Metformin Pharmland 1000 mg. The maximum daily dose is 3000 mg per day, divided into three doses. If you plan to switch from another hypoglycemic agent to Metformin Pharmland, you must stop taking this hypoglycemic agent and start taking Metformin Pharmland at the dose indicated above. Combination therapy with insulin To achieve better control of blood glucose levels, metformin and insulin can be used as a combination therapy. Usually, the starting dose of Metformin Pharmland 500 mg and 850 mg is one tablet 2-3 times a day, while the dose of insulin is selected based on the results of measuring blood glucose levels. Children and adolescents In children over 10 years of age, Metformin Pharmland can be used both as monotherapy and in combination with insulin. The usual starting dose is 500 mg once daily after or during a meal. After 10-15 days, the dose must be adjusted based on the results of measuring blood glucose levels. The maximum daily dose is 2000 mg divided into 2-3 doses. Elderly patients, due to a possible decrease in kidney function, the dose of metformin should be selected under regular monitoring of kidney function indicators (serum creatinine level at least 2-4 times a year). 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 a pregnancy, as well as in the event of pregnancy while taking metformin, it must 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 limited data, the use of metformin 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 is a rare but serious metabolic complication (high mortality in the absence of emergency treatment) that may occur due to the accumulation of metformin. Lactic acidosis is characterized by acidotic dyspnea, abdominal pain, and hypothermia followed by coma. Reported cases of lactic acidosis have occurred mainly in patients with diabetes mellitus with severe renal insufficiency. Other associated risk factors should also be considered: poorly controlled diabetes mellitus, ketosis, prolonged fasting, excessive alcohol consumption, liver failure, or any condition associated with severe hypoxia. You should also take into account the risk of developing lactic acidosis when nonspecific signs appear, such as muscle cramps, dyspeptic disorders, abdominal pain, severe asthenia. Diagnostic laboratory indicators are a decrease in blood pH (pH less than 7.25), a lactate content in blood plasma over 5 mmol / l, an increased anion gap and a lactate / pyruvate ratio. If metabolic lactic acidosis is suspected, it is necessary to stop using the drug and consult a doctor immediately. Renal failure. Since metformin is excreted by the kidneys, before and during treatment with the drug, it is necessary to check the level of creatinine in the blood serum (at least once a year with normal kidney function and 2-4 times a year in patients with impaired renal function and in elderly patients). Caution should be exercised with possible impaired renal function in elderly patients at the beginning of treatment with antihypertensive drugs, diuretics and NSAIDs. Surgical interventions. It is necessary to stop taking metformin 48 hours before elective surgery and resume no earlier than 48 hours after surgery and evaluation of kidney function. Children and teenagers. The diagnosis of type 2 diabetes mellitus must be confirmed before starting treatment with metformin. According to the results of clinical studies lasting 1 year, it was shown that metformin does not affect growth and puberty. However, there are no long-term data on the effect of metformin on growth and puberty with long-term use, therefore, the subsequent effect of metformin on these parameters in children during puberty, especially those aged 10 to 12 years, should be especially carefully monitored. Excipients The drug Metformin Farmland contains lactose. In patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, the use of the drug is not recommended. Other Precautions. Patients are advised to follow a diet with an even intake of carbohydrates throughout the day. Patients with overweight are advised to continue to follow a low-calorie diet (but not less than 1000 kcal / day). Regular laboratory tests are recommended to control diabetes. Metformin in monotherapy does not cause hypoglycemia, however, when it is used together with insulin, repaglinide or sulfonylurea derivatives, an increase in the hypoglycemic effect is possible. Interaction with other drugs Contraindicated combinations Iodine-containing radiopaque agents: against the background of functional renal failure in patients with diabetes mellitus, a radiological examination using iodine-containing radiopaque agents can cause the development of lactic acidosis. Treatment with Metformin Pharmland should be discontinued, depending on renal function, 48 hours before or at the time of an x-ray examination using iodine-containing radiopaque agents and not resumed earlier than 48 hours after, provided that normal renal function is determined. Not recommended combinations Alcohol: in acute alcohol intoxication, the risk of developing lactic acidosis increases, especially in the case of: malnutrition, low-calorie diet; liver failure. While taking Metformin Farmland, alcohol and medicines containing ethanol should be avoided. Combinations requiring caution 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 Metformin Pharmland is required under the control of blood glucose levels. 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, dose adjustment of the drug is required under the control of blood glucose levels. 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 their intake, dose adjustment of Metformin Pharmland is required under the control of blood glucose levels. Diuretics: The concomitant use of loop diuretics and metformin can lead to the development of lactic acidosis due to possible functional renal failure. Metformin Pharmland should not be given if creatinine clearance is below 60 ml/min. 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 Metformin Farmland with sulfonylurea derivatives, insulin, acarbose, salicylates, hypoglycemia may develop. Nifedipine increases the absorption and Cmax of metformin. Cationic drugs (amilord, 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. Influence on the ability to drive vehicles or work with other mechanisms Metformin Pharmland monotherapy does not cause hypoglycemia, therefore it does not affect the ability to drive vehicles and mechanisms. However, patients should be warned about the risk of hypoglycemia when using metformin in combination with other hypoglycemic drugs (sulfonylurea derivatives, insulin, repaglinide, etc.). Contraindications Contraindications Hypersensitivity to metformin or to any excipient of the drug; Diabetic ketoacidosis, diabetic precoma, coma; Impaired kidney function (creatinine clearance less than 60 ml/min); Acute conditions that occur with a risk of developing impaired renal function: dehydration of the body (with diarrhea, vomiting), severe infectious diseases, shock; Clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (heart or respiratory failure, acute myocardial infarction, etc.); Major surgery and trauma when insulin therapy is indicated (see Precautions section); Liver failure, impaired liver function; Acute alcohol intoxication, chronic alcoholism; Pregnancy; Lactic acidosis (including history); Application within 48 hours before and after radioisotope or X-ray studies with the introduction of an iodine-containing contrast agent (see the section “Interaction with other drugs”; Compliance with a hypocaloric diet (less than 100 kcal / day). Composition Active ingredient: metformin hydrochloride – 1000 mg; auxiliary ingredients: calcium hydrogen phosphate dihydrate, corn starch, lactose monohydrate, povidone K-30, gelatin, talc, magnesium stearate, croscarmellose sodium shell: titanium dioxide (E 171), hydroxypropyl methylcellulose, ethyl cellulose, propylene glycol, polyethylene glycol. 85 g (42.5 times the maximum daily dose) the development of glycemia was not observed.However, in this case, the development of lactic acidosis is observed.Early symptoms of lactic acidosis are nausea, vomiting, diarrhea, fever, abdominal pain, muscle pain, in the future may experience rapid breathing, dizziness, disruption of consciousness and development of coma. Treatment: If signs of lactic acidosis appear, treatment with the drug should be stopped immediately, the patient should be hospitalized and, after determining the concentration of lactate, the diagnosis should be clarified. The most effective measure for the release of lactate and metformin from the body is hemodialysis. Carry out symptomatic treatment. Side effects The indicated adverse reactions occurred with the following frequency: Very often (? 1/10); Often (?1/100, <1/10); Not often (?1/1000, <1/100); Rarely (?1/10,000, <1/1000); Very rare (<1/10000), including isolated reports. From the gastrointestinal tract: very often: nausea, vomiting, diarrhea, abdominal pain and lack of appetite. Most often they occur at the beginning of treatment and in most cases resolve spontaneously. To prevent the onset of symptoms, the recommended daily dose should be divided into 2 or 3 doses during or after meals. Slow dose escalation may improve gastrointestinal tolerance. From the side of metabolism and nutrition: very rarely: lactic acidosis (see "Special Instructions"). With long-term use of metformin, there may be a decrease in the absorption of vitamin B12, and if megaloblastic anemia is detected in a patient, the possibility of such an etiology must be considered. From the nervous system: often: taste disturbance. From the side of the liver and biliary tract: very rarely: impaired liver function and hepatitis; after the abolition of metformin, these adverse events completely disappear. On the part of the skin and subcutaneous tissue: very rarely: skin reactions such as erythema, itching, rash. Published data, post-marketing data, as well as controlled clinical studies in a limited pediatric population in the 10-16 age group show that side effects in children are similar in nature and severity to those in adult patients. Storage conditions In a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Metformin Farmland tablets p/o 1000mg No. 10x3