Consumer Medicine Information This leaflet answers some common questions about Metformin Sandoz. It does not take the place of talking to your doctor or pharmacist. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. This medicine is used to control blood sugar (glucose) in patients with diabetes mellitus. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Metformin Sandoz is used to treat Type 2 diabetes when it cannot be properly controlled by diet and exercise. It can also be used in patients with Type 1 diabetes mellitus where insulin alone is not enough to control your blood glucose levels. Metformin Sandoz can be used alone, or in combination with other medicines for treating diabetes. It contains the active ingredient metformin hydrochloride. Metformin belongs to a group of medicines called oral hypoglycaemics. It works to reduce high levels of blood glucose by helping your body to make better use of the insulin produced by your pancreas. Elderly patients are more likely to have decreased renal function; contraindicated in patients with renal impairment, carefully monitor renal function in the elderly and use with caution as age increases Not for use in patients 80 years unless normal renal function established Initial and maintenance dosing of metformin should be conservative in patients with advanced age due to the potential for decreased renal function in this population Controlled clinical studies of metformin did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients Asthenia Diarrhea Flatulence Weakness Myalgia Upper respiratory tract infection Hypoglycemia GI complaints Lactic acidosis (rare) Low serum vitamin B-12 Nausea/vomiting Chest discomfort Chills Dizziness Abdominal distention Constipation Heartburn Dyspepsia 5 mmol/L), decreased blood p H, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio; when metformin is implicated as the cause of lactic acidosis, metformin plasma concentrations 5 mcg/m L are generally found Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment; if metformin-associated lactic acidosis is suspected, immediately discontinue Patients with CHF requiring pharmacologic management, in particular those with unstable or acute CHF who are at risk for hypoperfusion and hypoxemia, are at an increased risk for lactic acidosis; the risk for lactic acidosis increases with the degree of renal dysfunction and the patient’s age Do not start in patients aged 80 years or older unless Cr Cl demonstrates that renal function is not reduced, because these patients are more susceptible to developing lactic acidosis; metformin should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis Should generally be avoided in patients with clinical or laboratory evidence of hepatic disease; patients should be cautioned against excessive alcohol intake, either acute or chronic, during metformin therapy because alcohol potentiates the effects of metformin on lactate metabolism Discontinue metformin at the time of or before an iodinated contrast imaging procedure in patients with an e GFR between 30-60 m L/minute/1.73 m²; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinate contrast The onset of lactic acidosis often is subtle and accompanied by nonspecific symptoms (eg, malaise, myalgias, respiratory distress, increasing somnolence, nonspecific abdominal distress); with marked acidosis, hypothermia, hypotension, and resistant bradyarrhythmias may occur; patients should be instructed regarding recognition of these symptoms and told to notify their physician immediately if the symptoms occur; metformin should be withdrawn until the situation is clarified; serum electrolytes, ketones, blood glucose, and, if indicated, blood p H, lactate levels, and even blood metformin levels may be useful Once a patient is stabilized on any dose level of metformin, GI symptoms, which are common during initiation of therapy, are unlikely to be drug related; later occurrences of GI symptoms could be due to lactic acidosis or other serious disease Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis who is lacking evidence of ketoacidosis (ketonuria and ketonemia); lactic acidosis is a medical emergency that must be treated in a hospital setting; in a patient with lactic acidosis who is taking metformin, the drug should be discontinued immediately and general supportive care measures promptly instituted; metformin is highly dialyzable (clearance up to 170 m L/min under good hemodynamic conditions); prompt hemodialysis is recommended to correct the acidosis and to remove the accumulated metformin; such management often results in prompt reversal of symptoms and recovery Increased risk of severe hypoglycemia especially in elderly, debilitated or malnourished, adrenal or pituitary insufficiency, dehydration, heavy alcohol use, hypoxic states, hepatic/renal impairment, stress due to infection, fever, trauma, or surgery Concomitant administration of insulin and insulin secretagogues (e.g., sulfonylurea) may increase risk of hypoglycemia; therefore, a lower dose of insulin or insulin secretagogue may be required to minimize risk of hypoglycemia when used in combination with metformin Withholding of food and fluids during surgical or other procedures may increase risk for volume depletion, hypotension, and renal impairment; therapy should be temporarily discontinued while patients have restricted food and fluid intake Rare lactic acidosis may occur due to metformin accumulation; fatal in approximately 50% of cases; risk increases with age, degree of renal dysfunction, and with unstable or acute CHF; if metformin-associated lactic acidosis suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of therapy; in patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable, with a clearance of up to170 m L/minute under good hemodynamic conditions); hemodialysis has often resulted in reversal of symptoms and recovery Possible increased risk of CV mortality May cause ovulation in anovulatory and premenopausal PCOS patients May be necessary to discontinue therapy with metformin and administer insulin if patient is exposed to stress (fever, trauma, infection), or experiences diabetic ketoacidosis Several of the postmarketing cases of metformin-associated lactic acidosis occurred in setting of acute congestive heart failure (particularly when accompanied by hypoperfusion and hypoxemia); cardiovascular collapse (shock) acute myocardial infarction, sepsis, and other conditions associated with hypoxemia have been associated with lactic acidosis and may also cause prerenal azotemia; discontinue therapy when such events occur May impair vitamin B12 or calcium intake/absorption; monitor B12 serum concentrations periodically with long-term therapy Not indicated for use in patients with type 1 diabetes mellitus that are insulin dependent due to lack of efficacy Withhold in patients with dehydration and/or prerenal azotemia Conclusive evidence of macrovascular risk reduction with metformin not established Limited data with in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage; published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk; poorly-controlled diabetes mellitus in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications; poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity Limited published studies report that metformin is present in human milk; however, there is insufficient information to determine effects of metformin on breastfed infant and no available information on effects of metformin on milk production; therefore, developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from the underlying maternal condition The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
Metformin Hydrochloride, as monotherapy, is indicated as an adjunct to diet to lower blood glucose especially in overweight patients with non-insulin-dependent diabetes mellitus (NIDDM) or type 2 diabetes mellitus whose hyperglycemia cannot be satisfactorily managed on diet alone. Metformin Hydrochloride may be used concomitantly with a sulfonylurea when diet and metformin hydrochloride or sulfonylureas alone do not result in adequate glycemic control. Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin reduces hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis, and stimulates intracellular glycogen synthesis by acting on glycogen synthase. In muscle, it increases insulin sensitivity, improving peripheral glucose uptake and utilization. Metformin also delays intestinal glucose absorption. Metformin increases the transport capacity of all types of membrane glucose transporters (GLUTs) known to date. In humans, independently of its action on glycemia, metformin has favorable effects on lipid metabolism. The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Метформин представляет вещество, которое относится к бигуанидам. Метформин является медицинским медпрепаратом, который используется для лечения диабета. Действие медпрепарата основано в том, что он способен затормаживать процесс глюконеогенеза в клетках печёночной ткани, снижает скорость абсорбции глюкозы из просвета кишечника и способствует усилению процессов периферической утилизации глюкозы. Дополнительно таблетки Метформин 850 мг способствуют увеличению чувствительности к инсулину у клеток инсулинозависимых тканей организма. Применение препарата не оказывает особого влияния на процесс продуцирования инсулина в поджелудочной, не провоцирует в организме развития состояния гипогликемии. Приём медицинского препарата позволяет понизить в крови концентрацию триглицеридов и липопротеинов. Лекарственный препарат затормаживает процессы развития полиферации гладкомышечных элементов стенок сосудистой системы. Pharma Code 244Pharma Code 244Artwork Same Size Size : 1 5 x 350 mm Kaypee Design([email protected])24 01 17Black PACKAGE LEAFLET: INFORMATION FOR THE USERMetformin 500mg & 850mg Tablets(metformin hydrochloride)Read all of this leaet carefully before you start taking this medicine because it contains important information for you. This includes any possible side effects not listed in this leaet. What you need to know before you take Metformin Tablets3. If you are pregnant or breast feeding If you are likely to have a surgery, or if you are likely to have a scan or Xray (see 'Other medicines and Metformin section) If you drink alcohol excessively If you have severely reduced kidney function If you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. If you have any further questions, ask your doctor or pharmacist. If you get any side effects, talk to your doctor or pharmacist. What Metformin Tablets is and what it is used for2. If you are suffering from severe infection or have recently suffer a severe injury. If you have been treated for heart problems or have recently had a heart attack or have problem with your circulation including shock or breathing difculty. It may harm them, even if their signs of illness are the same as yours. The tablet may either be used alone or in combination with other medicines called sulphonylureas or with insulin. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METFORMIN TABLETSDo not take Metformin Tablets If you are allergic (hypersensitive) to metformin or any of the ingredients in the tablet. Metformin Tablets are used for the treatment of type 2 (non-insulin dependant) diabetes particularly in overweight patients, where diet and exercise changes alone have not been sufcient to control it. WHAT METFORMIN TABLETS IS AND WHAT IT IS USED FORMetformin belongs to a group of medicines called oral hypoglycaemics, which work by reducing the level of sugar in the blood. Ketoacidosis is a condition in which substances called 'ketone bosies' accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness and your breath developing an unusual fruity smell.
Metformin 500mg Tablets. Metformin 850mg Tablets. Metformin Hydrochloride. UK/H/885/01-02/MR. UK licence no PL 20117/0001-2. Morningside Healthcare. Metformin Hydrochloride, as monotherapy, is indicated as an adjunct to diet to lower blood glucose especially in overweight patients with non-insulin-dependent.