METFODIAB table. 850 mg. 30 tablets
METFODIAB table. 850 mg. 30 tablets
Metfodiab is anti-hyperglycaemic agents that act via three mechanisms : decreased hepatic glucose production and increases the breakdown of glycogen , increasing insulin sensitivity thereby improving peripheral glucose uptake , slows the absorption of glucose in the intestines.
Metfodiab administered as single or in combination with other oral anti-diabetic drugs and insulin for the treatment of non-insulin dependent type diabetes mellitus (adults ) with overweight and obesity, where the only diet and exercise alone are not sufficient to adequately control the glucose .
INFORMATION . Needed before the use of medicinal products
Metfodiab not apply to :
• Hypersensitivity to the product or to any of the excipients ;
• Renal disease and changes in renal function ( serum creatinine > 1,5 mg / ml in males and > 1,4 mg / ml in women , or high levels of creatinine) , which may occur due to a cardiovascular collapse , acute myocardial infarction, bacterial infection of the blood ;
• Congestive heart failure requiring treatment;
• Acute or chronic metabolic acidosis , including diabetic ketoacidosis with or without coma . Diabetic ketoacidosis is treated with insulin ;
• Acute conditions with the potential for violations of renal function such as dehydration, severe infection , shock ;
• Liver failure , liver damage in alcoholism, acute alcohol intoxication;
• Respiratory failure ;
• catabolic states - tumor processes , peripheral arterial occlusive disease ;
• With intravascular administration of iodinated radiopaque agents.
SPECIAL PRECAUTIONS FOR USE
The product is administered with food . The initial dose should be low in order to avoid gastrointestinal disorders and determine the appropriate dose required . During the titration of blood sugar fasting is defined to identify the response and determine the minimum effective dose. Glycosylated hemoglobin should be monitored at quarterly intervals. Treatment aims to reduce the level of fasting glucose and glycated hemoglobin to levels close to normal at the minimum effective dose. Short-term treatment with the product may be sufficient during periods of transient lack of control in patients who control their diabetes with diet alone .
It is a rare but serious metabolic complication that may occur from the accumulation of Metfodiab during treatment . Typically fatal in about 50 %. Lactic acidosis may occur in many pathophysiological conditions , including diabetes , and in the insufficient supply of oxygen to the tissues . It is characterized by increased levels of lactate (> 5 mmol / L), decreased blood pH , electrolyte disturbances , changes in lactate / pyruvate ratio . The incidence of lactic acidosis in patients Metfodiab is very low. These cases are primarily in diabetic patients with renal insufficiency, including renal disease and decreased blood flow to the kidneys , often under massive medical / surgical problems and massive concomitant therapy . Patients with congestive heart failure , or at risk of a reduced supply of oxygen at an increased risk of the development of lactic acidosis . The risk increases with increasing the degree of renal dysfunction , as age of the patient . In monitoring renal function and application of the minimum effective dose of Metfodiab this risk can be reduced significantly. Monitoring of renal function with a creatinine determination at the start of lechenieto.Metfodiab not be used in patients over the age of 80 without prior clarification creatinine klirans.Pri patients with hepatic impairment should not be given due to the fact that lactate is released slower than the injured liver cells. During treatment, patients should not drink alcohol because it amplifies the effect of lactate on Metfodiab metabolizam.Pri impending intravascular X-ray examination or surgical procedure assumes the product is paused and can recover no earlier than 48 hours after the intervention . onset of lactic acidosis is characterized by non-specific symptoms such as malaise , myalgia, respiratory depression , hypersomnia , nonspecific abdominal pain . Can be added to a drop in body temperature, low blood pressure, sustained abnormal heart rhythm with acidosis. Patients should be cautioned about these symptoms and immediately seek medical help . Metfodiab treatment should be discontinued to clarify the situation . Research is under way to electrolytes , ketones, blood glucose , blood pH , lactate levels . Early symptoms of the gastrointestinal tract are common at the start of the treatment , but those at a later stage thereof, can be a sign of lactic acidosis or other serious illness. Lactate levels above the upper limit or normal , but less than 5 mmol / L in patients does not always mean Metfodiab lactic acidosis , and can be explained by other mechanisms, such as uncontrolled diabetes and obesity, increased physical activity or technical problems in the storage product . Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis without evidence of ketoacidosis - ketonemiya and ketonuria . Lactic acidosis is a medical emergency that is treated in a hospital . Metfodiab dialysable (for clearance of 170 ml / min and good hemodynamic performance ) and acidosis can be corrected .
Monitoring of renal function
Metfodiab is excreted primarily through the kidneys and the risk of accumulation of the product increases with the degree of impairment of renal function. Patients with creatinine clearance of the upper limit for their age should not take Metfodiab . In elderly patients the dose should be titrated to establish the establishment of a minimum dose for adequate glycemic control as you age renal function undergoing changes. Renal function should be monitored regularly and change treatment product be discontinued. X-ray studies with intravascular administration of contrast media ( intravenous urography , intravenous cholangiography , angiography, computed tomography ) . Such studies can impair renal function and lead to lactic acidosis . In planning this study , treatment with the product is discontinued 48 hours prior to the study and extend beyond the study of renal function.
Cardiovascular collapse of any nature , acute congestive heart failure , acute myocardial infarction , and other conditions of reduced oxygen content in the blood is associated with lactic acidosis , and may lead to increased levels of nitrogen in the blood. Surgical protseduriLechenieto with Metfodiab terminates when all surgical procedures ( except for minor procedures that do not require fasting and stop fluid intake ) until after the intervention did not establish normal renal function. Taking alkoholAlkoholat support Metfodiab effect on lactate metabolism.
Impaired liver function
Metfodiab should be avoided in patients with clinical or laboratory signs of liver zabolyavane.Promeni in the clinical condition of patients with previously controlled type II diabetes patients with type II diabetes who are well controlled and Metfodiab show laboratory abnormalities or clinical illness (especially vague symptoms) should be tested for ketoacidosis or lactic acidosis . Research is serum electrolytes and ketones, blood glucose , lactate, pyruvate, levels Metfodiab . If it is determined acidosis of any origin , treatment with the product is terminated. Hypoglycemia does not occur during normal use of Metfodiab , but can occur in reduced caloric intake or during concomitant use of other antidiabetics (insulin, sulfonylureas , ethanol) . Elderly damaged or malnutrition , as well as a failure of the adrenal and pituitary hormones are prone to hypoglycemia. Difficult to detect hypoglycemia in elderly patients and in those receiving beta-adrenergic blockers.
Loss of blood glucose control
When patients with established regime are exposed to stress such as fever , trauma, infection or surgical manipulation may occur temporary impairment of glycemic control . In such periods be avoided in Metfodiab temporarily applied insulin. Treatment with Metfodiab is restored when the acute epizod.Efektivnostta of oral antidiabetic drugs after opredelen_period reduced in most patients. This phenomenon, which may be due to progression of the underlying disease or to reduce the possibility of a response is known as a secondary treatment failure , as opposed to the primary failure , wherein the drug is ineffective in the beginning of the treatment. If failure occurs secondary to combination therapy Metfodiab and oral antidiabetics ( sulfonylurea ) , and if that occur in combination , should be considered the application of insulin.
Furosemide - combined with a single dose Metfodiab increase plasma Metfodiab without affecting the separation .
No evidence of continuous combined use.
Nifedipine - increased plasma levels and the amount Metfodiab recovered in urine in a single dose in healthy volunteers. Nifedipine increases the absorption of Metfodiab.Kamionni drugs ( amiloride , digoxin , morphine, procainamide , quinidine, quinine , ranitidine, triamterene , trimethoprim , vancomycin ) - released through the kidneys and can compete with Metfodiab for transport in renal tubules and cause an increase in the plasma concentration of Metfodiab (e.g. cimetidine ) .
Others - certain products lead to increased levels of blood sugar and loss of control over it. These products include the thiazide diuretics and other corticosteroids , phenothiazines , thyroid products , estrogens , oral antikontseptivi , phenytoin , nicotinic acid , sympathomimetics , calcium channel blockers , isoniazid . Combination therapy with Metfodiab and some of these products requires strict control of blood sugar due to the risk of losing control . Upon discontinuation of these products , patients taking Metfodiab should be observed for hypoglycemia.
ACE inhibitors , beta- blockers and antihypertensives reduce the level of glucose in the blood. Clinical significance is their lowering effect on the hormonal and neural counter- regulation in the presence of hypoglycemia, that affects the subjective perception of the warning signs . Iodinated X-ray contrast agents administered intravascularly may lead to renal failure and accumulation of Metfodiab increase the risk of lactic atsidoza.Pri prolonged treatment with Metfodiab may decrease the absorption of vitamin B 12 and a decrease in blood levels. This is usually not clinically significant.
Use in Pregnancy and lactation
Metfodiab not be used during pregnancy and breastfeeding.
The product is excreted into breast milk in amounts close to the plasma . Due to the risk of hypoglycemia in the infant having or discontinue nursing or choose another treatment option for the mother.
Effects on ability to drive and use machines
Metfodiab does not affect the ability to drive and use machines.
Patients should be cautioned about driving or operating machinery is to watch for signs of hypoglycaemia when the product is used in combination with other antidiabetic agents .
INFORMATION FOR PROPER USE
DOSAGE AND ADMINISTRATION
Prescription ! Dosage recommendations in private and combination with other oral antidiabetic produktiObichaynata starting dose is one tablet 2-3 times daily with meals or after. After 10-15 days, the dose can be changed depending on the measured values of blood glucose . The maximum recommended dose is 3 g daily. Switching to other antidiabetic lechenieKogato patients from standard oral hypoglycemic product other than chlorpropamide to Metfodiab not have a transitional period . When switching from treatment with chlorpropamide required to monitor the patient during the first two weeks, due to retention of chlorpropamide and risk hipoglikemiya.Kombinirana Metfodiab therapy and oral antidiabetics ( from sulphonylurea group ) in adult patients do not respond patsientiAko for four weeks of monotherapy with the maximum dose Metfodiab , stepwise addition of oral product sulphonylurea group. Should be considered the minimum effective dose of each product. In combination therapy risk of hypoglycaemia associated with a product from the aforementioned group exists , and can also be increased . If patients do not show a satisfactory response to the combination therapy for one to three months, with a maximum dose of a maximum dose Metfodiab oral antidiabetics ( from sulphonylurea group) should be considered as including other possibilities of insulin with or without therapy with Metfodiab.Kombinirana Metfodiab and insulin in elderly Metfodiab administered at doses of 500 mg once daily in patients on insulin therapy. In patients with an inadequate response, the dose should be increased to 500 mg after one week and 500 mg per week to achieve adequate control . The maximum recommended dose is 2500 mg. A reduction of insulin dose by 10% to 25 % when the blood glucose level in the fasting state reaches 120 mg / dL in a patient of a combination therapy.
Specific patient groups
Metfodiab not recommended for pregnant women.
Starting and maintenance dose in elderly patients must comply with reduced renal function. In general, such patients are not treated with the maximum therapeutic dose. Due to lack of data not be used in children .
Hypoglycemia does not occur even when taking 8 g Metfodiab , although these could be developed to laktoatsidoza.Prilaga hemodialysis for the removal of the product from the body.
In clinical studies of patients with type II diabetes induce side effects in about 5 % of them. The most common side effects are a metallic taste , diarrhea , nausea and vomiting, intestinal gas , asthenia , abdominal discomfort, headache. Can be observed even muscle pain, shortness of breath, rash, increased sweating, changes in taste , hot flushes , feeling fast heartbeat . In isolated cases may occur impaired absorption and a decrease in serum levels of vitamin B12 and violation of hematopoietic function. Very rarely - 0.03 sluchaya/1000 patients per year can be observed lactic acidosis.
Storage - at temperatures below 25 ° C. Do not store out of reach of children!
Metfodiab 850 mg - 5 (five ) years from date of manufacture.
Metfodiab tablet contains Metformin hydrochloride 850 mg
Excipients: povidone, polyethylene glycol, sorbitol, magnesium stearate, coloring (opadry), hard paraffin