Metformin (Formetin Long) XR 500 mg – [60 tablets]

Metformin is a biguanide with hypoglycemic action, reducing both basal and postprandial plasma glucose concentrations. It does not stimulate insulin secretion and therefore does not cause hypoglycemia. Increases the sensitivity of peripheral receptors to insulin and glucose utilization by cells. Reduces glucose production 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 transporters. During metformin administration, the patient’s body weight either remains stable or decreases moderately.

Metformin has a favorable effect on lipid metabolism: it reduces total cholesterol, low-density lipoproteins and triglycerides.

Diabetes mellitus type 2 in adults, especially in patients with obesity, with ineffectiveness of diet therapy and physical activity:

– As monotherapy;

– in combination with other oral hypoglycemic agents or with insulin.

– Hypersensitivity to metformin or any excipient;

– Diabetic ketoacidosis, diabetic precoma, coma;

– Renal insufficiency or impaired renal function (creatinine clearance less than 45 ml/min);

– acute conditions with risk of renal dysfunction: dehydration (with chronic or severe diarrhea, repeated bouts of vomiting), severe infectious diseases (e.g., respiratory tract infections, urinary tract infections), shock;

– clinically expressed manifestations of acute or chronic diseases that can lead to the development of tissue hypoxia (including heart or respiratory failure, acute myocardial infarction);

– major surgery and trauma when insulin therapy is indicated;

– hepatic insufficiency, liver dysfunction;

– chronic alcoholism; acute alcohol poisoning;

– pregnancy;

– lactoacidosis (including in anamnesis);

– use for less than 48 hours before and for 48 hours after radioisotopic or radiological studies with iodine-containing contrast agent (e.g., internal urography, angiography);

– adherence to a hypocaloric diet (less than 1,000 calories/day);

– lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

– children under 18 years of age due to the lack of data on its use.

• Metformin (Formetin Long), sustained release film-coated tablets 500 mg, 750 mg, 850 mg and 1000 mg are taken orally. Tablets are swallowed whole, without chewing, with small amount of liquid, once a day during dinner.
• Dose of drug is chosen by doctor individually for each patient based on the results of blood glucose concentration measurement.
• Monotherapy and combined therapy in combination with other hypoglycemic agents
• – Recommended initial dose of Metformin (Formetin Long), sustained release film-coated tablets for patients, who do not receive metformin, is 500 mg, 750 mg or 850 mg once a day during supper. It is recommended that the dose be adjusted every 10-15 days, depending on plasma glucose concentrations. Slowly increasing the dose helps to reduce gastrointestinal side effects;
• – for patients already treated with metformin, the initial dose of Formetin Long should be equivalent to the daily dose of normal-release tablets;
• – patients taking metformin in the form of normal-release tablets with an active ingredient dose greater than 2000 mg should not be recommended to switch to Metformin (Formetin Long);
• – if switching from another hypoglycemic agent is planned, the dose should be adjusted as described above, starting with Metformin (Formetin Long) at 500 mg, 750 mg or 850 mg, with possible subsequent switching to Metformin (Formetin Long) 1000 mg.
• Combination with insulin
• To achieve better control of blood glucose concentrations, metformin and insulin can be used as a combination therapy. Usual starting dose of Metformin (Formetin Long) is one tablet of 500 mg, 750 mg or 850 mg once a day during dinner, while the dose of insulin is chosen based on the results of blood glucose concentration measurement. Further switching to Metformin (Formetin Long) 1000 mg is possible.
• Daily dosage
• Maximum recommended dose of preparation Formetin® Long, sustained-release film-coated tablets 500 mg and 1000 mg is 4 tablets of 500 mg (2000 mg) or 2 tablets of 1000 mg (2000 mg) daily, respectively. If at administration of maximum recommended dose of Formetin® Long 500 mg or 1000 mg once a day it is not possible to achieve adequate glycemic control, the maximum dose can be divided into two intakes: 2 tablets 500 mg – at breakfast and 2 tablets 500 mg – at supper, or one tablet of 1000 mg – at breakfast and one tablet of 1000 mg at supper.
• Recommended dose of Metformin (Formetin Long), sustained release film-coated tablets 750 mg and 850 mg is respectively 2 tablets at 750 mg (1500 mg) or 2 tablets at 850 mg (1700 mg) once a day. If at administration of recommended dose of Formetin Long 750 mg or 850 mg it is not achieved the adequate glycemic control, it is possible to increase the dose to maximum – respectively, 3 tablets of 750 mg (2250 mg) or 3 tablets of 850 mg (2550 mg) of Formetin® Long once daily. For decrease of gastrointestinal side effects, the daily dose of Formetin Long 750 mg or 850 mg can be divided into two intakes.
• If adequate glycemic control is not achieved by taking maximum recommended dose of Formetin Long, it is possible change to metformin with regular release of active ingredient (for example, Formetin tablets 0.5 g, 0.85 g, 1.0 g) with maximum daily dose of 3000 mg.
• Administration of drug in patients with renal insufficiency
• Metformin can be used in patients with renal insufficiency of moderate degree of severity (creatinine clearance of 45-59 ml/min) only in case of absence of conditions that can increase the risk of lactacidosis.
• The initial dose is 500 mg or 750 mg once daily. The maximum dose is 1000 mg per day. Renal function should be closely monitored every 3-6 months. If creatinine clearance is lower than 45 ml/min, the drug should be discontinued.
• Drug administration in elderly patients
• In elderly patients, the dose of metformin is adjusted based on the assessment of renal function, which should be performed regularly, but at least twice a year.
• Treatment duration
• Formetin Long should be taken daily, without interruption. In case of discontinuation of treatment, the patient should inform the physician.
• Skipping a dose
• If a dose is missed, the patient should take the next dose at the usual time. Do not take a double dose of Metformin (Formetin Long).