Glucofage Long, 1000 mg 60 pcs

Type 2 diabetes

Type 2 diabetes mellitus in adults, especially in obese patients, when diet therapy and physical activity are ineffective:

• as monotherapy;

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

.

Indications

Type 2 diabetes mellitus in adults, especially in obese patients, with ineffective diet therapy and exercise:

as monotherapy;

in combination with other oral hypoglycemic agents or insulin.

Pharmacological effect

Pharmacotherapeutic group

Special instructions

Lactic acidosis
Lactic acidosis is a rare but serious complication (high mortality if not treated promptly) that may occur due to accumulation of metformin. Cases of lactic acidosis when taking metformin occurred mainly in patients with diabetes mellitus with severe renal failure.

Active ingredient

Metformin

Composition

1 tablet contains

Active ingredient:

metformin hydrochloride – 1000.0 mg;

Excipients:

carmellose sodium – 50.0 mg, hypromellose 2208 – 392.3 mg, magnesium stearate – 7.0 mg.

Contraindications

Hypersensitivity to metformin or any excipient.
Diabetic ketoacidosis, diabetic precoma, coma.
Renal failure or impaired renal function (creatinine clearance less than 45 ml/min).
Acute conditions with a risk of developing renal dysfunction: dehydration (with chronic or severe diarrhea, repeated bouts of vomiting), severe infectious diseases (for example, respiratory tract infections, urinary tract infections), shock.
Clinically pronounced manifestations of acute or chronic diseases that can lead to the development of tissue hypoxia (including acute heart failure, chronic heart failure with unstable hemodynamic parameters, respiratory failure, acute myocardial infarction).
Major surgical operations and injuries when insulin therapy is indicated (see section “Special Instructions”).
Liver failure, liver dysfunction.
Chronic alcoholism, acute alcohol poisoning.
Pregnancy.
Lactic acidosis (including history).
Use for less than 48 hours before and within 48 hours after radioisotope or x-ray studies with the introduction of iodine-containing contrast agent (for example, intravenous urography, angiography) (see section “Interaction with other drugs”);
Following a hypocaloric diet (less than 1000 kcal/day).
Children under 18 years of age due to lack of data on use.
With caution
Use the drug:
in patients over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis;
in patients with renal failure (creatinine clearance 45-59 ml/min)
during breastfeeding.

Side Effects

The frequency of side effects of the drug is assessed as follows:
Very frequent: ≥ 1/10
Frequent: ≥ 1/100, < 1/10
Uncommon: ≥ 1/1000, < 1/100
Rare: ≥ 1/10,000, < 1/1000
Very rare: ≤ 1/10,000

Interaction

Contraindicated combinations

Iodine-containing radiocontrast agents: against the background of functional renal failure in patients with diabetes mellitus, radiological examination using iodine-containing X-ray contrast agents can cause the development of lactic acidosis. Treatment with Glucophage®
Long should be discontinued depending on renal function 48 hours before or during an X-ray examination using iodine-containing radiocontrast agents and resumed no earlier than 48 hours after, provided that renal function was found to be normal at the time of the examination.

Not recommended combinations

Alcohol: with acute alcohol intoxication, the risk of developing lactic acidosis increases, especially in the case of:

• insufficient nutrition, adherence to a low-calorie diet;

• liver failure.

While taking the drug, you should avoid drinking alcohol and medications containing ethanol.

Combinations requiring caution

Medicines with indirect hyperglycemic effects (for example, glucocorticosteroids (GCS) and tetracosactide (systemic and local), beta2-agonists, danazol, chlorpromazine when taken in large doses (100 mg per day) and diuretics): More frequent monitoring of blood glucose concentrations may be required, especially at the beginning of treatment. If necessary, the dose of Glucophage®
Long can be adjusted during treatment and after its cessation, based on the level of glycemia.

Diuretics: Concomitant use of loop diuretics may lead to the development of lactic acidosis due to possible functional renal failure.

When using the drug Glucophage Long with sulfonylurea derivatives, insulin, acarbose, and 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 lead to an increase in its Cmax.

Colesevelam, when used concomitantly with metformin in the form of extended-release tablets, increases the plasma concentration of metformin (increased AUC without a significant increase in Cmax).

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.

Storage conditions

Store at a temperature not exceeding 30 °C.

Shelf life

3 years.

Manufacturer

Nanolek LLC, Russia