Merifatin MB, 500 mg 60 pcs

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Indications

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

Active ingredient

Composition

In one tablet:

The active ingredient: metformin hydrochloride – 500 mg.

Hypromellose 2208 – 256.0 mg; sodium carmellose (sodium carboxymethylcellulose) – 28.0 mg; hyprolose (hydroxypropylcellulose) – 10.0 mg; copovidone – 2.0 mg; magnesium stearate – 4.0 mg.

How to take, the dosage

Ingestion. Tablets are swallowed whole, without chewing, with a small amount of liquid, 1 time/day with dinner.

The dose of Merifatin MB is adjusted by the physician individually for each patient based on the results of blood glucose concentration determination.

Adult patients with normal renal function (CK ≥ 90 ml/min)

Monotherapy and combination therapy in combination with other hypoglycemic agents

Merifatin MB in dose of 1000 mg should be taken once daily (once/day) at supper time.

– If switching from another hypoglycemic drug, select the dose as described above, starting with Merifatin MB at 500 mg or 750 mg, with a possible subsequent switch to Merifatin MB at 1000 mg.

Combination with insulin

The daily dose

The maximum recommended dose of Merifatin MB is 4 tablets 500 mg daily (2000 mg) or 3 tablets 750 mg daily (2250 mg) or 2 tablets 1000 mg daily (2000 mg).

If adequate glycemic control is not achieved by taking the maximum recommended dose once daily during dinner, then the maximum dose may be divided into two doses: 2 500 mg tablets at breakfast and 2 500 mg tablets at dinner, or one 1000 mg tablet at breakfast and one 1000 mg tablet at dinner.

Use in Special Clinical Patient Groups

Dose skipping

If the next dose is missed, the next dose should be taken at the usual time. Do not take a double dose of Merifatin MB.

Patients with renal impairment

Metformin may be used in patients with renal impairment with a CK of 30 to 59 mL/min only if there are no conditions/risk factors that may increase the risk of lactoacidosis.

Patients in the elderly

Because of the possible decrease in renal function, the dose of metformin is adjusted based on renal function assessment, which should be performed regularly.

Children and adolescents under 18 years of age

The use of the drug is contraindicated in children and adolescents under 18 years of age (due to a lack of clinical data on efficacy and safety).

The duration of treatment

Merifatin MB should be taken daily, without interruption. If treatment is discontinued, the patient should inform the physician.

Renal function should be monitored closely: CK should be determined every 3-6 months in patients with a CK of 45-59 mL/min and every 3 months with a CK of 30-44 mL/min.

If creatinine clearance is below 30 mL/min, metformin should be stopped immediately.

Interaction

Contraindicated combinations

Iodine-containing radiopaque agents: Against the background of functional renal insufficiency in patients with diabetes mellitus, radiological examination with iodine-containing radiopaque agents may cause development of lactocidosis. Metformin administration should be discontinued depending on renal function 48 hours prior to or at the time of radiology with iodine-based radiopaque agents and should be restarted not earlier than 48 hours after, on condition that renal function was found to be normal during the examination.

Unrecommended combinations

Alcohol: acute alcohol intoxication increases the risk of lactoacidosis, especially if:

– inadequate diet, compliance with a low-calorie diet;

– hepatic insufficiency.

At the time of therapy with the drug it is necessary to refrain from drinking alcohol and taking drugs containing ethanol.

Combinations requiring caution.

Diuretics: concomitant use of “loop” diuretics may lead to the development of lactoacidosis due to possible functional renal failure.

The concomitant use of Merifatin MB with sulfonylurea derivatives, insulin, acarbose, salicylates may lead to hypoglycemia.

Nifedipine increases absorption and Cmax of metformin.

Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin) that are secreted in the renal tubules compete with metformin for tubular transport systems and may increase its Cmax.

Colesevelam, when used concomitantly with metformin in the form of sustained-release tablets, increases plasma metformin concentrations (increases AUC without significantly increasing Cmax).

Special Instructions

Lactoacidosis

Lactoacidosis is a rare but serious (high mortality if not treated urgently) complication that can occur due to metformin cumulation. Cases of lactoacidosis when taking metformin have occurred mainly in patients with diabetes mellitus with severe renal insufficiency.

Contraindications

– Hypersensitivity to metformin or any excipient;

– diabetic ketoacidosis, diabetic precoma, coma;

– renal insufficiency or impaired renal function (CKR less than 30 ml/min);

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

– clinically manifest acute or chronic conditions that may lead to the development of tissue hypoxia (includingacute 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 “Special Precautions. “

– hepatic insufficiency, impaired liver function;

– chronic alcoholism, acute alcohol intoxication;

– pregnancy;

– lactoacidosis (including

– use less than 48 hours before and 48 hours after radioisotopic or radiological studies with iodine contrast media (e.g., intravenous urography, angiography). “Interaction with other medicinal products”);

– compliance with a hypocaloric diet (<1000 calories/day);

– age under 18 years (due to the lack of data on the effectiveness and safety of use in this age group).

– In patients over 60 years of age who perform heavy physical work, due to the increased risk of lactoacidosis in them;

– In patients with renal insufficiency (CK 30-59 ml/min);

– During breastfeeding.

Side effects

Classification of the incidence of HP when using the drug according to the recommendations of the World Health Organization (WHO): very frequently (≥1/10); frequently (≥1/100, <1/10); infrequently (≥1/1000, <1/100); rarely (≥1/10000, <1/1000); very rarely (<1 /10000).

Metabolic disorders: very rare – lactoacidosis.

Long-term administration of metformin may result in decreased absorption of vitamin B12. If megaloblastic anemia is detected, the possibility of this etiology should be considered.

Nervous system disorders: often – taste disorders (metallic taste in the mouth).

Gastrointestinal disorders: very often – nausea, vomiting, diarrhea, abdominal pain and lack of appetite. They occur most frequently during the initial period of treatment and in most cases spontaneously go away. To prevent the symptoms, it is recommended that metformin be taken with or after meals. Slowly increasing the dose may improve tolerability on the gastrointestinal side.

Liver and biliary tract side effects: very rare – impaired liver function and hepatitis; these HP disappear completely after discontinuation of the drug.

Skin and subcutaneous tissue disorders: very rare – skin reactions such as erythema (skin redness), itching, urticaria.

If any of the HP listed in the instructions worsened or other HP not listed in the instructions appeared, you should tell your doctor.

Overdose

Hypoglycemic episodes were not observed when using metformin at a dose of up to 85 g (42.5 times the maximum daily dose). However, in this case, the development of lactoacidosis was observed. Significant overdose or associated risk factors may lead to the development of lactoacidosis.

The symptoms of lactoacidosis are: marked weakness, myalgia, abdominal pain, respiratory disorders, increased somnolence. In severe lactoacidosis, the development of arterial hypotension and resistant bradyarrhythmia has been noted.

Treatment: in case of signs of lactocidosis, the drug should be stopped immediately, the patient should be urgently hospitalized and, having determined the lactate concentration, the diagnosis should be clarified. The most effective measure for lactate and metformin elimination from the body is hemodialysis. Symptomatic treatment is also carried out.

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