Glimepiride-SZ pills 4mg, 30pcs

Composition

1 tablet contains: Active ingredient: glimepiride – 4 mg; excipients:   mannitol-130.4 mg, microcrystalline cellulose (102) – 24.0 mg, sodium carboxymethyl starch-20.0 mg, povidone K 30 (polyvinylpyrrolidone medium molecular weight) – 2.6 mg, crospovidone (Collidone CL) – 18.0 mg, magnesium stearate-1.0 mg.

Use during pregnancy and lactation

Glimepiride is contraindicated in pregnant women. In case of planned pregnancy or when pregnancy occurs, the woman should be transferred to insulin therapy.

Glimepiride penetrates into breast milk, so it should not be taken during breastfeeding. In this case, it is necessary to switch to insulin therapy or stop breastfeeding.

Contraindications

• diabetes mellitus type 1;

• diabetic ketoacidosis, diabetic precoma and coma;

• hypersensitivity to glimepiride or any subsidiary of the drug substance, to other derivatives of sulfonylurea, or to other sulfa drugs (risk of hypersensitivity reactions);

• hepatic failure, severe (absence of clinical experience);

• renal failure, severe, including patients on hemodialysis (lack of clinical experience);

• pregnancy and breastfeeding;

• in children and adolescents up to 18 years (no clinical experience).

With caution

• In the first weeks of treatment (increased risk of hypoglycemia).

• If there are risk factors for hypoglycemia (see section “Special instructions”, it may be necessary to adjust the dose of glimepiride or the entire therapy).

• For intercurrent diseases during treatment or when changing the lifestyle of patients (changing diet and meal times, increasing or decreasing physical activity).

• When glucose-6-phosphate dehydrogenase is insufficient.

• In case of malabsorption of food and medicines in the gastrointestinal tract (gastrointestinal tract) (intestinal obstruction, intestinal paresis).

Side effects

Adverse reactions with glimepiride are presented in accordance with the classification of the World Health Organization (WHO): very common (≥ 10%), often (≥ 1%, < 10%), infrequently (≥ 0,1%, < 1%), rarely (≥ 0,01%, < 0,1%), very rarely, including individual messages(

Metabolic disorders

Hypoglycemia

As a result of the hypoglycemic effect of Glimepiride-SZ, hypoglycemia may develop, which, as with other sulfonylurea derivatives, can be prolonged.

Symptoms of hypoglycemia include: headache, acute hunger, nausea, vomiting, fatigue, drowsiness, sleep disorders, restlessness, aggressiveness, impaired concentration and speed of psychomotor reactions, depression, confusion, speech disorders, aphasia, visual disturbances, tremor, paresis, sensitivity disorders, dizziness, loss of self-control, helplessness, delirium, cerebral convulsions, somnolence or loss of consciousness up to coma, shallow breathing, bradycardia.

In addition, there may be manifestations of adrenergic counterregulation in response to the development of hypoglycemia, such as: increased sweating, cold and wet skin, increased anxiety, tachycardia, increased blood pressure, angina pectoris, “palpitation sensation” and heart rhythm disorders.

The clinical picture of severe hypoglycemia may be similar to a stroke.

Symptoms of hypoglycemia almost always disappear after it is eliminated.

Weight gain

When taking glimepiride, as well as other sulfonylurea derivatives, an increase in body weight is possible (the frequency is unknown).

Visual disturbances

During treatment (especially at its beginning), transient visual disturbances may occur due to changes in the concentration of glucose in the blood. They are caused by a temporary change in the swelling of the lens, depending on the concentration of glucose in the blood, and due to this change in the refractive index of the lens.

Disorders of the gastrointestinal tract

Rarely: nausea, vomiting, heaviness or fullness in the epigastrium, abdominal pain, diarrhea.

Frequency unknown: dysgeusia (taste disorders).

Liver and biliary tract disorders

In some cases: hepatitis, increased activity of “liver” enzymes and / or cholestasis and jaundice, which may progress to life-threatening liver failure, but may reverse if the drug is discontinued

Disorders of the blood and lymphatic system

Rare: thrombocytopenia.

In some cases: leukopenia, hemolytic anemia, erythrocytopenia,

granulocytopenia, agranulocytosis and pancytopenia.

Frequency unknown: cases of severe thrombocytopenia with a platelet count of less than 10,000/µl and thrombocytopenic purpura have been reported with post-marketing use of the drug.

Immune system disorders

Rare: allergic and pseudoallergic reactions, such as pruritus, urticaria, skin rash. Such reactions are almost always mild, but they can turn into severe reactions with shortness of breath, a sharp decrease in blood pressure, which sometimes progress to anaphylactic shock. If you experience symptoms of urticaria, you should immediately consult a doctor. Possible cross-allergy with other sulfonylureas, sulfonamides, or similar substances.

In some cases: allergic vasculitis.

Skin and subcutaneous tissue disorders

In some cases: photosensitization.

Frequency unknown: alopecia.

Laboratory and instrumental data

In some cases: hyponatremia.

Interaction

Glimepiride is metabolized by the CYP2C9 isoenzyme of the cytochrome P450 system, which should be taken into account when it is co-administered with inducers (for example, rifampicin) or inhibitors (for example, fluconazole) of CYP2C9.

Potentiation of the hypoglycemic effect and in some cases the associated possible development of hypoglycemia can be observed when combined with one of the following drugs:

insulin and other hypoglycemic drugs for oral use, angiotensin converting enzyme inhibitors (ACE), anabolic steroids and male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, fibrates, fluoxetine, ifosfamide, inhibitors of monoamine oxidase (MAO), fluconazole, para-aminosalicylic acid, pentoxifylline (high dose parenteral), phenylbutazone, probenecid, chinolone, salicylates, clarithromycin, sulfonamides, tetracyclines.

A weakening of the hypoglycemic effect and the associated increase in blood glucose concentration can be observed when combined with one of the following drugs:

acetazolamide, barbiturates, glucocorticosteroids, diuretics, epinephrine and other sympathomimetic agents, glucagon, laxatives (with prolonged use), nicotinic acid (in high doses), estrogens and progestogens, phenothiazines, phenytoin, rifampicin, iodine-containing thyroid hormones.

H2-histamine receptor blockers, beta-blockers, clonidine and reserpine can both enhance and weaken the hypoglycemic effect of glimepiride.

Under the influence of sympatholytic agents, such as beta-blockers, clonidine and reserpine, signs of adrenergic counterregulation in response to hypoglycemia may decrease or be absent.

When taking glimepiride, there may be an increase or decrease in the effect of coumarin derivatives.

Single or chronic alcohol use may either increase or decrease the hypoglycemic effect of glimepiride.

Bile acid sequestrants: colesevelam binds to glimepiride and reduces the absorption of glimepiride from the gastrointestinal tract. If glimepiride is used at least 4 hours before taking colesevelam, no interaction is observed. Therefore, glimepiride should be taken at least 4 hours before taking colesevelam.

How to take, course of use and dosage

As a rule, the dose of Glimepiride-SZ is determined by the target concentration of glucose in the blood. The lowest dose should be used, sufficient to achieve the necessary glycemic control.

During treatment with Glimepiride-SZ, it is necessary to regularly determine the concentration of glucose in the blood. In addition, regular monitoring of the indicator of glycated hemoglobin is recommended.

Incorrect medication intake, such as skipping the next dose, should never be replaced by taking a higher dose later.

The patient’s actions in case of errors when taking Glimepiride-SZ (in particular, when skipping the next dose or skipping a meal) or in situations where it is not possible to take the drug, should be discussed by the patient and the doctor in advance.

Taking Glimepiride-SZ

Tablets of the drug Glimepiride-SZ are taken orally, whole, without chewing, with a sufficient amount of liquid (about 0.5 cups). If necessary, the tablets can be divided along the line into two equal parts.

Starting dose and dose selection

The initial dose is 1 mg of glimepiride once a day.

If necessary, the daily dose can be gradually increased (at intervals of 1-2 weeks).It is recommended to increase the dose under regular monitoring of blood glucose concentration and in accordance with the next step of increasing the dose: 1 mg – 2 mg – 3 mg – 4 mg – 6 mg (- 8 mg).

Dose range in patients with well-controlled diabetes mellitus

The usual daily dose for patients with well-controlled diabetes mellitus is 1 to 4 mg of glimepiride. A daily dose of more than 6 mg is more effective only in a small number of patients.

Dosage regimen

The time of taking Glimepiride-SZ and the distribution of doses throughout the day is determined by the doctor depending on the patient’s lifestyle at this time (meal time, amount of physical activity).

Usually, a single dose of the drug during the day is sufficient. It is recommended that in this case, the entire dose of Glimepiride-SZ should be taken immediately before a full breakfast or, if it was not taken at this time, immediately before the first main meal. It is very important not to skip meals after taking Glimepiride-SZ tablets.

Since improved glycemic control is associated with increased insulin sensitivity, the need for glimepiride may decrease during treatment. In order to avoid the development of hypoglycemia, it is necessary to reduce the dose or stop taking Glimepiride-SZ in a timely manner.

Conditions that may also require dose adjustment of glimepiride:

– weight loss in patients;

– changes in the patient’s lifestyle (changes in diet, meal times, amount of physical activity)–

– occurrence of other factors that lead to a predisposition to hypoglycemia or hyperglycemia (see the section “Special instructions”).

Duration of treatment

Treatment with glimepiride is usually carried out for a long time.

Transfer of a patient from taking another oral hypoglycemic agent to taking Glimepiride-SZ

There is no exact correlation between the dosage of Glimepiride-SZ and other hypoglycemic agents for oral use. When another oral hypoglycaemic agent is replaced with Glimepiride-SZ, it is recommended that the algorithm for prescribing it be the same as for the initial use of glimepiride, that is, treatment should begin with an initial dose of 1 mg (even if the patient is transferred to glimepiride from the maximum dose of another oral hypoglycaemic drug). Any increase in the dose should be carried out in stages, taking into account the reaction to glimepiride, in accordance with the recommendations given above.

It is necessary to take into account the strength and duration of the effect of the previous hypoglycemic agent for oral use. Discontinuation of treatment may be necessary to avoid any cumulative effects that may increase the risk of hypoglycemia.

Use in combination with metformin

Patients with insufficiently controlled diabetes mellitus who receive the maximum daily doses of glimepiride or metformin may be treated with a combination of these two drugs. In this case, the previous treatment with either glimepiride or metformin continues at the same dose level, and the additional intake of metformin or glimepiride begins with a low dose, which is then titrated depending on the target level of glycemic control up to the maximum daily dose. Combination therapy should be initiated under strict medical supervision.

Use in combination with insulin

Patients with insufficiently controlled diabetes mellitus who are taking

the maximum daily doses of glimepiride may be simultaneously prescribed insulin. In this case, the last dose of glimepiride prescribed to the patient remains unchanged. In this case, insulin treatment begins with low doses, which gradually increase under the control of blood glucose concentration. Combined treatment requires careful medical supervision.

Use in patients with renal insufficiency

There is limited information on the use of glimepiride in patients with renal insufficiency. Patients with impaired renal function may be more sensitive to the hypoglycemic effect of glimepiride (see sections “Pharmacokinetics”, “Contraindications”).

Use in patients with hepatic insufficiency

There is limited information on the use of glimepiride in patients with hepatic insufficiency (see section “Contraindications”).

Use in children

There are insufficient data on the use of the drug in children.

Overdose

Symptoms of overdose

Acute overdose, as well as prolonged treatment with too high doses of glimepiride, can lead to severe life-threatening hypoglycemia.

Overdose treatment

As soon as an overdose is detected, you should immediately inform your doctor. Hypoglycemia can almost always be quickly relieved by an immediate intake of carbohydrates (glucose or a piece of sugar, sweet fruit juice or tea). In this regard, the patient should always have at least 20 g of glucose (4 lumps of sugar). Sweeteners are ineffective in treating hypoglycemia.

Until the doctor decides that the patient is out of danger, careful medical supervision of the patient is necessary. It should be remembered that hypoglycemia may resume after the initial restoration of blood glucose concentration.

If a patient with diabetes is treated by different doctors (for example, during a hospital stay after an accident, or during a weekend illness), they must inform them about their illness and previous treatment.

Sometimes it may be necessary to hospitalize the patient, if only as a precautionary measure. A significant overdose and severe reaction with such manifestations as loss of consciousness or other serious neurological disorders are medical emergencies and require immediate treatment and hospitalization,

In case of unconsciousness of the patient, intravenous use (iv) of a concentrated dextrose (glucose) solution is necessary (in adults-starting from 40 ml of a 20% solution). Alternatively, subcutaneous or intramuscular use of glucagon to adults at a dose of 0.5 – 1 mg is possible.

When treating hypoglycemia due to accidental use of the drug by children or young children, the dose of dextrose administered should be carefully adjusted in terms of the possibility of dangerous hyperglycemia, and dextrose use should be carried out under constant monitoring of blood glucose concentration.

An overdose of glimepiride may require gastric lavage and the use of activated charcoal.

After rapid recovery of blood glucose concentration, it is necessary to conduct an intravenous infusion of dextrose solution at a lower concentration to prevent the resumption of hypoglycemia. The blood glucose concentration in such patients should be continuously monitored for 24 hours. In severe cases with a prolonged course of hypoglycemia, the risk of lowering the concentration of glucose in the blood to hypoglycemic levels may persist for several days.

Active ingredient

Glimepiride

Conditions of release from pharmacies

By prescription

Dosage form

Tablets