Glymeria-M tablets 500 mg/2 mg pack of 30 pcs

As a supplement to diet and exercise for patients with non-insulin-dependent diabetes (type II):

• if monotherapy with glimepiride or metformin does not provide an adequate level of glycemic control;
• in case of replacement of combined therapy with glimepiride and metformin.

• active substances: metformin, glimepiride;
• 1 tablet contains metformin hydrochloride 500 mg, glimepiride 2 mg;
• excipients: lactose, monohydrate; microcrystalline cellulose; sodium starch glycolate; crospovidone; povidone; magnesium stearate; shell: carnauba wax; mixture for film coating Opadry White: hypromellose (hydroxypropylmethylcellulose); polyethylene glycol (macrogol); titanium dioxide (E 171).

• Insulin-dependent diabetes mellitus type I (eg, diabetes with a history of ketonemia), diabetic ketonemia, diabetic coma and precoma, acute or chronic metabolic acidosis.
• Hypersensitivity to any of the excipients included in the medicinal product, or to sulfonylurea, sulfonamides, or biguanides.
• Hepatic failure, severe liver dysfunction, being on hemodialysis (so far, there is no experience of using the drug in such cases). In case of severe disorders of liver and kidney function, the patient must be transferred to insulin in order to achieve proper control over the blood sugar level.
• Pregnancy; probable pregnancy; breastfeeding period.
• Tendency to the development of lactic acidosis, cases of lactic acidosis in the anamnesis, renal insufficiency or impaired kidney function (as evidenced by, for example, a blood plasma creatinine level of 1.5 mg/dL in men and 1.4 mg/dL in women or a violation of creatinine clearance) , which can also be caused by conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.
• • Malnutrition, starvation or exhaustion of the patient.
• • Hypofunction of the pituitary gland or adrenal glands.
• Severe renal failure (glomerular filtration rate (GFR) ˂ 30 ml/min).
• Severe infections.

On the part of the gastrointestinal tract: gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal distention, lack of appetite, dyspepsia, constipation, abdominal pain) are the most frequent reactions to metformin and metformin monotherapy occurred more often than in patients , who took a placebo, especially at the beginning of treatment.

Treatment with glimepiride can sometimes cause nausea, vomiting, a feeling of bloating or tightness in the epigastric area, abdominal pain and diarrhea.

On the part of the senses: at the beginning of treatment with metformin, patients may complain of an unpleasant or metallic taste in the mouth, which usually disappears on its own. At the beginning of treatment, transient visual disturbances due to changes in the level of glucose in the blood may be observed, especially at the beginning of treatment. Dysgeusia is known to occur after taking glimepiride (frequency unknown).

Doses of antidiabetic drugs should be determined individually, depending on the patient’s blood glucose level.

It is recommended to start the treatment with the lowest effective dose and increase the dose taking into account the drugs that the patient is currently receiving, as well as depending on the level of glucose in the blood of the patient. For this, it is necessary to regularly monitor the level of glucose in the blood.

The starting dose of the drug in the study was 2 mg glimepiride/500 mg metformin, which was gradually increased to 8 mg glimepiride/2000 mg metformin, depending on the results of blood sugar control. Although the additional effects of glimepiride monotherapy were usually minimal when the drug was used at doses of 4 mg per day or higher, some patients experienced improved metabolic control when the dose was increased to 6 mg (or 8 mg).

The drug is used exclusively for adult patients.

The drug should be used 1 or 2 times a day before or during meals.

In the case of transition from combined therapy with glimepiride and metformin in the form of separate tablets, the drug Glimeria-M® is prescribed taking into account the doses and method of administration of glimepiride and metformin hydrochloride that the patient is already receiving.

If the previous dose is missed, the next dose of this drug should not be increased.

Use during pregnancy or breastfeeding

The drug Glimeria-M® cannot be taken during pregnancy due to the existing risk of harmful effects on the development of the child. Pregnant patients and patients who are planning to become pregnant should inform the doctor about this to reduce the risk of congenital malformations of the fetus caused by excessive blood glucose levels. If possible, such patients should be transferred to insulin to maintain a normal level of glucose in the blood.

To avoid getting glimepiride and metformin together with breast milk into the baby’s body, it should not be taken by women during breastfeeding. If necessary, the patient should be transferred to insulin or she should completely abandon breastfeeding.

Children

The safety and efficacy of the drug for children have not been established. Studies on the treatment of adult-onset non-insulin-dependent diabetes in young people have not been conducted.

The ability to influence the speed of reaction when driving vehicles or other mechanisms

Patients should be warned about the need to be careful when driving a vehicle and when working with other mechanisms.

Store in the original packaging at a temperature not higher than 25 °C.

Keep out of the reach of children.