Galvus Met pills coated 50mg + 850mg №30

Coated Tablets

Composition

1 coated pill contains: vildagliptin 50 mg, Metformin hydrochloride 850 mg.
Excipients: hyprolosis, Magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 4000, talc, iron yellow oxide (E172).

Packaging

In the blister of 10 tablets. In a carton 3 blisters.

Mechanism of action

Galvus Met is a combined oral hypoglycemic drug that allows you to more effectively control the level of glucose in the blood of patients with type 2 diabetes within 24 hours than monotherapy drugs of similar action.

Indications and usage

Type 2 diabetes (in combination with diet therapy and exercise):
- with insufficient effectiveness of monotherapy with vildagliptin or metformin.
- in patients previously receiving the combination therapy with vildagliptin and metformin in the form of monodrugs.

Contraindications

- renal failure or renal dysfunction: with serum creatinine level ≥1.5 mg% (> 135 mcmol / liter) for men and ≥1.4 mg% (> 110 mcmol / liter) for women;
- acute conditions that are at risk of developing renal dysfunction: dehydration (with diarrhea, vomiting), fever, severe infectious diseases, hypoxia (shock, sepsis, renal infections, bronchopulmonary diseases);
- acute and chronic heart failure, acute myocardial infarction, acute cardiovascular failure (shock);
- respiratory failure;
- abnormal liver function;
- acute or chronic metabolic acidosis (including diabetic ketoacidosis with or without coma). Diabetic ketoacidosis should be adjusted by insulin therapy;
- lactic acidosis (including in history);
- the drug is not prescribed 2 days before surgical operations, radioisotope, X-ray studies with the introduction of contrast agents and within 2 days after their implementation;
- pregnancy;
- lactation period;
- diabetes of the first type;
- chronic alcoholism, acute alcohol poisoning
- observance of a low-calorie diet (less than 1000 calories per day);
- children's age up to 18 years (efficiency and safety of use is not established);
- hypersensitivity to vildagliptin or metformin or any other components.

Dosage and administration

The drug Galvus Met is taken with meals in order to reduce the severity of side effects from the digestive system, characteristic of metformin. Dosing regimen Galvus Met should be selected individually, depending on the effectiveness and tolerability, the initial dose is selected taking into account the treatment regimens of vildagliptin and / or metformin already used in the patient. When using the drug Galvus Met should not exceed the recommended maximum daily dose of vildagliptin (100 milligrams).

Adverse reactions

On the part of the nervous system: often - headache, dizziness, tremor.
When using vildagliptin in combination with metformin in various doses, hypoglycemia was observed in 0.9 percent of cases (for comparison, in the placebo group in combination with metformin, 0.4 percent).
The incidence of adverse events on the part of the digestive system in combination with vildagliptin / metformin was 12.9 percent. When using metformin, these adverse events were observed in 18.1 percent of patients.
In groups of patients who received Metformin in combination with vildagliptin, gastrointestinal disturbances were observed with a frequency of 10-15 percent, and in the group of patients who received Metformin in combination with placebo, with a frequency of 18 percent.

Storage conditions

Store at a temperature not higher than 30 ° C.

3 years.