Betmiga tablets are indicated for the symptomatic treatment of urgent urge to urinate, an increase in the frequency of urination and / or urinary incontinence, which may occur in adult patients with overactive bladder syndrome (SHS).
Active ingredient: Mirabegron;
1 tablet contains 25 mg or 50 mg of Mirabegron;
Hypersensitivity to the active substance or to any of the excipients. Severe uncontrolled hypertension (systolic blood pressure ≥ 180 mm Hg and / or diastolic blood pressure ≥ 110 mm Hg).
The tablets should be taken once a day with a liquid; the tablet is swallowed whole; do not chew, divide, or crush a tablet.
Pregnant
It is not recommended to take Betmiga during pregnancy and women of reproductive age.
Drivers
Betmiga does not affect or has little effect on the ability to drive or operate machinery.
Mirabegron was used in a single dose of 400 mg to healthy volunteers, palpitations were noted (in 1 out of 6 volunteers) and an increase in heart rate of more than 100 beats per minute (in 3 out of 6 volunteers). With the daily intake of Mirabegron at a dose of 300 mg for 10 days in healthy volunteers, there was an increase in heart rate and systolic blood pressure.
Overdose treatment is symptomatic and supportive. In case of overdose, it is recommended to monitor the pulse rate, blood pressure and ECG monitoring.
The most common adverse reactions were tachycardia and urinary tract infections. The incidence of tachycardia was 1.2% and resulted in discontinuation of treatment in 0.1% of patients.
There were no clinically significant interactions of Mirabegron when used simultaneously in therapeutic doses with solifenacin, tamsulosin, warfarin, metformin or with combined oral contraceptives containing etylestradiol and levonorgestrel. No dose adjustment required.
Strengthening the effect of Mirabegron when used simultaneously with other drugs can be expressed in an increase in heart rate.
Store at a temperature not exceeding 30 ° C.
Keep out of the reach of children.
Shelf life is 3 years.
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