Medicinal Products

BETMIGA 25 mg

Generic drug of the therapeutic class: Urology nephrology
active ingredients: Mirabégron
laboratory: Astellas Pharma Sas

Sustained release tablet
box of 30
All forms

Indication

Symptomatic treatment of urinary urgency and pollakiuria and / or urge incontinence that may occur in adult patients with overactive bladder syndrome (OAB).

Dosage BETMIGA 25 mg prolonged-release tablet box of 30

Symptomatic treatment of urinary urgency and pollakiuria and / or urge incontinence that may occur in adult patients with overactive bladder syndrome (OAB).

Against indications

Mirabegron is contraindicated in patients with:

- Hypersensitivity to the active substance or to any of the excipients listed under Composition .

- Severe uncontrolled hypertension defined by systolic blood pressure ≥180 mmHg and / or diastolic blood pressure ≥110 mmHg.

Betmiga Lp side effects

Tolerance Profile Summary

The safety of Betmiga was evaluated in 8, 433 patients with overactive bladder (OAB), including 5, 648 patients who received at least one dose of mirabegron in the Phase II / III clinical program and 622 patients who received Betmiga for less than one year (365 days). In the three 12-week, placebo-controlled, placebo-controlled, double-blind, phase III studies, 88% of patients completed treatment with Betmiga and 4% discontinued due to adverse events. The severity of most side effects is mild to moderate.

The most common adverse reactions reported in patients treated with Betmiga 50 mg in the three 12-week placebo-controlled, double-blind, placebo-controlled studies were tachycardia and urinary tract infections. The frequency of tachycardias was 1.2% in patients receiving Betmiga 50 mg. Tachycardia resulted in discontinuation of treatment in 0.1% of patients treated with Betmiga 50 mg. The incidence of urinary tract infections was 2.9% in patients receiving Betmiga 50 mg. Urinary tract infections did not stop treatment in any patient treated with Betmiga 50 mg. Serious adverse events included atrial fibrillation (0.2%).

The type and severity of adverse events observed during the controlled study versus active comparator (antimuscarinic) for a duration of one year (long-term study) were similar to those observed in the three phase III double-blind studies. versus placebo of 12 weeks.

Tabulated list of adverse effects

The table below presents the adverse effects observed with mirabegron in the three 12-week, placebo-controlled, placebo-controlled, double-blind, phase III studies.

The frequency of adverse events is defined as follows: very common (≥ 1/10); frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000). Within each frequency group, adverse effects are presented in descending order of severity.

MedDRA Organ System Class

Frequent

Rare

Rare

indeterminate

(can not be determined on

the database available)

Infections and

infestations

Infection

urinary

Infection

vaginal

Cystitis

affections

psychiatric

Insomnia*

Eye disorders

Edema

eyelid

Heart conditions

tachycardia

palpitations

Fibrillation

auricular

Gastrointestinal disorders

intestinal

nausea *

Dyspepsia

Gastritis

Lip edema

Skin disorders

and sub-fabric

cutaneous

Urticaria

Skin rash

Eruption

macular

Eruption

papular

itching

vasculitis

leucocytoclasiqu

e

purpura

angioedema *

Musculoskeletal disorders

skeletal and systemic

Edema

articular

Affections of

organs of

reproduction and

breast

Vulvovaginal pruritus

investigations

Increase

Blood pressure Augmentation

GGT Augmentation

ASAT Augmentation

ALAT

Renal and urinary disorders

Retention

urinary*

* observed after marketing

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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