BETMIGA 50 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MIRABEGRON

Available from:

ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL

ATC code:

G04BD12

Pharmaceutical form:

TABLETS PROLONGED RELEASE

Composition:

MIRABEGRON 50 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ASTELLAS PHARMA EUROPE B.V, THE NETHERLANDS

Therapeutic area:

MIRABEGRON

Therapeutic indications:

Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome

Authorization date:

2020-02-29

Patient Information leaflet

_This leaflet was checked and approved by the Ministry of Health on
August 2016 and was updated _
_according to guidelines of the Ministry of Health in June 2019 _
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
BETMIGA 50MG
BETMIGA 25MG
_ _
_PROLONGED-RELEASE _
_TABLETS _
_ _
_PROLONGED-RELEASE _
_TABLETS_
COMPOSITION:
Each tablet of Betmiga 50mg contains: Mirabegron 50 mg.
Each tablet of Betmiga 25mg contains: Mirabegron 25 mg.
EXCIPIENTS - see section 6 "Additional Information"
PLEASE READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, please ask
the physician or the pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others. It
may harm them even if it seems to you that their ailment is similar.
The medicine is not intended for
children under the age of 18 as the safety and efficacy of Betmiga was
not established in this age group.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is meant for treatment of symptoms of an overactive
bladder.
THERAPEUTIC GROUP: Beta-3-adrenoreceptor agonist.
2.
BEFORE USING THE MEDICINE.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
Consult your physician before starting of treatment:
-
If you have difficulties in emptying your bladder, if you have weak
urine stream or if you take
other medicines for the treatment of an overactive bladder such as
anticholinergic medicines.
DO NOT USE THE MEDICINE:
-
If you have hypersensitivity (allergy) to the active substance or any
of the
additional components which the medicine contains (see section 6).
-
if you have very high uncontrolled blood pressure
-
If you have abnormal liver or kidney functions. Your physician may
need to reduce your dose
or may guide you not to use the medicine, especially if you are taking
other medicines, such
as Itraconazole, Ketoconazole (fu

Summary of Product characteristics

1
_ _
_The format of this leaflet was determined by the Ministry of Health
and its content was checked and _
_approved in 08.2016. _
_The content of this leaflet was updated according to guidelines of
the Ministry of Health in June 2019 _
1.
NAME OF THE MEDICINAL PRODUCT
Betmiga 25 mg.
Betmiga 50 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betmiga 25 mg prolonged-release tablets
Each tablet contains 25 mg of mirabegron.
Betmiga 50 mg prolonged-release tablets
Each tablet contains 50 mg of mirabegron.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
Betmiga 25 mg prolonged-release tablets
Oval, brown tablet, debossed with the company logo and “325” on
the same side.
Betmiga 50 mg prolonged-release tablets
Oval, yellow tablet, debossed with the company logo and “355” on
the same side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of urgency, increased micturition frequency
and/or urgency incontinence as may
occur in adult patients with overactive bladder (OAB) syndrome.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including elderly patients)_
The recommended dose is 50 mg once daily.
_Special populations _
_Renal and hepatic impairment _
Betmiga has not been studied in patients with end stage renal disease
(GFR < 15 mL/min/1.73 m
2
or patients
requiring haemodialysis) or severe hepatic impairment (Child-Pugh
Class C) and it is therefore not
recommended for use in these patient populations (see sections 4.4 and
5.2).
The following table provides the daily dosing recommendations for
subjects with renal or hepatic
impairment in the absence and presence of strong CYP3A inhibitors (see
sections 4.4, 4.5 and 5.2).
_ _
_ _
_ _
2
TABLE 1:
DAILY DOSING RECOMMENDATIONS FOR SUBJECTS WITH RENAL OR HEPATIC
IMPAIRMENT IN THE
ABSENCE AND PRESENCE OF STRONG CYP3A INHIBITORS
Strong CYP3A inhibitors
(3)
Without inhibitor
With inhibitor
Renal impairment
(1)
Mild
50 mg
25 mg
Moderate
50 mg
25 mg
Severe
25 mg
Not recommended
Hep