BETMIGA ® PROLONGED-RELEASE TABLETS 25MG

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Mirabegron

Διαθέσιμο από:

ASTELLAS PHARMA SINGAPORE PTE. LTD.

Φαρμακολογική κατηγορία (ATC):

G04BD12

Δοσολογία:

25 mg

Φαρμακοτεχνική μορφή:

TABLET, FILM COATED, EXTENDED RELEASE

Σύνθεση:

Mirabegron 25 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Avara Pharmaceutical Technologies. Inc.

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2014-09-15

Φύλλο οδηγιών χρήσης

1.4.3 Package Insert for Singapore 

1 
_ _

1. 
NAME OF THE MEDICINAL PRODUCT 

Betmiga
 ®
 prolonged-release tablets 25 mg 
Betmiga 
®
 prolonged-release tablets 50 mg 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 25 mg of mirabegron. 
Each tablet contains 50 mg of mirabegron. 
For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Prolonged-release tablet. 
25mg: Oval, brown tablet, debossed with the company logo and
“325” on the same side.  
50mg: 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 starting dose of Betmiga is 25 mg once daily. Based on individual patient efficacy 
and tolerability the dose may be increased
to 50mg once daily. 

Betmiga can be taken with or without food.  

_Special populations _
_ _
_Renal and hepatic impairment _
_ _
No dose adjustment is necessary in patients
with mild to moderate renal impairment (eGFR 30 to 89 
mL/min/1.73 m
2 
as estimated by MDRD).In patients with
severe renal impairment (eGFR 15 to 29 
mL/min/1.73 m
2
), the recommended dose is 25 mg dose once daily with
or without food. 

Betmiga has 
not been studied in patients with End Stage Renal Disease
(eGFR < 15 mL/min/1.73 m
2 
or patients 
requiring haemodialysis) (see sections 4.4 and 5.2). 

No dose adjustment is necessary in patients
with mild hepatic impairment (Child-Pugh Cla

Αρχείο Π.Χ.Π.

1
1.4.3 Package Insert for Singapore
2
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Betmiga
®
prolonged-release tablets 25 mg
Betmiga
®
prolonged-release tablets 50 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of mirabegron.
Each tablet contains 50 mg of mirabegron.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
25mg: Oval, brown tablet, debossed with the company logo and “325”
on the same side.
50mg: 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 starting dose of Betmiga is 25 mg once daily. Based on
individual patient efficacy
and tolerability the dose may be increased to 50mg once daily.
Betmiga can be taken with or without food.
_Special populations _
_ _
_Renal and hepatic impairment _
No dose adjustment is necessary in patients with mild to moderate
renal impairment (eGFR 30 to 89
mL/min/1.73 m
2
as estimated by MDRD).In patients with severe renal impairment (eGFR
15 to 29
mL/min/1.73 m
2
), the recommended dose is 25 mg dose once daily with or without food.
Betmiga has
not been studied in patients with End Stage Renal Disease (eGFR < 15
mL/min/1.73 m
2
or patients
requiring haemodialysis) (see sections 4.4 and 5.2).
No dose adjustment is necessary in patients with mild hepatic
impairment (Child-Pugh Class A). In
patients with moderate hepatic impairment (Child-Pugh Class B) the
recommended dose is 25 mg
once daily with or without food. Betmiga has not be studied in
patients with severe hepatic
impairment (Child-Pugh Class C) (see sections 4.4 and 5.2).
_Gender _
No dose adjustment is necessary according to gender.
3
_Paediatric population _
The safety and efficacy of mirab