Betmiga

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Mirabegron

Διαθέσιμο από:

Astellas Pharma Europe B.V.

Φαρμακολογική κατηγορία (ATC):

G04BD12

INN (Διεθνής Όνομα):

mirabegron

Θεραπευτική ομάδα:

Urologicals

Θεραπευτική περιοχή:

Urinary Bladder, Overactive

Θεραπευτικές ενδείξεις:

Symptomatic treatment of urgency.Increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladder syndrome.

Περίληψη προϊόντος:

Revision: 13

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2012-12-20

Φύλλο οδηγιών χρήσης

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BETMIGA 25 MG PROLONGED-RELEASE TABLETS
BETMIGA 50 MG PROLONGED-RELEASE TABLETS
mirabegron
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Betmiga is and what it is used for
2.
What you need to know before you take Betmiga
3.
How to take Betmiga
4.
Possible side effects
5.
How to store Betmiga
6.
Contents of the pack and other information
1.
WHAT BETMIGA IS AND WHAT IT IS USED FOR
Betmiga contains the active substance mirabegron. It is a bladder
muscle relaxant (a so called
beta 3-adrenoceptor agonist), which reduces the activity of an
overactive bladder and treats the related
symptoms.
Betmiga is used to treat the symptoms of an overactive bladder in
adults such as:
-
suddenly needing to empty your bladder (called urgency)
-
having to empty your bladder more than usual (called increased urinary
frequency)
-
not being able to control when to empty your bladder (called urgency
incontinence)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETMIGA
DO NOT TAKE BETMIGA:
-
if you are allergic to mirabegron or any of the other ingredients of
this medicine (listed in
section 6)
-
if you have very high uncontrolled blood pressure.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Betmiga:
-
if you have trouble emptying your bladder or you have a weak urine
stream or if you take other
medicines for the treatment of overactive bladder such as
anticholinergic medicines.
-
if you have kidney or liver problems. Your doctor m

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Betmiga 25 mg prolonged-release tablets
Betmiga 50 mg prolonged-release tablets
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 tablets
Oval, brown tablet, debossed with the company logo and “325” on
the same side.
Betmiga 50 mg 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).
3
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
Hepatic impairment
(2)
Mild
50 mg
25 mg
Moderate
25 mg
Not recommended
1.
Mild: GFR 60 to 89 mL/min/1.73 m
2
; moderate: GFR 30 to 59 mL/min/1.73 m
2
; severe: GFR
15 to 29 mL/min/1.73 m
2
.
2.
Mild