BETMIGA mirabegron 25 mg film-coated prolonged-release tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

mirabegron, Quantity: 25 mg

Commercializzato da:

Astellas Pharma Australia Pty Ltd

INN (Nome Internazionale):

Mirabegron

Forma farmaceutica:

Tablet, modified release

Composizione:

Excipient Ingredients: butylated hydroxytoluene; magnesium stearate; hyprolose; purified water; macrogol 2000000; macrogol 8000; hypromellose; iron oxide yellow; iron oxide red

Via di somministrazione:

Oral

Confezione:

10, 20, 30, 60, 90, 200

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

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

Dettagli prodotto:

Visual Identification: Oval, brown film-coated tablet, debossed with "325" and the Astellas logo; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2013-10-17

Foglio illustrativo

BETMIGA
®
B
E
T
M
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BETMIGA?
BETMIGA contains mirabegron, a beta 3-adrenoceptor agonist, which is
used to treat symptoms of an overactive bladder.
For more information, see Section 1. Why am I using BETMIGA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BETMIGA?
Do not use if you have ever had an allergic reaction to BETMIGA or any
of the ingredients listed at the end of the CMI.
Do not take BETMIGA if you have very high blood pressure (systolic
greater than or equal to 180mmHg and /or diastolic greater
than or equal to 110mmHg).
For more information, see Section 2. What should I know before I use
BETMIGA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BETMIGA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE BETMIGA?
•
The usual dose is 25 mg tablet once a day. Based upon your response
and tolerability, your doctor may increase your dose to
50 mg once daily. The maximum dose for BETMIGA is 50 mg once daily.
More instructions can be found in Section 4. How do I use BETMIGA? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BETMIGA?
THINGS YOU
SHOULD DO
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist that you are
taking BETMIGA.
•
Tell any other doctors, dentists, and pharmacists who treat you that
you are taking this medicine.
•
If you become pregnant while taking this medicine, tell your doctor
immediately.
•
Keep all of your doctor's appointments so that your progress can be
checked.
THINGS YOU
SHOULD NOT DO
•
Do not take BETMIGA to treat any other complaints unless your doctor
tells you to.
•
Do not give your medicine to anyone else, even if they have the same
condition as you.
•
Do not stop taking your medicine or alter t

Scheda tecnica

1
AUSTRALIAN PRODUCT INFORMATION – BETMIGA
® (MIRABEGRON)
PROLONGED-RELEASE FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Mirabegron
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BETMIGA contains mirabegron 25 mg or 50 mg as the active ingredient.
For the full list of excipients, see Section 6.1 - LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
BETMIGA is available as prolonged-release film-coated tablets for oral
administration. The tablets
are presented as the following:
25 mg: an oval, brown film-coated tablet, debossed with the
(Astellas logo) and “325”
50 mg: an oval, yellow film-coated tablet, debossed with the
(Astellas logo) and “355”
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Symptomatic treatment of urgency, increased micturition frequency
and/or urgency incontinence in
patients with overactive bladder (OAB) syndrome.
4.2
D
OSE AND METHOD OF ADMINISTRATION
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 50 mg once
daily.
BETMIGA can be taken with or without food. The tablet should be taken
with liquids, swallowed
whole and is not to be chewed, divided, or crushed.
Patients with Renal Impairment
No dose adjustment is necessary in patients with mild or moderate
renal impairment (eGFR 30 to 89
mL/min/1.73 m2 as estimated by MDRD). In patients with severe renal
impairment (eGFR 15 to 29
mL/min/1.73 m2), the recommended dose is 25 mg once daily with or
without food. BETMIGA has
not been studied in patients with End Stage Renal Disease (eGFR <15
mL/min/1.73 m2 or patients
requiring haemodialysis) (see Section 5.2 - PHARMACOKINETIC PROPERTIES
- Pharmacokinetic
Characteristics in Special Populations).
Patients with Hepatic Impairment
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 bee