Betmiga 25mg modified-release tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mirabegron

Available from:

Astellas Pharma Ltd

ATC code:

G04BD12

INN (International Name):

Mirabegron

Dosage:

25mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040200; GTIN: 5013346075606

Patient Information leaflet

-
Tell your doctor if you use dabigatran etexilate (a
medicine which is used to reduce the risk of brain or
body vessel obstruction by blood clot formation in adult
patients with an abnormal heart beat (atrial fibrillation)
and additional risk factors). This medicine may require
dose adjustment by your doctor.
PREGNANCY AND BREAST-FEEDING
If you are pregnant, think you may be pregnant or are
planning to have a baby you should not take Betmiga.
If you are breast-feeding, ask your doctor or pharmacist
for advice before taking this medicine. It is likely that this
medicine passes into your breast milk. You and your doctor
should decide if you should take Betmiga or breast-feed.
You should not do both.
DRIVING AND USING MACHINES
There is no information to suggest that this medicine
affects your ability to drive or use machines.
3. HOW TO TAKE BETMIGA
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
The recommended dose is one 50 mg tablet by mouth
once daily. If you have kidney or liver problems, your
doctor may need to reduce your dose to one 25 mg tablet
by mouth once daily. You should take this medicine with
liquids and swallow the tablet whole. Do not crush or
chew the tablet. Betmiga can be taken with or without
food.
IF YOU TAKE MORE BETMIGA THAN YOU SHOULD
If you have taken more tablets than you have been told
to take, or if someone else accidentally takes your tablets,
contact your doctor, pharmacist or hospital for advice
immediately.
Symptoms of overdose may include a forceful beating of
the heart, an increased pulse rate or an increased blood
pressure.
IF YOU FORGET TO TAKE BETMIGA
If you forget to take your medicine, take the missed dose
as soon as you remember. If it is less than 6 hours before
your next scheduled dose, skip the dose and continue to
take your medicine at the usual time.
Do not take a double dose to make up for a forgotten
dose. If you miss several doses, tell your doctor and follow
the advice given to you.
IF YOU STO

Summary of Product characteristics

OBJECT 1
BETMIGA 25MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 25-Sep-2017 | Astellas
Pharma Ltd
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).
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: GF