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 may need to reduce your dose or may tell you
not to take Betmiga, especially if you are taking other medicines such as itraconazole,
ketoconazole (fungal infections), ritonavir (HIV/AIDS) or clarithromycin (bacterial infections).
Tell your doctor about the medicines that you take.
- if you have an ECG (heart tracing) abnormality known as QT prolongation or you are taking
any medicine known to cause this such as
o medicines used for abnormal heart rhythm such as quinidine, sotalol, procainamide,
ibutilide, flecainide, dofetilide, and amiodarone;

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 o medicines used for allergic rhinitis;
o antipsychotic medicines (medicines for mental illness) such as thioridazine,
mesoridazine, haloperidol, and chlorpromazine;
o anti-infectives such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.

Mirabegron may cause your blood pressure to increase or make your blood pressure worse if you have
a history of high blood pressure. It is recommended that your doctor check your blood pressure while
you are taking Mirabegron

Children and adolescents

Do not give this medicine to children and adolescents under the age of 18 years because the safety and
efficacy of Betmiga in this age group has not been established.

Other medicines and Betmiga

Tell your doctor or pharmacist if you are taking, have recently used or might use any other medicines.

Betmiga may affect the way other medicines work, and other medicines may affect how this medicine
works.
- Tell your doctor if you use thioridazine (a medicine for mental illness), propafenone or
flecainide (medicines for abnormal heart rhythm), imipramine or desipramine (medicines used
for depression). These specific medicines may require dose adjustment by your doctor.
- Tell your doctor if you use digoxin (a medicine for heart failure or abnormal heart rhythm).
Blood levels of this medicine are measured by your doctor. If the blood level is out of range,
your doctor may adjust the dose of digoxin.
- 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 breastfeed. 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.

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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 stop taking Betmiga

Do not stop treatment with Betmiga early if you do not see an immediate effect. Your bladder might
need some time to adapt. You should continue taking your tablets. Do not stop taking them when your
bladder condition improves. Stopping treatment may result in recurrence of symptoms of overactive
bladder.

Do not stop taking Betmiga without talking to your doctor first, as your overactive bladder symptoms
may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects may include irregular heart beat (atrial fibrillation). This is an
uncommon side effect (may affect up to 1 in 100 people), but if this side effect occurs, immediately
stop taking the medicine and seek urgent medical advice.

If you get headaches, especially sudden, migraine-like (throbbing) headaches, tell your doctor. These
may be signs of severely elevated blood pressure.

Other side effects include:

Common side effects (may affect up to 1 in 10 people)

- Increased heart rate (tachycardia)
- Infection of the structures that carry urine (urinary tract infections)
- Nausea
- Constipation
- Headache
- Diarrhoea
- Dizziness

Uncommon side effects (may affect up to 1 in 100 people)

- Bladder infection (cystitis)
- Feeling your heartbeat (palpitations)
- Vaginal infection
- Indigestion (dyspepsia)
- Infection of the stomach (gastritis)
- Swelling of the joints
- Itching of the vulva or vagina (vulvovaginal pruritus)
- Increased blood pressure
- Increase in liver enzymes (GGT, AST and ALT)
- Itching, rash or hives (urticaria, rash, rash macular, rash papular, pruritus)
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Rare side effects (may affect up to 1 in 1,000 people)
- Swelling of the eyelid (eyelid oedema)
- Swelling of the lip (lip oedema)
- Swelling of the deeper layers of the skin caused by a build-up of fluid, which can affect any part
of the body including the face, tongue or throat and may cause difficulty in breathing
(angioedema)
- Small purple spots on the skin (purpura)
- Inflammation of small blood vessels mainly affecting the skin (leukocytoclastic vasculitis)
- Inability to completely empty the bladder (urinary retention)

Very rare side effects (may affect up to 1 in 10,000 people)

- Hypertensive crisis
- Confusion

Not known side effects (frequency cannot be estimated from the available data)
- Insomnia

Betmiga may increase your chances of not being able to empty your bladder if you have bladder outlet
obstruction or if you are taking other medicines to treat overactive bladder. Tell your doctor right away
if you are unable to empty your bladder.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly (for details see below). By reporting
side effects, you can help provide more information on the safety of this medicine.

Greece
National Agency for Medicines
Mesogeion 284
GR-15562 Cholargos, Athens
Tel: +30 21 32040380/337
Fax: +30 21 06549585
Website: http://www.eof.gr

Cyprus
Pharmaceutical Services
Ministry of Health
CY-1475 Nicosia
Fax: + 357 22608649
Website: www.moh.gov.cy/phs

5. How to store Betmiga

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after EXP.
The expiry date refers to the last day of that month.

After first opening of the bottle, the tablets can be stored for 6 months.

This medicine does not require any special storage conditions.

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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Betmiga contains

- The active substance is mirabegron.
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.
- The other ingredients are:
Tablet core: Macrogols, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate
Film-coating: Hypromellose, macrogol, iron oxide yellow (E172), iron oxide red (E172) (25 mg
tablet only).

What Betmiga looks like and contents of the pack

Betmiga 25 mg prolonged release film-coated tablets are oval, brown film-coated tablets, debossed
with the company logo and “325” on the same side.
Betmiga 50 mg prolonged release film-coated tablets are oval, yellow film-coated tablets, debossed
with the company logo and “355” on the same side.

Betmiga is available in aluminium-aluminium blister in packs containing 10, 20, 30, 50, 60, 90, 100 or
200 tablets and in high density polyethylene (HDPE) bottles with silica gel desiccant and
child-resistant closures containing 90 tablets.

Not all pack sizes may be available in your country. The bottle may not be available in your country.

Marketing Authorisation Holder and Manufacturer

Astellas Pharma Europe B.V.

Sylviusweg 62
2333 BE Leiden
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien Lietuva
Astellas Pharma B.V. Branch Biocodex UAB
Tél/Tel: +32 (0)2 5580710 Tel.: +370 37 408 681

България Luxembourg/Luxemburg
Астелас Фарма ЕООД Astellas Pharma B.V. Branch
Teл.: +359 2 862 53 72 Belgique/Belgien
Tél/Tel: +32 (0)2 5580710

Česká republika Magyarország

Astellas Pharma s.r.o. Astellas Pharma Kft.
Tel: +420 221 401 500 Tel.: +36 1 577 8200

Danmark Malta
Astellas Pharma a/s E.J. Busuttil Ltd.
Tlf: +45 43 430355 Tel: +356 21447184

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Deutschland Nederland
Astellas Pharma GmbH Astellas Pharma B.V.
Tel.: +49 (0)89 454401 Tel: +31 (0)71 5455745

Eesti Norge
Biocodex OÜ Astellas Pharma
Tel: +372 6 056 014 Tlf: +47 66 76 46 00

Ελλάδα Österreich
Astellas Pharmaceuticals AEBE Astellas Pharma Ges.m.b.H.
Τηλ: +30 210 8189900 Tel.: +43 (0)1 8772668

España Polska
Astellas Pharma S.A. Astellas Pharma Sp.z.o.o.
Tel: +34 91 4952700 Tel.: +48 225451 111

France Portugal
Astellas Pharma S.A.S. Astellas Farma, Lda.
Tél: +33 (0)1 55917500 Tel: +351 21 4401320

Hrvatska România
Astellas d.o.o S.C.Astellas Pharma SRL
Tel: +385 1670 0102 Tel: +40 (0)21 361 04 95/96/92

Ireland Slovenija
Astellas Pharma Co. Ltd. Astellas Pharma d.o.o
Tel: +353 (0)1 4671555 Tel: +386 14011400

Ísland Slovenská republika

Vistor hf Astellas Pharma s.r.o.
Sími: +354 535 7000 Tel: +421 2 4444 2157

Italia Suomi/Finland
Astellas Pharma S.p.A. Astellas Pharma
Tel: +39 (0)2 921381 Puh/Tel: +358 (0)9 85606000

Κύπρος Sverige
Ελλάδα Astellas Pharma AB
Astellas Pharmaceuticals AEBE Tel: +46 (0)40-650 15 00
Τηλ: +30 210 8189900

Latvija United Kingdom

Biocodex SIA Astellas Pharma Ltd.
Tel: +371 67 619365 Tel: +44 (0) 203 379 8700

This leaflet was last revised in 2 April 2019

Detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu.