BETMIGA 25 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

1. Betmiga 25 mg prolonged-release tablets, 50 mg prolonged-release tablets
   1. What is Betmiga and what is it used for
   2. What you need to know before taking Betmiga
   3. How to take Betmiga
   4. Possible side effects
   5. How to store Betmiga
   6. Package contents and other information
2. Betmiga 8 mg/mL granules for prolonged-release oral suspension
   1. What is Betmiga and what is it used for
   2. What you need to know before taking Betmiga
   3. How to take Betmiga
   4. Possible side effects
   5. How to store Betmiga
   6. Package contents and other information

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

mirabegron

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of 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 is Betmiga and what is it used for

Betmiga contains the active substance mirabegron. It is a bladder muscle relaxant (a so-called beta 3-adrenergic receptor agonist), which reduces the activity of an overactive bladder, treats its related symptoms and reduces neurogenic detrusor overactivity.
Betmiga is used for:

• the treatment of symptoms of a condition called overactive bladder in adults. These symptoms include: a sudden need to empty the bladder (so-called urgency); needing to empty the bladder more frequently than normal (so-called increased urinary frequency); inability to control bladder emptying (so-called urgency incontinence).
• the treatment of a condition called neurogenic detrusor overactivity in children aged 3 years and over, and less than 18 years. Neurogenic detrusor overactivity is a condition in which involuntary bladder contractions occur due to a condition present from birth or injury to the nerves that control the bladder. If left untreated, neurogenic detrusor overactivity can cause damage to the bladder and/or kidneys. Betmiga is used to increase the amount of urine that can accumulate in the bladder and to reduce urine leakage.

2. What you need to know before taking 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 blood pressure that is not controlled.

Warnings and precautions
Talk to your doctor or pharmacist before taking Betmiga

• if you have problems emptying your bladder or have a weak urine flow or if you are taking other medicines for the treatment of overactive bladder or neurogenic detrusor overactivity, such as antimuscarinic drugs.
• if you have kidney or liver problems. Your doctor may need to reduce the dose or may tell you not to take Betmiga, especially if you are taking other medicines such as itraconazole, ketoconazole (antifungal infections), ritonavir (HIV/AIDS) or clarithromycin (bacterial infections). Tell your doctor if you are taking any other medicines.
• if you have an abnormality on an ECG (heart activity tracing) known as prolonged QT interval or if you are taking a medicine known to cause such abnormality such as: o medicines used to treat heart rhythm disorders, such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide and amiodarone; o medicines used to treat allergic rhinitis; o antipsychotic medicines (medicines used to treat mental illnesses), such as thioridazine, mesoridazine, haloperidol and chlorpromazine; o anti-infectives, such as pentamidine, moxifloxacin, erythromycin and clarithromycin.

If you have a history of high blood pressure, Betmiga may increase or worsen blood pressure. Your
doctor is recommended to check your blood pressure while you are taking this medicine.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age for the
treatment of overactive bladder as the safety and efficacy of Betmiga in this population
has not been demonstrated.
Betmiga should not be used in children under 3 years of age for the treatment of neurogenic
detrusor overactivity.

Other medicines and Betmiga
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Betmiga can affect the action of other medicines and other medicines can have effects on
the way this medicine works.

• Tell your doctor if you are taking thioridazine (a medicine used to treat mental illnesses), propafenone or flecainide (medicines used to treat heart rhythm disorders), imipramine or desipramine (medicines used to treat depression). These specific medicines may require a dose adjustment by your doctor.
• Tell your doctor if you are taking digoxin (a medicine used to treat heart failure or heart rhythm disorders). Your doctor will measure the blood levels of this medicine. If the blood levels are abnormal, your doctor may choose to adjust the dose of digoxin.
• Tell your doctor if you are taking dabigatran etexilate (a drug that is used to reduce the risk of blockage of blood vessels in the brain or body, caused by the formation of blood clots in patients with heart rhythm abnormalities (atrial fibrillation) and with additional risk factors). This drug may require a dose adjustment by your doctor. Pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant or are planning a pregnancy, do not take Betmiga.

If you are breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine. It is likely that this medicine will pass into breast milk. Together with your doctor you will
decide whether to take Betmiga or to breastfeed. You cannot do both.

Driving and using machines
There is no data available to suggest that this medicine impairs the ability to drive or
use machines.

3. How to take Betmiga

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

Use in adults with overactive bladder
The recommended dose is one 50 mg tablet taken orally once a day. If you have
kidney or liver problems, your doctor may need to reduce the dose to one 25 mg
tablet taken orally once a day. Take this medicine with liquids and swallow the tablet
whole. Do not break or chew the tablet. Betmiga can be taken with or without food.

Use in children and adolescents (aged 3 years and over and under 18 years) with neurogenic
detrusor overactivity
Take this medicine orally once a day. You must take this medicine with
liquids and swallow the tablet whole. Do not break or chew the tablet. Betmiga must be
taken with food. Your doctor will tell you which dose you should take/which dose your child should take. The
doctor will calculate the correct dose for a patient based on body weight. You must carefully
follow their instructions.

If you take more Betmiga than you should
If you have taken more tablets than you have been prescribed, or if someone else has accidentally
taken your tablets, seek immediate medical attention from your doctor, pharmacist or hospital.
Symptoms of overdose may include a fast heartbeat, an increase in
pulse rate or an increase in blood pressure.

If you forget to take Betmiga
If you forget to take a dose, take it as soon as you remember, unless it is less than 6 hours
until your next dose. Then continue to take the medicine at the usual time.
Do not take a double dose to make up for a missed dose. If you forget to take
more doses, contact your doctor and follow their advice.

If you stop taking Betmiga
Do not stop treatment with Betmiga prematurely if you do not see an immediate effect. The
bladder may need some time to adjust. Continue to take the tablets. Do not
stop treatment when the condition of the bladder improves. Stopping treatment
may lead to the reappearance of symptoms of overactive bladder or neurogenic
detrusor overactivity.
Do not stop treatment with Betmiga without first talking to your doctor, as the symptoms
of overactive bladder or neurogenic detrusor overactivity may return.
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.
Among the most serious side effects may be irregular heartbeat (atrial fibrillation). This is an
uncommon side effect (may affect up to 1 in 100 people), but if this side effect occurs,
stop taking the medicine and consult your doctor immediately.
If headache occurs, especially sudden, headache similar to migraine (pulsating), consult your
doctor. These may be symptoms of a severe increase in blood pressure.
Other side effects include:

Common(may affect up to 1 in 10 people)
Infection of the urinary tract (urinary tract infections)
Headache
Dizziness
Increased heart rate (tachycardia)
Feeling unwell (nausea)
Constipation
Diarrhea

Uncommon(may affect up to 1 in 100 people)

• Vaginal infection
• Bladder infection (cystitis)
• Awareness of heartbeat (palpitations)
• Heart rhythm problems (atrial fibrillation)
• Indigestion (dyspepsia)
• Stomach infection (gastritis)
• Itching, rash or hives (urticaria, rash, maculopapular rash, papular rash, pruritus)
• Joint swelling
• Itching of the vulva or vagina (vulvovaginal pruritus)
• Increased blood pressure
• Increased liver enzymes (GGT, AST and ALT)

Rare(may affect up to 1 in 1,000 people)

• Swelling of the eyelid (eyelid edema)
• Swelling of the lips (lip edema)
• Inflammation of small blood vessels mostly affecting the skin (leucocytoclastic vasculitis)
• Small, purple skin spots (purpura)
• Swelling of the deeper layers of the skin, caused by fluid accumulation that can affect any part of the body including the face, tongue or throat and can cause difficulty breathing (angioedema)
• Inability to completely empty the bladder (urinary retention)

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

• Severely elevated blood pressure (hypertensive crisis)

Frequency not known(the frequency cannot be estimated from the available data)

• Insomnia
• Confusion

Betmiga may increase the difficulty of emptying the bladder if you have a bladder obstruction
or if you are taking other medicines to treat overactive bladder. Call your doctor immediately 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 side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.

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 box or blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Betmiga contains

• The active ingredient 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.
• Other ingredients are: Tablet core: Macrogol, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate Coating: hypromellose, macrogol, yellow iron oxide (E172), red iron oxide (E172) (only in 25 mg tablets). Description of the appearance ofBetmiga and contents of the packBetmiga 25 mg prolonged-release film-coated tablets are brown-colored, oval-shaped tablets, with the company logo and “325” imprinted on the same side. Betmiga 50 mg prolonged-release film-coated tablets are yellow-colored, oval-shaped tablets, with the company logo and “355” imprinted on the same side.

Betmiga is available in alu-alu blisters containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
Netherlands

Manufacturer
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
Netherlands
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Astellas Pharma B.V. Branch
Tél/Tel: + 32 (0)2 5580710

Lietuva
Astellas Pharma d.o.o.
Tel: + 370 37 408 681

България
Астелас Фарма ЕООД
Te л.: + 359 2 862 53 72

Luxembourg/Luxemburg
Astellas Pharma B.V. Branch
Belgique/Belgien
Tél/Tel: + 32 (0)2 5580710

Česká republika
Astellas Pharma s.r.o.
Tel: + 420 221 401 500

Magyarország
Astellas Pharma Kft.
Tel.: + 36 1 577 8200

Danmark
Astellas Pharma a/s
Tlf.: + 45 43 430355

Malta
Astellas Pharmaceuticals AEBE
Tel: + 30 210 8189900

Deutschland
Astellas Pharma GmbH
Tel: + 49 (0)89 454401

Nederland
Astellas Pharma B.V.
Tel: + 31 (0)71 5455745

Eesti
Astellas Pharma d.o.o.
Tel: + 372 6 056 014

Norge
Astellas Pharma
Tlf: + 47 66 76 46 00

Ελλάδα
Astellas Pharmaceuticals AEBE
Τηλ : + 30 210 8189900

Österreich
Astellas Pharma Ges.m.b.H.
Tel: + 43 (0)1 8772668

España
Astellas Pharma S.A.
Tel: + 34 91 4952700

Polska
Astellas Pharma Sp.z.o.o.
Tel.: + 48 225451 111

France
Astellas Pharma S.A.S.
Tél: + 33 (0)1 55917500

Portugal
Astellas Farma, Lda.
Tel: + 351 21 4401300

Hrvatska
Astellas d.o.o.
Tel: + 385 1670 0102

România
S.C. Astellas Pharma SRL
Tel: + 40 (0)21 361 04 95

Ireland
Astellas Pharma Co. Ltd.
Tel: + 353 (0)1 4671555

Slovenija
Astellas Pharma d.o.o.
Tel: + 386 14011400

Ísland
Vistor hf
Sími: + 354 535 7000

Slovenská republika
Astellas Pharma s.r.o.
Tel: + 421 2 4444 2157

Italia
Astellas Pharma S.p.A.
Tel: + 39 (0)2 921381

Suomi/Finland
Astellas Pharma
Puh/Tel: + 358 (0)9 85606000

Κύπρος
Ελλάδα
Astellas Pharmaceuticals AEBE
Τηλ : + 30 210 8189900

Sverige
Astellas Pharma AB
Tel: + 46 (0)40-650 15 00

Latvija
Astellas Pharma d.o.o.
Tel: + 371 67 619365
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Betmiga 8 mg/mL granules for prolonged-release oral suspension

mirabegron

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Betmiga and what is it used for

Betmiga contains the active substance mirabegron. It is a relaxant of the bladder musculature (a so-called beta 3 adrenergic receptor agonist), which reduces neurogenic detrusor overactivity.
Betmiga is used for the treatment of a condition called neurogenic detrusor overactivity in children aged 3 years and over and less than 18 years. Neurogenic detrusor overactivity is a condition in which involuntary bladder contractions occur due to a condition present from birth or injury to the nerves that control the bladder. If left untreated, neurogenic detrusor overactivity can cause damage to the bladder and/or kidneys. Betmiga is used to increase the amount of urine that can accumulate in the bladder and to reduce urine leakage.

2. What you need to know before taking 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 blood pressure that is not controlled.

Warnings and precautions
Talk to your doctor or pharmacist before taking Betmiga:

• if you have problems emptying your bladder or have a weak urine flow, or if you are taking other medicines for the treatment of neurogenic detrusor overactivity, such as antimuscarinic drugs.
• if you have kidney or liver problems. Your doctor may need to reduce the dose or may tell you not to take Betmiga, especially if you are taking other medicines such as itraconazole, ketoconazole (antifungal infections), ritonavir (HIV/AIDS) or clarithromycin (bacterial infections). Tell your doctor if you are taking any other medicines.
• if you have an abnormality on an ECG (heart activity tracing) known as prolonged QT interval or are taking a medicine known to cause such an abnormality, such as: medicines used to treat heart rhythm disorders, such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide and amiodarone; medicines used to treat allergic rhinitis; antipsychotic medicines (medicines used to treat mental illnesses), such as thioridazine, mesoridazine, haloperidol and chlorpromazine; or anti-infectives, such as pentamidine, moxifloxacin, erythromycin and clarithromycin.

If you have a history of high blood pressure, Betmiga may increase or worsen blood pressure. Your
doctor is recommended to check your blood pressure when you are taking this medicine.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age for the
treatment of overactive bladder as the safety and efficacy of Betmiga in this age group
have not been demonstrated.
Betmiga should not be used in children under 3 years of age for the treatment of neurogenic detrusor overactivity.

Other medicines and Betmiga
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Betmiga can affect the action of other medicines and other medicines can have effects on
the way this medicine works.

• Tell your doctor if you are taking thioridazine (a medicine used to treat mental illnesses), propafenone or flecainide (medicines used to treat heart rhythm disorders), imipramine or desipramine (medicines used to treat depression). These specific medicines may require a dose adjustment by your doctor.
• Tell your doctor if you are taking digoxin (a medicine used to treat heart failure or heart rhythm disorders). Your doctor will measure the blood levels of this medicine. If the blood levels are abnormal, your doctor may choose to adjust the dose of digoxin.
• Tell your doctor if you are taking dabigatran etexilate (a medicine that is used to reduce the risk of blockage of blood vessels in the brain or body, caused by the formation of blood clots in patients with irregular heart rhythm (atrial fibrillation) and with additional risk factors). This medicine may require a dose adjustment by your doctor.

Pregnancy and breastfeeding
If you are pregnant, if you suspect you are pregnant or are planning a pregnancy, do not take
Betmiga.
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine. It is likely that this medicine will pass into breast milk. Together with your doctor you will
decide whether to take Betmiga or to breastfeed. You cannot do both.

Driving and using machines
There is no data available to indicate that this medicine impairs the ability to drive or
use machines.

Betmiga contains ethyl hydroxybenzoate (E214), methyl hydroxybenzoate (E218) and sodium
It may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per 10 mL of oral suspension, i.e.
essentially ‘sodium-free’.

3. How to take Betmiga

Take this medicine always exactly as your doctor has told you. If you have doubts, ask your doctor or pharmacist.
Take this medicine by mouth once a day. Betmiga must be taken with food. Your doctor will tell you which dose to take/which dose your child should take. The doctor will calculate the
correct dose for a patient based on body weight. You must follow their instructions carefully.

How to take Betmiga using a syringe for oral administration
Reconstitution must be carried out by a pharmacist except in situations where pharmacists are not
able to do so. For situations where pharmacists are not able to carry out the
reconstitution, use the supplied measuring cup to measure the volume of water to be used
for reconstitution.
Use the oral administration syringe and adapter supplied with Betmiga granules for
prolonged-release oral suspension to measure the correct dose. If you need to take a dose
greater than 5 mL per day, you will need to use the oral administration syringe twice to
administer the total amount of each dose. The package contains the following items:

n a Syringe for administration i oral 5 mL l a Adapter t I Package insert a Box

Bottle Desiccant DESICCANT DO NOT INGEST Measuring cup (if supplied) Bag

Note: the bag includes a measuring cup (if supplied), the bottle and the desiccant. The
bag is included in the box together with the oral administration syringe, the adapter and the

Preparation for the first use of a bottle of Betmiga granules for prolonged-release oral
suspension (with measuring cup)
Note: if the reconstitution has already been carried out by the pharmacist, skip this section and go to the next section (Before each oral administration).

• 1. • Open the box and remove the bag, syringe and adapter.
• Keep the bottle in the bag still closed until the time of reconstitution.
• Open the bag and remove the bottle and measuring cup.

• 2. • Throw away the empty bag and the desiccant. Do not ingest the desiccant.

• 3. • Tap the top of the closed bottle several times to disperse the granules.
• Place the bottle on a flat surface and remove the cap.

• 4. • Use the measuring cup to measure 50 mL of water and pour it into the bottle.
• Use the measuring cup again to measure another 50 mL of water and pour it into the bottle to add a total of 100 mL of water.

2 x 50 mL
50 mL
50 mL

• 5. • Put the cap back on the bottle.
• Shake vigorously for 1 minute immediately, then let stand for 10-30 minutes.
• Shake vigorously again for 1 minute.

• 6. • Write 28 days from the date of reconstitution on the bottle label.

• 7. • Place the bottle on a flat surface and remove the cap.
• Press the adapter firmly into the neck of the bottle.
• Make sure the top of the adapter is aligned with the top of the bottle neck. The adapter must remain in the bottle neck until the end of the 28-day validity period.
• Put the cap back on the bottle.

Before each oral administration
Note: shake the bottle vigorously for 1 minute each day to ensure that the granules are
suspended.

• 1. • Shake the bottle vigorously for 1 minute.
• Let stand until the foam on the surface of the suspension disappears (about 1-2 minutes).

• 2. • Remove the cap from the bottle.
• Insert the tip of the oral administration syringe into the central opening of the bottle adapter until it is firmly in place.
• Do not pull the syringe plunger.

• 3. • Carefully turn the bottle and syringe upside down.

• 4. • Slowly pull back the syringe plunger to draw the prescribed amount from the inverted bottle. The medicine must be taken within 1 hour of transferring it to the syringe.
• If the doctor has prescribed more than 5 mL, the syringe will need to be used twice.

For example, if the dose is 8 mL, draw
first 5 mL and administer the medicine,
then draw 3 mL and administer
the medicine again.

• 5. • Leave the syringe in place and rotate the bottle upright, making sure the syringe plunger does not move.
• Gently remove the syringe from the adapter.
• Close the bottle with the cap after administration.

• 6. • Discard the excess if you have accidentally drawn too much medicine.

• 7. • Verify that the correct amount has been measured.

• 8. • Put the syringe in your mouth and gently press the plunger down to administer the medicine.

• 9. • Disassemble the syringe and rinse it with warm water.
• Let it dry before reusing it.

This medicine should not be mixed with other medicines.

If you take more Betmiga than you should
If you have taken too much Betmiga, or if someone else has accidentally taken Betmiga, contact
your doctor, pharmacist or hospital immediately.
Symptoms of overdose may include a rapid heartbeat, increased
pulsations or increased blood pressure.

If you forget to take Betmiga
If you forget to take the medicine, take the missed dose, unless more than 12 hours
have passed since the missed dose. If more than 12 hours have passed, skip the dose and continue to take the medicine
at the usual time.
Do not take a double dose to make up for a missed dose. If you forget to take
more doses, contact your doctor and follow their advice.

If you stop taking Betmiga
Do not stop taking Betmiga if you do not see an immediate effect. The bladder may
need some time to adjust. Continue to take the medicine. Do not stop
taking the medicine when the condition of the bladder improves. Stopping the
treatment may cause neurogenic detrusor overactivity to recur.
Do not stop treatment with Betmiga without first talking to your doctor, as
neurogenic detrusor overactivity may recur. If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Among the most serious side effects may be irregular heartbeat (atrial fibrillation). This is a
rare side effect (may affect up to 1 in 100 people), but if this side effect occurs, stop
taking the medicine and consult a doctor immediately.
If you experience headache, especially sudden, migraine-type headache (pulsating), consult
your doctor. These may be symptoms of a severe increase in blood pressure.
Other side effects include:

Common(may affect up to 1 in 10 people)

• Infection of the urinary tract (urinary tract infection)
• Headache
• Dizziness
• Increased heart rate (tachycardia)
• Feeling unwell (nausea)
• Constipation
• Diarrhea

Uncommon(may affect up to 1 in 100 people)

• Vaginal infection
• Bladder infection (cystitis)
• Awareness of heartbeat (palpitations)
• Heart rhythm problems (atrial fibrillation)
• Indigestion (dyspepsia)
• Stomach infection (gastritis)
• Itching, rash or hives (urticaria, rash, maculopapular rash, papular rash, pruritus)
• Joint swelling
• Itching of the vulva or vagina (vulvovaginal pruritus)
• Increased blood pressure
• Increased liver enzymes (GGT, AST and ALT)

Rare(may affect up to 1 in 1,000 people)

• Swelling of the eyelid (palpebral edema)
• Swelling of the lips (lip edema)
• Inflammation of small blood vessels, mainly affecting the skin (leucocytoclastic vasculitis)
• Small, purple skin spots (purpura)
• Swelling of the deeper layers of the skin, caused by fluid accumulation that can affect any part of the body including the face, tongue or throat and can cause breathing difficulties (angioedema)
• Inability to completely empty the bladder (urinary retention)

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

• Severely elevated blood pressure (hypertensive crisis)

Frequency not known(frequency cannot be estimated based on available data)

• Insomnia
• Confusion

Betmiga may increase difficulty emptying the bladder if you have a bladder obstruction
or if you are taking other medicines to treat overactive bladder. Call your doctor immediately if
you are unable to empty your bladder.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system detailed in
Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.

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 package, the sachet or the
bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store the bottle
in the bag still closed to protect it from humidity until the time of reconstitution.
Store the oral administration syringe in clean and dry conditions and protect it from sunlight
and heat.
Store the reconstituted suspension at a temperature below 25 °C for a maximum of 28 days
from the date of suspension preparation. Do not refrigerate or freeze. Discard any
remaining medicine 28 days after reconstitution.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Betmiga contains

• The active ingredient is mirabegron. One bottle of granules for oral prolonged-release suspension contains 830 mg of mirabegron. After reconstitution, one bottle contains 105 mL of oral suspension. Each mL of oral suspension contains 8 mg of mirabegron.
• The other ingredients are methyl hydroxybenzoate (E218), ethyl hydroxybenzoate (E214), sodium polystyrene sulfonate, dilute hydrochloric acid, xanthan gum, hypromellose, mannitol (E421), magnesium stearate, acesulfame potassium, simeticone; hydrated colloidal silica. See section 2 “Betmiga contains ethyl hydroxybenzoate (E214), methyl hydroxybenzoate (E218) and sodium”.

Description of the appearance of Betmiga and package contents
Betmiga granules for oral prolonged-release suspension are granules of a
yellowish-white color. After reconstitution, the oral suspension is a suspension of a pale
yellow-brown color.
There are two packages of Betmiga granules for oral prolonged-release suspension and both
are supplied with various components for reconstitution. One package contains:

• In the box: bag, 5 mL oral administration syringe, adapter and package leaflet
• In the bag: measuring cup, amber-colored (118 mL) polyethylene terephthalate (PET) bottle with a polypropylene (PP) screw cap and desiccant

The other package contains:

• In the box: bag, 5 mL oral administration syringe, adapter and package leaflet
• In the bag: amber-colored (118 mL) polyethylene terephthalate (PET) bottle with a polypropylene (PP) screw cap and desiccant

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands

Manufacturer
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
The Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Astellas Pharma B.V. Branch
Tél/Tel: + 32 (0)2 5580710

Lietuva
Astellas Pharma d.o.o.
Tel: + 370 37 408 681

България
Астелас Фарма ЕООД
Te л.: + 359 2 862 53 72

Luxembourg/Luxemburg
Astellas Pharma B.V. Branch
Belgique/Belgien
Tél/Tel: + 32 (0)2 5580710

Českárepublika
Astellas Pharma s.r.o.
Tel: + 420 221 401 500

Magyarország
Astellas Pharma Kft.
Tel.: + 36 1 577 8200

Danmark
Astellas Pharma a/s
Tlf.: + 45 43 430355

Malta
Astellas Pharmaceuticals AEBE
Tel: + 30 210 8189900

Deutschland
Astellas Pharma GmbH
Tel: + 49 (0)89 454401

Nederland
Astellas Pharma B.V.
Tel: + 31 (0)71 5455745

Eesti
Astellas Pharma d.o.o.
Tel: + 372 6 056 014

Norge
Astellas Pharma
Tlf: + 47 66 76 46 00

Ελλάδα
Astellas Pharmaceuticals AEBE
Τηλ : + 30 210 8189900

Österreich
Astellas Pharma Ges.m.b.H.
Tel: + 43 (0)1 8772668

España
Astellas Pharma S.A.
Tel: + 34 91 4952700

Polska
Astellas Pharma Sp.z.o.o.
Tel.: + 48 225451 111

France
Astellas Pharma S.A.S.
Tél: + 33 (0)1 55917500

Portugal
Astellas Farma, Lda.
Tel: + 351 21 4401300

Hrvatska
Astellas d.o.o.
Tel: + 385 1670 0102

România
S.C. Astellas Pharma SRL
Tel: + 40 (0)21 361 04 95

Ireland
Astellas Pharma Co. Ltd.
Tel: + 353 (0)1 4671555

Slovenija
Astellas Pharma d.o.o.
Tel: + 386 14011400

Ísland
Vistor hf
Sími: + 354 535 7000

Slovenská republika
Astellas Pharma s.r.o.
Tel: + 421 2 4444 2157

Italia
Astellas Pharma S.p.A.
Tel: + 39 (0)2 921381

Suomi/Finland
Astellas Pharma
Puh/Tel: + 358 (0)9 85606000

Κύπρος
Ελλάδα
Astellas Pharmaceuticals AEBE
Τηλ : + 30 210 8189900

Sverige
Astellas Pharma AB
Tel: + 46 (0)40-650 15 00

Latvija
Astellas Pharma d.o.o.Tel: + 371 67 619365
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu.