Leaflet: information for the user

Betmiga 25mg prolonged-release tablets

Betmiga 50mg prolonged-release tablets

mirabegrón

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

Betmiga contains the active ingredient mirabegron. It is a medication that relaxes the smooth muscle of the bladder (designated as a beta 3 adrenergic receptor agonist), which reduces symptoms associated with overactive bladder and reduces neurogenic hyperactivity of the detrusor.

Betmiga is used for:

• To treat symptoms of a condition called overactive bladder in adults.

These symptoms include:: sudden need to empty the bladder (designated as urgency), having to empty the bladder more often than normal (designated as increased urinary frequency), being unable to control when to empty the bladder (designated as urgency incontinence).

• To treat a condition called neurogenic detrusor overactivity in children aged 3 to less than 18 years. Neurogenic detrusor overactivity is a condition in which involuntary contractions of the bladder occur due to a birth defect or a nerve injury that controls 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 the bladder can hold and reduce urine loss.

Do not take Betmiga:

• if you are allergic to mirabegron or any of the other components of this medication (listed in section6);
• if you have uncontrolled high blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Betmiga

• if you have problems emptying your bladder or have a weak urine flow or if you take other medications for the treatment of overactive bladder or neurogenic detrusor overactivity,such as anticholinergic medications.
• if you have kidney or liver problems. Your doctor may need to reduce the dose or tell you not to take Betmiga, especially if you are taking other medications such as itraconazole, ketoconazole (fungal infections), ritonavir (HIV/AIDS) or clarithromycin (bacterial infections). Inform your doctor about the medications you are taking.
• if you have a known anomaly in the ECG (heart study) such as QT interval prolongation or are taking any medication known to cause this anomaly such as:

• medications used for cardiac rhythm disturbances such as, for example, quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide and amiodarone;
• medications used for allergic rhinitis;
• antipsychotic medications (medications for mental illnesses) such as, for example, thioridazine, mesoridazine, haloperidol and chlorpromazine;
• antibacterial agents such as, for example, pentamidine, moxifloxacin, erythromycin and clarithromycin.

Betmiga may increase your blood pressure or worsen your blood pressure if you have a history of high blood pressure. Your doctor should check your blood pressure while you are taking this medication.

Children and adolescents

Do not administer this medication to children and adolescents under 18years for the treatment of overactive bladder as the safety and efficacy of Betmiga in this population have not been established.

Betmiga should not be used in children under 3years for the treatment of neurogenic detrusor overactivity.

Other medications and Betmiga

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Betmiga may affect how other medications work, as well as how other medications may affect how this medication works.

• Inform your doctor if you are using thioridazine (a medication for mental illnesses), propafenone or flecainide (medications for cardiac rhythm disturbances), imipramine or desipramine (medications used for depression). These specific medications may require your doctor to adjust the dose.
• Inform your doctor if you are using digoxin, (a medication for heart failure or in case of cardiac rhythm disturbances). Your doctor will measure the blood levels of this medication. If the blood level is outside the permitted range, your doctor will adjust the dose of digoxin.
• Inform your doctor if you are using dabigatran etexilate (a medication used to reduce the risk of vascular or systemic thromboembolism in patients with abnormal heart rhythm (atrial fibrillation) and additional risk factors). Your doctor may need to adjust the dose of this medication.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or intend to become pregnant, do not take Betmiga.

If you are breastfeeding, consult your doctor or pharmacist before using this medication. It is likely that this medication will pass into breast milk. You and your doctor should decide whether to take Betmiga or breastfeed. Never do both.

Driving and operating machinery

There is no information to suggest that this medication affects your ability to drive or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Use in adults with overactive bladder

The recommended dose is one 50 mg tablet orally once a day. If you have kidney or liver problems, your doctor may need to reduce the dose to one 25 mg tablet orally once a day. You should take this medication with liquid and swallow the tablet whole. Do not crush or chew the tablet. Betmiga can be taken with or without food.

Use in children and adolescents (ages 3 to less than 18 years) with neurogenic detrusor overactivity

Take this medication orally once a day. You should take this medication with liquid and swallow the tablet whole. Do not crush or chew the tablet. Betmiga should be taken with food. Your doctor will tell you what dose your child should take. Your doctor will calculate the correct dose for the patient based on their body weight. You should follow their instructions carefully.

If you take more Betmiga than you should

If you have taken more tablets than you were told to, or if someone else has taken your tablets by accident, contact your doctor, pharmacist, or hospital immediately.

The symptoms of overdose may include a rapid heartbeat, an increase in heart rate, and an increase in blood pressure.

If you forgot to take Betmiga

If you forgot to take your medication, take the missed dose as soon as you remember. If there are less than 6 hours left until the next scheduled dose, skip the missed dose and continue taking the medication at the usual time.

Do not take a double dose to make up for the missed dose. If you forget several doses, consult your doctor and follow their recommendations.

If you interrupt treatment with Betmiga

Do not stop treatment with Betmiga before time if you do not see an immediate effect. Your bladder may need time to adapt. You should continue taking your tablets. Do not stop taking them when your bladder condition improves. Stopping treatment may lead to the recurrence of overactive bladder symptoms or neurogenic detrusor overactivity.

Do not stop taking Betmiga without consulting your doctor first, as symptoms of overactive bladder or neurogenic detrusor overactivity may reappear.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The most serious side effects may include irregular heartbeat (atrial fibrillation). This is a rare side effect (may affect 1 in 100 people), butif this side effect occurs, stop taking the medicine immediately and seek urgent medical advice.

Consult your doctor if you experience a headache, especially sudden, migrainous (palpitations) type. They may be signs of very high blood pressure.

Other side effects include:

Frequent(may affect up to 1 in 10 people)

• Urinary tract infections (urinary tract infections)
• Headache
• Dizziness
• Increased heart rate (tachycardia)
• Nausea (dizziness)
• Constipation
• Diarrhea

Rare(may affect up to 1 in 100 people)

• Vaginal infection
• Bladder infection (cystitis)
• Palpitations
• Problems with heart rhythm (atrial fibrillation)
• Indigestion (dyspepsia)
• Stomach infection (gastritis)
• Itching, rash or hives (urticaria, rash, macular rash, papular rash, pruritus)
• Swelling of the joints
• Itching in the vulva or vagina (vulvovaginal pruritus)
• High blood pressure
• Increased liver enzymes (GGT, AST, and ALT)

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

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

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

• Very high blood pressure (hypertensive crisis)

Unknown frequency(the frequency cannot be estimated from available data)

• Insomnia
• Confusion

Betmiga may increase the risk of not being able to empty your bladder if you have a blockage of the bladder outlet or if you are taking other medications to treat overactive bladder. Inform your doctor immediately if you are unable to empty your bladder.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box or blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through the drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Betmiga

• The active ingredient is mirabegron.

Betmiga 25mg prolonged-release tablets

Each tablet contains 25mg of mirabegron.

Betmiga 50mg prolonged-release tablets

Each tablet contains 50mg of mirabegron.

• The other components are:

Tablet core: macroglols, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate

Coating: hypromellose, macrogol, yellow iron oxide (E172), red iron oxide (E172) (only for 25mg tablets).

Appearance of the product and contents of the pack

Betmiga 25mg prolonged-release tablets coated with a film are brown-coated, oval-shaped tablets marked with the company logo and «325» on the same side.

Betmiga 50mg prolonged-release tablets coated with a film are yellow-coated, oval-shaped tablets marked with the company logo and «355» on the same side.

Betmiga is available in aluminium-aluminium blister packs containing 10, 20, 30, 50, 60, 90, 100 or 200tablets.

Only some pack sizes may be marketed in your country.

Marketing authorisation holder

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

Netherlands

Responsible for manufacturing

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

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Further information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.