MIRABEGRON ALTER 50 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Mirabegron Alter 50 mg prolonged-release tablets EFG

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Mirabegron Alter and what is it used for
2. What you need to know before taking Mirabegron Alter
3. How to take Mirabegron Alter
4. Possible side effects
5. Storage of Mirabegron Alter
6. Package contents and additional information

1. What is Mirabegron Alter and what is it used for

Mirabegron Alter contains the active substance mirabegron. It is a medication that relaxes the smooth muscle of the bladder (called a beta-3 adrenergic receptor agonist), which reduces the symptoms associated with an overactive bladder and reduces neurogenic detrusor overactivity.

Mirabegron is used to:

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

These symptoms include: sudden need to empty the bladder (called urgency), having to empty the bladder more often than normal (called increased urination frequency), and inability to control when to empty the bladder (called urge incontinence).

• 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 nerve damage that controls the bladder. If left untreated, neurogenic detrusor overactivity can cause damage to the bladder and/or kidneys. This medication is used to increase the amount of urine that the bladder can hold and reduce urine loss.

2. What you need to know before taking Mirabegron Alter

Do not takeMirabegron Alter

• if you are allergic to mirabegron or any of the other ingredients of this medication (listed in section 6),
• if you have uncontrolled high blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirabegron:

• if you have problems emptying your bladder or have a weak urine stream or if you are taking 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 mirabegron, 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 abnormality in the ECG (heart study) such as QT interval prolongation or are taking any medication known to cause such abnormality, such as:
• • medications used for cardiac rhythm disorders, such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone;
  • medications used for allergic rhinitis;
  • antipsychotic medications (medications for mental illnesses) such as thioridazine, mesoridazine, haloperidol, and chlorpromazine;
  • anti-infective agents such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.

Mirabegron may increase your blood pressure or worsen your blood pressure 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 administer this medication to children and adolescents under 18 years of age for the treatment of overactive bladder, as the safety and efficacy of mirabegron in this population have not been established.

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

Other medications and Mirabegron Alter

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

Mirabegron may affect how other medications work, and other medications may affect how this medication works.

• Tell your doctor if you are using thioridazine (a medication for mental illnesses), propafenone, or flecainide (medications for cardiac rhythm disorders), imipramine, or desipramine (medications used for depression). These specific medications may require your doctor to adjust the dose.
• Tell your doctor if you are using digoxin (a medication for heart failure or cardiac rhythm disorders). 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.
• Tell your doctor if you are using dabigatran etexilate (a medication used to reduce the risk of stroke or systemic embolism due to blood clots in patients with irregular heartbeat (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 plan to become pregnant, do not take mirabegron.

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 mirabegron or breastfeed. Never do both.

Driving and using machines

There is no information to suggest that this medication affects your ability to drive or use machines.

3. How to take Mirabegron Alter

Follow your doctor's instructions for taking this medication exactly. If you are unsure, 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. Mirabegron can be taken with or without food.

Use in children and adolescents (aged 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. Mirabegron should be taken with food. Your doctor will tell you what dose your child should take. The doctor will calculate the correct dose for the patient based on their body weight. You should follow their instructions carefully.

If you take more Mirabegron Alter than you should

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

Symptoms of overdose may include a strong heartbeat, increased heart rate, and increased blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Mirabegron Alter

If you forget to take your medication, take the missed dose as soon as you remember. If it is less than 6 hours until your 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 missed doses. If you miss several doses, consult your doctor and follow their recommendations.

If you stop taking Mirabegron Alter

Do not stop taking mirabegron early if you do not see an immediate effect. Your bladder may need time to adjust.

You should continue taking your tablets. Do not stop taking them when your bladder symptoms improve. Stopping treatment may lead to the recurrence of overactive bladder or neurogenic detrusor overactivity symptoms.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Among the most serious side effects may include 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 medication immediately and seek urgent medical advice.

Consult your doctor if you experience headache, especially sudden, migraine-like (palpitations). They may be signs of very high blood pressure.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Increased heart rate (tachycardia)
• Urinary tract infections
• Feeling of nausea (nausea)
• Constipation
• Headache
• Diarrhea
• Dizziness

Uncommon (may affect up to 1 in 100 people)

• Vaginal infection
• Bladder infection (cystitis)
• Feeling of heartbeats (palpitations)
• Heart rhythm problems (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)
• Increased blood pressure
• Increased liver enzymes (GGT, AST, and ALT)

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

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

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

• Very high blood pressure (hypertensive crisis)

Frequency not known (cannot be estimated from available data)

• Insomnia
• Confusion

Mirabegron may increase the risk of not being able to empty the bladder if you have a bladder outlet obstruction or are taking other medications to treat overactive bladder. Tell your doctor immediately if you cannot empty your bladder.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Mirabegron Alter

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

Do not use this medication after the expiration date stated on the carton or blister pack after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Mirabegron Alter

The active substance is mirabegron. Each tablet contains 50 mg of mirabegron.

The other ingredients are

• Core of the tablet:High molecular weight macrogol, microcrystalline cellulose, hypromellose, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate, and anhydrous colloidal silica.
• Coating material: Poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and package contents

Coated tablets, biconvex, oblong, light yellow in color, approximately 5.7 × 12.8 mm in size. Alu-OPA/Alu/PVC blisters in cartons containing 30 prolonged-release tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036, Madrid

Spain

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta.

Or

Adalvo Limited

Malta Life Sciences Park, Building 1, Level 4,

Sir Temi Zammit Buildings, San Gwann,

SGN 3000,

Malta

Date of last revision of this package leaflet:April 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).