MIRABEGRON TEVA 50 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Mirabegron Teva 50 mg prolonged-release tablets EFG

Read the entire package leaflet carefully before starting to take 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 Mirabegron Teva is and what it is used for.
2. What you need to know before taking Mirabegron Teva.
3. How to take Mirabegron Teva.
4. Possible side effects.
5. Storage of Mirabegron Teva.
6. Package contents and additional information.

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

Mirabegron Teva 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 activity of an overactive bladder and treats associated symptoms.

Mirabegron Teva is used to treat symptoms of overactive bladder in adults who:

• suddenly need to empty their bladder (called urgency).
• need to empty their bladder more often than normal (called increased urination frequency).
• are unable to control when to empty their bladder (called urge incontinence).

2. What you need to know before taking Mirabegron Teva

Do not takeMirabegronTeva

• 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 Teva.

• medications used for heart 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 this medication.

Children and adolescents

Do not administer this medication to children and adolescents under 18 years of age, as the safety and efficacy of mirabegron in this age group have not been established.

Other medications and Mirabegron Teva

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 heart 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 heart rhythm disorders). Your doctor will measure the blood levels of this medication. If the blood level is outside the allowed range, your doctor will adjust the dose of digoxin.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, do not use this medication.

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 this medication 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 Teva

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

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 25 mg orally once a day. If your doctor recommends taking 25 mg of mirabegron, you should use other medications containing 25 mg of mirabegron available on the market. Do not split the 50 mg tablet, as it may affect how the medication works.

You should take this medication with liquid and swallow the tablet whole. Do not crush or chew the tablet. This medication can be taken with or without food.

If you take more Mirabegron Teva than you should

If you take more tablets than prescribed, or if someone accidentally takes your tablets, seek immediate advice from your doctor, pharmacist, or hospital.

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

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to take the package and package leaflet of the medication to the healthcare professional.

If you forget to take Mirabegron Teva

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

If you stop taking Mirabegron Teva

Do not stop taking mirabegron 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 symptoms improve. Stopping treatment may lead to the recurrence of overactive bladder symptoms.

Do not stop taking this medication without consulting your doctor first, as overactive bladder symptoms may recur.

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

4. Possible side effects

Like all medications, this medication 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 (affecting 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 side effects (may affect up to 1 in 10 people)

• Increased heart rate (tachycardia)
• Infection of the urinary tract (urinary tract infections)
• Nausea
• Constipation
• Headache
• Diarrhea
• Dizziness

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

• Bladder infection (cystitis)
• Feeling of heartbeats (palpitations)
• Vaginal infection
• Indigestion (dyspepsia)
• Stomach infection (gastritis)
• Swelling of the joints
• Itching in the vulva or vagina (vulvovaginal pruritus)
• Increased blood pressure
• Increased liver enzymes (GGT, AST, and ALT)
• Itching, rash, or hives (urticaria, rash, macular rash, papular rash, pruritus)

Rare side effects (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)

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

• Hypertensive crisis

Side effects of unknown frequency (frequency cannot be estimated from available data)

• Insomnia
• Confusion

Mirabegron may increase the possibility of not being able to empty your bladder if you have a bladder outlet obstruction or are taking other medications for overactive bladder treatment. Inform your doctor immediately if you are unable to empty your bladder.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, 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: https//:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Mirabegron Teva

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the package and blister, after CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If you are unsure, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Mirabegron Teva composition

• The active substance is mirabegron.

Each tablet contains 50 mg of mirabegron.

• The other ingredients are:

Core of the tablet: macrogol 2,000,000; microcrystalline cellulose (E460); hypromellose type 2 208, K100 (E464); hydroxypropylcellulose; butylhydroxytoluene; magnesium stearate (E572); colloidal anhydrous silica

Coating:poly(vinyl alcohol); titanium dioxide (E171); macrogol 3,350; talc (E553b); yellow iron oxide (E172) and red iron oxide (E172)

Appearance of the product and package contents

Mirabegron Teva 50 mg are film-coated, biconvex, oblong tablets, approximately 6x13 mm in size, pale yellow in color.

Mirabegron Teva is available in Al-OPA/Al/PVC blisters in cardboard packages.

Package sizes:

10, 30, 50, 90, or 100 prolonged-release tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

c/Anabel Segura 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, (Madrid), Spain

Manufacturer

Pharmadox Healthcare Limited

Kw20a Kordin Industrial Park

Paola

PLA 3000

Malta

Date of the last revision of this package leaflet:July 2024

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/

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/publico/home.html