MIRABEGRON STADA 50 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Mirabegron Stada 50mg prolonged-release tablets EFG

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

• Keep this package 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.

Contents of the package leaflet:

1. What is Mirabegron Stada and what is it used for
2. What you need to know before you take Mirabegron Stada
3. How to take Mirabegron Stada
4. Possible side effects
5. Storage of Mirabegron Stada
6. Contents of the pack and further information

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

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

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

• suddenly need to urinate (called urgency)
• need to urinate more often than normal (called increased urination frequency)
• are unable to control themselves when their bladder is full (called urge incontinence)

2. What you need to know before you take Mirabegron Stada

Do not take mirabegron:

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

Warnings and precautions

Consult your doctor or pharmacist before taking mirabegron:

• if you have problems emptying your bladder or have a weak urine stream or if you are taking other medicines for the treatment of an overactive bladder such as anticholinergic medicines.
• if you have kidney or liver problems. Your doctor may need to reduce the dose or may tell you not to take mirabegron, especially if you are taking other medicines such as itraconazole, ketoconazole (for fungal infections), ritonavir (for HIV/AIDS) or clarithromycin (for bacterial infections). Inform your doctor about the medicines you are taking.
• if you have a known abnormality in the ECG (heart study) such as a prolonged QT interval or are taking any medicine known to cause such abnormality, such as:

• medicines used for heart rhythm disorders, such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone;
• medicines used for allergic rhinitis;
• antipsychotic medicines (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 give this medicine to children and adolescents under 18 years of age because the safety and efficacy of mirabegron in this age group have not been established.

Other medicines and Mirabegron Stada

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

Mirabegron may affect how other medicines work, and other medicines may affect how mirabegron works.

• Tell your doctor if you are using thioridazine (a medicine for mental illnesses), propafenone, or flecainide (medicines for heart rhythm disorders), imipramine, or desipramine (medicines used for depression). These specific medicines may require your doctor to adjust the dose.
• Tell your doctor if you are using digoxin (a medicine for heart failure or heart rhythm disorders). Your doctor will measure the levels of this medicine in your blood. If the level in your blood is outside the allowed range, your doctor will adjust the dose of digoxin.
• Tell your doctor if you are using dabigatran etexilate (a medicine used to reduce the risk of stroke or systemic embolism due to blood clots in adult patients with abnormal heart rhythm (atrial fibrillation) and additional risk factors). Your doctor may need to adjust the dose of this medicine.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, you should not take mirabegron.

If you are breastfeeding, consult your doctor or pharmacist before using this medicine. It is likely that this medicine 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 medicine affects your ability to drive or use machines.

3. How to take Mirabegron Stada

Follow exactly the instructions for administration of this medicine given by your doctor. 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 one 25 mg tablet orally once a day. If your doctor recommends you take 25 mg of mirabegron, you should use other medicines containing 25 mg of mirabegron available on the market. Do not split the 50 mg tablet, as this may affect how the medicine works.

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

If you take more Mirabegron Stada than you should

If you take more tablets than you were told to, or if someone else takes your tablets, contact your doctor, pharmacist, or hospital immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

Among the symptoms of overdose may include a strong heartbeat, increased heart rate, and increased blood pressure.

If you forget to take Mirabegron Stada

If you forget to take your medicine, take the missed dose as soon as you remember. If there are less than 6 hours until your next scheduled dose, skip the missed dose and continue taking the medicine 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 Stada

Do not stop taking mirabegron early 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.

Do not stop taking mirabegron without consulting your doctor first, as the symptoms of an overactive bladder may recur.

If you have any other questions about 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 include irregular heartbeat (atrial fibrillation). This is an uncommon side effect (it may affect up to 1 in 100 people), but if this side effect occurs, stop taking the medicine immediately and seek urgent medical advice.

Consult your doctor if you experience headache, especially sudden, migraine-type (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)
• Infection of the urinary tract (urinary tract infections)
• Nausea
• Constipation
• Headache
• Diarrhea
• Dizziness

Uncommon (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 (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 layers of the skin due to fluid accumulation, which can affect any part of the body, including the face, tongue, or throat, and may 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)

• Hypertensive crisis

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

• Insomnia
• Confusion

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

Reporting of side effects

If you experience 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 through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirabegron Stada

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 blister and the carton after “EXP”. The expiry date is the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Mirabegron Stada

• The active substance is mirabegron.

Each tablet contains 50 mg of mirabegron.

• The other ingredients are:

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

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

Appearance and packaging of the product

Mirabegron Stada 50 mg prolonged-release tablets EFG are film-coated tablets of light yellow color, oblong, biconvex, approximately 6 x 13 mm in size.

Mirabegron Stada is available in Alu-OPA/Alu/PVC blister packs in cardboard boxes.

Package sizes:

10, 20, 30, 50, 60, 90, 100, or 200 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

or

Adalvo Limited Life Sciences

Park, Building 1, Level 4

Sir Temi Zammit Buildings

San Gwann, SGN 3000

Malta

or

STADA Arzneimittel AG

Stadastrasse 2 18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel

Co. Tipperary

Ireland

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

Date of last revision of this leaflet:July 2024

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