BAXIRTO 50 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Baxirto 50 mg prolonged-release tablets EFG

mirabegron

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

• Keep this 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 pack

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

1. What is Baxirto and what is it used for

Baxirto 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 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 your bladder (called urgency), having to empty your bladder more often than normal (called increased urination frequency), being unable to control when to empty your bladder (called urge incontinence).

• treat a condition called neurogenic detrusor overactivity in children aged between 3 and less than 18 years. Neurogenic detrusor overactivity is a condition where there are involuntary contractions of the bladder due to a birth defect or injury to the nerves that control the bladder. If left untreated, neurogenic detrusor overactivity can cause damage to the bladder and/or kidneys. This medicine is used to increase the amount of urine that the bladder can hold and reduce urine leakage.

2. What you need to know before you take Baxirto

Do not takeBaxirto

• 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 starting to take mirabegron:

• if you have problems emptying your bladder or have a weak stream of urine or if you are taking other medicines for the treatment of overactive bladder or neurogenic detrusor overactivity 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 your 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 for the treatment of overactive bladder as the safety and efficacy of mirabegron in this population have not been established.

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

Other medicines and Baxirto

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 this medicine 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 by blood clot formation in patients with irregular heartbeat (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, do 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 Baxirto

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Use in adults with overactive bladder

The recommended dose is one 50 mg tablet by mouth once a day. If you have kidney or liver problems, your doctor may need to reduce the dose to one 25 mg tablet by mouth once a day. 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.

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

Take this medicine by mouth once a day. You should take this medicine 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 Baxirto than you should

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

The 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 medicine and the amount taken.

If you forget to take Baxirto

If you forget to take your medicine, 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 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 advice.

If you stop taking Baxirto

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 or neurogenic detrusor overactivity symptoms.

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

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 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 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)
• Feeling of dizziness (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 layers of the skin caused by 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 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 overactive bladder. Tell your doctor immediately if you cannot empty your bladder.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Baxirto

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Baxirto

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 pack contents

Film-coated tablets, biconvex, oblong, light yellow in color, with an approximate size of 5.7 × 12.8 mm. Alu-OPA/Alu/PVC blisters in cartons containing 30 prolonged-release tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 leaflet:April 2025

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