Mirabegron STADA 25 mg prolonged-release tablets – patient leaflet, side effects, dosage

1. What Mirabegron STADA is and what it is used for 2. What you need to know before you take

Mirabegron STADA

1. 3. How to take Mirabegron STADA
2. 4. Possible side effects
3. 5. How to store Mirabegron STADA
4. 6. Contents of the pack and other information
5. 1. What Mirabegron STADA is and what it is used for

Mirabegron STADA contain the active substance mirabegron. It is a bladder muscle relaxant (also called beta 3-adrenoceptor agonist), which reduces the activity of an overactive bladder, treats the related symptoms and reduces neurogenic detrusor overactivity.

Mirabegron is used to:

• treat the symptoms of a condition called

  overactive bladder in adults. These symptoms include: suddenly needing to empty your bladder (called urgency), having to empty your bladder more than usual (called increased urinary frequency), not being able to control when to empty your bladder (called urgency 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 bladder contractions occur due to a condition that you are born with or injury to the nerves, which control the bladder. If left untreated, neurogenic detrusor overactivity may lead to damage to your bladder and/or kidneys. Mirabegron STADA is used to increase the amount of urine your bladder can hold and reduce urine leakage.

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

Do not take Mirabegron STADA:

• if you are allergic to mirabegron or any of the

  other ingredients of this medicine (listed in section 6)

• if you have very high uncontrolled blood pressure.

Warnings and precautions

Talk to your doctor pharmacist or nurse before taking

Mirabegron STADA:

• if you have trouble emptying your bladder or you

  have a weak urine stream or if you take 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 your dose or may tell you not to take this medicine, especially if you are taking other medicines such as itraconazole, ketoconazole (fungal infections), ritonavir (HIV/AIDS) or clarithromycin (bacterial infections). Tell your doctor about the medicines that you take.

• if you have an ECG (heart tracing) abnormality

  known as QT prolongation or you are taking any medicine known to cause this such as: ° medicines used for abnormal heart rhythm

  such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone;

  ° medicines used for allergic rhinitis; ° antipsychotic medicines (medicines for

  mental illness) such as thioridazine, mesoridazine, haloperidol, and

  chlorpromazine;

  ° anti-infectives such as pentamidine,

  moxifloxacin, erythromycin, and

  clarithromycin.

Mirabegron STADA may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure. It is recommended that your doctor check your blood pressure while you are taking this medicine.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age for the treatment of overactive bladder because the safety and efficacy of mirabegron in this population has not been established.

Mirabegron STADA is not to be used in children under 3 years of age for the treatment of neurogenic detrusor overactivity.

Other medicines and Mirabegron STADA

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

Mirabegron STADA may affect the way other medicines work, and other medicines may affect how this medicine works.

• Tell your doctor if you use thioridazine (a

  medicine for mental illness), propafenone or flecainide (medicines for abnormal heart rhythm), imipramine or desipramine (medicines used for depression). These specific medicines may require dose adjustment by your doctor.

• Tell your doctor if you use digoxin (a medicine for

  heart failure or abnormal heart rhythm). Blood levels of this medicine are measured by your doctor. If the blood level is out of range, your doctor may adjust the dose of digoxin. - Tell your doctor if you use dabigatran etexilate (a

  medicine which is used to reduce the risk of brain or body vessel obstruction by blood clot

  formation in patients with an abnormal heart beat (atrial fibrillation) and additional risk factors). This medicine may require dose adjustment by your doctor.

  Pregnancy and breast-feeding

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

  If you are breast feeding, ask your doctor, pharmacist or nurse for advice before taking this medicine. It is likely that this medicine passes into your breast milk. You and your doctor should decide if you should take mirabegron or breast-feed. You should not 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

Always take this medicine exactly as your doctor has told you. Check with your doctor pharmacist or nurse if you are not sure.

Use in adults with overactive bladder

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

You must take this medicine with liquids and swallow the tablet whole. Do not crush or chew the tablet. This medicine can be taken with or without food.

Use in children and adolescents (age 3 to less than 18 years) with neurogenic detrusor overactivity Take this medicine by mouth once daily. You must take this medicine with liquids and swallow the tablet whole. Do not crush or chew the tablet. This medici

must be taken with food. Your doctor will tell you which dose you/your child should take. Your doctor will calculate the correct dose for a patient depending on their body weight. You should carefully follow their instructions.

If you take more Mirabegron STADA than you should

If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor, pharmacist or hospital for advice immediately.

Symptoms of overdose may include a forceful beating of the heart, an increased pulse rate or an 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 it is less than 12 hours before your next scheduled dose, skip the dose and continue to take your medicine at the usual time.

Do not take a double dose to make up for a forgotten dose. If you miss several doses, tell your doctor and follow the advice given to you.

If you stop taking Mirabegron STADA

Do not stop treatment with mirabegron early if you do not see an immediate effect. Your bladder might need some time to adapt. You should continue taking your tablets. Do not stop taking them when your bladder condition improves. Stopping treatment may result in recurrence of symptoms of overactive bladder or neurogenic detrusor overactivity.

Do not stop taking this medicine without talking to your doctor first, as your symptoms of overactive bladder or neurogenic detrusor overactivity may come back.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects may include an irregular heart beat (atrial fibrillation). This is an uncommon side effect (may affect up to 1 in 100 people), but if this side effect occurs, immediately stop taking the medicine and seek urgent medical advice.

If you get headaches, especially sudden, migraine-like (throbbing) headaches, tell your doctor. These may be signs of severely elevated blood pressure.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Infection of the structures that carry urine

  (urinary tract infections)

• Headache
• Dizziness
• Increased heart rate (tachycardia)
• Feeling sick (nausea)
• Constipation
• Diarrhoea

Uncommon (may affect up to 1 in 100 people)

• Vaginal infection
• Bladder infection (cystitis)
• Feeling your heartbeat (palpitations) - Heart rhythm problems (atrial fibrillation) - Indigestion (dyspepsia)
• Infection of the stomach (gastritis)
• Itching, rash or hives (urticaria, rash, rash macular, rash papular, pruritus)
• Swelling of the joints
• Itching of the vulva or vagina (vulvovaginal pruritus)
• Increased blood pressure
• Increase in liver enzymes (GGT, AST and ALT)

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

• Swelling of the eyelid (eyelid oedema) - Swelling of the lip (lip oedema)
• Inflammation of small blood vessels mainly affecting the skin (leukocytoclastic vasculitis) - Small purple spots on the skin (purpura) - Swelling of the deeper layers of the skin caused Version - Origination date: V1.0 - 25.03.25 Modified date/Initials: 25.03.25 / 27 Produkt/Product:

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by a build-up of fluid, which can affect any part of the body including the face, tongue or throat and may cause difficulty in breathing (angioedema)

• Inability to completely empty the bladder (urinary retention)

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

• Severely high blood pressure (hypertensive crisis)

Not known (frequency cannot be estimated from the available data)

• Insomnia
• Confusion

Mirabegron STADA may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction or if you are taking other medicines to treat overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 carton or blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Mirabegron STADA contain

• The active substance is mirabegron. Each

  prolonged-release tablet contains 25mg of mirabegron.

• The other ingredients are:

  Tablet core: macrogol 2,000,000;

  microcrystalline cellulose (E460); hypromellose (E464); hydroxypropylcellulose (E463); butylhydroxytoluene; magnesium stearate (E572); colloidal anhydrous silica

  Film-coating: poly(vinyl alcohol) (E1209); titanium dioxide (E171); macrogol 3350; talc (E553b).

What Mirabegron STADA looks like and contents of the pack

Mirabegron STADA 25 mg prolonged release film-coated tablets are white or almost white, oblong (13mm in length and 6mm in width), biconvex prolonged-release film-coated tablets with “1” on one side and plain on the other side.

This medicine is available in opaque

OPA/Alu/PVC//Alu blisters packed in carton packs.

Pack sizes:

10, 20, 28, 30, 50, 56, 60, 90 or 100 prolonged-release tablets

Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

STADA, Manchester Road, Linthwaite, Huddersfield, HD7 5QH, UK

Manufacturer

Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park, Paola PLA 3000, Malta

This leaflet was last revised in 07/2026

9388810 2603 GB